GRAS and fresh produce: Updates in the FDA world

Two updates on the food side of the FDA world this week: 

First, regarding GRAS, FDA proposed converting the current voluntary GRAS notification program into a mandatory GRAS notification program.  This is big, and we think that this is also potentially an enforcement signal. FDA has been focused on the GRAS issue since the new administration. From a transactional diligence perspective, this increases the importance of having a clear understanding of what is in the food product, and which ingredients rely on the self-GRAS affirmation framework. Manufacturers (and those that market in the U.S.) need to get safety documentation ready now, and it’s probably particularly relevant for foreign manufacturers due to various enforcement considerations.  

Second, and perhaps especially relevant these days considering the Cyclospora outbreak, FDA finalized guidance for manufacturers and processors of ready-to-eat fresh-cut produce under the Preventive Controls for Human Food rule. The guidance includes “recommendations” for minimizing biological hazards in fresh-cut produce, including recommendations addressing contamination risks throughout processing and distribution. Although FDA’s positions in guidance documents do not have the force of law, we expect that FDA will take the principles in the guidance into consideration during inspections and other regulatory activities. 

We are focusing on the first item in particular (regarding GRAS) because this has the potential to drastically change the legal framework regarding food in the U.S. The point is, manufacturers, importers, and distributors need to get ahead now and start thinking about how to respond, and should also consider whether the time-limited streamlined submission pathway that FDA referenced in the Federal Register Notice may be applicable to their business.