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Quick Minutes: Food Advisory Committee Meeting March 30-31, 2011

Food Advisory Committee Meeting Minutes
March 30-31, 2011

Certified Color Additives in Food and Possible Association with
Attention Deficit Hyperactivity Disorder in Children

Executive Summary

On March 30-31, 2011, the Center for Food Safety and Applied Nutrition (CFSAN) convened a meeting of the Food Advisory Committee (Committee) to consider available relevant data on the possible association between children's consumption of synthetic color additives in food and adverse effects on behavior. Please note that the presentations, Committee discussions, the Committee responses to questions posed by CFSAN and public testimony are recorded in the transcript of the meeting. A summary of the Committee responses to the questions also is provided in the Summary Minutes.

The Committee heard presentations on the following:

  • presentations on how color additives are regulated and safety decisions made;
  • the legal framework for labeling;
  • symptoms and diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD);
  • studies on hyperactivity and other adverse behaviors in children and the consumption of synthetic colors in food;
  • the limitations in methodologies of relevant studies and the challenges of conducting clinical trials; and
  • current acceptable daily intake levels and estimated exposure levels.

At the conclusion of the presentations, one hour was devoted to hearing from public stakeholders. During the Open Public Hearing, members of the Feingold Association, representatives of various trade associations, two physicians, a registered dietician, and other interested individuals spoke.

The Committee began deliberations on the charge and questions during the afternoon of the second day of the meeting. The Committee made the determination that relevant scientific data did not support a causal link between consumption of certified color additives in food and hyperactivity and other problematic behaviors in children. The Committee suggested that additional safety studies, such as developmental neurotoxicity testing of the color additives, be conducted and that a robust intake estimate be calculated. Additionally, 57% of the members of the Committee voted against additional labeling requirements for foods that contain certified color additives.

Quick Minutes 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
FOOD ADVISORY COMMITTEE MEETING

Certified Color Additives in Food and Possible Association with Adverse Effects on Behavior in Children

Wednesday, March 30, 2011, through Thursday, March 31, 2011

The Hilton Hotel
8727 Colesville Road
Silver Spring, Maryland 20910

PARTICIPANTS

Food Advisory Committee Standing Members:
Gary Acuff, Ph.D. – Acting Chairperson
Barbara Blakistone, Ph.D. (industry representative)
A.Wesley Burks, M.D.
Penelope Fenner-Crisp, Ph.D.
Maria Luz Fernandez, Ph.D.
Jeanne Freeland-Graves, Ph.D.
Charles Gerba, Ph.D.
George Gray, Ph.D.
Tim Jones, M.D.
Lisa Lefferts, MSPH (consumer representative)
Joan Menke-Schaenzer  (industry representative)
Duc Vugia, M.D.
Christopher Waldrop (consumer representative)
Carl Winter, Ph.D.

Temporary Voting Members:
F. Xavier Castellanos, M.D.
Charles Vorhees, Ph.D.

Food Advisory Committee Members Not Present:
Edward Kennelly, Ph.D.
Michael Msall, M.D.
Philip Nelson, Ph.D. (recused)

Food and Drug Administration:
Jason Aungst, Ph.D.
Mitchell Cheeseman, Ph.D.
Jessica P. O'Connell, J.D., M.P.H.      
Teresa Croce, Ph.D.
Angela Evans
Judith Kidwell
Linda Katz, M.D., M.P.H.
Donald Kraemer
Donna Robie, Ph.D.
Scott Thurmond, Ph.D.
Harold Woodall
Andrew Zajac

Designated Federal Official:
Carolyn Jeletic

Invited Speakers (March 30, 2011):
Mitchell Cheeseman, Ph.D.
Jessica O'Connell, J.D., MPH
Michael Jacobsen, Ph.D.
Bernie Weiss, Ph.D.
Shula Edelkind
Andrea Chronis-Tuscano, Ph.D.
Jim Stevenson, Ph.D.
David Schab, M.D.
L. Eugene Arnold, M.D., M.Ed.

Invited Speakers (March 31, 2011):
Sean Taylor, Ph.D.,
Jason Aungst, Ph.D., FDA

FDA Charge to the Committee

The Food Advisory Committee was asked to consider available relevant data on the possible association between consumption of certified color additives in food and adverse effects on behavior in children

March 30, 2011

Dr. Gary Acuff, Acting Chairperson, welcomed the Committee and introduced the members.

