21 U.S.C. § 350b

New dietary ingredients

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(a) In generalA dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 342(f) of this title 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 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, the decision of the Secretary shall be considered final agency action.

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) DefinitionsFor purposes of this subsection—(A) the term “anabolic steroid” has the meaning given such term in section 802(41) of this title; 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.

(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.)Editorial NotesAmendments

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

Statutory Notes and Related SubsidiariesGuidance

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.

Notes of Decisions

Cited in 6 cases (2 in the last 5 years), 1999–2022 · leading case: Joshua Debernardis v. IQ Formulations, LLC, 942 F.3d 1076 (11th Cir. 2019).

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Joshua Debernardis v. IQ Formulations, LLC, 942 F.3d 1076 (11th Cir. 2019). “See 21 U.S.C. § 350b(a)(1). And the complaint alleged that before selling the supplements, neither IQ nor Europa provided any notice to the FDA showing that DMBA had a history of harmless use in food products or supplements or containing other evidence of DMBA’s safety.”

Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999). “The actual sale of dietary supplements is regulated only when the supplement contains a “new dietary ingredient,” 21 U.S.C.A. § 350b (Supp.1998), or poses a safety risk, id.”

In re Elysium Health-Chromadex Litig., 354 F. Supp. 3d 330 (S.D. Ill. 2019). “That Elysium's Basis product contains a new dietary ingredient under 21 U.S.C. § 350b for which Elysium had not submitted a New Dietary Ingredient Notification ("NDIN"), thereby rendering the product adulterated under §§ 342(f)(1)(B) and 350(a).”

Pharmanex v. Shalala, 221 F.3d 1151 (10th Cir. 2000). “Pharmanex represents only that premarket notification would almost surely be required by § 21 U.S.C. § 350b (provision governing new dietary ingredients).”

Corbett v. PharmaCare U.S., Inc. (S.D. Cal. 2021). · cites it 2× “¶¶ 28, 30 (quoting 21 U.S.C. § 350b(a)(1).) A manufacturer or 3 distributor must provide the FDA with information that demonstrates “history of use or 4 other evidence of safety establishing that the dietary ingredient when used under the 5 conditions recommended or suggested in…”

In re: Elysium Health-Chromadex Litig. (S.D.N.Y. 2022). · cites it 2× “at 8 (quoting 21 U.S.C. § 350b(a)(2)). When a manufacturer or distributor submits an NDIN, the notification must contain the information based on which they believe that the dietary supplement with the NDI “will reasonably be expected to be safe.”

— 21 U.S.C. § 350b(a)(1) — 2 cases

Corbett v. PharmaCare U.S., Inc. (S.D. Cal. 2021). “¶¶ 28, 30 (quoting 21 U.S.C. § 350b(a)(1).) A manufacturer or 3 distributor must provide the FDA with information that demonstrates “history of use or 4 other evidence of safety establishing that the dietary ingredient when used under the 5 conditions recommended or suggested in…”

— 21 U.S.C. § 350b(a)(2) — 2 cases

In re: Elysium Health-Chromadex Litig. (S.D.N.Y. 2022). “at 8 (quoting 21 U.S.C. § 350b(a)(2)). When a manufacturer or distributor submits an NDIN, the notification must contain the information based on which they believe that the dietary supplement with the NDI “will reasonably be expected to be safe.”

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