Recently appointed U.S. Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. has instructed the Food and Drug Administration (FDA) to tighten food safety rules. The move could eliminate a key provision that allows companies to self-affirm that food additives are safe, which could have far reaching implications for the entire U.S. food supply chain.
The rule in Kennedy’s sites is the “self-affirmed GRAS” pathway. GRAS stands for “generally recognized as safe.” As currently written, the GRAS rule allows food companies to determine the safety of new ingredients. Self-affirmed GRAS status doesn’t legally require FDA review – instead, companies only need to conduct a safety assessment by a scientific panel, which can include both internal and external experts. Notifying the FDA is voluntary.
Created by a 1958 amendment to the 1938 Federal Food, Drug and Cosmetic Act, GRAS was intended to be narrowly applied to safe, commonly used ingredients such as garlic, oil, vinegar and baking soda. In 1997, however, an overwhelmed and underfunded FDA made the program voluntary, allowing industry to say a substance was GRAS without first providing safety data to the agency.
Since then, critics say, food manufacturers have introduced numerous untested additives into the food supply, many of which have later been identified as harmful.
One of these, brominated vegetable oil or BVO — a vegetable oil used in citrus sodas and sports drinks — was declared no longer GRAS in 1970. But the FDA did not officially ban the additive from use in the US food supply until July 2024.
“The FDA knew for decades that brominated vegetable oil, or BVO, would be harmful, but it was allowed to remain in use at the request of food manufacturers,” Illinois Secretary of State Alexi Giannoulias said at a September news briefing. Giannoulias was a coauthor of the Illinois Food Safety Act, which passed the Illinois Senate and is currently before the House of Representatives.
Tired of waiting for the FDA, other states have also acted. In October 2023, California banned four substances — BVO, potassium bromate, propylparaben, and red dye No. 3 — due to links with serious health concerns as cancer, endocrine and reproductive issues, and heart and liver problems.
The FDA banned red dye No. 3 in January, more than 30 years after scientists discovered links to cancer in animals. A synthetic color additive made from petroleum and chemically known as erythrosine, red dye No. 3 was used to give foods, candy, and beverages a bright cherry-red color.
Additional chemicals being targeted by legislative bills in 31 states include red dye No. 40; blue dye No. 1 and No. 2; green dye No. 3; yellow dye No. 5 and No. 6; titanium dioxide; and azodicarbonamide, a dough conditioner that is also used in yoga mats, according to the Environmental Working Group.
The GRAS rule has been criticized by watchdog groups as allowing the food industry to bypass safety checks. Some experts estimate that thousands of chemicals have entered the food supply without FDA oversight. Kennedy has long criticized GRAS as a “loophole” that allows ingredients with unknown safety concerns to enter the food chain.
If implemented, the proposed rule change would eliminate the voluntary provisions and mandate that companies seeking to introduce new food ingredients submit notifications, along with supporting safety data, to the FDA for review. The FDA said that would significantly increase the agency’s oversight and provide public access to information about new food additives. Acting FDA Commissioner Sara Brenner has pledged to cooperate with the directive, according to Kennedy.
Notably, the move could have major repercussions for producers of novel food ingredients, particularly those using non-traditional fermentation or cell cultivation technologies to create proteins used in faux-meat and dairy products.
Beyond food ingredients, the GRAS rule also provides an important pathway to commercialization for crops developed using biotechnology, such as CRISPR gene editing tools. Under current GRAS regulations, USDA does not regulate plants that could otherwise have been developed through traditional breeding techniques.
It’s not believed that Kennedy’s initial move to modify GRAS will impact such crops, though it could as biotech crops are technically considered food ingredients. The HHS leader has vowed to work with Congress to close the “GRAS loophole” completely, which would ultimately impact GM crop approvals.
It’s also not clear what losing GRAS might mean for companies that have already self-affirmed their products under the rule. For instance, will these self-affirmed ingredients be subject to new FDA scrutiny or possibly banned until new approvals are obtained?
Additionally, stakeholders are concerned about FDA’s ability to handle the extra workload amid steep cuts underway at the agency. The FDA has published more than 1,000 GRAS notices and evaluates approximately 75 notices every year. The new rules are expected to substantially increase the number of evaluations FDA will need to perform which could substantially raise the timeline and costs for businesses trying to bring new food products and crops to market. (Sources: UPI, Food Safety Magazine, Bloomberg Law)
