21 U.S.C. § 360pp — Enforcement
submitted 88 years ago by Pub. L. 90-602 to r/title-21-FOOD-AND-DRUGS · 463 words · no verdicts yet
Federal courts can order violators of the radiation-safety rules to stop breaking the law. A violation can bring a fine up to $1,000 per product, capped at $300,000 total. The FDA can reduce a fine, or just issue a warning for minor violations.
(a) Jurisdiction of courts
Federal district courts can, for good cause, order violators of section 360oo to stop, and can stop dealers and distributors from selling noncompliant electronic products — except when those products are simply being returned to the distributor or manufacturer*. These courts also have jurisdiction to enforce the civil-penalty rules in subsection (b).
(b) Penalties
(1) Anyone who violates section 360oo can face a civil penalty of up to $1,000. Each electronic product* involved, or each unlawful act or omission, counts as a separate violation — but the total penalty for one related series of violations cannot exceed $300,000.
(2) The FDA can reduce or excuse this penalty on request, considering the size of the violator's business and how serious the violation was. Once a penalty amount is finally set, it can be deducted from any money the government owes that person*.
(c) Venue; process
A case under subsection (a) or (b) can be filed in the federal district where the violation happened, or where the defendant is located or does business. Legal papers can be served wherever the defendant can be found.
(d) Warnings
The FDA doesn't have to pursue formal legal action for minor violations — a written warning can be enough if that serves the public interest just as well.
(e) Compliance with regulations
Except as stated in section 360ss, following this part or its regulations doesn't protect anyone from liability under other common law or statutes.
(f) Additional remedies
These remedies add to, rather than replace, any other remedies the law provides.
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.
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.
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.
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.
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.
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.
The remedies provided for in this part shall be in addition to and not in substitution for any other remedies provided by law.
Source credit: (June 25, 1938, ch. 675, § 539, formerly act July 1, 1944, ch. 373, title III, § 539, formerly § 360C, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1184; renumbered § 539 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(G), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.)
- 1938Enacted · Pub. L. 90-602 · 82 Stat. 1184
- 1990Amended · Pub. L. 101-629 · 104 Stat. 4529, 4530
- 1993Amended · Pub. L. 103-80 · 107 Stat. 779
A history note hasn’t been published yet. The record shows enactment by Pub. L. 90-602 on 1938-06-25.
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