U.S Code last checked for updates: Jun 16, 2024
§ 350b.
New dietary ingredients
(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
(c)
Notification
(1)
In general
(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; 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
(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.)
cite as: 21 USC 350b