FDA Issues Final Compliance Policy Guide on Food Facility Registration

By Robert A. Hahn

The Food and Drug Administration (FDA) has issued a final Compliance Policy Guide (CPG) on food facility registration.  Compliance Policy Guide Sec. 100.250; Food Facility Registration – Human and Animal Food.  The CPG provides guidance to FDA staff on enforcement of the requirement to register food facilities.  Comments may be submitted at any time.

All domestic and foreign food facilities that manufacture, process, pack, or hold human or animal food intended for consumption in the United States are required to register with FDA, unless a specific exemption applies.  Federal Food, Drug, and Cosmetic Act Section 415 (21 U.S.C. § 350d); 21 C.F.R. Part 1, subpart H.  The Food Safety Modernization Act (FSMA) made several changes to the registration requirement, including the following:

  • It requires certain additional information to be included in the registration form;
  • It requires covered facilities to renew their registrations every two years, between October 1 and December 31 of each even-numbered year; and
  • If FDA determines there is a reasonable probability that food manufactured, processed, packed, or held at the facility will cause serious adverse health consequences or death to humans or animals, FDA may suspend the registration of any facility that: (a) created, caused, or was otherwise responsible for the reasonable probability; or (b) knew or had reason to know of such reasonable probability but packed, received, or held the suspect food.

Failure to register a facility that is required to do so, or introducing food from such a facility into interstate commerce, is a “prohibited act,” subject to injunction and criminal prosecution.  If a foreign facility fails to register as required or its registration is suspended, food from the foreign facility must be held at the port of entry until the foreign facility is registered.  If a facility’s registration is suspended, then introducing food from that facility into interstate commerce is a prohibited act.  However, failure to register or suspension of registration does not cause food from the facility to become adulterated or misbranded.

According to the CPG, FDA may consider a facility to not be registered if:

  • The facility has not submitted a registration to FDA;
  • The facility’s registration is incomplete; or
  • The facility’s registration has expired, because the facility failed to renew it as required.  (The CPG states that FDA may notify the registrant if its facility registration has expired.)

During routine facility inspections, FDA investigators are instructed to determine whether the inspected facility is registered and whether its registration information is accurate and current.  If not, the investigator should advise the facility’s management of the requirement to register and update mandatory information on the registration form.  FDA may issue an untitled letter if the facility is not registered and the establishment file documents that facility management has been advised orally or in writing of its obligation to register.  In the case of a foreign facility, the Division of Food Defense Targeting will be notified in order to target future shipments of imported food from that facility.

FDA may suspend a facility’s registration if there is evidence that food manufactured, processed, packed, or held by the facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and the facility is responsible for the problem or the facility knew or had reason to know of the problem and packed, received, or held the food.  Examples of circumstances where FDA staff should consider recommending suspension include, but are not limited to, the following:

  • Inspectional or other evidence (e.g., a Class I recall situation, food associated with foodborne illness) indicates that the firm has significant violations and has not permanently corrected the source of the problem;
  • The firm is subject to a prehearing order to cease distribution and provide notice under FDA’s mandatory recall authority;
  • The firm is subject to an emergency permit order, or the District Office is considering a recommendation to issue an emergency permit order, under 21 C.F.R. Part 108 (for low acid canned foods and acidified foods); or
  • 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.

In the case of a foreign facility whose registration is suspended, the Division of Food Defense Targeting will be notified in order to target future shipments of imported food from that facility.

Registration of food facilities, which began as an administrative formality, is now a condition for doing business.