The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety and security of our nation’s food supply. The FDA requires that foods sold in the U.S. are safe, wholesome and properly labelled. This includes foods produced domestically, as well as imported foods. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act are the Federal laws governing food products under FDA’s jurisdiction.

The FDA requires that your food, beverage and/or dietary supplement label is accurate and in compliance with FDA’s rules and regulations. The FDA does not pre-approve labels. Diaz Trade Consulting provides label review services for all food products including dietary supplements.

The FDA regulates both domestic and international food facilities. A major requirement of the FDA Bioterrorism Act is that all domestic and foreign facilities that manufacture, process, pack, or hold food or beverages for importation or distribution in the U.S. register their facilities with the FDA.

Alcohol and dietary supplements are treated as a food by the U.S. FDA, therefore you must also register as a food facility under FDA’s Food Facility Registration before importing or distributing alcoholic beverages or dietary supplements in the U.S. 

The U.S. FDA Food Safety Modernization Act (FSMA) requires food facilities to renew their FDA Food Facility Registrations between October 1 and December 31, every two years, on even years. Companies located outside the United States must also designate a U.S. Agent for FDA communications. Diaz Trade Consulting provides both registration and U.S. agent services. Diaz Trade Consulting issues certificates of registration to provide confirmation to industry that you are fulfilling U.S. FDA registration to help prevent delays and inconvenient costs. 

If a facility does not timely renew their registration, FDA will suspend or cancel the facility registration, meaning the facility cannot import their food product into the U.S. Delays in registering or renewing registrations will cause delays upon importation.

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