---
kind: "section"
citation: "21 U.S.C. § 350b"
title: "21"
title_heading: "Food and Drugs"
number: "350b"
heading: "New dietary ingredients"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/350b"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IV — Food"
---

# §350b. New dietary ingredients

- (a) **In general—** A [dietary supplement](/usc/21/321.md?p=ff) which contains a new dietary ingredient shall be deemed adulterated under [section 342(f) of this title](/usc/21/342.md?p=f) unless it meets one of the following requirements:
  - (1) The [dietary supplement](/usc/21/321.md?p=ff) contains only dietary ingredients which have been present in the [food](/usc/21/321.md?p=f) supply as an article used for [food](/usc/21/321.md?p=f) in a form in which the [food](/usc/21/321.md?p=f) 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](/usc/21/321.md?p=m) of the [dietary supplement](/usc/21/321.md?p=ff) will reasonably be expected to be [safe](/usc/21/321.md?p=u) and, at least 75 days before being introduced or delivered for introduction into [interstate commerce](/usc/21/321.md?p=b), the [manufacturer](/usc/21/360hh.md?p=3) or distributor of the dietary ingredient or [dietary supplement](/usc/21/321.md?p=ff) provides the [Secretary](/usc/21/321.md?p=d) with information, including any citation to published articles, which is the basis on which the [manufacturer](/usc/21/360hh.md?p=3) or distributor has concluded that a [dietary supplement](/usc/21/321.md?p=ff) containing such dietary ingredient will reasonably be expected to be [safe](/usc/21/321.md?p=u).

  The [Secretary](/usc/21/321.md?p=d) shall keep confidential any information provided under [paragraph (2)](#a-2) for 90 days following its receipt. After the expiration of such 90 days, the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=e) may file with the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=u). The [Secretary](/usc/21/321.md?p=d) shall make a decision on such petition within 180 days of the date the petition is filed with the [Secretary](/usc/21/321.md?p=d). For purposes of [chapter 7](/usc/5/chptI/ch7.md) of title 5, the decision of the [Secretary](/usc/21/321.md?p=d) shall be considered final agency action.
- (c) **Notification—**
  - (1) **In general—** If the [Secretary](/usc/21/321.md?p=d) 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](/usc/21/321.md?p=ff) containing such article will reasonably be expected to be [safe](/usc/21/321.md?p=u) because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the [Secretary](/usc/21/321.md?p=d) shall notify the [Drug](/usc/21/321.md?p=g-1) Enforcement Administration of such determination. Such notification by the [Secretary](/usc/21/321.md?p=d) shall include, at a minimum, the name of the [dietary supplement](/usc/21/321.md?p=ff) or article, the name of the [person](/usc/21/321.md?p=e) or [persons](/usc/21/321.md?p=e) who marketed the [product](/usc/21/360eee.md?p=13) or made the submission of information regarding the article to the [Secretary](/usc/21/321.md?p=d) under this section, and any contact information for such [person](/usc/21/321.md?p=e) or [persons](/usc/21/321.md?p=e) that the [Secretary](/usc/21/321.md?p=d) has.
  - (2) **Definitions—** For purposes of this subsection—
    - (A) the term “anabolic steroid” has the meaning given such term in [section 802(41) of this title](/usc/21/802.md?p=41); 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.
- (d) **“New dietary ingredient” defined—** For purposes of this section, the term “new dietary ingredient” means a dietary ingredient that was not marketed 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.

## Source credit

(June 25, 1938, ch. 675, § 413, as added Pub. L. 103–417, § 8, Oct. 25, 1994, 108 Stat. 4331; amended Pub. L. 111–353, title I, § 113(a), Jan. 4, 2011, 124 Stat. 3920.)

## Notes

### Editorial Notes

### Amendments

2011—Subsecs. (c), (d). Pub. L. 111–353 added subsec. (c) and redesignated former subsec. (c) as (d).

### Statutory Notes and Related Subsidiaries

### Guidance

Pub. L. 111–353, title I, § 113(b), Jan. 4, 2011, 124 Stat. 3921, provided that: “Not later than 180 days after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with information as described in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350b(a)(2)], the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identify [sic] of a new dietary ingredient.”

### Construction of 2011 Amendment

Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.