FDA Moves to Close 'GRAS' Loophole Allowing Food Additives Without Federal Notification

On August 10, 2026, the FDA proposed a rule to close the decades-old 'GRAS' loophole, requiring food manufacturers to notify the agency when they deem an additive safe. Part of the Trump administration's 'Make America Healthy Again' initiative led by HHS Secretary Robert F. Kennedy Jr., the rule shifts the program from voluntary to mandatory. While advocates welcome the transparency, industry groups warn of regulatory bottlenecks, and some experts argue the rule fails to address root causes of chronic disease.

GRAS loophole closure proposal

• ▪The proposed rule stops short of establishing a pre-market approval system for food additives, which would require an act of Congress to amend the Food, Drug and Cosmetics Act of 1938.
• ▪The U.S. Food and Drug Administration issued a proposed rule on August 10, 2026, to require food manufacturers to notify the agency when they deem a food additive to be Generally Recognized as Safe.
• ▪The proposed rule would shift the Generally Recognized as Safe standard from a voluntary notification program to a mandatory reporting system.

Mandatory manufacturer notification requirement

• ▪The proposal establishes a time-limited submission pathway for manufacturers to provide the Food and Drug Administration with information about existing uses of Generally Recognized as Safe substances already on the market.
• ▪An unpublished version of the regulation estimates the proposed rule will cost an average of $10.5 million annually, with the bulk of the cost falling on complying companies.
• ▪Under the proposed rule, the Food and Drug Administration will review new ingredient notifications within 45 days for legal compliance and complete a substantive review within 180 days.

Public food additive database

• ▪At least 111 substances of unknown safety have been added to U.S. foods, drinks, and supplements without alerting the Food and Drug Administration, according to a March 2026 study.
• ▪The proposed rule would expand a public inventory of Generally Recognized as Safe notices, allowing researchers and the public to see how additives are used and how safety was determined.

MAHA movement policy agenda

• ▪The proposed rule is part of the Trump administration's 'Make America Healthy Again' initiative led by Health and Human Services Secretary Robert F. Kennedy Jr. to address chronic disease and food safety.
• ▪The Department of Health and Human Services and the Department of Agriculture submitted the federal government's first proposed definition of ultra-processed foods for final review on August 10, 2026.

Industry pushback concerns

• ▪Nutritionist Marion Nestle and former FDA Commissioner David Kessler expressed concern that the proposal does not address the root causes of chronic disease, such as refined carbohydrates and sweeteners.
• ▪Food manufacturers and trade groups argue that tightening the rules will increase costs, disrupt supply chains, stifle innovation, and create a regulatory bottleneck at an understaffed agency.
• ▪Food industry groups, including the Consumer Brands Association, support federal legislation establishing national uniformity for ingredient safety and disclosure, including a mandatory notification process.