Background:

The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011, and amended the Federal Food, Drug, and Cosmetic (FD&C) Act, Section 415 to require biennial registration for regulated facilities. Facilities must re-register every 2 years, during the period beginning on Oct. 1 and ending on Dec. 31 in even numbered years, beginning this year, 2012.

Domestic and foreign facilities that manufacture, process, pack or hold food, including dietary supplements, for human or animal consumption in the U.S. are affected. Previously, these facilities were subject only to a one-time registration.

Registrations are required to contain the email address for the contact person of the facility, or for a foreign facility, the email address of the U.S. agent for the facility, and an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act.

Additionally, as provided by Section 102 of FSMA, FDA has determined it necessary to require information regarding other applicable food categories for foods manufactured/processed, packed, or held at registering facilities. For dietary supplements, these categories include: Proteins, Amino Acids, Fats and Lipid Substances; Animal By-Products and Extracts; Herbals and Botanicals. Other categories may also be relevant to dietary supplement manufacturers and ingredient suppliers, so companies should review FDA's most recent Guidance.