Ms. Carolyn Jeletic, the Designated Federal Official/Executive Secretary, read and explained the conflict of interest statement.

Mr. Donald Kraemer, Acting Deputy Director for Operations, Center for Food Safety and Applied Nutrition (CFSAN), welcomed the Committee members on behalf of FDA, thanked them for their service, and presented the issue before the Committee for consideration.

Dr. Mitchell Cheeseman, Acting Director, Office of Food Additive Safety, CFSAN, provided an overview of FDA's Safety Assessment of Color Additives. He discussed how color additives are regulated and how safety decisions are made, citing a standard from legislative history that "requires proof of a reasonable certainty that no harm will result from the proposed use of an additive……".2 Dr. Cheeseman explained the following: 1) that safety decisions do not weigh benefits, 2) are made under some level of uncertainty, and 3) can and may be reconsidered based on new information that raises serious questions related to intended use.

During discussion, the Committee asked Dr. Cheeseman questions about the safety assessment for certified color additives and the batch color additive certification process. There also was discussion about the legal standard for determining safety.

Dr. Cheeseman's presentation was followed by Ms. Jessica O'Connell, an attorney in FDA's Office of Chief Counsel, who explained the legal framework for food labeling. Ms. O'Connell stated that a product is misbranded if its labeling is false or misleading, that labeling can be misleading if it fails to reveal facts that are material with respect to consequences that could result from the use of the article, and FDA has the authority to require additional information (e.g., a warning statement) in food labeling to ensure that the labeling is not false or misleading.

Following Ms. O'Connell's presentation, the Committee asked questions on the criteria for warning statements on labels.

The first two presentations of the day were followed by presentations by Dr. Michael Jacobson, petitioner and Executive Director of the Center for Science in the Public Interest (CSPI), Dr. Bernard Weiss of the University of Rochester, and Ms. Shula Edelkind of the Feingold Association, who presented their positions and interpretations of investigations on synthetic color additives and hyperactivity in children. Dr. Weiss stated that the current data demonstrate that consumption of certified colors may adversely affect behavior in some children and may have adverse effects on the general population. Mike Jacobsen stated that certified color additives are not necessary ingredients in the food supply. Ms. Edelkind questioned whether a dose-response relationship could be observed between a challenge with food dyes and the percentage of children reacting to the challenge.

The Committee asked questions about available clinical studies and asked for clarification on data from these studies and the conclusions drawn by the presenters.

The next speaker, Dr. Andrea Chronis-Tuscano, Associate Professor and Director of the ADHD Program at the University of Maryland, provided an overview of ADHD. Dr. Chronis-Tuscano presented information on diagnostic criteria, prevalence, symptoms, etiological factors, and treatments for ADHD.

The Committee asked Dr. Chronis-Tuscano questions about prevalence of ADHD, diagnosis of the disorder, and dietary treatments.

Following lunch, Dr. Jim Stevenson, Emeritus Professor in the School of Psychology at the University of Southampton, provided an overview of the Southampton Study. Commissioned by the U.K. Food Standards Authority, the study investigated whether mixtures of synthetic colors and a sodium benzoate preservative when consumed in a beverage by three-year-old and eight- and nine-year-old demographically-representative sample of children (not preselected for ADHD or purported responsiveness to food additives), promoted hyperactivity-related behaviors, including a composite index. Dr. Stevenson addressed questions about the study by FDA and other regulatory authorities, including the use of a global hyperactivity measurement based on parent teacher ratings, and the rationale for the use of adding sodium benzoate in the color additive mixtures. He stated that some mixtures of synthetic color additives and sodium benzoate may affect the level of hyperactive behavior in children, but noted that removal was not a panacea for ADHD.

Following Dr. Stevenson's presentation, the Committee asked a series of questions about methodology, measurements, dose selection, and interpretation of results. The Committee asked, if because only mixtures of colors were tested, it was possible to determine whether the effects observed in the study were due to a particular color, sodium benzoate, or a combination of ingredients.

