C.F.R. » Title 16 » CHAPTER I—FEDERAL TRADE COMMISSION › SUBCHAPTER E—RULES, REGULATIONS, STATEMENT OF GENERAL POLICY OR INTERPRETATION AND EXEMPTIONS UNDER THE FAIR PACKAGING AND LABELING ACT › PART 500—REGULATIONS UNDER SECTION 4 OF THE FAIR PACKAGING AND LABELING ACT

16 C.F.R. § 500.4

Statement of identity

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(a) The principal display panel of a consumer commodity shall bear a specification of the identity of the commodity.

(b) Such specification of identity shall comprise a principal feature of the principal display panel, shall be in such type size and so positioned as to render it easily read and understood by the consumer, and shall be in lines generally parallel to the base on which the package or commodity rests as it is designed to be displayed.

(c) Such specification of identity shall be in terms of:

(1) The name now or hereafter specified in or required by any applicable Federal law or regulation; or in the absence thereof,

(2) The common or usual name of the commodity; or in the absence thereof,

(3) The generic name or in other appropriately descriptive terms such as a specification which includes a statement of function.

(d) The specification of identity shall not be false, misleading, or deceptive in any respect. Ingredients or components which are not present in the commodity in a substantial or significantly effective amount may not be mentioned in the specification of identity; except that a component present in a formulation in substantial and effective amounts, but not present in the final product due to conversion or transformation into a different entity (which different entity is present in the final product), may be mentioned in the specification of identity.

Notes of Decisions
Cited in 1 case, 2012–2012 · leading case: Smith v. Phoenix Seating Sys., LLC, 894 F. Supp. 2d 1088 (S.D. Ill. 2012).
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Smith v. Phoenix Seating Sys., LLC, 894 F. Supp. 2d 1088 (S.D. Ill. 2012). “See 16 C.F.R. § 500.4 . However, Apria also contends the 312G is a device covered under the FDCA.”
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