Health care update (RFK/Trump – nutrition policy)

Recent/upcoming developments… Since President-elect Trump’s selection of RFK Jr as his nominee for HHS Secretary, nutrition policy has been and will continue to take on an increased profile among policy makers.  Ahead of RFK’s confirmation hearings next year, RFK has begun holding meetings with Republican Senators to discuss his policy positions on a variety of issues, including around nutrition.  Amid those meetings, Senate Republicans announced the formation of the “Make America Healthy Again” caucus, which aims to enhance the Senate’s focus on nutrition and chronic disease prevention.  And separately, the Senate HELP Committee held a hearing to explore the FDA’s efforts to combat chronic disease, during which the issue of nutrition reforms found bipartisan support (at least in concept).

Our outlook… As with other areas of FDA policy (i.e., pharmaceuticals), we expect RFK to influence the Trump administration’s broader nutrition agenda.  However, it remains the case that RFK will be overseeing a litany of agencies and will be unable to engage in every aspect of policy.  Rather, it will be Trump’s FDA Commissioner nominee Marty Makary spearheading the granular nutrition policies at the FDA.  And for his part, Makary is largely aligned with RFK in the belief that (1) consumption of ultra-processed foods contributes to chronic health issues, (2) there is not enough oversight of food additives compared to other developed nations, and (3) consumers do not fully understand of what they are consuming.  In general, we anticipate these views will result in more ingredients subjected to pre-market review, an increase the number of ingredients banned from the market, more onerous labeling/marketing requirements, and an increase in enforcement actions.  However, retailers and food manufacturers are pushing back on this agenda, raising concerns regarding regulatory overreach and a lack of scientific justification – suggesting that the breadth/impact of what can be achieved may be blunted by legal and technical dynamics.  Below, we outline how Makary and RFK may change policy around nutrition and the scope of their authority.

* Regulation of Ingredients… As a technical matter, the FDA has the authority to subject food ingredients/additives to pre-market review and ban certain substances from the food supply.  This can be achieved through a variety of mechanisms, such as the Generally Recognized as Safe (GRAS process (which allows companies to avoid pre-market review if they can self-certify that substances are safe), the Food Additive Authority (which requires pre-market review of new additives to determine risk), and the Delaney Clause authority (zero-risk standard for carcinogens).  Groups aligned with RFK (i.e., CSPI, Children’s Health Defense) have called for these processes to be tightened such that manufacturers’ ability to self-certify ingredient safety under GRAS is constrained, scientific standards for evaluating risks are strengthened, and more ingredients are subject to review for carcinogenic effect – all of which would increase the number of ingredients subject to pre-market review and possible removal from market.  This authority, however, is constrained by the ability of the FDA to convincingly demonstrate that its decisions to limit or block the use of certain ingredients is backed by science and is not arbitrary/capricious (which would give rise to potentially compelling court challenges by industry).

* Regulation of Ingredient Levels… Under the Federal Food, Drug, and Cosmetics Act (FFDCA), the FDA has the authority to issue nonbinding, voluntary targets for added sugars and sodium content in food products.  However, it does not have the authority to mandate maximum levels of added sugars and sodium in foods.  RFK and Makary could revise the existing voluntary targets and use a public pressure campaign to induce industry compliance with those revised levels.  However, the implementation of mandatory limits on added sugars and sodium would likely face legal challenges from the food industry, which would (rightly) argue that such limits represent an overreach of FDA authority.

* Regulation of Food Marketing/Labeling… The Nutrition Labeling & Education Act (NLEA) grants the FDA authority to require nutrition labeling on most packaged foods and to regulate nutrient content claims and health claims on food labels to ensure they are accurate, not misleading, and consistent with established scientific evidence.  RFK and Makary could leverage this authority to update and strengthen standards for nutrient content claims, such as revising the definition of “healthy” to exclude foods high in added sugars or ultra-processed ingredients.  This authority can also be leveraged to alter the Nutrition Facts Label, such as by adding new line-items to those charts to provide more transparency.  However, there are First Amendment questions about whether this authority can be used to (for example) require new front-of-package labeling that warns of a product’s high sugar/sodium content or designates a product as ultra-processed.  Separately, RFK and Makary can use their authority under the Affordable Care Act (ACA, Section 4205) to expand menu labeling requirements at restaurants to include disclosures for added sugars and sodium.

* Enhanced Enforcement… RFK and Makary could push for increased enforcement against industry by leveraging the FDA’s misbranding and adulteration provisions under the FFDCA.  They could, for example, advocate for stricter oversight of misleading labels, such as claims like “natural” or “immune boosting,” by directing the FDA to conduct targeted audits and issuing warning letters to companies that fail to meet labeling standards.  They could also strengthen enforcement through random testing of food products for undeclared allergens, excessive contaminants, or unapproved additives, using the FDA’s authority under 21 U.S.C. § 342(a).  RFK and Makary could also expand the FDA’s compliance programs by increasing inspections and sampling of foods suspected of violating federal labeling or safety standards, particularly in areas such as added sugars and sodium misrepresentation or with respect to children’s foods (areas which RFK and to a lesser extent Makary have flagged as priorities).

Watch for these developments… With respect to the various policy changes noted above, the regulation of ingredients (i.e., pre-market reviews and the ability of the FDA to block or remove a product from market) is the most impactful for industry.  There are >10k chemicals and additives that are permitted in food in the U.S., so the agency will need to triage which of those it subjects to pre-market review and constrains/bans.  As such, we are watching for statements from RFK, Makary, aligned groups, and Congressional Republicans as to which ingredients are viewed as particularly problematic, as this would clarify the types of ingredients most likely to be scrutinized (and therefore the products most likely to be impacted by reviews/bans).  Additionally, we are watching for indications that pushback from industry is resonating with Republicans on the Hill, as this would increase the pressure on RFK and Makary to take a more measured approach to nutrition policy (i.e., only targeting ingredients/products where broad-based scientific concern exists).