21 U.S.C. § 360pp: Enforcement

Summary

U.S. district courts can order people to stop breaking the rules in section 360oo and can stop dealers or distributors from selling electronic products that do not meet the required federal standards, except when the products are just being returned to the seller or maker. The courts also have power under 28 U.S.C. 1355 to make sure the penalty rules are followed. A civil fine for breaking section 360oo is up to $1,000 for each product or unlawful act, but related violations are capped at $300,000. The Secretary can reduce or cancel a fine, and may take the final fine from money the government owes the person. Cases can be filed where the bad act happened, where the defendant is found, or where they do business, and papers can be served where the defendant lives or is found. For minor problems, the Secretary can choose to give a written warning instead of starting a case. Following these rules does not remove other legal responsibilities except as noted in the first sentence of section 360ss. The remedies here are extra and do not replace other legal remedies.

Title 21, §360pp

Food and Drugs, Source: USLM XML via OLRC

(a)Jurisdiction of courts

The district courts of the United States shall have jurisdiction, for cause shown, to restrain violations of section 360oo of this title and to restrain dealers and distributors of electronic products from selling or otherwise disposing of electronic products which do not conform to an applicable standard prescribed pursuant to section 360kk of this title except when such products are disposed of by returning them to the distributor or manufacturer from whom they were obtained. The district courts of the United States shall also have jurisdiction in accordance with section 1355 of title 28 to enforce the provisions of subsection (b) of this section.

(b)Penalties

(1)Any person who violates section 360oo of this title shall be subject to a civil penalty of not more than $1,000. For purposes of this subsection, any such violation shall with respect to each electronic product involved, or with respect to each act or omission made unlawful by section 360oo of this title, constitute a separate violation, except that the maximum civil penalty imposed on any person under this subsection for any related series of violations shall not exceed $300,000.

(2)Any such civil penalty may on application be remitted or mitigated by the Secretary. In determining the amount of such penalty, or whether it should be remitted or mitigated and in what amount, the appropriateness of such penalty to the size of the business of the person charged and the gravity of the violation shall be considered. The amount of such penalty, when finally determined, may be deducted from any sums owing by the United States to the person charged.

(c)Venue; process

Actions under subsections (a) and (b) of this section may be brought in the district court of the United States for the district wherein any act or omission or transaction constituting the violation occurred, or in such court for the district where the defendant is found or transacts business, and process in such cases may be served in any other district of which the defendant is an inhabitant or wherever the defendant may be found.

(d)Warnings

Nothing in this part shall be construed as requiring the Secretary to report for the institution of proceedings minor violations of this part whenever he believes that the public interest will be adequately served by a suitable written notice or warning.

(e)Compliance with regulations

Except as provided in the first sentence of section 360ss of this title, compliance with this part or any regulations issued thereunder shall not relieve any person from liability at common law or under statutory law.

(f)Additional remedies

The remedies provided for in this part shall be in addition to and not in substitution for any other remedies provided by law.

Notes & Related Subsidiaries

Editorial Notes

Codification Section was classified to section 263k of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.

Amendments

1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, § 19(a)(4), which renumbered section 263k of Title 42, The Public Health and Welfare, as this section. 1990—Subsec. (a). Pub. L. 101–629, § 19(a)(2)(G)(i), (ii), substituted “section 360oo” for “section 263j” and “section 360kk” for “section 263f”. Subsec. (b)(1). Pub. L. 101–629, § 19(a)(2)(G)(ii), substituted “section 360oo” for “section 263j” in two places. Subsec. (d). Pub. L. 101–629, § 19(a)(1)(B), substituted “this part” for “this subpart” in two places. Subsec. (e). Pub. L. 101–629, § 19(a)(1)(B), (2)(G)(iii), substituted “section 360ss” for “section 263n” and “this part” for “this subpart”. Subsec. (f). Pub. L. 101–629, § 19(a)(1)(B), substituted “this part” for “this subpart”.

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal AgenciesEnactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.

§360pp Enforcement