Food

has for the first time, specifically put the onus on importers to have a program to verify that the food products they are bringing into this country are safe. The idea behind FSMA is to change FDA regulatory enforcement and focus to more of a preventative approach, instead of reactionary. These new requirements include risk-based controls, foreign supplier verification program, certification, and audits. A brief overview of the requirements may be found here.

I’ve summarized the requirements relevant to your Bioterrorism Act Registration below, so you can be sure your registration doesn’t lapse.

New Biennial Registration Requirements
FSMA amended the Food, Drug & Cosmetic Act (FD&C Act) Section 415 to provide for biennial registration updates. Facilities which are required to register will have to re-register every 2 years, during the period beginning on October 1 and ending on December 31 in even numbered years. This will first occur in October-December 2012.

Note that even facilities which are already registered with the FDA are still required to renew their registrations during the October 1 – December 2012 registration renewal period.

U.S. Agent
FDA requires that foreign facilities have a U.S. agent. The U.S. agent must:

1. live or maintain a place of business in the U.S. and
2. be physically present in the U.S.

The U.S. Agent is also responsible for the payment of “reinspection fees” of foreign facilities and failure to comply with recall orders.  Reinspections are follow-up inspections conducted by the FDA after a previous inspection by the FDA where the FDA identified non-compliance issues materially related to food […]