HHS directs FDA to close GRAS 'loophole': what it could mean for alternative proteins

The US Department of Health and Human Services (HHS) has announced a significant shift in food safety policy, directing the Food and Drug Administration (FDA) to explore rulemaking that would eliminate the ability of companies to self-affirm food ingredients as Generally Recognized as Safe (GRAS). The move, spearheaded by HHS Secretary Robert F. Kennedy Jr., aims to bring greater transparency and regulatory oversight to the food industry, a decision that could have far-reaching implications, particularly for alternative proteins and food innovation.

“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the US food supply without notification to the FDA or the public,” Kennedy said in a statement. “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”

The FDA currently allows companies to determine on their own that an ingredient is GRAS based on publicly available scientific data, without requiring formal notification or review by the agency. While the FDA maintains a voluntary GRAS Notification Program that has processed over 1,000 GRAS notices, industry remains free to bypass this process entirely by conducting its own safety assessments.

If the FDA moves forward with this rulemaking, companies seeking to introduce new food ingredients would be required to publicly notify the agency and provide underlying safety data before their substances enter the market. Acting FDA Commissioner Sara Brenner, M.D., M.P.H., emphasized the agency’s commitment to this initiative, stating, “The FDA is committed to further safeguarding the food supply by ensuring the appropriate review of ingredients and substances that come into contact with food.”

The proposed shift in regulatory oversight could have profound implications for the alternative proteins sector, which frequently relies on novel ingredients and processing technologies to develop sustainable meat, dairy, and seafood analogs. Many startups and established players in the space have used the GRAS self-affirmation process to bring innovative ingredients—such as precision-fermented proteins, cultivated fats, and plant-derived functional compounds—to market efficiently. A stricter FDA review process could significantly alter product development timelines, regulatory costs, and investment strategies for these companies.

For alternative protein companies, the ability to self-affirm GRAS status has provided a relatively quick and cost-effective path to market. If this pathway is removed, companies will need to undergo a formal FDA review, which could add months or even years to approval timelines. Additional safety testing and regulatory documentation requirements could further increase costs, making it harder for smaller startups to compete with well-funded incumbents.

Several alternative protein companies have recently pursued self-affirmed GRAS to accelerate market entry. Bon Vivant has sought GRAS status for its animal-free dairy proteins, while New Culture has done the same for its precision-fermented casein, enabling its animal-free mozzarella to closely mimic conventional cheese. Similarly, AQUA Cultured Foods has utilized self-affirmed GRAS to advance its fermentation-based seafood analogs, and Vivici has leveraged the process to bring its dairy proteins to market without waiting for prolonged regulatory approvals.

Many foodtech companies are working on groundbreaking formulations, including cultivated meat and precision-fermented dairy proteins, which often use ingredients with little regulatory precedent. Increased oversight could create a bottleneck in bringing these products to consumers, stifling innovation in a sector that is striving to meet global sustainability and food security challenges.

The regulatory uncertainty introduced by this potential rule change may also impact investor confidence in the alternative proteins space. Venture capital firms and institutional investors prioritize regulatory clarity when evaluating foodtech startups. If FDA approvals become more complex and time-consuming, companies may struggle to secure funding, delaying commercialization efforts. Some U.S.-based companies might also consider launching their products in other markets with more predictable regulatory pathways before seeking FDA approval.

While alternative protein companies could face new hurdles, traditional food manufacturers that already operate within highly regulated environments may see this as an opportunity to slow down disruptive competitors. Conventional meat and dairy industries, which have long resisted competition from plant-based and cultivated alternatives, may view stricter FDA oversight as a way to maintain their market dominance for longer.

Many food advocacy groups have long criticized the self-affirmed GRAS system, arguing that it allows companies to introduce ingredients into the food supply without sufficient independent oversight. However, industry stakeholders—including foodtech companies and trade associations—are likely to push back, emphasizing that eliminating the self-affirmation process could stifle innovation and limit consumer access to next-generation food products.

HHS has also signaled its intention to work with Congress to explore legislative options for closing the GRAS loophole permanently. Such legislative action, combined with FDA rulemaking, could bring about the most significant change in U.S. food ingredient regulation in decades.

For alternative protein stakeholders, the key questions now are: How will the FDA implement these changes? What will the timeline look like? And how can the industry work collectively to ensure that increased regulation does not hinder progress toward a more sustainable and resilient food system? The coming months will be critical in determining the future trajectory of food innovation in the USA.