21 CFR 500.5 Under the FPLA: Name and Place of Business of the Manufacturer, Packer or Distributor

In U.S. federal regulations, the Fair Packaging and Labeling Act (FPLA) is intended to ensure the transparency and accuracy of consumer-commodity label information, helping consumers obtain clear, verifiable information at the time of purchase. 21 CFR § 500.5 sets out the prominence, forms of expression and acceptable alternatives for the name and place of business of the manufacturer, packer or distributor on the label. This article systematically interprets the key points of the provision and offers practical advice for companies in label design and compliance review. 1. Overview of key requirements (the core of § 500.5(a)–(e)) (a) Prominence and connecting phrases The label should clearly and conspicuously specify the name and place of business of the manufacturer, packer or distributor. If the name on the label is not that of the entity that actually manufactured the consumer commodity, the name must be qualified by a phrase revealing that person's connection with the commodity, such as “Manufactured for ______,” “Distributed by ______,” or other wording that expresses the facts. (b) Name standards for corporations and individuals/partnerships/associations For a corporation, the declaration is satisfied only by the actual corporate name, which may be preceded or followed by the name of a particular division (such as a specific department or subsidiary). For an individual, partnership or association, the name under which the business is conducted should be used. (c) Key points on the place of business It must include the street address, city, state and zip code. However, the street address may be omitted if it is listed in a readily accessible, widely published and publicly available resource (such as a printed directory, electronic database or website). (d) Manufacturing/packing/distribution at a place other than the principal place of business If manufacturing, packing or distribution takes place at a place other than the principal place of business, the label may state the principal place of business in lieu of the actual place, unless this would be misleading. (e) Use of abbreviations Standard abbreviations may be used, provided the requirements are met. 2. Practical points and application scenarios What is “conspicuous labeling” Place the name and place of business on the front of the package or in the main information area, with a type size, contrast and layout that ensure easy reading under normal lighting. How to handle the name of a non-manufacturer If the label reads “Distributed by Acme Co.,” make sure the underlying fact is clear: the company's relationship to the commodity is distribution, not manufacture. Boundaries of the company name When using the legal corporate name, a division name may be added before or after it (such as “Acme Corp., Packaging Division”), but the information must not lead to misunderstanding. Flexibility of address information If there is no street address, ensure the city, state and zip code are complete; and keep records of publicly searchable address evidence (such as directories, databases or official web pages) to demonstrate compliance. Handling production across locations When manufacturing/packing at a place other than the principal production location, use the principal place of business to represent it; if this would mislead consumers, additional disclosure or explanation is needed to avoid false statements. 3. Compliance checklist Label design stage Clearly define where the “name” and “place of business” appear, ensuring they are visually clear and easy to identify. Choose a compliant form of expression: official name, the name of another party, or approved descriptive wording, following the logic of § 500.5(a). Information verification and evidence Keep the basis for the legal name, the name under which business is conducted, and evidence of the street address's public source (such as links to directories or screenshots of databases). For descriptive wording, ensure it contains no misleading information and has supporting materials (such as authorizations, contracts or distribution agreements). Address-disclosure strategy If the street address is to be omitted, ensure that publicly accessible resources actually cover the address information, and that its public availability can be demonstrated. Change management If the company structure, address or distribution relationship changes, establish a quick update process to ensure the label text is revised and re-verified in time. 4. Common scenarios and example wording Example 1: Manufacturer information Label: “Manufactured by Zenith Labs, 123 Innovation Way, Springfield, IL 62704” Example 2: In the name of a distributor Label: “Distributed by Acme Distributors, 456 Market Street, Anytown, NY 10001” If the actual manufacturer is not this company, add a note: “Manufactured for Acme Distributors” or “Manufactured for Acme Distributors, Inc.” Example 3: A place other than the principal production location Label: “Manufactured at Main Plant, 789 Central Ave, Metropolis, CA 90210; Distributed by Zenith Labs, 123 Innovation Way, Springfield, IL 62704” If an alternative location description is needed, ensure it does not mislead. 5. Common pitfalls and risk warnings Treating the name as the only text and ignoring the requirement for a connecting/qualifying phrase. Failing to provide sufficient address information, or failing to provide publicly verifiable address evidence, increasing regulatory scrutiny. Using vague or exaggerated descriptive wording that misleads consumers. For products sold across borders or regions, failing to cross-check the naming and address-disclosure requirements of different jurisdictions. 6. Full text of 21 CFR § 500.5 § 500.5 Name and place of business of manufacturer, packer or distributor. (a) The label of a consumer commodity shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. Where the consumer commodity is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such commodity; such as “Manufactured for ______,” “Distributed by ______,” or any other wording that expresses the facts. (b) The requirement for declaration of the manufacturer, packer, or distributor shall in the case of a corporation be deemed to be satisfied only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. (c) The statement of the place of business shall include the street address, city, state, and zip code; however, the street address may be omitted if it is listed in a readily accessible, widely published, and publicly available resource, including but not limited to a printed directory, electronic database, or Web site. (d) If a person manufactures, packs, or distributes a consumer commodity at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such consumer commodity was manufactured or packed or is to be distributed, unless such statement would be misleading. (e) Standard abbreviations may be used in complying with the requirements of this section.