FDA Panel Rejects Warning Label on Food Dyes, Calls for More Research

The FDA advisory panel was convened to review the safety of eight dyes currently in use in foods: FD&C Blue 1 and 2; FD&C Green 3, Orange B, FD&C Red 3, FD&C Red 40, FD&C Yellow 5 and 6, followong a petition from the Center for Science in the Public Interest (CSPI).

4/1/2011 --- Although there is no clear indication that artificial food dyes cause hyperactivity or other behavioral problems in children, enough uncertainty exists to justify more research, an advisory panel has told the US Food and Drug Administration.

An expert panel voted 8-6 on against recommending a warning on the wide range of snacks, cereals, candy, beverages and other foods brightened with artificial colors, according to a Reuters report.

The FDA advisory panel was convened to review the safety of eight dyes currently in use in foods: FD&C Blue 1 and 2; FD&C Green 3, Orange B, FD&C Red 3, FD&C Red 40, FD&C Yellow 5 and 6, followong a petition from the Center for Science in the Public Interest (CSPI).

It also follows a mandatory labeling requirement that came into effect in the EU last year for products containing one or more of the “Southampton Six” azo-dye colors. Since mid-2010, every product containing Tartrazine (E102), Quinoline Yellow (E104), Sunset Yellow (E110), Carmoisine (E122), Ponceau 4R (E124) or Allura Red (E129) has to carry the warning notice “May have an adverse effect on activity and attention in children” on its packaging.

All but three of the 14 FDA panelists agreed that a causal relationship between dyes and hyperactivity has not been established. All but one voted to recommend more studies on the safety of color additives.

The panel's discussion frequently turned on whether the standard for action should be scientific certitude, which is clearly lacking, or enough evidence to prompt public health warnings.

The advisers called for more study to determine if the colors worsen hyperactivity in some kids, as a consumer group and other critics argue, keeping the door open on a debate that has concerned parents since the 1970s.

The International Food Information Council (IFIC) said in a statement that it supported FDA’s decision: “It was not surprised by the FDA Food Advisory Committee’s determination that artificial food colors do not cause hyperactivity in children. The scientific evidence currently does not show that food colors cause or exacerbate hyperactivity or other behavior problems in the majority of children."

The Grocery Manufacturers Association also commented on the safety of artificial colors:  “The safety of artificial colors has been affirmed through extensive review by the US Food & Drug Administration (FDA) (via the food additive review process) and the European Food Safety Authority (EFSA) and neither agency sees the need to change current policy.  All of the major safety bodies globally have reviewed the available science and have determined that there is no demonstrable link between artificial food colors and hyperactivity among children.  These expert evaluations were conducted by the European Food Safety Authority(EFSA); the US Food and Drug Administration (FDA); Food Standards Australia New Zealand (FSANZ); the United Kingdom Committee on Toxicity (of Chemicals in Food, Consumer Products and the Environment) (UK COT); the German Federal Institute of Risk Assessment (BfR); the Panel on Food Additives, Flavourings, and the Processing Aids, Materials in Contact with Food and Cosmetics of the Norwegian Scientific Committee for Food Safety.”

“GMA is comprised of producers, packagers and others who produce and sell food, beverages, and other packaged consumer goods.  Ensuring the safety of our products – and maintaining the confidence of consumers – is the single most important goal of our industry.  Product safety is the foundation of consumer trust, and our industry devotes enormous resources to ensure that our products are safe.  Our companies continuously review and monitor all emerging science and scientific studies and incorporate these as warranted into our manufacturing practices to help ensure that we are always producing the safest possible product for our consumers,” the statement concluded.

Dr. Michael Jacobson, executive director of the advocacy group, The Center for Science in the Public Interest (CSPI) said he was disappointed but pleased that the debate about the safety of artificial colorings had been renewed. “At least the FDA is now acknowledging that dyes affect some children,” he said. “That’s a big change.”