FDA Cracks Down on 65-Year Loophole
Thousands of unvetted chemicals in US food supply to be disclosed for the first time, sparking transparency overhaul.
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FDA authorizes first wearable device to continuously monitor both ketone levels and blood sugar.
The FDA will accept public comments on the proposal for 120 days.
HHS submitted a proposed definition of ultra-processed foods for final review.
HHS also submitted a proposed definition of ultra-processed foods for final review.
HHS also submitted a proposed definition of ultra-processed foods for final review.
HHS submitted a proposed definition of ultra-processed foods for final review.
HHS also submitted a proposed definition of ultra-processed foods for final review.
HHS also submitted for final review the federal government's first proposed definition of ultra-processed foods, a separate initiative announced Monday alongside the GRAS rule change.
Story published. Thousands of unvetted chemicals in US food supply to be disclosed for the first time, sparking transparency overhaul.
The US Food and Drug Administration has proposed a rule requiring food manufacturers to notify the agency when they determine an ingredient is 'Generally Recognized as Safe' (GRAS), marking the first mandatory disclosure requirement for such additives in decades.
Under the proposal announced by the Department of Health and Human Services, companies would be required to submit data about how GRAS ingredients are used. Manufacturers with GRAS substances already on the market would need to inform the FDA for the first time how the additive is used, with that information made public in a database.
The GRAS designation was established in 1958 and was originally intended to allow common food ingredients like paprika, garlic and vanilla to bypass lengthy safety reviews and free up the FDA's limited resources. However, the FDA currently operates only a voluntary GRAS notification program, meaning manufacturers are not required to notify the agency when they determine an ingredient is GRAS.
This voluntary system has created what critics describe as a loophole. Thousands of chemical additives have entered the American food supply without any vetting of their health effects, leaving even the FDA uncertain about what food companies are putting in their products.
HHS Secretary Robert F. Kennedy Jr. has been a prominent critic of the GRAS loophole for years and has called for its closure. The proposed rule aligns with his administration's broader focus on food safety and transparency.
The proposal would give the FDA greater visibility into the substances used in human and animal food, allowing agency staff and outside researchers to begin identifying which additives may be harmful to human health. However, the rule would not establish a premarket approval system for GRAS substances, meaning companies would not need to prove existing additives are safe.
The FDA will accept public comments on the proposal for 120 days before any final rule is issued.
