FDA Proposes Mandatory GRAS Notifications for the Food Industry

The FDA has proposed a significant change, transitioning from a voluntary notification programme to a mandatory requirement for substances that are deemed to be generally recognized as safe (GRAS) under section 201(s) of the FD&C Act. The aim of this rule (91 FR 51834) is to eliminate ‘information gaps’ caused by ingredients entering the US market without federal oversight.   

The FDA will prioritize substances for post-market review based on non-compliance with this mandatory notification. Notification is no longer just a transparency exercise. It should be seen as a vital step in mitigating enforcement risk.  

The proposed rule applies to all human and animal food substances introduced into US interstate commerce under the GRAS provision section 201(s) of the FD&C Act, including new substances and new uses; substances and uses that are already present in the food supply; direct and indirect food ingredients and food-contact substances claimed to be GRAS.   

Some exceptions to the mandatory rule are expected, which will not require a new GRAS notification. These include substances that are already covered by a ‘no questions’ letter, substances that are already recognized as GRAS by regulation (21 CFR parts 182, 184 or 186), animal food ingredients listed in the AAFCO 2024, and ingredients that are already on the US market and  would be part of a streamlined listing.

• Mandatory electronic filing by a Centralized Online Submission Module (COSM).  

• English language requirement 

• Compliance timeline: 18-month period following the effective date of the final rule to ensure full compliance.  

For ingredients already on the market with an independent GRAS conclusion, the FDA proposes a streamlined submission pathway, during the one-year period from the effective date. Submitters must provide:   

• submitter (name and address)  

• substance identity 

• conditions of use and evidence of prior presence in commerce.  

• any previous ‘Cease to Evaluate’ GRN file numbers.  

Please note that ingredients previously associated with ‘Cease to Evaluate’ letters are considered a higher priority for FDA review and will likely face heightened scrutiny.  

The FDA is planning to release the data collected from these submissions to the public through a database.  

  For Food Contact Substances (FCS), manufacturers must decide whether to submit a GRAS notice or utilize the existing Food Contact Notification (FCN) process.   

Ingredients described in Section 201(ff) of the FD&C Act that are intended strictly for dietary supplements remain excluded from this rule, as they are excepted from the ‘food additive’ definition in section 201(s).  

• Public comment deadline: 9 December 2026.  

• Effective date: the final rule would become effective 60 days after publication.  

• Compliance period for mandatory notification: 18 months from the effective date.  

• Subpart F streamlined submissions for substances already on the market : 12 months after the effective date.    

 While dietary supplements are not subject to this GRAS notification requirement, the FDA’s initiative indicates a move towards greater transparency, documentation and the regulation of ingredients entering the US market. Businesses should therefore assess their ingredient portfolios, review existing GRAS determinations, and identify any new obligations. A proactive approach now will be crucial in minimising compliance risks and maintaining consumer confidence.