A Food Color Safety Petitionwas submitted to U.S. Food and Drug Administration on March 22, 2011 by FIHRI, Institute of Neurotoxicology and Neurological Disorders, American Association of Intellectual and Developmental Disorders, TRANSCEND Research/Neuroscience, Institute for Agriculture and Trade Policy and Government Accountability Project. Download PDF file below and for more information read Food Color FAQs.
What do food color additives and high fructose corn syrup have in common? High fructose corn syrup and certain food color additives may be sources of mercury exposure because Federal and international food regulations allow mercury containing chlor-alkali products to be used in manufacturing these ingredients (1, 2, 3, 4). Consumption of these ingredients may also lead to zinc loss and/or deficiency in humans (5, 6, 7). There are regulations in place to monitor the mercury exposure in the food color additives (8) but no specific regulations to monitor the mercury levels that can be found as a contaminant in high fructose corn syrup. For example, each batch of formulated food colors must be analyzed by FDA and certified "safe" prior to market (8). There is no such certification process for high fructose corn syrup.
What regulations are in place to monitor the mercury levels in food color additives?
The United States Federal Code of Regulations (CFR) specifies that food color additives undergo a certification process for each batch that is manufactured by the food industry (8). During the certification process, each food color additive must be analyzed to determine that the food additive conforms to certain specifications and is free from impurities other than those listed and allowed by the CFR. The CFR allows mercury to exist as an impurity in certain food color additives as long as the level does not exceed 1 part per million or 1 ppm (2). Not all food color additives are required to undergo this certification process but the ones associated with hyperactivity in children must undergo this process. FD &C Yellow No. 5 and FD & C Yellow No. 6 are the food colors associated with hyperactivity in children and they must undergo this certification process (2). How do we know that mercury can be found as an impurity in high fructose corn syrup? Three different studies have found mercury in high fructose corn syrup and/or products containing high fructose corn syrup (3, 4, 9). The results of two of these studies were published in a peer reviewed science journal. How do we know that mercury in food color additives and high fructose corn syrup is harmful to children?
Mercury exposure through the consumption of high fructose corn syrup and food color additives may alter metabolism in children leading to zinc deficiency. Such deficiency may impact learning in hyperactive and autistic children. One review article published by Dufault et al. in the Behavioral and Brain Functions Journal in 2009 provides a model that explains how this may happen (10). Another article published in the Lancet in 2007 by McCann et al describes a study in which children were given a daily dose of food color additives in the United Kingdom and then their behavior was tracked in three different ways by different observers (11). The authors concluded that artificial colors or a sodium benzoate preservative (or both) in the diet result in increased hyperactivity in 3-year old and 8/9 year -old children in the general population. The authors of course did not know to look for mercury in the food colors or even to determine that the healthy children had likely been exposed to mercury. We can only presume that the children probably had mercury exposure based upon the fact that the food colors in the McCann study are allowed by law to contain a certain level of mercury in them (2). In clinical trials long ago, Dr. Neil Ward found that hyperactive children showed a significant reduction in zinc over a relatively short period time with the consumption of certain food colors - FD & C #5 Tartrazine and FD & C #6 Sunset Yellow (6, 7). The model published in 2009 by Dufault et al in the Behavioral and Brain Functions journal explains how this zinc deficiency may occur when mercury exposure occurs through the consumption of food color additives (10). Did the U.S. Food and Drug Administration recently host a hearing to take another look at the safety of food colors? From March 30- 31, 2011, the U.S. Food and Drug Administration (FDA) hosted a meeting for the FDA Food Advisory Committee. The FDA Food Advisory Committee is made up of 17 members, 15 of whom can vote on recommendations to give to the FDA regarding food safety issues (12). Only two of these members are allowed to represent consumer interests. During this meeting in March, the FDA Food Advisory Committee reviewed a petition submitted by the Center for Science in the Public Interest (CSPI) requesting the recall of the color additive approvals of eight synthetic dyes for use in food (13). As part of their review, the Committee was tasked to look at the peer reviewed literature to determine what if any evidence exists to show that food color additives impact child behavior. The Committee was provided a bibliography entitled All References Related to Overview Assessment of Artificial Food Colors/Additives and Hyperactivity (ADHD) and Problem Behaviors in Children (14). Copies of the papers found in the bibliography were apparently provided to the Committee. Of the thirty three human clinical trial studies listed in the bibliography, thirty one were published before the year 2000 and nine were published before 1980. Upon completion of their review, the Committee voted 11-3 against the recommendation to recall the food color additive approvals or provide any warnings to parents regarding the adverse health effects associated with eating foods containing the food colors under review (15). Why did the FDA Food Advisory Committee vote against banning these food colors and refuse to recommend putting warning labels on food products that contain harmful food color additives? Unfortunately the bibliography provided to the Committee was incomplete. It did not list the clinical trial data and findings published by Dr. Neil Ward and his colleagues (6, 7). Over his lengthy career, Dr. Ward has published several studies on the adverse effects children experience from food color consumption. Whoever provided the bibliography to the FDA (a contractor) did not do their homework. The bibliography also did not reference the review article published by Dufault et al. in 2009 that explains how mercury exposure from consumption of food additives such as high fructose corn syrup and food colors can lead to zinc deficiency and impact behavior and learning (10). The bibliography did not include any studies on the adverse effects food color additives have on the human immune system. Had the committee been provided with all of the relevant information perhaps they would have decided differently. Does the FDA have to follow the Food Advisory Committee's recommendation? FDA has consistently taken the view that food color additives are safe for children despite evidence to the contrary. The agency could choose to disregard the Committee's recommendation. There might be a reason why the agency does not want to take these food color additives off the market. Perhaps manufacturers are relying on these food colors for product shelf life. These food color additives might contain impurities needed to enhance product shelf life and prevent spoilage. For example, mercury has long been used as an antimicrobial agent. The FDA writes the regulation that allows mercury impurities to be present at or below 1 ppm in certain food colors (2). Why would the agency allow mercury impurities in one food color but not another?
