FDA Issues Final Compliance Policy Guide on Food Facility Registration for Food and Dietary Supplements

July 23, 2014 By

In June 2014, the FDA has announced the release of the final compliance policy guide for food facility registration entitled “Compliance Policy Guide Sec. 100.250 Food Facility Registration – Human and Animal Food”.   This final guide replaces the “Compliance Policy Guide Sec. 110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.”

The final compliance policy guide has not seen any significant changes from the comment period beginning April 2013. Only two comments were received during the comment period and did not recommend any significant changes to the draft guidance document.

The food facility compliance guide provides guidance for FDA staff and industry regarding the enforcement of the food facility registration provisions of section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was amended by the FDA Food Safety Modernization Act (FSMA). The requirements of the food facility registration process applies to all food facilities that manufacture, process, pack, or hold food for human and animal consumption in the U.S. These requirements include that registered facilities biennially renew their registrations with FDA. These requirements also still apply to all foreign facilities outside of the U.S that manufacture, process, pack, or hold food intended for human and animal consumption in the U.S.

Food products offered for export or import into the U.S. from foreign facilities that are not registered will not be permitted to enter until the foreign food facility is registered. Food products from a non-registered facility would not be considered misbranded unlike drug products, where if the drug facility is not registered then the drug product would be deemed misbranded at the border and refused entry. It is within FDA’s authority to suspend a facility registration and if a food facility registration has been suspended, then no person shall export or import food from the facility into the U.S. during the suspension period.

Food facilities that do not renew biennially will have expired registration numbers and will not be able to import or export until the registration has been re-instated. If a domestic facility with an expired license offers food products into intrastate or interstate commerce, then the FDA may take enforcement actions such as administrative detention, seizure, injunction, mandatory recall, prosecution, or a combination of such actions, as appropriate. Some examples of cases that could warrant a suspension of a food facility registration are as follows:

  • Inspectional or other evidence indicates that the firm has significant violations of the FD&C Act and has not permanently corrected the source of the problem.
  • The firm is subject to an emergency permit order under 21 CFR part 108 or the District or Center is considering a recommendation to issue an emergency permit order to the firm.
  • The firm is a foreign facility and food from the firm is subject to an Import Alert that provides for detention without physical examination because the food may cause serious adverse health consequences or death to humans or animals.

When a foreign food facility registration is suspended, the Center for Food and Applied Nutrition will advise the Division of Food Defense Targeting (DFDT, formerly known as the Prior Notice Center) of the suspension so that the DFDT may target (or red flag) the facility for future shipments coming in.

It is extremely important that all domestic and foreign facilities are aware of the food facility requirements and ensure that both domestic and foreign facilities are in compliance with their applicable food or dietary supplement GMPs to ensure that the facility registration is not suspended upon an inspection.

dicentra can assist with food and dietary supplement GMP audits to help ensure your facility is ready for an FDA audit or help to put in place the applicable GMPs or HACCP program. Assistance is also available for importation and exportation services to ensure you have all the necessary components in place in order to avoid being red flagged by FDA and Customs.

dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. Contact us at info@dicentra.com or at 1-866-647-3279.