FDA Mandates Ingredient Disclosure With 45-Day Review Window

The FDA proposed a rule Monday requiring food companies to notify the agency of new ingredients and disclose why they consider them safe, closing a self-verification loophole dating to the 1950s.

"We cannot reverse America's chronic disease epidemic without transforming our food system," Robert F. Kennedy Jr., Health and Human Services secretary, said in a statement.

The rule would require companies to submit a notice of a new ingredient and inform the FDA it has been determined safe. The agency would review the notification within 45 days for completeness and substantively within 180 days. Kennedy said nearly 60 percent of the American diet is made up of ultraprocessed foods, and childhood obesity affects more than one in five American children.

The change is more limited than some advocates sought — acting FDA Commissioner Kyle Diamantas said blocking ingredients before agency signoff would require Congress to update the Food, Drug, and Cosmetic Act. Food industry groups have fiercely opposed a federal definition of ultraprocessed food, worried state legislators will use it to impose new requirements or bans.

The proposed rule updates the Generally Recognized as Safe, or GRAS, standards that since the 1950s have let food companies self-verify that ingredients are safe without seeking agency approval or notifying the public. Under the new framework, companies would notify the FDA of new ingredients shortly after going to market, and the agency would gain authority to conduct post-market reviews of ingredient safety.

Health officials said they would also make public the information companies provide about new ingredients, a change that will let food industry watchdogs and other groups scrutinize changes to the U.S. food supply more closely.

GRAS Reform Stops Short of Premarket Approval

Diamantas stressed the rule creates a postmarket review and transparency system rather than a premarket approval process. Companies would not be blocked from entering the market before notifying the FDA, and it was unclear what enforcement mechanism the agency would use to ensure notices are submitted, which Diamantas called mandatory.

The FDA commissioner said Congress would need to intervene to update the Food, Drug, and Cosmetic Act to give the agency authority to conduct premarket ingredient approvals. Both the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee have advanced food reform legislation this session, including updating GRAS standards and labeling requirements for levels of salt, sugar, and saturated fats in ultraprocessed foods.

Ultraprocessed Definition Delayed Again

Health officials gave no timeline for the proposed definition of ultraprocessed food, saying only that the draft is still being reviewed by other agencies. Kennedy had told podcast host Joe Rogan he would release the definition in April, with the goal of using it for food labels that would help Americans choose what to eat.

Food industry groups have fiercely opposed a federal definition because they worry state legislators will use it to put new requirements or bans on certain foods. Companies have had mixed opinions about the ingredients regulatory effort, since some have pushed Congress to pass rules that could pre-empt a patchwork of state laws. Concerns about the affordability of groceries slowed both efforts as White House officials debated them.

The FDA also publicized final guidance on microbiological food safety aimed at helping companies improve compliance for fresh-cut produce during multiple foodborne infectious disease outbreaks. The guidance clarifies supply chain control and provides additional time and temperature control recommendations to reduce the risk of pathogen growth and spread. The multistate outbreak of cyclospora, a parasite that causes gastrointestinal distress, has constricted sales of prewashed salads and berries, while eggs and jalapenos have been recalled across several states due to a salmonella outbreak.

The push for nutrition reform from the Make America Healthy Again movement marks a departure from the laissez-faire posture toward food corporations from the pre-Trump era GOP. In the 2010s, Republicans denounced Democrat-led food reform initiatives as government overreach, such as proposed restrictions on soda from then-New York Mayor Michael Bloomberg and the activity and nutrition campaign of then-first lady Michelle Obama. Following the COVID-19 pandemic, voters in both parties have shown an increased appetite for imposing regulations on major food corporations.

The rule, if finalized, would add regulatory steps for companies introducing new ingredients, though the postmarket review process in theory creates a lower burden than the preapproval system some MAHA advocates sought. Food companies are likely to protest the added steps. The delayed ultraprocessed definition leaves the packaged food industry facing ongoing uncertainty about future labeling and reformulation requirements.

This article is for informational purposes only and does not constitute investment advice.