PRIA, Government Policy, Made Personal

Summary

New dietary ingredients are treated as unsafe unless they meet one of two tests. Either the ingredient was already in the food supply and used as food without being chemically changed, or the maker can show it is safe and sends the Food and Drug Administration (FDA) the safety information at least 75 days before selling it. The FDA must keep that safety info secret for 90 days, then put it on public display unless parts are trade secrets or other confidential business information. Anyone can ask the FDA to set safe-use conditions for a new ingredient by filing a petition. The FDA must decide within 180 days, and that decision is treated as final agency action. If the FDA finds the safety notice is missing or weak because the ingredient might be an anabolic steroid or a close chemical copy, the FDA must tell the Drug Enforcement Administration. “Anabolic steroid” is defined in section 802(41) of the law. A “analogue” means a chemical very like an anabolic steroid. A “new dietary ingredient” is one that was not sold in the U.S. before October 15, 1994.

Title 21, §350b

Food and Drugs, Source: USLM XML via OLRC

(a)In general

A 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.

(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)

(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.

Notes & Related Subsidiaries

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 AmendmentNothing 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 section 2206, 2251, and 2252 of this title.

§350b New Dietary Ingredients