FDA released a draft guidance today identifying additional food categories to be included as part of the mandatory registration program for any domestic or foreign facility that manufactures, processes, packs or holds food for human or animal consumption. The draft guidance acts on authority delegated by section 102 of the Food Safety Modernization Act (FSMA), which amends section 415 of the Federal Food, Drug & Cosmetic Act (FD&C Act) to allow FDA to require food facilities to register based on “other food categories” as determined appropriate by FDA, “including by guidance.”
The draft guidance differs from ordinary FDA guidance documents in that it will establish a binding requirement for food facilities to include the prospective food categories, as applicable, in their food facility registrations. The draft guidance explains that “[b]ecause of Congress’s explicit statutory authorization to establish a binding requirement based on a finding in guidance,” the document is not subject to the usual restrictions for guidance documents.
Under section 415(a)(2) of the FD&C Act, domestic and foreign food facilities must register by notifying FDA of the name and address of the food facility, the trade name under which it conducts business, an email address for a contact person, and the general food category of any food manufactured, processed, packed, or held at the facility. As of now, all general food categories are listed under 21 C.F.R. § 170.3. The draft guidance proposes to establish additional food categories, both for foods for human and animal consumption, which would be included as mandatory fields in the food facility registration form once the guidance was finalized.
According to FDA, the new categories would “enable FDA to quickly alert facilities potentially affected by [food-related emergencies] if FDA receives information indicating the type of food affected.” For instance, if FDA received information suggesting that a bioterrorist incident or other food-related emergency could affect dietary supplement manufacturers, then FDA would alert dietary supplement manufacturers, processors, packers and holders about the potential incident.
The draft guidance proposes both to add entirely new food categories (e.g., acidified food as defined in 21 C.F.R. § 114.3(b)) and break down existing food categories into more detailed categories (e.g., include “Soft, Ripened Cheese” as its own category within the larger Cheese and Cheese Product Category). FDA urges comments on the draft guidance to be submitted by September 14, 2012 so they can be considered before FDA begins work on the final version of the guidance.