Dr. David Schab, Assistant Clinical Professor in the Department of Psychiatry at Columbia University, presented his 2004 meta-analysis of a number of double-blind placebo-controlled clinical trials on consumption of color additives by children diagnosed with ADHD. Dr. Schab noted an error in his original analysis of one study that led to a slight revision of a plot. This revision did not alter the meta-analysis of findings suggesting "that administration of food dyes to kids with underlying broadly-defined hyperactive syndromes does seem associated with further hyperactivity."

The Committee asked Dr. Schab to elaborate on study selection and statistical analyses of his results.

Next, Dr. L. Eugene Arnold, Professor Emeritus at Ohio State University and past member of the Advisory Board for the non-profit organization Children and Adults with Attention Deficit/ Hyperactivity Disorder (CHADD) discussed possible causes of ADHD and how diagnoses are made. He stated that the causes are multifactorial and presented CHADD's view that compelling scientific evidence linking food dyes to the cause of ADHD does not appear to exist and that "there may be a subset of children with a hypersensitivity to certain foods or food additives that result in an increase in activity level and/or inattention."

Following a series of questions by the Committee members to Dr. Arnold, the meeting recessed for the day at 5:24 PM ET.

March 31, 2011

The second day of the meeting began at 8:32 AM ET with a call to order and a few introductory remarks by Dr. Acuff.

Dr. Sean Taylor of the International Association of Color Manufacturers (IACM) presented the Safety and Benefits of Food Colors. He discussed limitations in the Southampton Study, including the lack of clear statistical significance of observed effects. He presented toxicological data, including Acceptable Daily Intakes (ADIs), on certified color additives and reviewed the opinions of several international food safety authorities and discussed differences in US and European food labeling.

The Committee asked Dr. Taylor several questions about the basis for setting ADIs, present knowledge on pharmacokinetics of the additives, exposure calculations, and industry support of additional safety studies. Dr. Taylor stated that industry would support conducting additional safety studies if given guidance on methodology that would be accepted globally.

Next, Dr. Jason Aungst, a neurotoxicologist in FDA's Office of Food Additive Safety, gave a presentation summarizing FDA's review of the data related to consumption of color additives and hyperactivity in children. He discussed the review procedure as well as the evaluation and interpretation of clinical studies involving elimination diets and artificial food color challenges. Dr. Aungst presented FDA's conclusion that the studies suggest that artificial food colors are not neurotoxic in children, but that there may be a predisposition for food intolerance or hypersensitivity in certain children.

The Committee asked Dr. Aungst questions about the criteria used to evaluate relevant clinical studies on potential adverse effects of color additives. One Committee member questioned whether available safety studies conducted on these additives adequately evaluate adverse behavioral effects.

Following questions for Dr. Aungst by the Committee members, Dr. Acuff commenced the public comment portion of the meeting. Ms. Carolyn Jeletic read into the record the statement regarding FDA's policy about disclosure of financial relationships for public comments. The following members of the public made oral presentations:

Renee Shutters, member of the Feingold Association
Amy Yutter, member of the Feingold Association
Ed Takken, Ph.D.
Will Fisher, Institute of Food Technologists
Mai Jack, Grocery Manufacturers' Association
Keith Ayoub, EdD, RD, FADA
Maureen Lamm, M.D.
Jorma J. Takada
Karen Lynett Bauer, M.D.
Betty Douglas, member of the Feingold Association
Dave Schoneker, Colorcon
Eric Hentges, International Life Sciences Institute, North America

Following the public comment session and a break for lunch, the Committee deliberated on the questions presented by FDA. First, Dr. Acuff read the charge to the Committee:

Charge: The task before this Food Advisory Committee is to consider available relevant data on the possible association between consumption of certified 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 Committee proposed and agreed to change the language of the charge to reflect a broader scope (i.e., other adverse effects on behavior and not limited to hyperactivity). Dr. Cheeseman concurred with the Committee's proposed revision of the charge.

The Committee Responses to FDA's Questions:

  1. In the review of published research presented in the "Overview and Evaluation of Proposed Association Between Artificial Food Colors and Attention Deficit Hyperactivity Disorders (ADHD) and Problem Behaviors in Children3," studies were evaluated based on the criteria described in Part III of the review. Were these review criteria appropriate in the evaluation of these studies? Should the criteria be modified in any specific way, and if so, how and what is the basis for the committee's recommendation? Are there other criteria or other studies that should be considered, and if so, what is the basis for the committee's recommendation?

