Standards and Regulations

• The Fair Packaging and Labelling Act (FPLA) in U.S. federal regulations aims to ensure that information on the packaging and labeling of food and consumer products is accurate and non-misleading, enabling consumers to make informed purchasing choices.

• CFR 21 § 500.4 specifies the basic requirements, expression, and prohibitions for the "declaration of product name" on the main display surface of consumer goods. This article provides a systematic interpretation of the key points of this clause and offers practical suggestions to help companies comply with regulations and reduce risks when designing packaging.

  
  

I. Scope of Application and Core Concepts (Overall Framework of § 500.4(a)–(c))

• Key Takeaways Summary

• The product name declaration must appear on the "main display side" of the consumer product (usually the most prominent position on the front of the packaging).

• The statement should be a prominent feature of the main display surface, with an easy-to-read font size and clear placement, and its lines should be aligned parallel to the bottom of the packaging or product, which is the base on which the product is displayed.

• The representation should follow one of three precedence orders:

1. The official name required by federal laws or regulations;

2. If the name cannot be obtained, use the generic or common name of the product;

3. If no name is provided above, use a generic name or other appropriate descriptive term (e.g., a statement that includes a description of the features).

• During the design phase, the boundaries and available space of the "main display area" should be clearly defined to ensure the readability and visual prominence of the product name statement.

• For products involving names regulated by multiple countries, it is necessary to check the specific requirements of current federal regulations for the "official name" to avoid misuse, misremembering, or confusion.

• If the official name required by regulations cannot be used, the feasibility and potential compliance risks of using a generic name, common name, or descriptive term as an alternative should be assessed.

• The font, size, and contrast of the product name declaration must meet the company's internal accessibility standards to ensure that people with color blindness or low vision can read it clearly.

II. Priority and Alternative Paths of the Three Expression Methods (Details of § 500.4(c))

• Specific path

• (1) Preferred: Use the “prescribed official name” (legal name, name required by law).

• (2) Secondary option: If the official name cannot be obtained, use the product’s “generic name” or “common name”.

• (3) Alternative: If neither of the above is feasible, use “generic name or other appropriate descriptive term”, such as a statement that includes a functional description.

• Practical Points

• Before implementation, a name verifiability assessment is required: Is there a clear, legally recognized official name? Is there a generally accepted common name within the industry?

• When using alternative paths (descriptive terms), avoid leading to misunderstandings, exaggerating efficacy, or concealing important information. Descriptive terms should be as concise and objective as possible, avoiding any implication of non-phenomenal attributes.

• For products across different categories, the applicable "official name" requirements must be verified separately, as different categories (such as food, non-food daily necessities, etc.) may have different naming conventions.

III. Prohibitory Principles and Exceptions (Core Prohibitions of § 500.4(d))

• Prohibitionary points

• Product name statements must not be false, misleading, or deceiving to consumers in any way.

• The product name declaration must not mention any ingredient or component that is not present in the product in a substantial or significantly effective amount.

• Exceptions

• If a component is present in a substantial and effective amount in the formulation, but is not present in its original form in the final product because it has been transformed into another entity (and that entity is present in the final product), then the component may be mentioned in the product name declaration.

• Practical Points

• Conduct a comparison check between the ingredient list and the "Product Name Declaration" to exclude any indications of ingredients that do not actually exist.

• If intermediates or transformation processes are involved, resulting in a component appearing in the final product in different physical forms, the presentation and wording of that component should be appropriately defined to avoid misleading consumers.

• For descriptive terms that include "functional claims", avoid equating functional descriptions with unproven efficacy.

IV. Practical Application and Compliance Practice Recommendations

• Label Design Process

• During the design phase, the "product name declaration" is placed in a prominent position on the main display surface to ensure high visual priority and strong readability.

• Use high-contrast fonts, clear font sizes that meet readability requirements, and arrange them parallel to the bottom of the packaging.

• Clearly record a list of alternative names, including official names, generic names, common names, and descriptive terms, to facilitate rapid compliance implementation across different product lines and packaging versions.

• Data and evidence preparation

• In accordance with current regulations and industry guidelines, retain the legal basis for the official name, authoritative references to the industry generic name, and supporting evidence for any descriptive claims (such as data sources for functional claims, clinical/experimental data, regulatory interpretation documents, etc.).

• Establish a change management process: If regulations are updated or market requirements change, the product name declaration text needs to be quickly assessed and updated.

• Exceptions and Communication

• For products involving special materials or numerous functional claims, be prepared to provide explanations to external parties and ensure that customer service and the regulatory/compliance team communicate consistently with external parties.

• Audit and Compliance Assessment

• Establish an internal audit mechanism, including at least cross-audits by legal/compliance, marketing, and packaging design departments, to ensure that the text complies with the requirements of § 500.4.

• Before releasing information to the public, conduct a compliance self-check checklist, covering key points such as display location, font size, line arrangement, accuracy of name selection and description, and disclosure and conversion of ingredients.

V. Conclusion

• CFR 21 § 500.4 provides a clear framework for consumer product name declarations, emphasizing the core principles of distinctiveness, readability, and avoiding misleading information.

• During the packaging design phase, companies should establish a clear name selection path (formal name → generic name/common name → descriptive wording) and strictly control the presentation of the text to ensure consistency between the product name declaration and the actual attributes of the product.

• By implementing systematic processes, providing supporting evidence, and conducting multi-party audits, compliance risks can be effectively reduced while increasing consumer trust in product information.