If your firm engages in the manufacture or processing, packing or holding of food, beverages, or dietary supplements for either human or animal consumption, and those goods are destined for the United States, you are required to register with the U. S. Food and Drug Administration (FDA). Foreign facilities must also designate a U.S. agent for FDA communications purposes.

What You Need to Know to Get Your FDA Regulated Products Across the Border

The registration regulations apply to all facilities that handles any of the following:

  • Dietary supplements and dietary ingredients
  • Infant formula
  • Beverage - including alcoholic beverages and bottled water
  • Fruits and vegetables
  • Fish and seafood
  • Dairy products and shell eggs
  • Raw agricultural commodities for use as food or components of food
  • Canned and frozen foods
  • Bakery goods, snack food, and candy - including chewing gum
  • Live food animals
  • Animal feeds and pet food
U.S. FDA Requirements for Regulated Goods

The Food Modernization Safety Act requires that all food facilities that are required to register must renew their registration every other year. The next registration renewal cycle will occur from October 1 to December 31, 2016.

We all know how quickly summer wanes and fall comes back around, and October will be here before we know it. Now might be a good time to review the information submitted on your original FDA registration and to be prepared to make any adjustments or amendments that may be necessary. While official re-registration will not be accepted until October 1, 2016, the FDA encourages you to review and update your registration information regularly. To electronically update your facility registration, on the FDA web page.

Be aware that there are a number of private firms who are available to handle your registration for a fee, however the above link will take you directly to the FDA site, and there is no charge to register or update or re-register your facility. This allows you to retain control over the information that is provided to the FDA, and to make necessary updates promptly.

{This blog post was last updated September 26, 2016}

 

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About Author
April Collier
LCB, CCS

April Collier is a Sr. Trade Advisor with Pacific Customs Brokers USA with over 35 years of experience in international trade. April has been a valued member of the Pacific Customs Brokers team for 14 years, having taking the lead in implementing the Compliance department for U.S. imports. Her current responsibilities include advising and coaching clients on a variety of regulatory compliance matters, and include expertise in Antidumping & Countervailing matters. April develops, maintains and conducts various training workshops and seminars for staff and importers related to regulatory compliance, including Free Trade Agreements, Valuation and HTS classification. In addition to her regular duties, April is also the CTPAT coordinator for Pacific Customs Brokers.

While we strive for accuracy in all our communications, as the Importer of Record it is incumbent upon your company to ensure that you are aware of the requirements under the new regulations so that you maintain compliance as always.