FDA Manufacturer Address Label Requirements

Required Information

The name and place of business must include all of the following:

• Company name — the legal name of the manufacturer, packer, or distributor
• Street address — unless the firm is listed in a current city, telephone, or trade directory
• City
• State (or country for imported products)
• ZIP code

Manufacturer vs. Distributor Wording

If the product is not manufactured by the company whose name appears on the label, a qualifying phrase is required to clarify the relationship.

When You Can Omit the Street Address

The street address may be omitted if the company is listed in a current city directory, telephone directory, or trade directory that is available to the public. However, the city, state, and ZIP code must always be present.

Foreign Manufacturers and Importers

For products manufactured outside the U.S. and imported by a U.S. company, the label must identify the U.S. importer or distributor. The foreign manufacturer's address may also be included, but the U.S. contact information is the minimum requirement.

Common Mistakes

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  Omitting the street address without confirming the company is listed in a public directory
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  Missing the ZIP code — all five components (name, street, city, state, ZIP) are required unless the street address exemption applies
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  Not using a qualifying phrase like "Distributed by" or "Manufactured for" when the named company didn't manufacture the product
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  Using a P.O. Box as the address when not listed in a public directory
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  Using only a website URL or email address — a physical address is required
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  Placing the manufacturer information on the principal display panel — it belongs on the information panel