FDA has issued guidance updating the food product categories that companies can select when registering as a food facility with the agency.
- Under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. must register with FDA. The registration requirement has been in effect since 2003. However, the Food Safety Modernization Act (FSMA) added new provisions to the FD&C Act related to the registration of food facilities. These new provisions were codified in a final rule published on July 14, 2016 (see previous blog coverage here).
- On September 26, 2016, FDA issued guidance updating the food product categories that companies can select when registering with the agency. Updates include:
- Acidified foods and low acid canned foods are no longer listed as food product categories because they are now activity types
- Additions to animal food categories of botanicals and herbs, direct fed microbials, animal protein products, forage products, human food by-products not otherwise listed and technical additives (The “animal protein products” category replaces the previous “animal derived products” category, and the “processed animal waste products” category replaces the “recycled animal waste products” category.)
- Molluscan shellfish is now a food product category (previously, molluscan shellfish establishment was listed among the optional activity types)
- The updated guidance explains that food companies will be required to select appropriate food product categories from the updated categories during the October – December 2016 registration renewal period. The guidance also explains that under certain FSMA amendments FDA is authorized to determine appropriate food product categories through guidance. More specifically, under section 415(a)(2) of the FD&C Act (as amended by FSMA), a food facility must submit to FDA a registration containing information about the general food category (as identified in 21 CFR 170.3 or any other food categories as determined appropriate by FDA, including by guidance) of a food manufactured/processed, packed or held at such facility, if the Agency determines through guidance that such information is necessary.
- Food industry stakeholders required to register with FDA should review and familiarize themselves with this newly-revised guidance and any potential implications for their businesses.