research paper on food dyes

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• Published: 29 April 2022

Potential impacts of synthetic food dyes on activity and attention in children: a review of the human and animal evidence

• Mark D. Miller   ORCID: orcid.org/0000-0002-9301-0093 1 ,
• Craig Steinmaus 1 ,
• Mari S. Golub 1 ,
• Rosemary Castorina 2 ,
• Ruwan Thilakartne 2 ,
• Asa Bradman 2 , 3 &
• Melanie A. Marty 1  

Environmental Health volume  21 , Article number:  45 ( 2022 ) Cite this article

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Concern that synthetic food dyes may impact behavior in children prompted a review by the California Office of Environmental Health Hazard Assessment (OEHHA). OEHHA conducted a systematic review of the epidemiologic research on synthetic food dyes and neurobehavioral outcomes in children with or without identified behavioral disorders (particularly attention and activity). We also conducted a search of the animal toxicology literature to identify studies of neurobehavioral effects in laboratory animals exposed to synthetic food dyes. Finally, we conducted a hazard characterization of the potential neurobehavioral impacts of food dye consumption. We identified 27 clinical trials of children exposed to synthetic food dyes in this review, of which 25 were challenge studies. All studies used a cross-over design and most were double blinded and the cross-over design was randomized. Sixteen (64%) out of 25 challenge studies identified some evidence of a positive association, and in 13 (52%) the association was statistically significant. These studies support a relationship between food dye exposure and adverse behavioral outcomes in children. Animal toxicology literature provides additional support for effects on behavior. Together, the human clinical trials and animal toxicology literature support an association between synthetic food dyes and behavioral impacts in children. The current Food and Drug Administration (FDA) acceptable daily intakes are based on older studies that were not designed to assess the types of behavioral effects observed in children. For four dyes where adequate dose-response data from animal and human studies were available, comparisons of the effective doses in studies that measured behavioral or brain effects following exposure to synthetic food dyes indicate that the basis of the ADIs may not be adequate to protect neurobehavior in susceptible children. There is a need to re-evaluate exposure in children and for additional research to provide a more complete database for establishing ADIs protective of neurobehavioral effects.

Peer Review reports

Concerns about possible associations between exposure to synthetic food dyes and the exacerbation of symptoms of Attention Deficit/Hyperactivity Disorder (ADHD) in children have surfaced periodically since the 1970s. The concern prompted the California legislature to request a review by the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) of available studies to evaluate whether the synthetic food dyes currently allowed in foods and medications in the United States impact neurobehavior in children [ 1 ]. This paper provides an overview of key portions of OEHHA’s peer-reviewed assessment, specifically the evaluation of the clinical trials of synthetic food dyes in children and available animal toxicology studies, as well as discussion of our hazard characterization and the possible public health implications of our findings.

Our evaluation focused on seven of the nine food dyes subject to FD&C batch certification by the US Food and Drug Administration (FDA) and approved for general use in food in the US (Table  1 ). These seven dyes contribute nearly all of the exposure to synthetic food dyes for the general US public [ 1 ]. The term “FD&C batch-certified” refers to the Food Drug and Cosmetic Act requirements for chemical analysis of each manufactured batch of food dye to ensure that specific contaminants are present below legal limits. OEHHA evaluated the literature to determine whether there is any evidence supporting the association of exposure to synthetic food dyes with adverse neurobehavioral impacts in children in the general population with or without a diagnosis of ADHD.

The literature review methods were designed to identify all the literature most relevant to the assessment of evidence on the neurological or neurobehavioral effects of the synthetic food dyes listed in Table 1 . The search was executed to identify peer-reviewed open-source and proprietary journal articles, print and digital books, reports, and gray literature that potentially reported relevant toxicological and epidemiological information. We also included Citrus Red No. 2 and Orange B/CI Acid Orange in the search terms since these food dyes are part of an overlapping literature that might contain information on the commonly used FD&C synthetic food dyes. PubMed MeSH browser (PubMed MeSH browser) and PubChem ( PubChem ) were used to identify subject headings, other index terms and synonyms for the food dyes of interest and their metabolites, as well as for the concepts related to exposure, food, mechanisms of action, and neurological outcomes. Preliminary searches were run and results reviewed to identify additional terms. The concepts were combined in the following manner:

((food/dietary terms) AND (specific food dye terms)) OR ((specific food dye terms) AND (neurological outcome terms) OR (general exposure terms) OR (mechanisms of action terms))

The detailed search strategy executed in PubMed on November 26, 2018 is summarized in the additional information (Table A.1). This search was run again to capture literature updates, on March 8, 2019 and April 22, 2019, and again in October 2020.

Additional databases (PubMed, Embase, Scopus) and other data sources (European Food Safety Authority (EFSA) Journal, EFSA Scientific Output, US FDA Safety Information Office, University of California, San Francisco Food Industry Documents Archive, and Dyes and Pigments Journal) were also searched; strategies were tailored according to the search features unique to each database and data source. Relevant literature was also identified from citations in individual articles. In addition, we searched NIH RePort to identify additional unpublished clinical trials or animal research. In our systematic review of the epidemiologic research on synthetic food dyes and neurobehavioral outcomes in children, we summarized the major strengths and weaknesses of each study, described any consistencies across study results, and if heterogeneity exists, identified its sources as far as possible [ 1 ].

Our epidemiologic review focused on clinical trials. A major advantage of this type of study is that investigators generally have control over the exposure which can help reduce bias and confounding compared to other study designs. Next, we conducted systematic evaluations of study methods and quality to ensure an emphasis on the high quality studies for our conclusions. In evaluating study quality, we utilized criteria based on the National Toxicology Program’s OHAT Risk of Bias Rating Tool [ 2 ]. We modified these to be specific to randomized clinical trials (RCT) on artificial food dyes and childhood neurobehavior. We examined several key characteristics of each study to assess study quality including design, participant selection, exposure levels, age groups, washout period, infractions, outcome metric, and funding (Table A.2). This table also includes key information on results including statistical significance, effect size, dose-response, and subgroups. The coding used in our statistical analyses and quality scoring is provided in Tables A.3 and A.4. These tables show the criteria used to evaluate study quality, which included randomization, placebo use, dropout rate, blinding, whether dose-response was assessed, outcome metric validation, replication, and adequate washout. All this information was considered in making our overall conclusions about the human study results.

In determining whether the study reported an association, we define association as either a statistically significant outcome ( p value <.05 or 95% confidence intervals that excluded 1.0 for relative risk estimates or 0 for mean differences) or an effect size ≥20% or standardized effect size ≥0.20. Most studies involved small sample sizes and thus may not have had sufficient statistical power to identify effects that are relatively small but still of public health importance. Because of this, in addition to statistical significance, bias and effect size were also considered in our evaluations of association and causal inference. There are several arguments against solely using statistical significance to identify associations [ 3 , 4 ].

We searched the animal toxicology literature and identified numerous studies of neurobehavioral effects in laboratory animals exposed to synthetic food dyes. These included studies of exposures during prenatal, infant, and juvenile development, examining neurobehavioral effects in the offspring manifest during development and/or later in adult animals. The availability of studies at different developmental stages allowed a comprehensive review of adverse developmental effects, although it limited the ability to compare results across study designs, as exposures during different developmental stages may manifest differently later in life. The OEHHA report reviewed all available studies and provided strengths and limitations for the individual studies [ 1 ].

Acceptable Daily Intakes (ADIs) for synthetic food dyes were established by the US FDA between the 1960s and the1980s based on general toxicology studies. OEHHA therefore also evaluated whether newer studies that included neurobehavioral assessment would be useful for developing updated acceptable exposure levels that explicitly account for and protect against neurobehavioral effects of individual food dyes. OEHHA compared the results of those specific studies to the existing US FDA ADIs, as well as ADIs developed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Review of clinical trial studies

In total, 27 clinical trials were identified that met each of the following criteria:

Human study

Clinical trial design

Participants were given a known quantity of synthetic food dyes or a diet low in or eliminating synthetic food dyes

A neurobehavioral outcome related to hyperactivity or inattention was assessed

The majority of participants were children ≤19 years of age

The effects of an active ingredient or elimination diet were compared to those of a placebo

Studies were excluded if they were:

Studies involving cohort, case-control, or cross-sectional designs

Studies that assessed the effects of a broad range of food groups, including elimination studies, and did not specifically evaluate synthetic food dyes. Any effect identified in such studies would be difficult to ascribe specifically to synthetic food dyes.

No exclusions were made based on the number of participants, participation rates, blinding, randomization, or source (e.g., government reports), although each of these factors was considered in our review of study quality and in our overall conclusions.

Figure  1 presents the results of our literature search as the number of clinical studies reporting adverse neurobehavioral outcomes by key study variables. Of the 27 studies meeting our criteria for inclusion, 25 involved challenge studies, which we consider most relevant as they directly challenge children with food dyes, and two involved diet elimination studies. Detailed descriptions of the 25 included challenge studies are provided in Table A.2. Table  2 below summarizes the characteristics and overall findings of the reviewed challenge studies. Several studies of exposure to dye mixtures also included other dyes not used in the US.

Number of clinical studies reporting positive associations by key study variables

The most frequent study locations were in the US (44%), followed by the UK (22%), and Australia and Canada (15% each). The mean number of participants was 44 (range 1–297). All studies used cross-over designs. In the cross-over design, each subject receives each treatment (including placebo) and, thus, the subjects serve as their own controls, which minimizes bias and confounding. Most challenge studies were double-blinded and the cross-over design was randomized, although in two studies the use of blinding was unclear. Randomization was either not done or was unclear in seven studies. Six studies assessed tartrazine only, whereas the rest studied mixtures of common dyes. The average dose assessed was 55.8 mg/day (range 1.2 to 250 mg/day, doses relevant to children’s exposure in the US). In all but one challenge study, participants were placed on an elimination diet during the study. Most studies (70%) used a validated or otherwise commonly accepted metric to assess neurobehavioral outcomes, with the most common being the Conners Parent scale.

Sixteen (64%) out of 25 challenge studies identified some evidence of an association and in 13 (52%), the association was statistically significant (Fig.  1 and Table 2 ; Table A.2). Associations (either large effect sizes or statistically significant results) were most commonly identified in studies that assessed neurobehavioral outcomes using information from the child’s parents. Out of eight challenge studies that provided results for both parents and teachers, four found associations only when examining parent reports [ 5 , 6 , 7 , 8 ], one found associations for both parent and teacher reports [ 9 ], two did not report an association for any outcome metric [ 10 , 11 ], and one found an association only for another metric [ 12 ].

Positive associations were also more frequently reported in studies published after the year 1990 (83.3 vs. 57.9%, p  = 0.26), in studies that used validated metrics for assessing outcome (70.6 vs. 50.0%, p  = 0.17) and in studies with larger numbers of participants (see Fig. 1 and Table 2 ). The reason why more recent studies tended to report associations compared to earlier studies is unclear.

While two positive studies tested mixes of dyes plus preservatives [ 13 , 14 ], the large majority did not include preservatives and many of these (59.1% overall), identified associations between these dyes and adverse effects on neurobehavior with 10 of them reporting associations that were statistically significant [ 5 , 7 , 15 , 16 , 17 ].

Rowe and Rowe [ 17 ] saw a dose-response pattern between increasing doses of 1, 2, 5, 10, 20, and 50 mg of Yellow No. 5 (tartrazine) per day and worsening behavioral scores. Only two other studies reported information on dose-response, one using multiple dyes and one with Yellow No. 5 alone, with neither finding a clear dose-response pattern [ 18 , 19 ] However, Rowe and Rowe used many more doses and had a larger sample size than the other two studies. These differences and other study design issues may have affected whether a dose-response could be seen.

