21 USC 348 - Food additives

Editorial Notes

Amendments

2018—Subsec. (k). Puspan. L. 115–234 added subsec. (k).

1997—Subsec. (a). Puspan. 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under subsection (h)(1) relating to a food additive that is a food contact substance, is in effect, and has not been revoked pursuant to subsection (i), a food shall not, by reason of bearing or containing such a food additive in accordance with the regulation or notification, be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). Puspan. L. 105–115, § 309(a)(1), substituted “subsection (j)” for “subsection (i)”.

Subsec. (a)(3). Puspan. L. 105–115, § 309(a)(1)(B), (2), (3), added par. (3).

Subsec. (h). Puspan. L. 105–115, § 309(span)(2), added subsec. (h). Former subsec. (h) redesignated (i).

Subsec. (i). Puspan. L. 105–115, § 309(span)(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) to no longer be effective.”

Subsec. (j). Puspan. L. 105–115, § 309(span)(1), (4), redesignated subsec. (i) as (j) and substituted “subsections (span) to (i)” for “subsections (span) to (h)”.

1984—Subsec. (g)(2). Puspan. 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). Puspan. 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). Puspan. 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.

Statutory Notes and Related Subsidiaries

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 Puspan. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Puspan. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1984 Amendment

Amendment by Puspan. L. 98–620 not applicable to cases pending on Nov. 8, 1984, see section 403 of Puspan. L. 98–620, set out as an Effective Date note under section 1657 of Title 28, Judiciary and Judicial Procedure.

Effective Date of 1962 Amendment; Exceptions

Amendment by Puspan. L. 87–781 effective Oct. 10, 1962, see section 107 of Puspan. L. 87–781, set out as an Effective Date of 1962 Amendment note under section 321 of this title.

Effective Date

Section effective Sept. 6, 1958, see section 6(a) of Puspan. L. 85–929, set out as an Effective Date of 1958 Amendment note under section 342 of this title.

Guidance on Pre-Petition Consultation Process for Animal Food Additives

Puspan. L. 115–234, title III, § 306(c), Aug. 14, 2018, 132 Stat. 2441, provided that:

“(1)In general.—Not later than 18 months after the date of enactment of this Act [Aug. 14, 2018], the Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’) shall publish draft guidance relating to the voluntary pre-petition consultation process for food additives intended for use in animal food.

“(2)Contents.—The guidance under paragraph (1) shall include—

“(A) the recommended format to submit to the Food and Drug Administration existing data, including any applicable foreign data, for assessment prior to submission of a food additive petition for animal food under section 409(span) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 348(span)];

“(B) the manner and the number of days by which the Food and Drug Administration intends to review and respond to such existing data, including with respect to providing a scientific rationale for any additional data request;

“(C) circumstances under which the submission of study protocols is recommended prior to submission of a food additive petition under such section 409(span);

“(D) the manner in which the Secretary intends to inform the person submitting a study protocol for a food additive if the review of such study protocol will take longer than 50 days; and

“(E) best practices for communication between the Food and Drug Administration and industry on the development of pre-petition submissions of study protocols and existing data for food additives.

“(3)Final guidance.—The guidance under paragraph (1) shall be finalized, withdrawn, or reissued not later than 1 year after the close of the comment period on the draft guidance.”

Glass and Ceramic Ware

Puspan. 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.

“(span)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

Puspan. L. 95–203, § 3, Nov. 23, 1977, 91 Stat. 1452, as amended by Puspan. L. 96–88, title V, § 509(span), Oct. 17, 1979, 93 Stat. 695; Puspan. L. 96–273, June 17, 1980, 94 Stat. 536; Puspan. L. 97–42, § 2, Aug. 14, 1981, 95 Stat. 946; Puspan. L. 98–22, § 2, Apr. 22, 1983, 97 Stat. 173; Puspan. L. 99–46, May 24, 1985, 99 Stat. 81; Puspan. L. 100–71, title I, § 101, July 11, 1987, 101 Stat. 431; Puspan. L. 102–142, title VI, Oct. 28, 1991, 105 Stat. 910; Puspan. 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 180.37 of part 180, subchapter B, chapter 1, title 21, Code of Federal Regulations (42 Fed. Reg. 14638)), or

“(2) may, except as provided in section 4 [enacting section 343a of this title, amending sections 321 and 343 of this title, and enacting provisions set out as notes under section 343 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,

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.”

[Definition of “saccharin” as used in section 3 of Puspan. L. 95–203, set out above, to include calcium saccharin, sodium saccharin, and ammonium saccharin, see Puspan. L. 95–203, § 2(d), Nov. 23, 1997, 91 Stat. 1452.]