Source: https://casetext.com/statute/united-states-code/title-21-food-and-drugs/chapter-9-federal-food-drug-and-cosmetic-act/subchapter-iv-food/section-350b-new-dietary-ingredients
Timestamp: 2019-11-12 01:54:27
Document Index: 620691721

Matched Legal Cases: ['§ 350', '§ 350', '§413', '§8', '§113', '§113']

Section 350b - New dietary ingredients, 21 U.S.C. § 350b | Casetext
21 U.S.C. § 350b
Section 350b - New dietary ingredients
(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.
AMENDMENTS 2011-Subsecs. (c), (d). Pub. L. 111-353 added subsec. (c) and redesignated former subsec. (c) as (d).
GUIDANCEPub. 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 sections 2206, 2251, and 2252 of this title.
Section 350a - Infant formulas
Section 350c - Maintenance and inspection of records
(Dkt. No. 80-20, P's NOL, Ex. 16, FDA Draft Guidance for Industry, dated July 2011 at 5; see 21 U.S.C. §…
The requirement that health claims be approved before being added to the label of a dietary supplement…