Standards and Regulations

The Fair Packaging and Labelling Act (FPLA) in U.S. federal regulations aims to ensure the transparency and accuracy of information on consumer product labels, helping consumers obtain clear and verifiable information when making a purchase.

CFR 21 § 500.5 specifies the distinctiveness, form of expression, and acceptable alternatives for the name and place of business of the manufacturer/assembler/distributor on labels. This article will systematically interpret the key points of this clause and provide practical advice for companies in label design and compliance review.

I. Key Points Overview (Core Requirements of § 500.5(a)-(e))

• (a) Significance and Association Explanation

• The label should clearly and prominently indicate the name and place of business of the manufacturer, assembler or distributor.

• If the name on the label is not that of the actual manufacturer of the consumer product, the name must be accompanied by a qualifying statement that reveals the person’s relationship with the product, such as “Manufactured for ______”, “Distributed by ______”, or other statements that express the facts.

• (b) Standards for the names of companies and individuals/partnerships/associations

• For companies, the declaration should only include the company's actual legal name, and may include the name of a specific department (such as Department X, Subsidiary X, etc.) before or after the name.

• For individuals, partnerships or associations, their registered business name or the name used in their business operations should be used.

• (c) Key points for expressing business location

• It must include the street address, city, state, and zip code.

• However, if the street address is already available in easily accessible, widely published, and publicly available resources (such as print catalogs, electronic databases, websites, etc.), the street address can be omitted.

• (d) Manufacturing/assembly/distribution at locations other than the principal place of business

• If manufacturing, assembly, or distribution takes place at a location other than the principal place of business, the label may use the principal place of business in place of the actual location, unless such description would be misleading.

• (e) Use of abbreviations

• Standard abbreviations may be used, provided they meet the requirements.

II. Key Practical Points and Application Scenarios

• What is "prominent labeling"?

• Place the name and business address on the front of the packaging or in the main information area. The font size, contrast, and layout should ensure that it is easy to read under normal lighting.

• How to handle the name of non-manufacturing party?

• If the label says "Distributed by Acme Co.", make sure the underlying facts are clear: the company's relationship with the product is one of distribution, not manufacturing.

• Company name boundaries

• When using the legal company name, it is permissible to add department names before or after (e.g., "Acme Corp., Packaging Division"), but you must ensure that the information does not lead to misunderstanding.

• Flexibility of address information

• If a street address is unavailable, ensure the city, state, and zip code are complete; and retain records of publicly searchable address evidence (such as directories, databases, official website pages, etc.) to prove compliance.

• Processing of cross-location production

• When manufacturing/packaging occurs at a location other than the principal place of business, using the principal place of business as the description is required if it would mislead consumers. Additional disclosure or explanation is needed to avoid false statements.

III. Compliance Practices Checklist

• Label design stage

• Clearly define the placement of the "Name" and "Location of Business" to ensure they are visually clear and easily identifiable.

• Choose a compliant form of expression: official name, another person's name, or approved descriptive wording, with priority given to the logic of § 500.5(a).

• Information verification and evidence

• Preserve evidence such as the basis for the legal name, the name used in business operations, and publicly available links or directory screenshots of the street address.

• For descriptive wording, ensure it does not contain misleading information and has supporting materials (such as authorizations, contracts, distribution agreements, etc.).

• Address Disclosure Strategy

• If a street address is omitted, ensure that publicly accessible resources actually cover that address information and can demonstrate its public availability and accessibility.

• Change Management

• If the company structure, address, or distribution relationships change, establish a rapid update process to ensure that label text is revised and re-verified in a timely manner.

IV. 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, please add the note: "Manufactured for Acme Distributors" or "Manufactured for Acme Distributors, Inc."

• Example 3: Non-primary production locations

• 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 required, ensure it is not misleading.

V. Common Misconceptions and Risk Warnings

• Treating names as unique texts and ignoring the requirement for qualifiers related to their relevance.

• Failure to provide sufficient address information or publicly verifiable address evidence increases regulatory scrutiny.

• Using vague or exaggerated descriptive language can mislead consumers.

• For products sold across borders or regions, no comparison was made between the naming and address disclosure requirements of different jurisdictions.

six,Full text of CFR 21 § 500.5

§ 500.5 Name and place of business of manufacturer, packer or distributor.

§ 500.5 Name and place of business of the manufacturer, assembler 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.

(a) The label of a consumer product shall prominently indicate the name and place of business of the manufacturer, assembler or distributor. If the name appearing on the label is not that of the person who actually manufactures the consumer product, the name shall be limited by a phrase that indicates the person’s relationship to the consumer product, such as “manufactured for ______”, “distributed by ______” or any other language that expresses the fact.

(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.

(b) For companies, the reporting requirements for manufacturers, assemblers, or distributors are satisfied only by the actual company name, which may be preceded or followed by the name of a specific department. For individuals, partnerships, or associations, the name used in their business registration or for conducting business should 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.

(c) The description of the business location should include the street address, city, state and zip code; however, if the street address is already available in an easily accessible, widely published and publicly available resource (including but not limited to print catalogs, electronic databases or websites), the street address may be omitted.

(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.

(d) If a person manufactures, assembles, or distributes a consumer product at a place other than his principal place of business, the label may use his principal place of business in place of the actual place of manufacture, assembly, or distribution, unless such description would be misleading.

(e) Standard abbreviations may be used in complying with the requirements of this section.

(e) Standard abbreviations may be used when complying with the requirements of this clause.