    The Committee members discussed the criteria that FDA selected and the merits of additional criteria for inclusion in their review. Two Committee members suggested that application of Bradford Hill criteria would have been a useful tool for the FDA review.

    The committee members were asked to address each portion of this question separately.

    • Were these review criteria appropriate in the evaluation of these studies?

      The Committee members voted 93 percent (%) yes; 7% no.

    • Are additional criteria needed?

      The Committee members voted 57% yes; 43% no.

  2. Do the current relevant data support FDA's conclusion, as set forth in the September 1, 2010 Interim Toxicology Review Memorandum, that a causal relationship between consumption of certified color additives in food and hyperactivity or other adverse effects on behavior in children in the general population has not been established?

    The Committee discussed whether there was sufficient scientific evidence to support a causal relationship between hyperactivity and consumption of the color additives.

    The Committee members voted 79% yes; 21% no.

  3. The National Institutes of Health's 1982 Consensus Development Panel on defined diets and childhood hyperactivity concluded that for some children with both ADHD and a confirmed food allergy, dietary modification has produced some improvement in behavior.4 The Panel recommended that elimination diets should not be used universally to treat childhood hyperactivity (with or without the presence of food allergies), since there is no scientific evidence to predict which children may benefit. The Panel, however, also recognized that initiation of a trial of dietary treatment or continuation of a diet in patients whose families and physicians perceive benefits may be warranted. Are these conclusions and recommendations still relevant today in light of subsequently published studies, especially as those conclusions and recommendations apply to certified color additives?

    Committee members noted that elimination diets had not been reviewed or discussed, since its focus was on color additives. It proposed and agreed to revise this question to reflect that their response is based on data from the clinical studies presented in FDA's report. The proposed revised question was, "Would the Committee recommend that elimination diets should not be used universally to treat childhood hyperactivity and that dietary treatment in patients whose families and physicians perceive benefits may be warranted?"

    The Committee members voted 93% yes; 7% no.

  4. Under current FDA regulations, the label of any food to which a certified color additive has been added must declare the color additive as an ingredient by its certified name (e.g., FD&C Yellow No. 5). In light of the scientific evidence presented to the Committee concerning the consumption of certified color additives in food and hyperactivity in children, what additional information, if any, should be disclosed on the product label of foods containing certified color additives to ensure their safe use in food?

    The Committee discussed FDA's legal authority for food labeling and possible alternatives to labeling, such as appropriate consumer information on FDA's website. The Committee also discussed labeling efforts from a historical perspective, such as California's Proposition 65 labeling requirements and its impact on consumers.

    Voting Question presented to the Committee: Should additional information be disclosed on the product label of food containing certified color additives to ensure their safe use?

    The Committee members voted 43% yes; 57% no.

  5. Regarding the possible association between consumption of certified color additives and hyperactivity in children, are additional studies necessary to address any questions that have been raised as to whether, and under what conditions, the continued use of these certified color additives is safe? If so, what type of studies?

    The Committee discussed additional data needs, including developmental toxicity testing and a robust intake estimate.

    Voting Question to the Committee: Regarding the possible association between consumption of certified color additives and hyperactivity in children, are additional studies necessary to address any questions that have been raised as to whether, and under what conditions, the continued use of these certified color additives is safe?

    The Committee members voted 93% yes; 7% no.

The meeting adjourned at 4:04 PM ET.

Respectfully submitted:  Gary Acuff, Ph.D. Acting Chairperson, Food Advisory Committee

I certify I attended the March 30-31, 2011, meeting of the Food Advisory Committee, and these summary minutes accurately reflect what transpired.

 

/Carolyn.Jeletic/______________6/9/2011___________
Carolyn Jeletic                                Date
Designated Federal
Official/Executive Secretary

/Gary.Acuff/_________________6/9/2011___________
Gary Acuff, Ph.D.                           Date
Acting Chairperson


1The entire meeting was open to the public. A verbatim transcript of the meeting will be made available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/FoodAdvisoryCommittee/ucm149740.htm

2 HR Report No. 2284, 85th Congress 1958

3 Provided in background materials for Committee members.

4 National Institutes of Health. Defined Diets and Childhood Hyperactivity: NIH Consensus Development Conference Statement. 1982 (Jan 13-15).