Wanna Bring in the Meats? Essential FDA Regulations to Know to Improve Your Business

FDA Regulations

The United States food and beverage industry is arguably the largest and most competitive in the world. Any business owner who is interested in entering the market should perform its due diligence to ensure compliance with local law and regulations. But what if you wanted to import food products into the States? The Food and Drug Administration (FDA) requires no specific license for the general importation of most items, but that doesn’t mean there aren’t any regulatory requirements for the importation of certain animal products, such as dairy, meats, and seafood.

Failure to comply with regulations set forth by the FDA and the USDA’s Food Safety and Inspection Service (FSIS) could ultimately block your product from even entering U.S. jurisdiction. Here’s a breakdown of the most pertinent regulations to be aware of before importing your food product into America. 

While the FDA is not authorized under law to approve, certify, license, or sanction individual food importers or their products, importers must nevertheless register their food production facilities with the FDA, and provide prior notice to the agency regarding any incoming shipments.

Registration requires the following information:

(1) Type of registration

(2) Facility name and address

(3) Preferred mailing address of the facility

(4) Address of the parent company

(5) Emergency contact information

(6) Alternate trade name

(7) United States agent

(8) Seasonal facility operation dates

(9) General product categories 

(10) Owner, operator, or agent in charge information

(11) Inspection statement

(12) Certification statement

Imported food products are also subject to FDA inspection at U.S. ports of entry. The FDA may detain shipments offered for import if they are found not to be in compliance with U.S. import regulations. Additionally, both imported and domestic food products must adhere to the same legal requirements in the United States. Some of the FDA’s most pertinent requirements include:

  1. Registering your facility
  2. Abiding by the Food Safety Modernization Act (FSMA)
  3. Labeling and packaging your produce accurately
  4. Submitting Prior Notice for import shipments 

Apart from compliance with FDA inspections, the produce importer must attain FDA/APHIS Import Permits for specific product types, and a FSIS foreign inspection certificate

Additionally, foreign facilities must designate a U.S. agent who lives or maintains a place of business in the Unites States. This agent must be physically present in the United States for the purposes of communication between the facility and the FDA. This agent may also be authorized  to register the facility on behalf of the importer.

Check out this USDA’s FSIS import checklist to see if your product adheres to U.S. standards for importation. 

If you have any doubts, feel free to reach out to us. Our group of expert professional attorneys will be happy to help you improve your business.

EPGD Business Law is located in beautiful Coral Gables. Call us at (786) 837-6787, or contact us through the website to schedule a consultation.

*Disclaimer: this blog post is not intended to be legal advice. We highly recommend speaking to an attorney if you have any legal concerns. Contacting us through our website does not establish an attorney-client relationship.*

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Eric Gros-Dubois

Founding partner Eric Gros-Dubois established EPGD Business Law in 2013. With over a decade of experience expanding the firm and leading it to its current success, Eric now primarily manages the corporate division of EPGD. Given Eric’s educational background, holding both a JD and MBA, combined with his own unique experience of starting a business from scratch and growing it to a multi-million dollar firm, he brings a specialized and invaluable perspective to those seeking legal assistance for themselves and their businesses. Having now instilled his same values in our team of skilled corporate associates, Eric leads a firm that is always ready, willing, and equipped to handle any and every legal matter that a business owner may have.

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