We could not divide studies based solely on age as there was a wide range of ages studied with broad overlap across studies reviewed. However, based on sensitivity analyses examining age, in three studies, results varied minimally [ 11 , 17 , 20 ], while in three others, greater effects were seen in younger participants [ 5 , 14 , 21 ].

Nigg et al., 2012 meta-analysis

A high-quality meta-analysis [ 22 ] is supportive of the hypothesis that synthetic food dye exposures is associated with adverse behavioral effects in children. This study identified statistically significant summary associations for findings based on parent reports or on attention tests, with effect sizes about one-sixth to one-third of those seen for improvements from ADHD medications. Nigg et al. estimated that 8% of children with ADHD may have symptoms related to synthetic food dyes. Our report evaluated the same studies used in the Nigg et al. meta-analysis as well as two pilot or preliminary reports [ 7 , 19 ], two studies with only 1–2 participants [ 8 , 16 ], and a study published after the meta-analysis was published [ 10 ]. These five studies reported mixed results. It is unlikely their inclusion in a meta-analysis would dramatically affect its results because most of these studies had small sample sizes. Additionally, the Lok et al. study [ 23 ] did not present means and standard deviations for analyses comparing placebo to artificial food dyes, and as such would be difficult to include in meta-analysis with most other studies.

Bias and confounding

As documented in Tables S.2-S.4 we performed extensive evaluations of quality for each study. One strength of our findings is that they are based on clinical trials with cross-over designs and placebo control. Non-compliance can lead to exposure misclassification in clinical trials, but we found that infraction rates were generally low in the studies when they were reported. Potential confounding can be markedly reduced with the use of cross-over designs since subjects are being compared to themselves. Bias that may be introduced by the expectations of the researchers and participants is minimized by use of blinding and placebo control. We performed a sensitivity analysis in which we only included studies that were double-blinded and had the cross-over randomized, and found that our conclusions were similar to that of our analysis that included all studies (Table 2 , rows for RCDP).

Recruitment strategies and participation rates were not always clearly described in the studies, and most seemed to involve convenience samples. The use of convenience samples or low participation rates can introduce bias. However, in studies in which the participants, parents, and others were blinded, we found no clear evidence or obvious reason that convenience sampling or low participation might cause false positive results. While convenience sampling and low participation rates might affect the generalizability of some studies, we see no reason why they would affect the ability of a study to examine whether at least some children might be adversely affected by synthetic food dyes, especially given the cross-over design.

Adjustments for publication bias by Nigg et al. [ 22 ] attenuated summary effect sizes in the meta-analysis, although several remained statistically significant. However, these adjustment methods are imperfect. In addition, given the widespread interest in the potential health effects of synthetic food dyes, it seems unlikely that well-conducted clinical trials would remain unpublished resulting in publication bias.

Susceptibility

From the studies reviewed, it appears that not all children react to the dyes with adverse behavioral outcomes. Possible explanations for this sensitivity are not clear. Studies that included only children who were previously diagnosed with hyperactivity were not more likely to report positive associations between synthetic food dye exposure and poorer behavioral outcomes. Stevenson et al. [ 24 ] found that children (both 3 year-olds and 8/9 year-olds) with certain polymorphisms in histamine degradation genes had greater adverse responses to synthetic food dyes. In addition, gene polymorphisms in the dopamine transporter gene in 8/9 year-old children moderated the effects of the food dyes. Since histamine plays a role as a neurotransmitter in the brain and is involved in wakefulness, polymorphisms in the histamine degradation genes are a plausible basis for varied behavioral sensitivity to dyes associated with histamine release. Replication of this study and further research of the impacts of gene polymorphisms on response to food dyes are needed.

Review of animal toxicology studies

Animal toxicology studies were used by FDA as the basis for regulatory risk assessments of food dyes [ 25 ]. All current dye registrations were made between 1969 and 1986 based on studies performed 35 to 50 years ago. These studies were not designed to assess neurobehavioral endpoints. Dye registration was accompanied by derivation of an “acceptable daily intake” (ADI) based on these studies. FDA ADIs have not been updated since original dye registration, although there have been several reviews of specific effects since then, the latest in 2011 [ 25 ].

Our review of animal toxicology studies was intended to examine neurobehavioral toxicity of food dyes and included any study administering one or more of the FDA registered food dyes and measuring a behavioral endpoint. We obtained 25 reports from the peer-reviewed literature. Two reports could not be reviewed due to lack of study information. The 23 studies reviewed had the following characteristics:

Rodent models (rats or mice)

Oral administrations (diet or gavage)

Dosing with individual dyes (14 studies) or dye mixtures (9 studies) (Fig.  2 )

Dosing included at or below that in studies used to establish FDA ADIs

Durations ranging from a single dose to lifetime daily dosing (Fig.  3 )

Behavioral endpoints including preweaning motor development, spontaneous motor activity and/or learning and memory tests

Comparison of dosed and control groups

Number of animal developmental neurobehavioral toxicity studies by dye and year

Experimental designs of developmental neurotoxicity studies in animals with synthetic food dye exposures

The study designs varied (Fig. 3 ) and included exposures during prenatal, infant, juvenile and adult life stages, and examined neurobehavioral effects during development and/or adulthood. Due to the wide range of designs, an overall integration of findings was not possible but a broader picture of the potential for food dye neurobehavioral toxicity is seen. Details of the studies are presented in Table A.5 and A.6. Detailed evaluation and interpretation of each study is reported in the OEHHA document [ 1 ]. First author and dates of publication are shown.

Details from all the studies reviewed in this section are shown in Table A.5.

Findings from these studies have greatly advanced our knowledge of neurobehavioral effects of synthetic food dyes:

Long term consequences of exposure during pregnancy [ 26 , 27 , 28 , 29 ]. This is the first research using the classical developmental neurotoxicology (DNT) design where exposure begins during pregnancy to identify long-term effects of perinatal exposure. Prior regulatory developmental toxicology studies have been limited to effects on mortality, malformation, and growth. There are no studies in humans using exposure in pregnancy.

Effects of synthetic food dyes on behavior in adult rats after a single administration [ 30 , 31 ]. These are the only available animal studies measuring behavior shortly after a single dye administration.

Behavioral effects when synthetic food dyes are administered at juvenile/adolescent life stages [ 32 , 33 ]

Effects on behavior in adult rodents with chronic exposures [ 31 , 34 , 35 , 36 ]. Due to the emphasis on behavioral effects in children, more general studies of neurobehavioral toxicity in adults have been lacking but have recently been undertaken in animal models.

Prevention of effects of synthetic food dyes on behavior by antioxidants [ 35 , 36 ]. This line of investigation has also been pursued for other aspects of dye toxicity [ 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ]

Brain changes associated with behavioral effects [ 26 , 29 , 30 , 31 , 34 , 35 , 36 ]. Emerging research in the last 10 years has begun to explore effects of synthetic food dye exposures on the brain at doses that affect behavior.

Individual dye studies

A series of neurobehavioral studies of individual dyes has been performed by one laboratory in Japan for 5 of the 7 food dyes approved for use in the US [ 46 , 47 , 48 , 49 , 50 , 51 ]. These studies used lifetime exposure beginning prior to parental mating. Details of the studies can be found in Table A.5. For three of the dyes, behavioral effects were identified at doses below those producing the toxicological effects used to establish the FDA ADIs. Several considerations limit the use of these studies in assessing food dye risk to children, including reproductive toxicity in the studies, multiple life stage exposure, dosing both before and during testing, and lack of litter-based statistics for preweaning endpoints.

Eight studies were from US laboratories, all published prior to 1987. We did not find any programmatic investigator-initiated research on neurobehavioral effects of food dyes currently being performed in the US.

The US FDA supported early studies of three synthetic food dyes (Yellow No. 5, Red No. 3, Red No. 40) that also used lifetime exposures beginning prior to or shortly after conception and continuing through adult animal testing [ 52 , 53 , 54 ]. Dosing was based on known non-behavioral toxicity of the dyes. Behavioral effects were reported for Red No. 3 [ 54 ] and Red No. 40 [ 53 ] using an extensive test battery.

The other 5 studies of individual dyes were conducted more recently and administered individual dyes to postpubertal (adolescent and adult) rodents [ 30 , 31 , 34 , 35 , 36 ]. These investigators were interested in specific hypotheses about food dye mechanism of action and included brain assays: brain microhistomorphometry [ 35 , 36 ]; measures of oxidative stress [ 34 ]; and measures of influence on the serotonin system [ 30 , 31 ].

Mixture studies

Early studies used dye mixtures designed to parallel US food dye exposure at that time [ 33 , 55 , 56 , 57 , 58 ]. More recent studies used dosing based on a multiple of regulatory ADIs [ 27 , 28 , 29 , 32 ]. Study details are presented in Table A.6. Animal mixture studies, like children’s mixture studies, are valuable for hazard identification, but not for ADI development, which is based on each dye individually.

The two studies using synthetic food dye mixtures that are most relevant to the studies in children reported behavioral effect during dye administration to immature rats [ 32 , 33 ]. Both studies reported effects on regulation of spontaneous motor activity. Shaywitz et al. [ 33 ] used a mixture based on human exposure and found greater activity in rats dosed at twice the estimated average exposure at that time in children. Erickson et al. [ 32 ] found increased movement time using a mixture of dyes in drinking water, each dye at a dose less than 2 times the FDA ADI.

One series of studies examined exposure to a mixture of synthetic food dyes during pregnancy [ 27 , 28 , 29 ]. The 9 dyes were administered at either the JECFA ADI [ 28 ] or 100 times the JECFA ADI [ 27 , 29 ]. Six of the seven FDA registered food dyes were included. Effects on activity and emotionality were reported with testing of one-month old (early adolescence) and three-month old (adulthood) offspring, but learning and memory tests were not affected.

Behavioral endpoints

Behavioral assessments were primarily conducted in a few domains: preweaning motor development (4 studies), spontaneous motor activity (21 studies), and trial-based learning and memory tests (18 studies). Some recent studies included emotionality tests [ 27 , 28 , 29 , 32 ].

Spontaneous motor activity, a sensitive and widely used test in developmental neurotoxicology, was the most frequently used test in animal dye studies because of the findings of hyperactivity in children’s studies. While the test apparatus and specific endpoints affected (vertical/horizontal activity, speed, distance, duration) varied, altered regulation of activity was seen in 17 of the 21 of the studies.

Sensitivity of learning and memory tests in developmental neurotoxicology is less consistent [ 59 , 60 ]. For the food dye studies we examined, tests included shock-motivated avoidance, food motivated mazes, and water mazes, with 12 of 18 studies reporting dye effects. Our review found that many of the test results could not be used for risk assessment due to design and statistical issues. For example, some studies did not use litter-based statistics.

