(June 25, 1938, ch. 675, § 409, as added Pub. L. 85–929, § 4,Sept. 6, 1958, 72 Stat. 1785; amended Pub. L. 86–546, § 2,June 29, 1960, 74 Stat. 255; Pub. L. 87–781, title I, § 104(f)(1),Oct. 10, 1962, 76 Stat. 785; Pub. L. 98–620, title IV, § 402(25)(B),Nov. 8, 1984, 98 Stat. 3359; Pub. L. 105–115, title III, § 309,Nov. 21, 1997, 111 Stat. 2354.)
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(h)(1) of this section relating to a food additive that is a food contact substance, is in effect, and has not been revoked pursuant to subsection (i) of this section, a food shall not, by reason of bearing or containing such a food additive in accordance with the regulation or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
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
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), redesignatedsubsec. (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), redesignatedsubsec. (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
” 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.
Change of Name
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.
Effective Date of 1997 Amendment
Amendment by Pub. L. 105–115
effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 ofPub. L. 105–115
, set out as a note under section
of this title.
Effective Date of 1984 Amendment
Amendment by Pub. L. 98–620
not applicable to cases pending on Nov. 8, 1984, see section 403 ofPub. L. 98–620
, set out as an Effective Date note under section
, Judiciary and Judicial Procedure.
Effective Date of 1962 Amendment; Exceptions
Amendment by Pub. L. 87–781
effective Oct. 10, 1962, see section 107 ofPub. L. 87–781
, set out as an Effective Date of 1962 Amendment note under section
of this title.
Section effective Sept. 6, 1958, see section 6(a) ofPub. L. 85–929
, set out as an Effective Date of 1958 Amendment note under section
of this title.
Glass and Ceramic Ware
Pub. L. 105–115
, title III, § 308,Nov. 21, 1997, 111 Stat. 2353
, provided that:
“(a) In General.—The Secretary may not implement any requirement which would ban, as an unapproved food additive, lead and cadmium based enamel in the lip and rim area of glass and ceramic ware before the expiration of one year after the date such requirement is published.
“(b) Lead and Cadmium Based Enamel.—Unless the Secretary determines, based on available data, that lead and cadmium based enamel on glass and ceramic ware—
“(1) which has less than 60 millimeters of decorating area below the external rim, and
“(2) which is not, by design, representation, or custom of usage intended for use by children,
is unsafe, the Secretary shall not take any action before January 1, 2003, to ban lead and cadmium based enamel on such glass and ceramic ware. Any action taken after January 1, 2003, to ban such enamel on such glass and ceramic ware as an unapproved food additive shall be taken by regulation and such regulation shall provide that such products shall not be removed from the market before 1 year after publication of the final regulation.”
Moratorium on Authority of Secretary With Respect to Saccharin
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: “During the period ending May 1, 2002, the Secretary—
“(1) may not amend or revoke the interim food additive regulation of the Food and Drug Administration of the Department of Health and Human Services applicable to saccharin and published on March 15, 1977 (section
.37 of part 180, subchapter B, chapter 1, title
, Code of Federal Regulations (42 Fed. Reg. 14638)), or
solely on the basis of the carcinogenic or other toxic effect of saccharin as determined by any study made available to the Secretary before the date of the enactment of this Act [Nov. 23, 1977] which involved human studies or animal testing, or both.”
“(2) may, except as provided in section
of this title, amending sections
of this title, and enacting provisions set out as notes under section
of this title] and the amendments made by such section, not take any other action under the Federal Food, Drug, and Cosmetic Act [this chapter] to prohibit or restrict the sale or distribution of saccharin, any food permitted by such interim food additive regulation to contain saccharin, or any drug or cosmetic containing saccharin,
[Definition of “saccharin” as used in section 3 ofPub. 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