Former FDA Commissioner Petitions for FDA Ban on UPF Ingredients

As we explained previously, the FDA and USDA issued their Request for Information (RFI) on July 25 to solicit public input with the goal of establishing a federally recognized uniform definition for ultra-processed foods. Noting that the US faces a growing epidemic of preventable diet-related chronic diseases, the FDA and USDA stated that research has linked consumption of UPFs to a range of negative health outcomes, with some researchers estimating that more than half the calories consumed by adults and children in the United States are from UPFs. Per the RFI, the FDA and USDA are seeking data and information that would enable them to define UPFs to allow for consistency in research and policy.

Against this backdrop, on August 6, former FDA Commissioner Dr. David Kessler sent a letter to US Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr., and filed a citizen petition with the FDA regarding the use of specific ingredients in UPFs.

In his letter, Dr. Kessler notes that the Secretary has “made UPFs a central focus of [his] health agenda and argued that the increased intake of [UPFs] is a ‘primary culprit’ behind an epidemic of chronic diseases in the U.S., including obesity, diabetes, autoimmune diseases, and some cancers.” Furthermore, Dr. Kessler states, the Secretary has “called for curbing of [UPFs] in our food supply.” Dr. Kessler asserts that his citizen petition “provides a realistic, science-based, and legally sound path for the Administration to do just that.”

Broadly speaking, Dr. Kessler’s petition calls on the FDA to remove processed refined carbohydrates from the food supply on the basis that they should no longer be considered generally recognized as safe (GRAS). More specifically, the petition focuses on the regulatory status of the following substances.

• Refined sweeteners, including corn syrup, glucose syrups, dextrose, high fructose corn syrups, and maltodextrin.

• Refined flour and starches that are subjected to food extrusion technology, including wheat, corn, tapioca, oat, and potato flour.

• Sucrose, refined flours, or starches that are used with emulsifiers, dough conditioners and strengtheners, humectants, stabilizers, and gums, or modified starches and fillers.

Per Dr. Kessler, such processed refined carbohydrates are the “primary causal determinants of metabolic harm” and, “[i]n light of the substantial concerns regarding the safety of processed refined carbohydrates, there is no longer a basis for finding that these products are GRAS.”

It is worth noting that the citizen petition specifically does not cover flour, table sugar (sucrose), starch, salt, or corn syrup when used at home.

Among other things, the citizen petition requests that the FDA:

• Declare that it no longer considers the use of the processed refined carbohydrates identified in this petition to be GRAS based on the likelihood that they contribute to metabolic harm.

• Promptly initiate proceedings to revoke any existing GRAS regulation for these processed refined carbohydrates used in industrial processing.

• Inform industry that continued use of these products depends on the industry notifying FDA within 12 months of its intent to file a food additive petition.

• Remove these products from commerce unless their use in food is authorized by a food additive petition.

Much of the remaining 66 pages of the citizen petition cover the basis for these requests, including the current state of US food consumption, the role of processed refined carbohydrates, the impacts of UPFs and processed refined carbohydrates, the legal requirements for GRAS status, and the scientific evidence demonstrating that processed refined carbohydrates should no longer have GRAS status.

Under the federal regulations governing citizen petitions, the FDA has 180 days to respond to Dr. Kessler’s requests. In practice, however, the agency often takes far longer to provide a substantive response, especially when petitions — such as this one — touch upon controversial and/or hotly contested policy issues. In determining how to respond to Dr. Kessler’s citizen petition, the FDA may be forced to decide just how far, and over what issues, it’s willing to fight with the trillion dollar food industry. The agency’s, and Administration’s, decision remains to be seen.

If you are interested in more information about the FDA/USDA RFI, Dr. Kessler’s citizen petition (including the submission of a comment on the docket), or guidance on the regulation of food products in the United States, please contact the authors or any member of ArentFox Schiff’s Food, Drug, Medical Device & Cosmetic group.