Identify the manufacturer, packer, or distributor correctly

What 21 CFR 101.5 addresses

The label must specify the name and place of business of the manufacturer, packer, or distributor. When the named company is not the manufacturer, the regulation calls for a qualifying phrase that reveals the connection, such as “Manufactured for” or “Distributed by.” The required place-of-business elements and the conditions for omitting a street address should be checked against the current rule.

Review the real supply chain

1. Name the legal entity: confirm the entity intended to appear on the label rather than using only a brand or storefront name.
2. Confirm its role: determine whether the entity manufactured, packed, or distributes the product and whether a qualifying phrase is required.
3. Verify the address: review street address, city, state, and ZIP Code requirements and the factual basis for any permitted omission.
4. Check consistency: compare label, website, complaint contact, importer records, contracts, and facility documents without treating any one record as proof of all roles.
5. Control revisions: update artwork when the legal entity, role, or place of business changes.

Recurring problems

• A brand name appears without identifying the responsible legal entity.
• “Manufactured by” is used although the named company uses a contract manufacturer.
• A foreign factory, U.S. distributor, and importer are present, but the label review does not document which declaration is being made.
• An address is incomplete or copied from a website without checking the regulation.
• OCR recognizes the company name but drops the role phrase or address line.

Official starting points

• 21 CFR 101.5 — Food; name and place of business
• FDA Dietary Supplement Labeling Guide

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