21 U.S. Code § 348 - Food additives
The Secretary may at any time, upon his own initiative, propose the issuance of a regulation prescribing, with respect to any particular use of a food additive, the conditions under which such additive may be safely used, and the reasons therefor. After the thirtieth day following publication of such a proposal, the Secretary may by order establish a regulation based upon the proposal.
Any order, including any regulation established by such order, issued under subsection (c) or (d) of this section, shall be published and shall be effective upon publication, but the Secretary may stay such effectiveness if, after issuance of such order, a hearing is sought with respect to such order pursuant to subsection (f) of this section.
The Secretary shall by regulation prescribe the procedure by which regulations under the foregoing provisions of this section may be amended or repealed, and such procedure shall conform to the procedure provided in this section for the promulgation of such regulations. The Secretary shall by regulation prescribe the procedure by which the Secretary may deem a notification under subsection (h) of this section to no longer be effective.
Without regard to subsections (b) to (i), inclusive, of this section, the Secretary shall by regulation provide for exempting from the requirements of this section any food additive, and any food bearing or containing such additive, intended solely for investigational use by qualified experts when in his opinion such exemption is consistent with the public health.
1997—Subsec. (a). Pub. L. 105–115, § 309(a)(4), in closing provisions, substituted “While such a regulation relating to a food additive, or such a notification under subsection (h)(1) of this section relating to a food additive that is a food contact substance, is in effect, and has not been revoked pursuant to subsection (i) of this section, a food shall not, by reason of bearing or containing such a food additive in accordance with the regulation or notification, be considered adulterated under section 342(a)(1) of this title.” for “While such a regulation relating to a food additive is in effect, a food shall not, by reason of bearing or containing such an additive in accordance with the regulation, be considered adulterated within the meaning of clause (1) of section 342(a) of this title.”
Subsec. (a)(1). Pub. L. 105–115, § 309(a)(1), substituted “subsection (j)” for “subsection (i)”.
Subsec. (a)(3). Pub. L. 105–115, § 309(a)(1)(B), (2), (3), added par. (3).
Subsec. (h). Pub. L. 105–115, § 309(b)(2), added subsec. (h). Former subsec. (h) redesignated (i).
Subsec. (i). Pub. L. 105–115, § 309(b)(1), (3), redesignated subsec. (h) as (i) and inserted at end “The Secretary shall by regulation prescribe the procedure by which the Secretary may deem a notification under subsection (h) of this section to no longer be effective.”
Subsec. (j). Pub. L. 105–115, § 309(b)(1), (4), redesignated subsec. (i) as (j) and substituted “subsections (b) to (i)” for “subsections (b) to (h)”.
1984—Subsec. (g)(2). Pub. L. 98–620 struck out provision that required the court to advance on the docket and expedite the disposition of all causes filed therein pursuant to this section.
1962—Subsec. (c)(3)(A). Pub. L. 87–781 excepted proviso from applying to use of a substance as an ingredient of feed for animals raised for food production, if under conditions of use specified in proposed labeling, and which conditions are reasonably certain to be followed in practice, such additive will not adversely affect the animals and no residue will be found in any edible portion of such animal after slaughter, or in any food from the living animal.
1960—Subsec. (g)(2). Pub. L. 86–546 substituted “forthwith transmitted by the clerk of the court to the Secretary, or any officer” for “served upon the Secretary, or upon any officer”, “shall file in the court the record of the proceedings on which he based his order, as provided in section 2112 of title 28” for “shall certify and file in the court a transcript of the proceedings and the record on which he based his order”, and “Upon the filing of such petition the court shall have jurisdiction, which upon the filing of the record with it shall be exclusive,” for “Upon such filing, the court shall have exclusive jurisdiction”, and inserted sentence authorizing the Secretary to modify or set aside his order until the filing of the record.
Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.
Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.
Amendment by Pub. L. 98–620 not applicable to cases pending on Nov. 8, 1984, see section 403 of Pub. L. 98–620, set out as an Effective Date note under section 1657 of Title 28, Judiciary and Judicial Procedure.
Pub. L. 95–203, § 3, Nov. 23, 1977, 91 Stat. 1452, as amended by Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 96–273, June 17, 1980, 94 Stat. 536; Pub. L. 97–42, § 2, Aug. 14, 1981, 95 Stat. 946; Pub. L. 98–22, § 2, Apr. 22, 1983, 97 Stat. 173; Pub. L. 99–46, May 24, 1985, 99 Stat. 81; Pub. L. 100–71, title I, § 101, July 11, 1987, 101 Stat. 431; Pub. L. 102–142, title VI, Oct. 28, 1991, 105 Stat. 910; Pub. L. 104–180, title VI, § 602, Aug. 6, 1996, 110 Stat. 1594, provided that:
[Definition of “saccharin” as used in section 3 of Pub. L. 95–203, set out above, to include calcium saccharin, sodium saccharin, and ammonium saccharin, see Pub. L. 95–203, § 2(d), Nov. 23, 1997, 91 Stat. 1452.]