Brain assays in behavioral studies

Many animal studies we reviewed conducted brain assays that evaluated a number of parameters with a focus on neurotransmitter systems. Early studies did not identify effects of synthetic food dye exposures on tissue catecholamine neurotransmitter concentrations [ 33 , 55 , 56 , 57 ]. More recent studies identified effects on gene receptor expression, enzyme activity in neurotransmitter systems, and localized changes in neurotransmitter levels [ 26 , 29 , 30 , 31 ]. Also, brain histomorphology assessed with contemporary methods has identified effects (decreased medial prefrontal cortex volume, decreased numbers of glia and neurons, changes in dendritic morphology) of the two most used food dyes, Red No. 40 and Yellow No. 5 [ 35 , 36 ]. Protective effects of antioxidants [ 35 , 36 ], as well as changes in brain anti-oxidant defense systems [ 34 ] provide evidence for oxidative stress as a mechanism of toxicity. Two other papers with no behavioral measures found markers of oxidative stress in the brain after in vivo treatment of rats with Yellow No. 5 [ 61 , 62 ].

Data from a human study provide evidence for a mechanism involving the neurotransmitter histamine. The investigators demonstrated that polymorphisms in the histamine degradation gene for histamine-N-methyltransferase influences response to a dye mixture [ 24 ]. In addition to its role in the inflammatory process, histamine is recognized for its role in regulating synaptic transmission alone and in concert with other neurotransmitters [ 2 ].

Considering both in vivo and in vitro research, other potential pathways for food dye neurotoxicity have been suggested [ 63 , 64 , 65 ].

Endocrine (thyroid, estrogen) mediated effects

Interference with neuronal proliferation and differentiation

Effects secondary to general physiological toxicity

Immune mediated effects

Interference with nutrient bioavailability

The relevance of the animal toxicology findings to humans ingesting synthetic food dyes in food and medications would be better understood with more information about food dye toxicokinetics. In particular, the breakdown of azo dyes in the gut prior to absorption requires toxicological examination of metabolites. Future studies should evaluate whether the parent compounds act on the gut to influence behavior via the gut-brain axis [ 66 ].

Hazard characterization

The studies that form the basis of the FDA (and JECFA) ADIs are many decades old and as such were not capable of detecting the types of neurobehavioral outcomes measured in later animal studies, or in clinical trials in children consuming synthetic food dyes.

Nonetheless, OEHHA first compared the US FDA ADIs and the No-Observed-Adverse-Effect Levels (NOAELs) from which they were derived to NOAELs from the animal toxicology studies that were reviewed [ 1 ]. Next, we compared the estimated food dye exposures (mg/kg/d) from food consumption to available regulatory benchmarks in a traditional Hazard Index approach for noncancer health effects. The Hazard Index approach divides estimated exposures by a toxicity benchmark. If that ratio is greater than 1, then it is indicative of a possible risk of adverse noncancer effects. Finally, we compared the ADIs to NOAELs and Lowest-Observed-Adverse-Effect Levels (LOAELs) observed in the few key animal and human studies of sufficient quality. This comparison should help inform future revisions of the ADIs aimed at protecting children from neurobehavioral effects.

Comparing neurobehavioral effect levels to FDA ADI NOAELs

To derive the ADI for each dye, US FDA divided NOAELs reported by investigators from animal studies by a factor of 100. While reviewing animal neurobehavioral toxicology studies, we compared the effective doses (LOAELs) to animal NOAELs used by US FDA to derive human ADIs (hereinafter referred to as ADI NOAELs). The purpose of this comparison was to see if neurobehavioral effects were found at doses that FDA determined were not causing effects in the older general toxicology studies . Tables  3 and 4 presents these comparisons for both developmental and adult neurotoxicology studies where a single dye was administered.

Comparing food dye exposures to available regulatory benchmarks

OEHHA [ 1 ] derived exposure estimates based on NHANES 2015–2016 Dietary Interview data, and information on food dye concentration data sourced from Doell et al. [ 67 ]. We calculated single-day and two-day average cumulative daily synthetic food dye intake estimates (mg/person/day) for the following demographic categories:

Pregnant women 18 years and older

Women of childbearing age (18–49 years)

Children: 0- < 2 years, 2- < 5 years, 5- < 9 years, 9- < 16 years, and 16–18 years

We estimated daily synthetic food dye intakes (mg/person/day) for

The typical-exposure scenario , which represents exposure to a given FD&C batch-certified synthetic food dye for a typical consumer, an individual who may not always eat products with the lowest or highest levels of that food dye but some combination of both.

The high-exposure scenario , which represents the highest exposure where the individual is only consuming products with the highest levels of that food dye.

We divided each individual’s FD&C batch-certified synthetic food dye intake estimate (mg/person/day) by their body weight (kg) reported in NHANES 2015–16 [ 68 ] to produce synthetic food dye dose estimates in units of mg/kg/day. The most commonly consumed dyes for the various age ranges of children expressed as the mean of typical-exposure scenario estimates were Red No. 40 (ranged from 0.11 to 0.3 mg/kg-day), Red No. 3 (ranged 0.02 to 0.54 mg/kg-d), Yellow No. 5 (ranged from 0.05 to 0.19 mg/kg-d) and Yellow No. 6. (ranged from 0.05–0.20 mg/kg-d) [ 1 ]. The 95th percentile of the high-exposure scenario estimates ranged from about 1 to 8 mg/kg-day for these four dyes. Children’s exposures tended to be higher than adult women.

We compared the synthetic food dye dose estimates to the US FDA and JECFA ADIs (Table  5 ) by calculating the ratio of the dose estimates to the established ADIs [ 25 , 69 , 70 , 71 , 72 ] as the Hazard Index. Hazard index > 1 signifies that the food dye exposure estimates (mg/kg/day) exceeded the established ADI.

With the exception of FD&C Red No. 3, all exposure estimates (mg/kg/day) from foods were below the US FDA or JECFA ADIs. The Hazard Indices (HI) that exceeded 1 for Red No. 3 are bolded in Table  6 . Children’s single day mean FD&C Red No. 3 exposure estimates for typical- and high-exposure scenarios ranged from 0.01 to 0.60, not exceeding the FDA ADI of 2.5 mg/kg-day. The 95th percentile exposure estimates ranged up to 3.16 (although it represents few children). For several age categories the mean single day typical- and high-exposure scenarios exceeded the JECFA ADI of 0.1 mg/kg-day, with HI ranging from 0.21 to 15; the 0 < 2 year age category had the highest HI.

Comparing US FDA ADIs to key neurobehavioral studies

There are several animal studies and one human study that could be used to evaluate whether existing ADIs are protective of neurobehavioral effects for Red No. 3, Red No. 40, Yellow No. 5 and Yellow No. 6. No suitable studies of green or blue dyes were found for this comparison.

Tanaka et al. [ 48 ] conducted a developmental toxicity study of Red No. 3 where various doses were administered via diet from preconception through PND 63 and reported increased activity measurements in female offspring. For adult female dams, more turning was reported in the high-dose group than in controls. Activity in male offspring was affected at 3 weeks of age ( p  < 0.01 for linear dose trend), but not at 8 weeks of age. In the female offspring at 8 weeks, statistically significant dose-dependent dye-induced increases in activity were seen, but not at 3 weeks of age. These included number of activity bouts, distance traveled in each bout, greater speed, total time moving and total distance. This interesting finding of greater activity is particularly valuable because of the absence of more severe developmental toxicity.

The NOAEL was 24 mg/kg/day for the female offspring. This NOAEL is a factor of 10 higher than the FDA ADI of 2.5 mg/kg/day. If one were to apply the same methodology as US FDA (dividing the NOAEL by a factor of 100) to derive an ADI, the resulting ADI would be a factor of 10 lower.

The studies by Dalal and Poddar [ 30 , 31 ] (Table A.5) provide unique information on brain serotonin pathway changes, and on behavioral changes in young adult animals either following single gavage administration or following 15 or 30 day exposures to Red No. 3. In their first study, the investigators measured activity (vertical rearing frequency detected automatically) for 5 min at 30 to 60 min intervals up to 9 h post-dosing after single gavage doses of 0, 1, 10, 100 or 200 mg/kg. A dose-dependent pattern of diminished activity was observed that reached a low at 2 h after dye administration and then returned to baseline by 7 h (Fig. 1 in Dalal and Poddar (2009)). The effect of diminished activity was replicated in an experiment demonstrating reversal of this effect by inhibitors of monoamine oxidase (MAO), the enzyme that metabolizes serotonin. In the second report, the investigators administered the same doses daily for a period of 15 or 30 days and activity was measured following the last administration. Following the 15 or 30 day treatments, activity was increased rather than decreased in a dose-dependent fashion (Fig. 1 in Dalal and Poddar (2010)). One explanation for these contrasting results is the role of two neuronal corticotrophin releasing factor (CRF) receptors that determine an active versus passive response to stress [ 73 ]. The NOAEL from these studies is 1 mg/kg/day based on changes in vertical activity in male rats, on increased serotonin levels in specific brain regions, and increased plasma cortisone levels. The NOAEL of 1 mg/kg/day in these studies is lower than the FDA ADI of 2.5 mg/kg/day. If one were to use a 100-fold safety factor with this NOAEL, the ADI would be 0.01 mg/kg/day.

Red no. 40 and yellow no. 5

Noorafshan et al. [ 35 ] administered Red No. 40 to adult male rats ( N  = 10 per dose group) at doses of 0, 7, or 70 mg/kg/day (Table A.6) with and without 200 mg/kg/day of the anti-inflammatory molecule taurine, by gavage for 6 weeks. Both Red No. 40 treated groups performed more reference memory errors and working memory errors in the radial arm maze than controls ( p  < 0.01). Taurine administration mitigated this effect. Histomorphology and stereology found that, in the high dose Red No. 40 group, the medial prefrontal cortex volume was smaller, and there were fewer neurons and glial cells in this brain area. Interpretation of these results is somewhat complicated by the lack of information on body weight and brain weight. The LOAEL is 7 mg/kg/day for this study, which is the same as the US FDA and JECFA ADI of 7 mg/kg/day.

These investigators used the same protocol to evaluate the effect of another azo dye, Yellow No. 5 [ 36 ]. Adult male rats ( N =  10 per dose group) were gavaged with Yellow No. 5 at 0, 5, or 50 mg/kg/day for 7 weeks with and without vitamin E. Exploration time in the novel object test was decreased at the high dose (p < 0.01). More days were required for Yellow No. 5 treated rats (low- and high-dose groups were combined) to reach the learning criterion in the radial arm maze test, and more errors occurred during the learning and retention phases. The brain assays demonstrated a smaller volume of the medial prefrontal cortex in the high-dose group, and lower cell count and shorter dendrites with lower spine density at both doses; qualitative alterations in cell shape were described. These effects were ameliorated by concomitant administration of the antioxidant vitamin E. The LOAEL was 5 mg/kg/day, based on morphometry, the same as the US FDA ADI of 5 mg/kg/day and lower than the JECFA ADI of 10 mg/kg/day. If this study were to be used as the basis for setting an ADI, the resulting ADI would be considerably lower than the existing ADI. Changes in the medial prefrontal cortex can be directly related to the cognitive performance of the animals, as this part of the rodent brain is involved in spatial memory, decision-making and attention [ 35 , 74 ], and may predict similar effects in children.

One study in children used several doses and demonstrated a dose response effect on behavioral scores for Yellow No. 5 [ 17 ]. For this study, the investigators recruited 34 children whose parents had brought them to the Royal Children’s Hospital in Melbourne to be evaluated for hyperactivity and 20 children whose parents had no concern about behavior. The children, ranging in age from 2 to 14 years, were enrolled in a double blind, placebo-controlled repeated measures study of the effects of Yellow No. 5 on behavioral score. The investigators developed a Behavioral Rating Inventory for this study that included 11 items measuring irritability, 9 items that measured sleep disturbance, 4 items that measured restlessness, 3 items that measured aggression and 3 items that measured attention span. In addition, the investigators also used the Conners 10-item Abbreviated Parent-Teacher Questionnaire to assess behavior, which focuses on attention related problems. Children were placed on a dye-free diet for at least 6 weeks before the trial, and then given doses (randomly) of 0, 1, 2, 5, 10, or 20 mg Yellow No. 5 with 2 days in between each dosing. Parents rated the behavior daily using the two instruments.

