§ 350b. New dietary ingredients

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Dietary Supplement Health and Education Act of 1994

   Pub. L. 103–417 § 8 · 108 Stat. 4325

   Enacted · 21 U.S.C. § 350b

   June 25, 1938, ch. 675, § 413, as added Pub. L. 103–417, § 8, Oct. 25, 1994, 108 Stat. 4331

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 413, as added Pub. L. 103–417, § 8, Oct. 25, 1994, 108 Stat. 4331

   Enacted provision · exact public law section
   SEC. 8. NEW DIETARY INGREDIENTS. Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end the following: “Sec. 413. (a) In General.— A dietary supplement which contains 21 USC 350b. a new dietary ingredient shall be deemed adulterated under section 402(f) unless it meets one of the following requirements: “(1) The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered. “(2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe. The Secretary shall keep confidential any information provided Classified information. under paragraph (2) for 90 days following its receipt. After the expiration of such 90 days, the Secretary shall place such information on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information. “(b) Petition.— Any person may file with the Secretary a petition proposing the issuance of an order prescribing the conditions under which a new dietary ingredient under its intended conditions of use will reasonably be expected to be safe. The Secretary shall make a decision on such petition within 180 days of the date the petition is filed with the Secretary. For purposes of chapter 7 of title 5, United States Code, the decision of the Secretary shall be considered final agency action. “(c) Definition.— For purposes of this section, the term ‘new dietary ingredient’ means a dietary ingredient that was not mar-keted in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15,1994.”.

2. 2011

   FDA Food Safety Modernization Act

   Pub. L. 111–353 title I § 113(a) · 124 Stat. 3885

   1. Added · 21 U.S.C. § 350b(c); 21 U.S.C. § 350b(d)

      Pub. L. 111–353 added subsec. (c)

   2. Redesignated · 21 U.S.C. § 350b(c); 21 U.S.C. § 350b(d)

      Pub. L. 111–353 redesignated former subsec. (c) as (d)

   Source evidence

   Code amendment note
   Subsecs. (c), (d). Pub. L. 111–353 added subsec. (c) and redesignated former subsec. (c) as (d).

   Enacted provision · exact public law section
   (a) In General.— Section 413 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b) is amended— (1) by redesignating subsection (c) as subsection (d); and (2) by inserting after subsection (b) the following: “(c) Notification.— “(1) In general.— If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination. Such notification by the Secretary shall include, at a minimum, the name of the dietary supplement or article, the name of the person or persons who marketed the product or made the submission of information regarding the article to the Secretary under this section, and any contact information for such person or persons that the Secretary has. “(2) Definitions.— For purposes of this subsection— “(A) the term ‘anabolic steroid’ has the meaning given such term in section 102(41) of the Controlled Substances Act; and “(B) the term ‘analogue of an anabolic steroid’ means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.” .

3 of 3 references resolved to an enrolled provision