Does FDA approve my food label before I sell?

No. There is no pre-market approval for a conventional food or dietary supplement label. You are responsible for compliance on your own, and the first agency review may be a detained shipment or a Warning Letter.

Do I have to register my facility with FDA?

Yes, if the facility manufactures, processes, packs or holds food for consumption in the United States. Registration must be renewed between October 1 and December 31 of every even-numbered year, regardless of when you first registered.

How many allergens do I have to declare?

Nine. The original eight under FALCPA plus sesame, which became the ninth major allergen on January 1, 2023.

What is a new dietary ingredient?

An ingredient not marketed in the United States before October 15, 1994 that is not present in the food supply as an article used for food. A premarket safety notification must be submitted to FDA at least 75 days before introducing the product into interstate commerce.

What is FSVP and do I need one?

The Foreign Supplier Verification Program. If you import food or dietary supplements into the U.S. you must have a program verifying your foreign suppliers meet U.S. food safety standards. It is the importer's obligation, not the supplier's.

How far in advance does Prior Notice have to be filed?

At least 2 hours before arrival by road, 4 hours by rail or air, and 8 hours by water. For international mail, before the article is sent.

How much does a federal trademark cost?

USPTO fees are currently $350 per class for a standard electronic filing, with surcharges for items such as free-form goods descriptions. Morsel Law flat fee filings run $899 to $1,999 depending on scope.

Patrick Morin

Food & FDA Attorney

EDUCATION

L.L.M. in Agriculture and Food Law, University of Arkansas School of Law
Graduate Certificate in Entrepreneurship, Louisiana State University
J.D., University of New Hampshire School of Law
B.A., Northeastern University.

Patrick is a seasoned food lawyer and founder of Morsel Law. Patrick works side by side with entrepreneurs, startups and small and mid-size companies alike as a strategic business partner and counsel.

Previously, Patrick served as general counsel of two food manufacturers and practiced in the transactional and commercial groups at several national law firms, including Sullivan & Worcester LLP in Boston, Bass, Berry & Sims PLC in Nashville and Dickinson Wright PLLC in Detroit. Before attending law school, Patrick served as an officer in the U.S. Marine Corps and is a veteran of Operation Iraqi Freedom.

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