FDA Amends Food Facility Registration Requirements | Practical Law

FDA Amends Food Facility Registration Requirements | Practical Law

The Food and Drug Administration (FDA) has published a final rule amending the agency's registration regulations for food facilities under the Food, Drug, and Cosmetic Act (FDCA). These amendments are part of the FDA's implementation of the Food Safety Modernization Act (FSMA).

FDA Amends Food Facility Registration Requirements

Practical Law Legal Update w-002-8122 (Approx. 4 pages)

FDA Amends Food Facility Registration Requirements

by Practical Law Commercial Transactions
Law stated as of 18 Jul 2016 • USA (National/Federal)
The Food and Drug Administration (FDA) has published a final rule amending the agency's registration regulations for food facilities under the Food, Drug, and Cosmetic Act (FDCA). These amendments are part of the FDA's implementation of the Food Safety Modernization Act (FSMA).
On July 14, 2016, the FDA published a final rule to implement provisions of the FSMA and amend the agency's food facility registration requirements under the FDCA (Amendments to Registration of Food Facilities, 81 Fed. Reg. 45912-01 (July 14, 2016)).
This final rule amends the FDA's registration rules by now requiring:
  • Registrations for domestic food facilities to contain the email address of the facility's contact person.
  • Registrations for foreign food facilities to contain the email address of the U.S. agent for the facility.
  • All food facility registrations to contain an assurance that the FDA will be permitted to inspect the facility at the times and in the manner the FDCA allows.
As part of this final rule, the FDA is also implementing an FSMA provision that authorizes the agency to require all food facility registrations to be submitted electronically. However, the FDA is delaying the date for mandatory electronic registration until January 4, 2020.
In addition to updating registration requirements, this final rule:
  • Clarifies that the definition of "retail food establishment" includes establishments for the:
    • sale of food products or food directly to consumers at a roadside stand or farmers' market when the stand or market is located other than where the food was manufactured or processed;
    • sale and distribution of food through a community supported agriculture program; and
    • sale and distribution of food at any other direct sales platform.
  • Improves the food facility registration database's utility by:
    • requiring certain additional data elements in food facility registrations, for example a unique facility identifier (UFI) for food facility registrations;
    • employing measures to verify certain information submitted in registrations; and
    • identifying additional circumstances under which the FDA will cancel registrations to ensure that the registration database is up-to-date.
This rule becomes effective on September 12, 2016.
For more information on the FDA's registration requirements for food facilities, see Practice Note, FDA Food and Dietary Supplement Regulations: Food Facility Registration Requirements and FDA Food and Dietary Supplement Regulations Checklist.