How to Register with the FDA
As mentioned above, according to the Bioterrorism Act, as of October 16, 2003, FDA certification is required for any food, beverage, and medication to be sent to the United States. Additionally, these companies must register with the FDA. Products from companies not registered with the FDA will be seized upon entry into the U.S., and entry for these products will not be allowed. The necessary information under FDA registration includes the company’s (and, if applicable, the parent company’s) name, address, phone number, the name, address, and phone number of the company owner or authorized representative, all trade names used by the company, categories of products subject to processing, and a declaration by the form-filler that the provided information is true and accurate. For foreign companies, the name, address, phone number of the U.S. representative, and, for emergencies, the U.S. representative’s or another designated person’s phone number are also required. Optional additional information may also be provided.
Food items considered under the Bioterrorism Act include foods, baby foods, beverages, fruits and vegetables, dairy products and eggs, fish and seafood, raw agricultural commodities used as food, bakery products, canned foods, frozen foods, snacks and sweets (including gum), live food animals, pets, animal feed, and food. According to regulations, there is no obligation to register records for food processing or manufacturing, packaging, or storage facilities used as residences, establishments distributing non-bottled drinking water, farms, food transport vehicles, retail food establishments (such as markets), restaurants, non-profit food companies, fishing vessels, records of poultry, meat, and egg companies inspected by the U.S. Department of Agriculture.
If a foreign company’s food product is imported into the U.S. through another foreign company, the first foreign company is not obligated to register, but if the second company performs even minimal activities (such as labeling), both companies must register.
For FDA registration required for exports to the United States:
- Company Tax Certificate,
- Activity Certificate,
- Signature Circulars,
- Product Information,
- Compliance Statement,
- Product Technical File.
Pricing is based on the product technical file.
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