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.

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Where Can I Find a Lawyer to Help Me Import Dietary Supplements Into the United States and Handle FDA Compliance?

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Dietary Supplement Imports: Selling on Amazon Legally

Dietary supplement imports are a booming business on Amazon, but to you must comply with FDA regulations or risk having products removed.

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If You Make Food, It’s Time to Renew FDA Registration

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FDA Label Review to Prevent Food Import Refusals

Labeling violations are one of the leading causes of food import refusals to the United States. If FDA discovers that your food product has one of these labeling violations, FDA will refuse entry or seize your product. FDA label review can help ensure compliance with labeling laws.