• On February 15, 2026, Health and Human Services Secretary Robert F. Kennedy Jr. appeared on 60 Minutes, along with former FDA Commissioner Dr. David Kessler, to discuss plans to reform the so-called “generally recognized as safe (GRAS) loophole.”
    • In 1958, Congress amended the Federal Food, Drug, and Cosmetic Act to define the term “food additive.” Congress specifically excluded GRAS substances from the definition of “food additive” because such substances are “generally recognized, among experts qualified by scientific training and experience to evaluate [their] safety, as having been adequately shown . . . to be safe under the conditions of [their] intended use.”
    • Under the 1958 amendments, firms can make a GRAS determination without notifying FDA that a substance meets the requirements of the statute and regulations. Even under a “self-determined” GRAS position, a substance is still subject to the same safety standard as a food additive, i.e., “reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.” 21 CFR 170.3.
  • Kennedy stated that the GRAS exemption was “hijacked by the [food] industry” and used to introduce “thousands upon thousands” of ingredients into the U.S. food supply. He repeated the common misperception that there are only 400 food ingredients permitted in Europe, while estimates show that there are between 4,000 and 10,000 ingredients used in food in the U.S. Further, according to Kennedy, “[t]here is no way for any American to know if a product is safe if it is ultraprocessed.”
    • The “10,000” number originates from a 2011 research paper that overestimated the total number of substances used in food in the U.S., including pesticides, processing aids, and food contact materials and counted many substances more than once. On the other hand, the “400” number represents only a subset of food additives with an “E number” used in the European Union and does not include food contact materials, flavors and flavor preparations, colors from food, processing aids, pesticide residues, novel foods and foods grandfathered under the novel food regulation, i.e., those from before 1997. When counting the same categories of substances permitted in the U.S. and Europe, the numbers are similar. See “Debunking the U.S.-EU ‘Additive’ Divide: 10,000 Falsehoods.”
    • As mentioned above, all substances used in food in the U.S. are subject to the same safety standard, regardless of whether they are subject to a food additive regulation, GRAS regulation, GRAS notification, or self-determined GRAS position. 
  • Kessler stated that the prevalence of ultraprocessed foods in the American diet is “as large, if not larger” of a public health crisis compared to tobacco. He discussed his pending citizen’s petition calling for FDA to revoke the GRAS status of several processed refined carbohydrates, stating that certain ingredients are “subject to industrial processing” so that “our system can’t handle it.” Specifically, he called out corn syrup, corn solids, maltodextrin, dextrose, xylose, and high fructose corn syrup. Each of these ingredients is recognized as GRAS in the U.S.
  • Regarding Kessler’s petition, Kennedy stated that FDA intends to take action to answer its questions and review GRAS ingredients.