We have no idea but while some food color additives are allowed to contain mercury impurities others are allowed to contain impurities of arsenic and/or lead (2). Both of these elements have been used as active ingredients in consumer products to prevent mold or bacterial growth.
Do all governmental food safety agencies share FDA's view? It is important for the consumer to realize that the FDA has a point of view that is not shared by all governments. For example, the United Kingdom (UK) Food Standards Agency is now warning parents about the impact harmful food color additives may have on their children (16). The UK is a member of the European Union. There are twenty seven countries in the European Union (EU) and all of these countries must follow the same food safety regulations (17). In the EU, all foods containing food colors Sunset yellow, Tartrazine, Quinoline yellow, Carmoisine , Allura red and Ponceau 4R must bear the following warning label: may have an adverse effect on activity and attention in children (18). Why does the EU view differ from that of the FDA? The EU apparently bases its view on food color safety on the findings of the European Food Safety Authority (EFSA). The EFSA also conducted a review of the food color additives in question. For tartrazine, the EFSA reviewed human studies that looked at the food color additive's effect on child behavior and the immune system. Of the forty three human studies cited during their review, ten were published after the year 2000 and all were published after 1980. While the EFSA did not review Dr. Ward's findings of zinc loss in hyperactive children after tartrazine consumption or the Dufault et al. mercury toxicity model explaining how zinc loss impacts the immune system and learning, the EFSA did review the numerous human studies showing the body's immune system response to tartrazine exposure. The EFSA advisory panel concluded that tartrazine ( FD & C Yellow #5) appears to be able to elicit intolerance reactions in a small fraction of the exposed population. The panel also noted that the specifications for tartrazine need to be updated with respect to the percentage of material not accounted for that may represent sodium chloride and/or sodium sulphate as the principal uncoloured components (19). Did the Food Ingredient and Health Research Institute do anything to try to educate FDA and its Food Advisory Committee prior to the March 2011 meeting? In preparation for the Food Advisory Committee meeting in March we put together a petition and submitted it to FDA for consideration by the Food Advisory Committee members. Representatives from the following non-profit groups signed our petition. Steven G. Gilbert, PhD - Institute of Neurotoxicology and Neurological Disorders http://toxipedia.org/display/toxipedia/The+Institute+of+Neurotoxicology+and+Neurological+Disorders+%28INND%29 Renee J. Dufault, DHEd (candidate) - Food Ingredient and Health Research Institute http://www.foodingredient.info/
Amanda Hitt, MPH, JD - Government Accountability Project http://www.whistleblower.org David Wallinga, MD - Institute for Agriculture and Trade Policy http://www.iatp.org Martha Herbert, MD - TRANSCEND Research/Neuroscience http://nmr.mgh.harvard.edu/transcend/ Joyce Martin, JD - American Association of Intellectual and Developmental Disabilities http://www.aaidd.org Along with our petition we provided a power point that was presented for the American Association of Intellectual and Developmental Disabilities explaining how consumption of certain food colors and high fructose corn syrup leads to zinc deficiency and impacts learning in children. We have not heard back from the FDA on our petition so we don't know if they read it or not. Is there any reason to explain why FDA would continue to allow these food color additives if they are harmful to children? It is hard to say why FDA would continue to allow these food color additives when evidence seems to indicate they are clearly harmful to some children. One explanation may have to do with the way FDA is funded to accomplish its mission of food safety. FDA earns money from certifying food color additives. For every batch submitted to FDA for certification, the manufacturer must pay fees (20). Part of FDA's mission is to provide services to food manufacturers for fees rendered and the fees are used to pay the operating costs of the FDA programs providing the services. As long as FDA employee salaries and programs are paid for by industry user fees, FDA will not be in a position to survive as a regulatory agency unless Congress makes changes in the way FDA programs are funded. Where can I go to find out what foods contain these potentially harmful food color additives? Visit the Institute for Agriculture and Trade Policy (IATP) website to download the Smart Guide to Food Dyes (21). What can I do if I am a concerned about the safety of food color additives in our food supply? Don't take our word for it! Visit the FDA Food Safety Advisory Committee webpage and download all of the materials that were given to the Committee members during the meeting and take a look at the minutes that were provided after the meeting (22). Check out the references listed below! Visit the IATP website and read the Smart Guide for Food Dye publication. Educate yourself. Become a member of our organization by giving your donation today so that we may fund a study to determine the level of impurities commonly found in food color additives!