The investigators found 24 children who had significant behavioral responses to dye challenge, based on ranking the behavioral scores for the six dye-challenge days paired with a set of placebo days; these children were labelled as reactors. The mean behavioral scores on dye-challenge days were significantly different than the scores for the placebo (day before) challenge for all dose/placebo pairs ( p  < 0.05) in the reactors, while the nonreactors showed random fluctuations in behavioral scores. Using repeated measures ANOVA on the six dye-challenge scores with reactors and nonreactors as the between-groups factor, the authors report a significant between-groups effect ( p  < 0.001). There was a dose-dependent effect and the mean score difference between the reactor and the nonreactor groups were significant at doses of 2 mg and higher (p < 0.05). There were no significant differences in mean behavioral rating between the groups on the placebo days. OEHHA identifies 1 mg tartrazine as a NOAEL. The children ranged from 2 to 14 years, with a mean of 7 years. To determine a NOAEL dosage, OEHHA divided the NOAEL of 1 mg by a reference body weight of 25.5 kg for the mean age of 7 years (US EPA, 2011, Table 8–10, based on NHANES 1988–1994); a NOAEL dosage of 0.04 mg/kg/day is obtained. This NOAEL is more than 100-fold lower than the US FDA ADI for Yellow No. 5 of 5 mg/kg/day.

While not all of the human trials demonstrated effects of mixtures of food dyes or of Yellow No. 5 on behavior, the findings of Rowe and Rowe [ 17 ] are supported by some of the other clinical trials in children (Table  7 ). Note that in all these studies, effects were observed at estimated doses lower than the US FDA ADI for Yellow No. 5 of 5 mg/kg/day. One study [ 9 ] reports that in a six-week open trial of the Feingold diet in 55 subjects, ages 3 to 15 years, who had been suspected of reacting to food dyes, 40 children demonstrated improvement when on the Feingold diet, based on assessment of attention span, activity level, distractability, frustration tolerance, and social and manipulative skills by therapists, and teacher and parent questionnaires. In the same study, 8 of the children were challenged with Yellow No. 5 using a double-blinded cross-over design, and two of these children were observed to exhibit strong behavioral responses to the dye. Based on reference body weights for children ages 3 to 15 years, the dosages employed in that study [ 9 ] would have been 0.9–2.7 mg/kg/day. In a double-blind crossover study of 22 children, 4 to 8 years of age, both objective tests for attention and parent and teacher ratings (Conners Parent Teacher Rating Scale) were administered before and after a 4 week dye-free diet, after a 2 week Yellow No. 5 (5 mg daily) challenge and after a 4 week washout dye-free diet [ 7 ]. The investigators report statistically significant effects of Yellow No. 5 based on parental ratings in a subgroup of children whose mothers had reported improved behavior while on the elimination diet. The dose for this range of ages and body weights to the children would be 0.2 to 0.3 mg/kg/day. Levy and Hobbs [ 75 ] reported that mothers’ ratings using the Conners scale were an average of 13% lower when children ( N  = 8) ate placebo cookies compared to those containing Yellow No. 5, in a 2 week crossover trial with daily ratings by parents for a 3 h period after eating the cookies. While there were no statistically significant differences noted, the authors reported that this effect “just failed to reach the .05 level of significance”. The dose of Yellow No. 5 in this study was about 0.1 to 0.2 mg/kg/day.

Taken together, these studies provide support for an effect of Yellow No. 5 on behavior and for use of a neurobehavioral endpoint to determine a safe level of exposure for Yellow No. 5 to protect children who respond to this food dye.

Yellow no. 6

There is only one study of Yellow No. 6 with neurobehavioral endpoints [ 47 ]. Some neurobehavioral effects in offspring were reported for preweaning development and maze learning, but it was not possible to draw firm conclusions due to the statistical approach and varying group sizes in the study.

Goldenring et al. demonstrated that sulfanilic acid (1 mg/kg/day I.p.), a common metabolite of the azo food dyes Yellow No. 5 and Yellow No. 6, increased activity in pups following direct administration assessed three times during a treatment extending throughout juvenile development [ 55 ].

Honohan et al. reported gastrointestinal absorption of sulfanilic acid of 37.4% [ 76 , 77 ]. The 1 mg/kg intraperitoneal dose of sulfanilic acid used by Goldenring et al. would be equivalent to 2.7 mg/kg produced in the gastrointestinal tract, which in turn would result from metabolism of 7 mg/kg of orally administered Yellow No. 5. Thus, one could view 7 mg/kg−/day of Yellow No. 6 to be a free-standing LOAEL. This LOAEL is about twice the FDA (3.75 mg/kg/day) and JECFA (4 mg/kg/day) ADIs for Yellow No. 6. The study by Goldenring et al. [ 55 ] indicates the ADIs for Yellow No. 6 may not be adequately protective of neurobehavioral effects.

Current evidence from studies in humans, largely from controlled exposure studies in children, supports a relationship between food dye exposure and adverse behavioral outcomes in children, both with and without pre-existing behavioral disorders. There appears to be considerable interindividual variability in the sensitivity to synthetic food dyes. While there were a range of results in the studies we identified, the majority reported at least some evidence of an association, including higher quality studies. Importantly, none of the factors we examined (e.g., parent vs teacher report, publication year, validated outcome metric) explained the majority of the heterogeneity seen across the study results. For example, although a large fraction of the studies published since 1990 reported statistically significant results (5 of 6 challenge studies), many studies published before 1990 also reported statistically significant results (8 of 19). And, while studies using a validated outcome metric were more likely to report associations, several studies without validated outcome metrics reported similar associations. Despite the various study limitations, we were unable to identify strong evidence for any apparent biases or other factors that invalidated the positive results reported in the literature.

Studies of Yellow No. 5 alone provide evidence that this dye affects children’s behavior. Most of the challenge studies involved administering multiple dyes at the same time so no single offending agent could be identified from those studies. Regardless, studies involving mixtures more closely represent real-life scenarios, where most children are exposed to multiple dyes in a single day.

Importantly, impacts on behavior and/or neurotransmitter systems or cellular architecture in the brain have been observed in animal studies. Several studies examining exposures during development, during pregnancy only, or as adolescents or adults reported changes in activity using a variety of metrics either in the offspring or in the adolescent or adult animals. In utero exposure was observed to have behavioral effects in the adult offspring. Thus, the animal literature provides support for behavioral effects of synthetic food dyes, including those most often consumed.

Taken together, the scientific literature supports an effect of synthetic food dye exposures on neurobehavior in children at environmentally relevant exposure levels.

Comparing estimated exposures we derived from the 2015–16 NHANES dietary interview to the FDA and JECFA ADIs revealed that for most dyes we analyzed, exposures do not exceed the ADIs. The exception is Red No. 3, where the Hazard Index based on the mean ranged up to 15 for the youngest age groups (Table 6 ).

Comparisons of the effective doses in some of the animal studies that measured behavioral or brain effects following exposure to synthetic food dyes indicates that the basis of the FDA ADIs are not adequate to protect neurobehavior in susceptible children. Three of the studies using developmental exposures reported LOAELS that were below the NOAEL that was used for the FDA ADI. Almost all studies in mature animals that measured behavioral changes and/or changes in the brain found effects of the synthetic food dyes at doses lower than the NOAELs used by the US FDA for the derivation of the ADIs. Several studies observe effects on behavior in animals at doses close to or even lower than the existing FDA ADIs. As noted above, the animal studies that form the basis of the FDA ADIs were not capable of detecting the types of neurobehavioral outcomes observed in many human challenge studies.

For four of the dyes with adequate animal studies explicitly reporting neurobehavioral effects, applying results from these studies would result in lower ADIs and likely exceedances of those ADIs from typical food consumption by children. Consumption of over-the-counter medications and vitamins adds to the exposure from foods [ 78 , 79 ].

If the ADI for Yellow No. 5 were based on the one study that evaluated a dose-response in children for behavioral effects, the ADI would be considerably lower. The human challenge studies provide support for an effect of Yellow No. 5 on behavior and for use of a neurobehavioral endpoint to determine a safe level of exposure for Yellow No. 5 to protect children who respond to this food dye.

It is not possible to compare the results of the animal or human mixtures studies to an ADI for a single dye. However, Erikson et al. [ 32 ] reported increased activity in male rats administered synthetic food dye mixtures where each dye was given at less than twice the ADI NOAEL. Shaywitz et al. [ 33 ] and Goldenring et al. [ 56 ] found greater activity and decreased habituation in a rodent model following administration of mixtures at doses near the ADIs. These mixture doses are in the range of doses in human mixture studies. Doses used in the human mixture studies were designed to mimic actual exposures in children.

A broad range of potential mechanisms by which the synthetic food dyes may impact behavior in susceptible children have been proposed. Additional research is warranted including:

Animal testing in immature animals that includes a within-subjects design and measures of neurobehavior more similar to those in the human studies.

Studies of the toxicokinetics of food dyes in humans and animals using modern techniques and including exposures during different life stages.

Mechanistic studies and studies of underlying genetic susceptibility.

Additional adequately powered clinical trials in children of the FD&C batch-certified synthetic food dyes with a cross-over, placebo-controlled, double blinded design utilizing validated outcome measures, inclusion of behavioral assessments by parents, and objective tests of attention and other behavioral measures by trained psychometricians. Such studies should attempt to evaluate whether the response differs by age, gender, ethnicity, race, or socioeconomic status through a design that evaluates dosing on a mg/kg/day basis.

Studies that evaluate the potential long-term impacts of repeated exposures to food dyes in children.

Such research would provide additional data to inform appropriate acceptable daily intakes that explicitly protect children from neurobehavioral effects. In the short-term, the neurobehavioral effects of synthetic food dyes in children should be acknowledged and steps taken to reduce exposure to these dyes in potentially susceptible children.

Availability of data and materials

As this is a review, data sharing is not applicable to this article as no datasets were generated during the current study. Details of the studies we reviewed are contained in the supplementary tables. The study quality review and coding are available in the supplementary files. Exposure estimates were based on the National Health and Nutrition Examination Survey conducted in 2015 and 2016: CDC. 2017. NHANES 2015–2016 Demographics Data. Available: https://wwwn.cdc.gov/nchs/nhanes/search/datapage.aspx?Component=Demographics & CycleBeginYear = 2015: CDC. 2018. NHANES Dietary Data. Available: https://wwwn.cdc.gov/nchs/nhanes/Search/DataPage.aspx?Component=Dietary . CDC. 2019. National Health and Nutrition Examination Survey. Available: https://www.cdc.gov/nchs/nhanes/index.htm .

