The U.S. Food and Drug Administration (FDA) recently started including reinspection fee information on emails sent to U.S. Agents of newly registered foreign food facilities. The new emails now broadcast the possibility of reinspection fees and prominently define what they entail.
“Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)].For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. agent for the facility.”
Since 2003, foreign food and beverage companies selling to the U.S. have been required to list a U.S. Agent for FDA communications. The Bioterrorism Act of 2002 stated that the U.S. Agent’s role would be to facilitate communication between the FDA and the foreign facility. Since then thousands of foreign registrants have listed importers, customs brokers or even relatives living in the U.S. as their U.S. Agent for FDA communications. A company or individual may not even be aware that they were listed as a U.S. Agent.
The U.S. Food Safety Modernization Act (FSMA) of 2011 expands the role of the U.S. Agent. Under FSMA, the U.S. Agent is responsible for FDA’s re-inspection costs which are billed per hour without limit. For the Fiscal Year 2014, the hourly rate for foreign food facility inspections is $302 (and $237 for domestic facilities) [1]. This can quickly result in charges of over $10,000 USD.
Individuals who feel they may be listed as a U.S. Agent and do not wish to be responsible for these fees should promptly opt out. It is only after the company has opted out of being a U.S. Agent that the FDA “will inform the facility that you notified us that you have not agreed to serve as the U.S. Agent for the facility and request that the facility amend its registration to designate as its U.S. Agent a person who has affirmatively agreed to serve as the facility’s U.S. Agent.” If you need assistance opting out of U.S. Agent responsibilities or are in need of a U.S. Agent for FDA communications, contact Registrar Corp at 1-757-224-0177 or receive online Live Help from our regulatory specialists: https://www.registrarcorp.com/livehelp.
As a foreign facility’s U.S. Agent, Registrar Corp Regulatory Specialists help food facilities with their FDA registration and FDA communications. In addition, as part of Registrar Corp’s U.S. Agent service, Registrar Corp will dispatch a food safety expert trained in FDA inspections to the foreign facility to help the manufacturer prepare for an FDA inspection. This assistance is included in Registrar Corp’s U.S. Agent Service at no additional charge, other than travel and lodging expenses, if FDA has confirmed an actual date for an inspection.
With 17 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company comply with U.S. FDA Regulations. For more information on U.S. FDA Food Facility Registration, U. S. Agent services, or any other FDA regulation, go to www.registrarcorp.com. About Registrar Corp: Registrar Corp is an FDA Compliance Consulting Firm that helps companies with U.S. FDA Regulations, including Food Facility Registrations and Food label reviews. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 17 global offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations.
