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FDA Commences Enforcement of FSMA Registration Requirements

Effective today the FDA is implementing the Food Safety Modernization Act registration requirements.  Section 102(a) of the FSMA, which created 21 U.S.C. § 350d(a)(3), requires biennial registration renewals beginning October 1st and ending December 1st of each even-numbered year.   The FDA’s updated food facility registration system became operational today and, so, FDA is now accepting food facility registration renewals.

The registration requirement applies to all entities previously registered under the Bioterrorism Act, to wit, “any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States,” including both domestic facilities and foreign facilities.  Id. at § 350d(a)(1).  That includes dietary supplement manufacturers.  A foreign facility is exempt from the registration requirement if the food produced undergoes further processing or packaging—which does not include labeling—by another foreign facility before export to the U.S.  The FSMA amended the provisions in the FDCA that governed prior registrations, previously under the Bioterrorism Act.  Regulated entities are now required to renew those registrations biennially.

Initial registration and registration renewals can be completed online, by mail, fax, or by CD-ROM.  Information you must submit as part of the registration process includes the following:

  • the name, email, and address of each facility the registrant conducts business;
  • the trade name(s) under which the registrant conducts business;
  • the email address of the contact person of the facility or, for foreign firms, the U.S. agent for the facility;
  • the general food category of any food manufactured, processed, packed or held at the facility.

Id. at § 350d(a)(2).  Changes to information in a FSMA registration must be timely reported to the FDA.  In addition, the FSMA registration now requires registrants to assure that FDA has permission to inspect the facility at the times and in the manner permitted under the FDCA.  Id.

The FSMA also permits FDA to suspend registrations.  Id. at § 350d(b).  FDA can suspend a registration if it “determines that food manufactured, processed, packed, received, or held by a [registered facility] has a reasonable probability of causing serious adverse health consequences or death to human or animals[.]”  Id. at § 350d(b)(1).  A suspension effectively prohibits imports or exports of food into the U.S. from a facility or the introduction of food from the facility into U.S. commerce. Id. at § 350d(b)(4).

Please do not hesitate to contact us with any questions concerning the scope of the FSMA provisions.

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