Abbreviations

Attention deficit hyperactivity disorder

Acceptable daily intake

Corticotrophin releasing factor

Developmental neurotoxicology

US Food and Drug Administration

The NOAEL used by FDA to derive the current FDA ADI

Food Drug and Cosmetic Act, referring to dyes that must be batch-certified per FDA regulations

Food and Agriculture Organization of the World Health Organization

Joint FAO/WHO Expert Committee on Food Additives

lowest-observed-adverse-effect level in a study

Mg of substance per kg body weight per day

Monoamine oxidase

National Institutes of Health

National Toxicology Program

National Health and Nutrition Examination Survey

No-observed-adverse-effect level in a study

Office of Environmental Health Hazard Assessment, California Environmental Protection Agency

Office of Health Assessment and Translation

Postnatal day

Randomized clinical trial

Clinical trials that are randomized cross-over design, double-blinded and placebo controlled

United Kingdom

United States Food and Drug Administration

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Acknowledgements

The authors would like to acknowledge Marjannie Akintunde, Ph.D. for help organizing information from available animal toxicology studies for the OEHHA (2021) review, and Nancy Firchow for library services.

The California state legislature appropriated funding to conduct this review. The legislature had no input into or control over the design of the study, collection, analysis, or interpretation of the data, or writing, reviewing or editing the manuscript.

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MDM and MAM were involved in conception, interpretation of results, and substantially drafted, reviewed and edited the paper. CS designed and conducted the review of the clinical trials of food dyes in children. MSG designed and conducted the review of animal toxicology studies. RC, RT, and AB conducted the exposure assessment and subsequent calculations of hazard index. All authors reviewed the paper.

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Additional file 1: table a.1..

Search Strategy. This table illustrates the literature search strategy. Table A.2 . Clinical trials of synthetic food dyes and neurobehavioral outcomes in children: study details. This table provides study details for the 25 challenge studies in children reviewed by OEHHA. Table A.3 . Clinical trials of synthetic food dyes and neurobehavioral outcomes: coding. This table provides the variables and coding used in the study quality analysis. Table A.4 . Coding dictionary. This table defines the variables and numerical codes used in the study quality evaluation. Table A.5 . Individual dyes. Developmental and adolescent/adult studies. This table provides study details of the animal toxicology studies of individual dyes reviewed by OEHHA. Table A.6 . Dye mixtures. Developmental and adolescent/adult studies. This table provides study details of the animal toxicology studies of dye mixtures reviewed by OEHHA

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Miller, M.D., Steinmaus, C., Golub, M.S. et al. Potential impacts of synthetic food dyes on activity and attention in children: a review of the human and animal evidence. Environ Health 21 , 45 (2022). https://doi.org/10.1186/s12940-022-00849-9

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New report shows artificial food coloring causes hyperactivity in some kids

• 2 min. read ▪ Published May 24, 2021
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A report released in April 2021 by the state of California—with contributors from UC Berkeley and UC Davis—confirmed the long-suspected belief that the consumption of synthetic food dyes can cause hyperactivity and other neurobehavioral issues for some children.

The report also found that federal rules for safe amounts of consumption of synthetic food dyes do not reflect the most current research and may not be protecting children’s behavioral health.

Over the past 20 years, the percentage of American children and adolescents diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD) has increased from an estimated 6.1% to 10.2%. Concerns over ADHD and other behavioral disorders led the California Legislature to ask the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) to conduct the report, which is based on two years of extensive evaluation of existing studies on the seven synthetic food dyes currently approved by the FDA.

“Evidence shows that synthetic food dyes are associated with adverse neurobehavioral outcomes in some children,” said OEHHA Director Lauren Zeise. “With increasing numbers of U.S. children diagnosed with behavioral disorders, this assessment can inform efforts to protect children from exposures that may exacerbate behavioral problems.”

Researchers found that all of the FDA’s Acceptable Daily Intake levels (ADIs) for synthetic food dyes are based on 35- to 70-year-old studies that were not designed to detect the types of behavioral effects that have been observed in children. Comparisons with newer studies indicate that the current ADIs may not adequately protect children from behavioral effects.

“This is the most comprehensive study examining dietary exposure to artificial food coloring in vulnerable populations such as young children and pregnant women. We found that children tended to have higher exposures than adults, and some exposures might exceed regulatory guidelines,” said UC Berkeley Environmental Health Sciences Professor Asa Bradman, who contributed to the report. “We also observed higher exposures in lower-income populations, pointing to the need to improve consumption of, and access to, healthier food.”

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Artificial food dyes and attention deficit hyperactivity disorder

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• 1 Department of Psychology, Tufts University, Medford, Massachusetts, USA. [email protected]
• PMID: 21729092
• DOI: 10.1111/j.1753-4887.2011.00385.x

Attention deficit hyperactivity disorder (ADHD) is one of the most common behavioral disorders in children. Symptoms of ADHD include hyperactivity, low frustration tolerance, impulsivity, and inattention. While the biological pathways leading to ADHD are not clearly delineated, a number of genetic and environmental risk factors for the disorder are recognized. In the early 1970s, research conducted by Dr. Benjamin Feingold found that when hyperactive children were given a diet free of artificial food additives and dyes, symptoms of hyperactivity were reduced. While some clinical studies supported these findings, more rigorous empirical studies conducted over the next 20 years were less positive. As a result, research on the role of food additives in contributing to ADHD waned. In recent years, however, interest in this area has revived. In response to more recent research and public petitions, in December 2009 the British government requested that food manufacturers remove most artificial food dyes from their products. While these strictures could have positive effects on behavior, the removal of food dyes is not a panacea for ADHD, which is a multifaceted disorder with both biological and environmental underpinnings.

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Identification of synthetic food dyes in beverages by thin layer chromatography.

• N. Zahra , Alim-un-Nisa , +2 authors K. Saeed
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• Introduction
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OR indicates odds ratio. Comparing extreme quintiles of intake, artificially sweetened beverages, and artificial sweeteners were associated with greater risk of depression (strict definition) after multivariable regression.

Data Sharing Statement

• Errors in the Table JAMA Network Open Correction October 18, 2023

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Samuthpongtorn C , Nguyen LH , Okereke OI, et al. Consumption of Ultraprocessed Food and Risk of Depression. JAMA Netw Open. 2023;6(9):e2334770. doi:10.1001/jamanetworkopen.2023.34770

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Consumption of Ultraprocessed Food and Risk of Depression

• 1 Clinical and Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, Boston
• 2 Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School, Boston
• 3 Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston
• 4 Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
• 5 Channing Division of Network Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
• 6 Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
• 7 Broad Institute of MIT and Harvard, Cambridge, Massachusetts
• 8 Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
• Correction Errors in the Table JAMA Network Open

Increasing evidence suggests that diet may influence risk of depression. 1 - 3 Despite extensive data linking ultraprocessed foods (UPF; ie, energy-dense, palatable, and ready-to-eat items) with human disease, 4 evidence examining the association between UPF consumption and depression is scant. Prior studies have been hampered by short-term dietary data 1 , 2 and a limited ability to account for potential confounders. 1 , 3 Additionally, no study has identified which UPF foods and/or ingredients that may be associated with risk of depression or how the timing of UPF consumption may be associated. Therefore, we investigated the prospective association between UPF and its components with incident depression.

This cohort study was approved by the institutional review board (IRB) at the Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health. The return of a completed questionnaire was accepted by the IRB as implied informed consent. The study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) reporting guideline.

We conducted a prospective study in the Nurses’ Health Study II between 2003 and 2017 among middle-aged females free of depression at baseline. Diet was assessed using validated food frequency questionnaires (FFQs) every 4 years. We estimated UPF intake using the NOVA classification, 2 which groups foods according to the degree of their processing. In secondary analyses, we classified UPF into their components, including ultraprocessed grain foods, sweet snacks, ready-to-eat meals, fats and sauces, ultraprocessed dairy products, savory snacks, processed meat, beverages, and artificial sweeteners. 4 We used 2 definitions for depression: (1) a strict definition requiring self-reported clinician–diagnosed depression and regular antidepressant use and (2) a broad definition requiring clinical diagnosis and/or antidepressant use.

We estimated hazard ratios (HRs) and 95% CIs for depression according to quintiles of UPF intake using Cox proportional hazards models, with adjustment for known and suspected risk factors for depression, including age, total caloric intake, body mass index (BMI; calculated as weight in kilograms divided by height in meters squared), physical activity, smoking status, menopausal hormone therapy, total energy intake, alcohol, comorbidities (eg, diabetes, hypertension, dyslipidemia), median family income, social network levels, marital status, sleep duration, and pain. In an exploratory analysis, we examined the association between changes in UPF consumption updated every 4 years with incident depression. All analyses were performed using 2-sided tests from SAS (version 9.4). Data were analyzed from September 2022 to January 2023.

Our cohort included 31 712 females, aged 42 to 62 years at baseline (mean [SD] age, 52 [4.7] years; 30 190 [95.2%] non-Hispanic White females). Participants with high UPF intake had greater BMI, higher smoking rates, and increased prevalence of comorbidities like diabetes, hypertension, and dyslipidemia and were less likely to exercise regularly. We identified 2122 incident cases of depression using the strict definition and 4840 incident cases using the broad definition. Compared with those in the lowest quintile of UPF consumption, those in the highest quintile had an increased risk of depression, noted for both strict definition (HR, 1.49; 95% CI, 1.26-1.76; P  < .001) and broad definition (HR, 1.34; 95% CI, 1.20-1.50; P  < .001) ( Table ). Models were not materially altered after inclusion of potential confounders. We did not observe differential associations in subgroups defined by age, BMI, physical activity, or smoking. In a 4-year lag analysis, associations were not materially altered (strict definition: HR, 1.32; 95% CI, 1.13-1.54; P  < .001), arguing against reverse causation.

Next, we examined the association of specific UPF components with risk of depression. Comparing extreme quintiles, only artificially sweetened beverages (HR, 1.37; 95% CI, 1.19-1.57; P  < .001) and artificial sweeteners (HR, 1.26; 95% CI, 1.10-1.43; P  < .001) were associated with greater risk of depression and after multivariable regression ( Figure ). In an exploratory analysis, those who reduced UPF intake by at least 3 servings per day were at lower risk of depression (strict definition: HR, 0.84; 95% CI, 0.71-0.99) compared with those with relatively stable intake in each 4-year period.

These findings suggest that greater UPF intake, particularly artificial sweeteners and artificially sweetened beverages, is associated with increased risk of depression. Although the mechanism associating UPF to depression is unknown, recent experimental data suggests that artificial sweeteners elicit purinergic transmission in the brain, 5 which may be involved in the etiopathogenesis of depression. 6 Strengths of our study include the large sample, prospective design, high follow-up rate, ability to adjust for multiple confounders, and extensively validated dietary assessment tools. This study had limitations. The cohort primarily included non-Hispanic White females. Additionally, without structured clinical interviews, misclassification of the outcome may be considered.

Accepted for Publication: August 15, 2023.

Published: September 20, 2023. doi:10.1001/jamanetworkopen.2023.34770

Correction: This article was corrected on October 18, 2023, to fix transcription errors in the Table.

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2023 Samuthpongtorn C et al. JAMA Network Open .

Corresponding Authors: Raaj S. Mehta, MD, MPH ( [email protected] ), and Andrew T. Chan, MD, MPH ( [email protected] ), Clinical and Translational Epidemiology Unit, Massachusetts General Hospital and Harvard Medical School, 100 Cambridge St, Ste 1580 Boston, MA 02114.

Author Contributions: Drs Samuthpongtorn and Mehta had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Samuthpongtorn, Chan, Mehta.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Samuthpongtorn, Chan, Mehta.

Critical review of the manuscript for important intellectual content: All authors.

Statistical analysis: Samuthpongtorn, Chan, Mehta.

Obtained funding: Chan.

Administrative, technical, or material support: Samuthpongtorn, Okereke, Song, Chan, Mehta.

Supervision: Chan, Mehta.

