On July 26, 2021, Representative Jan Schakowsky (D-IL), Chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, introduced the Food Chemical Reassessment Act of 2021 (H.R. 4694), which would require the U.S. Food and Drug Administration (FDA) to study and reassess chemicals used in food. Representative Rosa DeLauro (D-CT) joined Schakowsky in introducing the legislation. According to Schakowsky’s July 26, 2021, press release, “thousands” of chemicals are added to food to make it “last longer, taste better, and look more enticing,” but most of these chemicals have entered the food supply through the Generally Recognized As Safe (GRAS) “loophole” and “have not been reevaluated for safety in decades.”

The bill would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to create an Office of Food Safety Reassessment (Office) within FDA’s Center for Food Safety and Applied Nutrition. Its purpose would be to reassess the safety of food additives, food contact substances, GRAS substances, and prior-sanctioned substances or classes thereof. Beginning in 2022 and at least once every three years, the Office would reassess the safety of at least ten of these substances. The Office would determine that a substance is safe within the meaning of FFDCA Section 409 and establish conditions of use, if any, under which the substance can be used safely, or the Office would determine that the substance is unsafe within the meaning of Section 409.

Under the bill, the first ten substances to be reassessed would be:

• Perfluoroalkyl substances and polyfluoroalkyl substances (PFAS);

• Ortho-phthalates;

• Tert-butylhydroquinone;

• Titanium dioxide;

• Potassium bromate;

• Perchlorate;

• Butylated hydroxyanisole (BHA);

• Butylated hydroxytoluene (BHT);

• Brominated vegetable oil (BVO); and

• Propyl paraben.

The bill would reestablish the Food Advisory Committee to advise the Secretary of Health and Human Services on the standards for reassessments and the process and methods necessary to complete the work of the Office.

The Food Chemical Reassessment Act of 2021 is endorsed by Environmental Working Group, Environmental Defense Fund, Consumer Reports, Center for Science in the Public Interest, Healthy Babies Bright Futures, Breast Cancer Prevention Partners, Defend Our Health, and Earthjustice.

Commentary

Because the bill was referred to a busy House Energy and Commerce Committee for action, and with no Senate companion legislation introduced to date, Bergeson & Campbell, P.C. suspects that the likelihood of this bill moving forward this year is low. Still, calls for FFDCA modernization continue to build, along with increased awareness about the chemicals in our food. Creating a new FDA Office of Food Safety Reassessment would be a significant undertaking for FDA; reestablishing a Food Advisory Committee would likely be noncontroversial. Proposals to “reform” the GRAS-listing procedures are not new, and even if this proposal is unlikely to be taken up in the near future, calls for revising current food additive requirements will continue. We will continue to update our clients and friends on this important issue.