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21 U.S.C. § 379sPreemption for labeling or packaging of cosmetics

submitted 88 years ago by Pub. L. 105-115 to r/title-21-FOOD-AND-DRUGS · 313 words · no verdicts yet

in plain englishAI-generated · not legal advice

States generally can't set their own labeling or packaging rules for cosmetics that differ from federal rules. States can apply to the FDA for a limited exemption.

(a) In general. Except as allowed under subsections (b), (d), or (e), a state or local government cannot create or keep in effect a labeling or packaging requirement for a cosmetic that is different from, adds to, or is not identical with a requirement that specifically applies to that cosmetic or class of cosmetics under this chapter, the Poison Prevention Packaging Act of 1970, or the Fair Packaging and Labeling Act. (b) Exemption. A state or local government can apply to the Secretary for an exemption from subsection (a). After giving notice and a chance for written and oral comment, the Secretary may grant the exemption, with conditions, if the state or local labeling or packaging requirement: (1) protects an important public interest that would otherwise be unprotected; (2) would not make a cosmetic violate an applicable federal requirement or prohibition; and (3) would not unduly burden interstate commerce. (c) Scope. For subsection (a), a state requirement "relates to" the packaging or labeling of a cosmetic if it covers the same aspect of that cosmetic as a requirement that specifically applies to that cosmetic or class of cosmetics under this chapter for packaging or labeling — this includes any state requirement about public information or other public communication. (d) No effect on product liability law. Nothing in this section changes or affects any lawsuit or a person's liability under a state's product liability law. (e) State initiative. This section does not apply to a state requirement adopted through a public initiative or referendum enacted before September 1, 1997.
the actual law source: uscode.house.gov ↗public domain
(a) In general

Except as provided in subsection (b), (d), or (e), no State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this chapter, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).

(b) Exemption

Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a State or political subdivision requirement for labeling or packaging that—

(1)

protects an important public interest that would otherwise be unprotected;

(2)

would not cause a cosmetic to be in violation of any applicable requirement or prohibition under Federal law; and

(3)

would not unduly burden interstate commerce.

(c) Scope

For purposes of subsection (a), a reference to a State requirement that relates to the packaging or labeling of a cosmetic means any specific requirement relating to the same aspect of such cosmetic as a requirement specifically applicable to that particular cosmetic or class of cosmetics under this chapter for packaging or labeling, including any State requirement relating to public information or any other form of public communication.

(d) No effect on product liability law

Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.

(e) State initiative

This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.

Source credit: (June 25, 1938, ch. 675, § 752, as added Pub. L. 105–115, title IV, § 412(d), Nov. 21, 1997, 111 Stat. 2376.)

history & why it existsrecord from the source credit
  • 1938Enacted · Pub. L. 105-115 · 111 Stat. 2376

A history note hasn’t been published yet. The record shows enactment by Pub. L. 105-115 on 1938-06-25.

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