Tom Neltner, J.D., Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant
Update: FDA published the citizen petition upon receipt on 9/23, and is requesting public comment.
More than 60 years ago, Congress enacted legislation requiring the Food and Drug Administration (FDA) and the food industry to evaluate the cumulative effects of substances in the diet that have related health impacts when assessing the safety of chemical additives. In our decade of analyzing FDA and industry actions, we have been increasingly concerned that both have ignored this requirement. To figure it out, we investigated all safety determinations contained in Generally Recognized as Safe (GRAS) notifications voluntarily submitted by food manufacturers to FDA since the program began in 1997. We looked at GRAS notices because they are publicly available and because FDA rules explicitly require that food manufacturers include in the notice an explanation of how they considered the requirement. If there was an omission, it would be more easily noticeable.
We found that in only one of 877 GRAS notices did a food manufacturer consider the cumulative effect requirement in a meaningful way. And we found no evidence that the agency either recognized this single attempt to follow the law or had objected to the omissions in the 876 other notices. This failure has significant consequences for public health, particularly for communities who already face significant health and socio-economic disparities, and for children, who are uniquely susceptible to dietary exposures to multiple chemicals.
For this reason, EDF joined with other health, environmental, and consumer groups to file a formal petition to demand FDA and food manufacturers start following the law. The petition requests specific changes to rules designed to reinforce the existing requirement and make it easier to verify compliance. Still, given the lack of transparency in agency reviews, success still largely depends on FDA and the food industry taking seriously the mandate and the food safety implications.