Whether you are in agreement or not, you shouldn’t be surprised. With the new administration’s direction having been communicated loud and clear directly and through media and social media outlets, any hope that it wouldn’t impact the food industry has been fruitless at best. And that impact has now come into play with RFK Jr’s “urgent desire” to chop artificial food coloring from foods and cut self-affirmed GRAS, along with the early March axing of two food safety advisory committees.
What impacts might we expect to see from these three eliminations? Following is TAG’s take.
The elimination of Artificial Dyes. In a meeting RFK held with top food company executives last week, he told them that the Trump administration held a “strong desire and urgent priority” to eliminate artificial colorings from foods. While stating that he wanted to work with industry on the initiative, he made it clear that he would take action himself if the industry wasn’t proactive in doing so. Exactly what action he expected of the industry, or how he would enforce it, wasn’t made clear (e.g., USDA, FDA or state regulation, association member guidelines, individual company formulation changes, etc.); nor was the action he would take if he were not satisfied with industry action. But it was emphasized that not only was it a priority, but it wouldn’t be the only action to be taken against “the worst ingredients” in food.
TAG’s Take: Again, this should come as no surprise, not only because RFK has promoted this stance since he came on the public scene, but also because additives, including numerous dyes, have been a focal point of state bans, with FDA joining the fray in January with a ban against the use of Red No. 3. While FDA’s stance on the ban did not appear to be in complete accord with the ruling, its Federal Register discussion of the rule indicates that more additive bans are likely to follow, as the FD&C “Delaney Clause” requires that color additive be deemed unsafe for any use which will or may result in ingestion of an additive, if the additive is found “to induce cancer when ingested by man or animal.” Thus, with even the de minimis finding of cancer in male rats falling under the clause, the industry should expect continued studies on additives, state bans, and consumer advocacy, all pushing further federal bans.
The elimination of Self-Affirmed GRAS. In an effort to promote “radical transparency” of food, RFK has directed the FDA to explore rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS option. Currently, companies can achieve GRAS designation for a substance in two ways:
- Submit a GRAS petition to FDA in which they indicate the safety of the substance by describing its intended use, target population, risks, and the science behind it. FDA reviews the scientific assessment, assigning GRAS if it is in agreement.
- Undertake a self-affirmed determination that the use of a substance is GRAS. Although the original intent was that this would involve the same scientific rigor as a submission to FDA, there is no requirement to share with FDA the result or that the process was undertaken.
It is that self-affirmation “loophole” that RFK intends to close, which would mean companies must publicly notify FDA of the intended use of a new ingredient, along with its safety data, before it could be introduced in the food supply. These submissions to FDA are also publicly available thus making the process more transparent.
TAG’s Take: Assuming that the elimination of self-affirmation goes through, RFK may also require that all GRAS substances currently in use through self-affirmation be submitted to FDA for official review; he may also go a step further to require that all substances grandfathered in with the 1958 FD&C Act Food Additives Amendment be reviewed as well. Should he go this route, FDA will need to have the resources to undertake the reviews in a timely manner. And given that the initial reason for the self-affirmation option was FDA’s assessment in 1997 that it “could no longer devote substantial resources to the GRAS affirmation petition process,” its ability to take on such a load today – particularly in reviewing any new requests as well as the existing self-affirmation and grandfathered substances – is highly questionable. However, it, like additives, is a topic that is unlikely to go away without some action. But this will promote new regulations and need a significantly more experienced head count at FDA, which is contrary to the general theme of the new Administration.
The elimination of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and the National Advisory Committee on Meat and Poultry Inspection (NACMPI). In 1992, the seven foundational principles of HACCP, which have become the basis for USDA, FDA, and global food safety standards and regulations since then, were presented for the first time. In 2024, a rule was finalized by USDA to declare Salmonella an adulterant in raw, breaded, and stuffed chicken products, which were disproportionately associated with outbreaks. If NACMCF and NACMPI had never existed, it is possible that neither the seven principles of HACCP nor the Salmonella regulation, as they are, would exist. Nor would numerous other regulations or food safety protections that form today’s food safety practices. With USDA, FDA, and CDC having extensively relied on the impartial advice and recommendations on science-based microbiological standards for food safety (NACMCF) and on meat and poultry inspection programs (NACMPI) for decades, their dissolution could have significant impact on the safety of the U.S. food supply.
TAG’s Take: With two TAG associates (David Acheson and Ruth Petran) having served on NACMCF for a number of years, they saw firsthand that the committee did a lot of good in analyzing the science and risk around food safety issues. NACMCF did not set policy, but helped inform regulators to make good policy. Thus, its elimination, along with that of NACMPI, is more disquieting. By impaneling the committees of impartial scientific experts to identify and address public health issues related to food safety in the U.S., and then advise the food agencies, FDA and USDA are freed up to focus on their inspection and enforcement responsibilities to ensure the practices are being implemented to keep consumers safe.
As a final TAG’s Take, we would say to simply expect such actions to continue. We said 2025 would be a year of change in the food industry, and at less than 3 months into the year, that is playing out to be very true.
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