Pediatrics Group Calls for Change in Food Additive Regulation

The American Academy of Pediatrics (AAP) is calling for reforms in the way food additives are regulated in the United States. The group wants a more rigorous and transparent “Generally Recognized as Safe” (GRAS) designation process, including new requirements for toxicity testing before additives are used in food that is made available to the public and re-testing chemicals that were approved previously.

In a news release, the AAP notes that the U.S. allows the use of more than 10,000 additives to preserve, package, or modify the taste, appearance, texture, or nutrients in foods. Many were grandfathered in for approval during the 1950s, and around 1,000 additives are used under a GRAS designation process that doesn’t require U.S. Food and Drug Administration (FDA) approval.

We went to a pair of our experts to learn more about the GRAS designation and how food additives are regulated. Dr. Carl Winter is a specialist in Cooperative Extension in Food Science and Technology at the University of California at Davis. Dr. James Hollis is an associate professor in the Department of Food Science and Nutrition at Iowa State University.

Can you give us a general explanation of how the GRAS designation works? Is the process viable?

Dr. Winter: This GRAS classification basically grandfathers in historically-used food additives as approved food additives without the need for additional toxicological testing. It is a controversial classification but one that has nevertheless streamlined the regulation of food additives in the U.S. In cases where additional toxicological information suggests an additive does not meet the GRAS criteria, the FDA is allowed to remove the GRAS classification. The burden for doing toxicological testing rests with others outside of the food additive manufacturer, however.

Dr. Hollis: Under the Federal Food, Drug and Cosmetic act, any food that is intentionally added to a food is viewed as a food additive. Food additives are required to undergo review and approval by the FDA before it is marketed. However, if a food additive can be shown to be safe under the conditions of intended use, to the satisfaction of a panel of experts, it is deemed generally recognized as safe (GRAS).

The AAP says the additives of most concern are bisphenols, phthalates, perfluoroalkyl chemicals, perchlorates, artificial food colors, and nitrates and nitrites. What’s the concern here?

Dr. Winter: As is the case with all chemicals in food, the key component is how much are consumers exposed and whether this level of exposure provides a sufficient buffer of safety. All of the above chemicals listed above obey the basic principle of toxicology, meaning that all can display toxicological effects at a high enough dose. This, by itself, is not justification for consumers to avoid foods containing such chemicals.

Dr. Hollis: While all chemicals are potentially toxic, it all depends on the dose. The level of exposure to food additives under normal use is highly unlikely to reach levels where toxicological effects appear. However, data exist that link several food additives with increased risk of chronic disease. For instance, nitrites and nitrates are food additives used to prevent the growth of pathogenic bacteria in processed meats. Studies have shown a modest association between dietary nitrite/nitrate and certain cancers. Other studies report that dietary nitrate is associated with reducing blood pressure and may reduce risk of cardiovascular disease. It is important to note that these studies only show an “association” between dietary nitrate/nitrite with these diseases and do not demonstrate that they are the causal factor in this relationship. At present, the data is imperfect, inconclusive and it is not possible to draw strong conclusions.

What’s your advice to parents who read about this policy statement? Are there steps they can take to play it safe?

Dr. Winter: The best thing parents can do is to make sure their children consume a healthy and balanced diet full of fruits, vegetables, and whole grains. The theoretical risks posed by GRAS food additives pale in comparison to the health benefits of eating a good diet. There are mechanisms in place to revoke GRAS status if sufficient evidence warrants such an action.

Dr. Hollis: Consuming a diet that meets dietary guidelines and includes a variety of fruits, vegetables and whole grains is key to good health. There are still some unanswered questions in this area but I don’t think parents should be unduly alarmed.

Food additives are regulated by the Food and Drug Administration. Typical levels of exposure are not likely to affect health. For children, eating a balanced diet with lots of fruit, vegetables and whole grains is the best way to be healthy.