Conflict of Interest Disclosures: Dr Okereke reported receiving grants from the National Institutes of Health and royalties from Springer Publishing outside the submitted work. Dr Chan reported receiving grants from Bayer Pharma AG and Zoe and personal fees from Boehringer Ingelheim, Pfizer, and Freenome outside the submitted work. No other disclosures were reported.

Funding/Support: The Nurses’ Health Study II was funded by grant U01 CA176726 from the National Cancer Institute, National Institutes of Health.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Data Sharing Statement: See the Supplement .

Additional Contributions: We thank the participants and staff of the Nurses’ Health Study II for their valuable contributions. They received no compensation for their contributions.

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Synthetic Food Colors and Neurobehavioral Hazards: The View from Environmental Health Research

Background: The proposition that synthetic food colors can induce adverse behavioral effects in children was first enunciated in 1975 by Feingold [ Why Your Child Is Hyperactive . New York:Random House (1975)], who asserted that elevated sensitivity to food additives underlies the signs of hyperactivity observed in some children. Although the evidence suggested that some unknown proportion of children did respond to synthetic food colors, the U.S. Food and Drug Administration (FDA) interpreted the evidence as inconclusive. A study published in 2007 [McCann et al. Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial. Lancet 370:1560–1567 (2007)] drew renewed attention to the hypothesis because of the study’s size and scope. It led the FDA to review the evidence, hold a public hearing, and seek the advice of its Food Advisory Committee. In preparation for the hearing, the FDA reviewed the available evidence and concluded that it did not warrant further agency action.

Objectives: In this commentary I examine the basis of the FDA’s position, the elements of the review that led to its decision and that of the Food Advisory Committee, and the reasons that this is an environmental health issue.

Discussion: The FDA review confined itself, in essence, to the clinical diagnosis of hyperactivity, as did the charge to the committee, rather than asking the broader environmental question of behavioral effects in the general population; it failed to recognize the significance of vulnerable subpopulations; and it misinterpreted the meaning of effect size as a criterion of risk. The FDA’s response would have benefited from adopting the viewpoints and perspectives common to environmental health research. At the same time, the food color debate offers a lesson to environmental health researchers; namely, too narrow a focus on a single outcome or criterion can be misleading.

In 1973, at a meeting of the American Medical Association, a retired pediatric allergist proposed a hypothesis that seemed ludicrous at the time. He claimed that at least some of the children labeled as hyperactive, or hyperkinetic, or afflicted with minimal brain dysfunction actually possessed an elevated sensitivity to certain elements of the diet. He followed with a book directed at the general public ( Feingold 1975 ). He singled out food additives for special treatment. Feingold named artificial flavors and colors as primary culprits but also indicted some preservatives. Adopt a diet free of these offending ingredients, he advised, and many of the unsettling behavioral problems exhibited by these children will wane. Neither Feingold nor his critics defined hyperactivity in current terms of the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders [DSM-IV ( American Psychiatric Association 2000 )]. The DSM-IV identifies three types of attention-deficit and/or hyperactivity disorder (AD/HD): predominantly inattentive (attention deficit disorder; ADD), predominantly hyperactive (attention-deficit/hyperactivity disorder; ADHD), and combined subtype (the most common). Boyle et al. (2011) give the proportion of U.S. children diagnosed with ADHD as 6.69%.

Feingold’s claims drew wide public attention and also provoked a series of studies directed at his hypotheses. Some tested elimination diets free of additives and other substances, such as salicylates, that Feingold linked to hyperactivity (e.g., Conners et al. 1976 ; Harley et al. 1978a , 1978b ). Others focused on artificial colors because they represented only a small fraction of the additives in the food supply and could be manipulated more easily (e.g., Swanson and Kinsbourne 1980 ; Weiss et al. 1980 ; Williams et al. 1978 ). Most of these adopted the tactic of challenging children with one or a blend of food colors and a placebo. By the early 1980s, enough evidence about the Feingold hypothesis had accrued that even some of its most severe critics viewed it as plausible in some respects. For example, Stare et al. (1980) observed that “challenge experiments indicate that the symptoms of a small subgroup of all hyperactive children appear to be sensitive to the artificial food colors in their diet.”

After the early 1980s, interest in assessing behavioral reactions to food colors abated. During the intervening years, occasional studies both supporting and contradicting Feingold’s assertions about food colors made their way into the literature. From the point of view of the U.S. Food and Drug Administration (FDA), the positive studies taken together failed to constitute enough evidence to require regulatory action (FDA 2010). The data available up to 1982 ( Weiss 1982 ) were considered not substantial enough to cause any shift in the FDA position. Debates about the behavioral toxicity of food colors continued but did not arouse singular interest.

The debate reignited with publication of a large study conducted by a group at the University of Southampton in the United Kingdom ( McCann et al. 2007 ). It enrolled about 300 preschool and elementary school children who were challenged by a blend of food colors and sodium benzoate in a double-blind design employing a variety of behavioral measures. The study used two different mixtures, and the amounts chosen were based on estimates of intake by the British Food Standards Agency and probably are close to U.S. levels. Mix A included 20 mg artificial food colorings for 3-year-old children and 24.98 mg for 8- to 9-year old children. Mix B included 30 mg for the younger children and 62.4 mg for the older children. The doses for the 3-year-old children corresponded roughly to the amounts found in 112 g of candy.

The behavioral measures used by McCann et al. (2007) , combined into a single score (as well as some components of the total score), demonstrated statistically significant adverse responses in both groups of children to the food color challenge. Although some of these measures are used in ADHD research and diagnosis, the Southampton study was aimed not at ADHD but at the more general question of behaviors evoked by food colors. Neither was the study aimed at the question of sensitivity to food colors in ADHD children; the subjects came from the general population of school children.

Because of the uniqueness and size of the study by McCann et al. (2007) , it drew renewed attention to the food color debate, which was introduced to the environmental health community by an article in Environmental Health Perspectives ( Barrett 2007 ), followed by a letter from Weiss (2008) . Barrett (2007) solicited a response from a spokesperson for the FDA (Mike Herndon), who replied as follows:

However, we have no reason at this time to change our conclusions that the ingredients that were tested in this study that currently are permitted for food use in the United States are safe for the general population.

The article by McCann et al. (2007) elicited a petition to the FDA from the Center for Science in the Public Interest (CSPI), a public interest group that earlier had called for a ban on food colors (CSPI 2008). This petition, together with congressional interest and media publicity, led to an FDA decision to review the food color literature and to hold a public hearing before its established Food Advisory Committee. The hearing was held on 30–31 March 2011. After listening to testimony from FDA reviewers and the public, the committee concluded that the evidence was too inconclusive to link food colors to hyperactivity and too insufficient to recommend warning labels for products containing artificial food colors. (I testified before the committee that the available evidence indicated a connection between adverse behavioral responses and food color consumption.)

As described by the FDA Food Advisory Committee (2011a), the FDA framed the question put to the advisory committee primarily in the form, “Are food colors a cause of hyperactivity?” Only as a secondary question did the FDA ask if food colors might be a source of other kinds of adverse behavioral responses. Although the food color question was framed quite narrowly by the FDA, it is representative of many of the questions that confront the environmental health sciences. What kind of data—and how much data—does it take to render an outcome conclusive enough for action? The committee decision and the FDA’s current view (as quoted by Barrett 2007 ) signify a group of persistent questions pertaining both to environmental health science and to regulatory practices. In this commentary, I try to place the FDA committee decision in this broader context.

Identifying the appropriate measures. The FDA described the committee’s mission in these terms (FDA Food Advisory Committee 2011a):

The task before this Food Advisory Committee is to consider available relevant data on the possible association between consumption of synthetic color additives in food and hyperactivity in children, and to advise FDA as to what action, if any, is warranted to ensure consumer safety.

The charge did not explicitly conform to the DSM-IV definition of ADHD, which is multifaceted, so the charge was somewhat ambiguous.

Two review documents were contracted for and submitted to the Food Advisory Committee before the meeting: a background document, describing the FDA’s history of food color regulation (FDA Food Advisory Committee 2011a), and a literature review of publications about the connections between food colors and hyperactivity (FDA Food Advisory Committee 2011b). These documents provided the basis for the review presented to the committee by the FDA Office of Food Additive Safety.

In their review the FDA apparently decided to focus on Feingold’s 35-year-old hypothesis ( Feingold 1975 ) rather than on the broader environmental issue of whether food colors may induce adverse behavioral responses. This is a broader issue because, as noted above, most U.S. children, not just those diagnosed with ADHD, consume synthetic food colors in their diet.

Moreover, few of the artificial food color challenge studies did so to test the hypothesis that food colors cause ADHD as defined by the DSM-IV. No one, of course, can specify any predominant cause of ADHD. It is clearly a multicausal disorder as well as one with notable variation in expression. The food color literature is aimed mostly at the short-term effects of challenges, not chronic disease. Although the questionnaires, rating scales, and performance assays prominent in ADHD research have proven useful in challenge studies, they do not encompass all the behaviors evoked by food colors. Swanson and Kinsbourne (1980) found that performance on a paired-associate learning task deteriorated after administration of a color mixture challenge. Goyette et al. (1978 ; see also Conners et al. 1976 ) identified 3 of the 16 children they assessed as responders by their performance on a visual tracking task. Even the FDA review observed that measures confined to ADHD symptoms may not reflect responses evoked by food colors. It noted the following in discussing a study by Rowe and Rowe (1994) :

The behavioral effects elicited by the tartrazine challenges, however, involved irritability, fidgetiness and sleep problems which are not typically representative of hyperactivity related behaviors. Several other investigators also reported behavioral responses to color challenge that were not particularly characteristic of ADHD. (FDA Food Advisory Committee 2011b)

By narrowing the scope of the committee’s task to a judgment of whether artificial food colors are associated with ADHD, the FDA Food Advisory Committee (2011b) effectively eliminated a much more relevant and important question: Is there evidence that food colors are behaviorally toxic to the general population of children?

The large investment by the National Institute of Environmental Health Sciences (NIEHS) in bisphenol A research is, in many ways, a design for answering questions of similar scope. Bisphenol A is often labeled as “estrogenic.” Had the NIEHS bisphenol A initiative been restricted to this question ( Spivey 2009 ), it might have limited its breadth only to questions bearing on the chemical’s alleged estrogenic properties. The NIEHS, however, recognized the scope of associations between bisphenol A exposure and health effects, including those such as obesity and externalizing behavior in young girls, that could not be linked firmly to estrogenicity, if at all. Analogously, if questions about the adverse health effects of airborne particulates had been restricted to lung function, the superficially obvious target organ, the association with cardiovascular function, its primary adverse effect, would have been overlooked.

One possible source of the FDA review’s misleading charge may be its limited view of brain–behavior relationships. In summarizing its findings, the FDA Food Advisory Committee (2011a) offered the following statement:

For certain susceptible children with attention deficit/hyperactivity disorder and other problem behaviors, however, the data suggest that their condition may be exacerbated by exposure to a number of substances in food, including, but not limited to, synthetic color additives. Findings from relevant clinical trials indicate that the effects on their behavior appear to be due to a unique intolerance to these substances and not to any inherent neurotoxic properties.

This statement surely does not mean to assert that the central nervous system is not the essential substrate for behavior or that behavior is a phenomenon independent of the brain. Its roots perhaps may be found in how toxicology was practiced in the past, when pathology—overt tissue damage—was far more important than function in assessing chemical safety.

