FDA plans mandatory GRAS notification rule for food, feed ingredients by 2026

USA – The US Food and Drug Administration (FDA) is preparing to introduce a rule that will require all food and beverage companies to submit Generally Recognized As Safe (GRAS) notices for human and animal food ingredients starting in 2026. 

The move is intended to eliminate the long-standing practice of self-affirmation, under which companies can independently determine an ingredient’s GRAS status without informing the FDA.

Currently, the GRAS system operates on a voluntary notification process that began in 1997, replacing the older GRAS affirmation program. 

The FDA at the time explained it could no longer dedicate resources to lengthy reviews, which in the 1970s and 1980s sometimes stretched more than six years. 

The voluntary process allowed food manufacturers to self-affirm safety based on published scientific data, streamlining the introduction of new ingredients into the market.

However, critics, including consumer advocates and some policymakers, have argued that this approach creates a loophole for manufacturers to introduce chemicals without sufficient oversight. 

Former FDA officials have warned that companies have “exploited” the system, adding substances to the food supply with limited or uncertain safety data.

The new rule would formalise the FDA’s GRAS inventory and establish a process for determining when a substance does not qualify as GRAS. 

Substances already listed in the inventory, currently holding over 1,200 entries, or those that have received a “no questions” letter from the agency, will remain exempt. 

The FDA is supposed to respond to GRAS notices within 180 days, though in practice, reviews often take longer.

The proposal stems from a directive by the US Department of Health and Human Services to phase out self-affirmed GRAS determinations, creating a more consistent regulatory framework. 

Once published in the Federal Register, the rule will be subject to public comment before it can be finalised.

Hurdles foreseen

Still, legal experts caution that the FDA could face hurdles. Law firm Venable LLP noted in a client alert that the agency’s authority to mandate GRAS notifications may be challenged in court. 

They suggested that controversial changes could face delays or reversals, particularly as the FDA navigates internal restructuring and layoffs in food safety divisions.

If adopted, the rule would mark the most significant shift in food ingredient oversight in decades, signalling stronger federal involvement in ensuring food safety while raising new questions about the scope of regulatory authority.

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