Identifying special populations. The literature on behavioral toxicity of food additives is replete with observations by investigators—and by much of the applicable data—that not all children are sensitive to additives in general, or food colors in particular, at common dietary levels. Indeed, not even Feingold asserted that all hyperactive children were sensitive to food additives. In a convincing example of such findings, Rowe and Rowe (1994) , in a double-blind controlled challenge study with tartrazine, identified a subgroup of 24 children within their sample of 54 that responded consistently on each occasion that they consumed a color rather than a placebo capsule. Moreover, these children displayed a clear dose–response function, with the higher doses eliciting higher scores on their 30-item behavior inventory, including five clusters of related behaviors: a ) irritability/control, b ) sleep disturbances, c ) restlessness, d ) aggression, and e ) attention span.

The FDA review, however, seemed to insist that proving a connection between food color ingestion and adverse behavioral effects requires a uniformity of response in the sample under study that is virtually impossible to achieve in the diverse human population. For example:

Generally, the various reported findings across these 10 reviewed post-1982 portion of Group I trials, suggests that certain susceptible subgroups of problem behavior children with and without ADHD and, possibly, certain susceptible children from the general population without particular behavioral problems may exhibit a unique intolerance to artificial food colors resulting in typically small to moderate adverse behavioral changes which may not necessarily be characteristic of the ADHD syndromes. (FDA Food Advisory Committee 2011b).

Such a rejection of evidence stemming from data suggesting a subpopulation of children with enhanced sensitivity to food colors is perplexing. The FDA review implies that, because such a subpopulation may represent only a small proportion of children (hardly a proven proposition), it does not represent a significant health problem. Such a contention is inconsistent with the tenets of public health. Much of biomedical research, including environmental health research, is devoted to identifying and treating especially sensitive or vulnerable subpopulations. The underlying health goals of the Human Genome Project surely embraced that perspective. FDA drug warnings often are directed at special subpopulations. Finally, the FDA view on how this question pertains to food colors is an outlier among federal agencies. Note how the U.S. Environmental Protection Agency (2011) interpreted the Clean Air Act:

The National Ambient Air Quality Standards (NAAQS) are designed to protect the most vulnerable populations from outdoor air pollutants. Identifying these groups more precisely and understanding why they are more susceptible is of great importance to scientists and policy makers.

Effect size. In its critique of McCann et al. (2007) , the FDA is somewhat dismissive of the results, at least as conveyed by this statement:

Whatever behavioral changes [in the Southampton study] may have occurred were apparently of rather low magnitude (effect size of 0.18). This would suggest that the type of treatment effects reported in this study, even though the investigators referred to increases in levels of “hyperactivity,” were not the disruptive excessive hyperactivity behaviors of ADHD but more likely the type of overactivity exhibited occasionally by the general population of preschool and school age children. (FDA Food Advisory Committee 2011b).

This is a puzzling statement because an important facet of an ADHD diagnosis is excessive or inappropriate activity. Also, the DSM-IV lists six kinds of hyperactivity, not just the variation described above. The term “occasionally,” in this context, is at least equally puzzling. Respiratory infections are also occasional events for most children. If a survey were to find, say, a significant rise in the incidence of such infections among a group of schoolchildren, questions would be asked and actions possibly taken. This question, in fact, is the theme of many reports in environmental health.

The more significant paradox about the passage above by the FDA Food Advisory Committee (2011b) is its view that an effect size of 0.18 [in the range of many of the published studies (see Schab and Trinh 2004 ; Stevens et al. 2011 )] can be considered trivial. Effect size is often used to gauge the importance or strength of a finding; therefore, how it applies to McCann et al. (2007) —and its interpretation—is worth examining with a more familiar example.

Consider Figure 1 . For an IQ (intelligence quotient) distribution with a mean of 100 and and an SD of 15 (which describes a standardized IQ test such as the Stanford-Binet), 2.3% of the population will receive a score of < 70, a score that many school districts will view as warranting remedial attention. Now, define effect size, as used by McCann et al. (2007) and typically in the psychological literature, in terms of the standardized mean difference:

For an IQ distribution with a mean of 100 and SD of 15 (e.g., the Stanford-Binet), 2.3% of the population will have an IQ score < 70, a score that many school districts consider warranting remedial attention. If an environmental exposure shifts the mean IQ score by –3% (from 100 to 97), the proportion of the population with an IQ score < 70 will increase. Based on the current U.S. figure of 76 million children 0–17 years of age (Childstats.gov 2011), this represents an increase of 990,000 children in that category.

(mean 1 – mean 2) ÷ (pooled SD).

If an environmental exposure shifts the mean by 3%, equivalent to an effect size of 0.2, to a mean of 97, 3.6% of the population represented by the distribution will have a score < 70. Based on Census 2000 counts, the U.S. government (Childstats.gov 2011) estimates that there are 76 million children 0–17 years of age in the nation. Of these, 1.75 million would be presumed to have an IQ score of < 70, given a mean of 100. A shift of the mean IQ to 97 would indicate that 2.74 million children would have an IQ < 70 (an increase of 990,000 children). Most observers would not consider this to be a value of “rather low magnitude.”

Figure 2 presents another set of implications based on an effect size of 0.2, or a 3% shift in IQ. It depicts the calculations by Herrnstein and Murray (1994) of the broader social consequences of a population IQ increase of 3%, which was converted into the effects of a corresponding decrease in IQ by Weiss and Bellinger (2006) . Although some of the presuppositions of these authors have aroused controversy, the relationships between IQ scores and lifetime earnings (e.g., Grosse et al. 2002 ), and how income influences the outcomes shown in Figure 2 , lends credibility to the calculations.

Depiction of calculations by Herrnstein and Murray (1994) of societal benefits achieved by a 3% rise in the population IQ.

One other aspect of effect size calculations that the FDA review failed to consider is how such values are influenced by population heterogeneity. In their Figure 2 , Weiss and Bellinger (2006) showed how effect size calculations can be distorted if the sample population contains two subpopulations. Assume that the sample population consists of 70% nonresponders and 30% responders, and that the mean of the responders is shifted by 1 SD when presented with a challenge, such a food color. Under these conditions, it would require a total sample of 265 subjects to achieve an effect size of 1.0 as defined above. It is easy to see how true effects of a food color challenge to an unselected population can be missed if the sample size is small or if a minority of the sample consists of responders. Given such circumstances, it made sense for some investigators, such as Rowe and Rowe (1994) , to screen subjects for responsiveness to an elimination diet before undertaking the tartrazine challenge portion of their study. It is analogous to the cancer bioassay strategy of using high doses to identify carcinogenic potential in reasonably small samples of rodents.

Conclusions: The View from Environmental Health

The food color issue is emblematic of many questions in environmental health. What is the border between “inconclusive” and “conclusive” evidence? How is a susceptible population identified, and how large must it be for it to be seen as significant for public health? How broadly (or narrowly) should an outcome or criterion be defined and still remain relevant? From these standpoints, the FDA’s review, current position, charge to the Food Advisory Committee, and view of the issue’s future reflect a somewhat narrow vision. It is revealed in the conclusion by both the committee and the review (FDA FAC 2011c) that further research on the topic is necessary (committee members voted 93% yes and 7% no, when asked if more research was needed). This is hardly a statement to evoke disagreement, but consider the way such studies would have to be carried out. They would require institutional review board (IRB) approval. How would the investigator address the question of risk? How likely is it that an IRB would approve a study design in which the investigator states that, according to the published literature and the FDA, some children respond to a food color challenge with adverse behavioral effects? What, then, asks the IRB, is the purpose of the study? The difficulty in devising an argument for conducting a study that would satisfy most IRBs reveals the flaws in the FDA’s current position.

The next phase of the protocol would prove at least equally daunting. Parents would have to provide informed consent. As with the argument to the IRB, the parent would have to be made aware that food color challenges have been reported to induce adverse behavioral effects in some children. Would more than a small proportion of parents agree to have their child included?

Consider the cost of such a study. The Southampton study ( McCann et al. 2007 ) enrolled about 300 children, about 150 of nursery-school age and about 150 in elementary school, and it used a blend of food colors. According to the principal investigator, the study cost about $1 million to complete. If the FDA demands that each of the certified colors be studied individually, the total cost would reach $7 million. Additional studies are unlikely ever to be performed on the scale of that performed by the Southampton investigators.

If the FDA had approached the food color question from an environmental health perspective, it would have enlisted a broad sample of scientists from a variety of relevant disciplines to examine the question. Its model would have been that exemplified by the April 2011 issue of Environmental Health Perspectives , which highlighted the health effects of airborne particulate matter. That issue of the journal contained articles addressing topics such as differential susceptibility in populations, the effects of different particulate matter components on mortality, cardiovascular effects, coronary heart disease, and respiratory health.

Had the FDA approached the food color question with the breadth of inquiry adopted in 1977, when a select committee reviewed the toxicity of food additives permitted under the GRAS (Generally Regarded as Safe) criteria ( Siu et al. 1977 ), it would have arrived at a different conclusion. That committee, whose deliberations were supported by the FDA, looked beyond the simple question of “safety.” It enlisted public comment early in the process; made the penultimate draft of its report available to the public via the Federal Register and solicited comments; noted the importance of “psychotoxicology” in food safety evaluation; and emphasized the unique risks to neonates, a vulnerable group not considered in the FDA review but that is exposed to food colors.

If the FDA had given consideration to how the food color question might effectively be resolved, it might have adopted the vision described by NIEHS in the promise of Green Chemistry for Environmental Endocrine Disruptors, a meeting held in March 2011 in Sausalito, California ( Schug 2011 ). In a parallel fashion, the FDA might have called for a “green chemistry” approach to synthetic food colors.

In defense of the FDA position, one might argue that the narrow scope of the review and committee charge simply were products of the CSPI petition (CSPI 2008). But the agency has had 35 years since the Feingold book ( Feingold 1975 ) and 37 years since the GRAS report ( Siu et al. 1977 ) to address the neurobehavioral toxicity of food colors. Perhaps a regulatory agency is not capable of being proactive. However, the British Food Standards Agency has advised parents to consider eliminating artificial food colors from the diet, and the European Union has called for eliminating six colors or listing on the label the warning that “[the color] may have an adverse effect on activity and attention in children” ( Food Standards Agency 2011 ).

Preparation of this commentary was supported in part by research grant RC2 ES018736 and center grant ES01247 from the National Institute of Environmental Health Sciences.

The author declares he has no actual or potential competing financial interests.

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Two decades of advancements in cold supply chain logistics for reducing food waste: a review with focus on the meat industry.

1. Introduction

Objective and scope of study.

• What is the current state of the art on beef CSCL in terms of management, sustainability, network design, and the use of information technologies for red meat waste reduction?
• To provide an overview of the current state of the art and to identify the gaps and contemporary challenges to red meat waste reduction;
• To identify key research themes and their potential role and associated elements in mitigating red meat waste reduction, especially across the beef CSCL systems;
• To pinpoint the directions in each theme that warrant further research advancement.

2. Materials and Methods

2.1. literature retrieval and selection, 2.2. extracting the research themes, 3.1. the literature review identified themes and subjects, 3.2. the literature’s evolution and descriptive results, 3.3. management, 3.3.1. logistics management and chronological evolution, 3.3.2. management and regulations, 3.3.3. management and collaboration, 3.3.4. management and costs, 3.3.5. management and inventory, 3.3.6. management and decision-making, 3.3.7. management and risks, 3.3.8. management and waste reduction, 3.3.9. management and information, 3.3.10. management and cold chain deficiencies, 3.4. sustainability, 3.4.1. sustainability and closed-loop scs (clscs), 3.4.2. sustainability and business models, 3.4.3. sustainability and wastage hotspots, 3.4.4. sustainability and packing, 3.4.5. sustainability and information flow, 3.5. network design optimisation, 3.5.1. network design and decision levels, 3.5.2. network design and the location–inventory problem, 3.5.3. network design and routing-inventory problem, 3.5.4. network design and the location routing problem, 3.5.5. network design and the integrated location–inventory routing problem, 3.5.6. network design and sustainability, 3.5.7. network design and information flow, 3.6. information technologies, 3.6.1. it and meat sc transformation, 3.6.2. emerging information technologies and meat scs, technical instruments, technological systems, 4. discussion, 4.1. management, 4.2. sustainability, 4.3. network design, 4.4. information technology, 5. conclusions.

• Management: ◦ Effective management practices are crucial for addressing FLW in beef CSCL systems. ◦ There is a notable transition from LM to FLM and SFLM, with the potential for emerging technologies to create an “Intelligent Sustainable Food Logistics Management” phase. ◦ Suboptimal management practices continue to contribute significantly to FLW, underscoring the need for enhanced strategies and adherence to regulations and standards.
• Sustainability: ◦ Sustainability in beef CSCL involves addressing social, economic, and environmental benefits. ◦ Reducing FLW can lead to increased profits, improved customer satisfaction, public health, equity, and environmental conservation by minimising resource use and emissions. ◦ Comprehensive research integrating all sustainability dimensions is needed to fully understand and mitigate FLW. Current efforts often address only parts of sustainability. A more holistic approach is required to balance environmental, economic, and social dimensions effectively.
• Network Design: ◦ Effective network design and optimisation are pivotal in reducing FLW within beef CSCL systems. ◦ There is a necessity for integrating all three levels of management decisions in the logistics network design process. Decision levels in network design must be considered to understand trade-offs among sustainability components in this process. ◦ Future research should focus on integrating management decisions and network design, CSCL uncertainties, sustainability dimensions, and advanced technologies to enhance efficiency and reduce waste in beef CSCL systems.
• Information Technologies: ◦ Information technologies such as Digital Twins (DTs) and Blockchain (BC) play a significant role in improving efficiency and reducing FLW in beef CSCL. ◦ The integration of these technologies can enhance understanding of fluid dynamics, thermal exchange, and meat quality variations, optimising the cooling process and reducing energy usage. ◦ Challenges like data security and management efficiency need to be addressed to maximise the benefits of these technologies.

Author Contributions

Data availability statement, acknowledgments, conflicts of interest.

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Share and Cite

Davoudi, S.; Stasinopoulos, P.; Shiwakoti, N. Two Decades of Advancements in Cold Supply Chain Logistics for Reducing Food Waste: A Review with Focus on the Meat Industry. Sustainability 2024 , 16 , 6986. https://doi.org/10.3390/su16166986

Davoudi S, Stasinopoulos P, Shiwakoti N. Two Decades of Advancements in Cold Supply Chain Logistics for Reducing Food Waste: A Review with Focus on the Meat Industry. Sustainability . 2024; 16(16):6986. https://doi.org/10.3390/su16166986

Davoudi, Sina, Peter Stasinopoulos, and Nirajan Shiwakoti. 2024. "Two Decades of Advancements in Cold Supply Chain Logistics for Reducing Food Waste: A Review with Focus on the Meat Industry" Sustainability 16, no. 16: 6986. https://doi.org/10.3390/su16166986

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40 Best Toys for 7-Year-Olds Who Are Coming Into Their Own

Unique, educational and just plain cool gifts that will shoot to the top of their lists!

We've been independently researching and testing products for over 120 years. If you buy through our links, we may earn a commission. Learn more about our review process.

The Good Housekeeping Institute helps narrow down the search, testing and evaluating toys throughout the year, soliciting feedback from real 7-year-olds while on the hunt for our annual Good Housekeeping Best Toy Award winners. We mixed their picks with some trendy toys, best-sellers and editor favorites to put together this list of the best toys and gifts for 7-year-olds in 2024.

Our Top Picks

• Search for a Giant Squid: Pick Your Path Book , $14 at amazon.com
• Crayola Wixels Animals Art Activity Kit , $15 at amazon.com
• Klutz Make Your Own Soap , $19 at amazon.com
• Pixicade Pets , $20 at amazon.com
• VTech Kidizoon Creator Cam , $55 at amazon.com

Whether you're looking for gifts for 7-year-old boys , gifts for 7-year-old girls or any other gifts for kids, there's something on this list to please every type of kid.

Skillmatics Guess in 10 Disney

Who's the biggest Disney fan in the family? This game includes different Disney characters on the cards, and players have to try and guess who it is while asking just 10 questions about who it is — a good use of logic and deduction skills. The cards also give suggestions for hints, along with fun facts. Good Housekeeping Institute testers say they liked having a game that anyone in the family could play. There's also a Marvel edition. Ages 6+

LEGO Minions’ Music Party Bus

LEGO fans and Despicable Me 4 watchers can come together to build this 379-piece set. The bus opens to reveal a DJ station, dance floor and hot tub, and it comes with accessories like an electric guitar, a piano, a microphone, lights and speakers. Good Housekeeping testers loved putting it together and using it as a play set. Ages 7+

Make Your Own Soap Kit

Kids will complain less about washing up when they've made their own soap in fun, cool shapes. They'll learn that a lot goes into making soap, from mixing the ingredients to molding the shape to adding fragrance. There are even ideas for soap-based, at-home experiments kids can do while their soap hardens. It comes with enough to make 10 soaps in shapes like stars and cats, plus color tablets, glitter, coconut papaya fragrance and even gift boxes and tags. Ages 6+

'Search for a Giant Squid' Book

Kids get to choose their own paths through these books, and they'll pick up plenty of science facts along the way. First they choose their pilot and sub, and then they go on a hunt for a giant squid. "I sat with my 6- and 4-year-olds for 30 minutes, reading various scenarios,” said one reviewer. “Every time I tried to stop, they wanted to start over on a different adventure!” Ages 6 – 9

RELATED: The Good Housekeeping Best Kids' Book Awards

Exploding Kittens Card Game

This game is worth it just for the irreverent art on the cards. The goal is not to get an exploding kitten card — and to try and push them onto the other players until you're the last one standing. It's silly, easy to learn and easy to break out whenever there's a lull in the action. Ages 7+

KiwiCo Marble Roller Coaster

Kids will be amazed that they can actually build their own, never-ending marble run that includes a ferris wheel that brings the marble up to the top of the track. They can experiment with different layouts of the track, and learn some physics and engineering in the process. Ages 7+

Crayola Wixels Animals Activity Kit

There's a little STEM lesson in this art project: Kids moisten a board filled with squares, touch the marker to each space, and watch as capillary action fills the square with color to make a picture in a pixelated style. It comes with two animal patterns for them to follow, or they can make their own designs. Ages 6+

Schleich Buckbeak Figurine

Schleich is known for its incredibly intricate, pass-down-quality figures, and they've brought this attention to detail to the Wizarding World of Harry Potter. And while you can get the human characters, like Harry , Ron and Hermione , it's the creatures that really shine, like this glorious Hippogriff with wings spread open. ( Fluffy the Cerberus is pretty good, too.) Ages 6+

Aphmau MeeMeows Classic Mystery Plush

You don't have to be a fan of Aphmau's gaming YouTube channel to want one of these adorable kitties. At 11 inches, they're bigger and more huggable than some mystery plush, and there are eight cats collect. Good Housekeeping testers gushed over how cute each of the designs were. Ages 3+

Pixicade Virtual Pet Maker

Kids can draw out their dream pet, then scan it into an app and actually make their drawings play-able. There are step-by-step guides that take kids through the process of caring for their pets by giving them food and water. Ages 6+

Pokémon Twilight Masquerade Elite Trainer Box

There are lots of ways to be a Pokémon fan, and if the cards are the main focus, this is the ultimate gift. It'll easily improve their collection with nine booster packs, plus 45 extra energy cards. In addition, there are fun accessories, with damage-counter dice, card sleeves, status markers and coins to toss, all with an Ogerpon theme from the Pokémon Scarlet & Violet DLC. And there are more Elite Trainer Boxes on the way, including Shrouded Fable (releases August 23) and Stellar Crown (releases September 13) Ages 6+

One Question a Day for Kids

If the creative 7-year-old in your life likes the idea of journaling but doesn't know what to write, this journal will prompt them with a thought-starter a day. It asks questions both fun (favorite superpowers) and serious (about who they trust the most). When they're done, they'll have a time capsule that covers three years. Ages 5+

VTech KidiZoom Creator Cam

Kids love creating and editing their own videos, using special effects like green screens and animated backgrounds. Parents love that it doesn't connect to Wi-Fi, so they don't have to worry about safety and privacy. Ages 5+

Teenage Mutant Ninja Turtles Mutations Station Play Set

This Ninja Turtles set comes with four small figures, plus a big vehicle that looks like the Pizza Van. But when you open the back of the car, there's a "mutation station," where you can mix up the heads, torsos and legs of the figures and create a new creature that gets launched out of the van! "My son loves building and drawing his own characters and to have a mechanism in place to create his own tangible designs was perfect for him," one parent tester wrote. Ages 4+

Kanoodle 3D

It looks simple, but its deceptively difficult. Each puzzle challenges players to copy a design from the instruction book, then complete it using the remaining pieces. They'll have their brains thinking overtime as they try to work out the 3D and 2D shapes. Ages 7+

BrainBolt Genius

This brainteaser will keep your little ones engaged while challenging their smarts. Players use their memory skills to re-create patterns that the game flashes on the buttons. Our testers love that this game can be brought along while traveling and even has a silent mode. Ages 7+

Air Hogs Flippin’ Frenzy

Air Hogs RC cars have long been a hit with Good Housekeeping Institute testers, who appreciate that the wheels are soft enough to drive indoors (but still big enough to drive over obstacles). This one is also designed to do spins and tricks, and there's a red car on one side and a blue one on the reverse, so it'll keep going no matter which way it lands. Ages 4+

RELATED: The Best Remote-Controlled Cars for Kids

Make Your Own Paper Kit

Their creative mind will take a homemade piece of paper and turn it into something even more special. Help them set up the paper pulp and then watch them have fun using the included dried flowers to create a beautiful design you (and they!) will want to use as décor once it's done. Ages 4+

Hide & Seek Rock Painting Kit

The perfect rainy-day project for 7-year-olds, this kit lets kids decorate rocks either with their own painted-on designs or with cool water-based transfers (like a temporary tattoo for rocks). Then, when it's nice out again, they can use the rocks to decorate a garden or be a hidden moment of surprise along a path or trail. It comes with 10 rocks, but you can also send them out into nature to scout out more. Ages 6+

Reversible Axolotl Plushie

Reversible plushes are still the rage. Axolotls are the animal of the moment. Put them together, and you've got an unmistakable hit. Flip this axol inside-out to change its mood from happy to angry while keeping its cool blue-and-teal color scheme. (Though it does come in several other colors.) Ages 3+

Marisa (she/her) has covered all things parenting, from the postpartum period through the empty nest, for Good Housekeeping since 2018; she previously wrote about parents and families at Parents and Working Mother . She lives with her husband and daughter in Brooklyn, where she can be found dominating the audio round at her local bar trivia night or tweeting about movies.

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