Dietary Supplement Law and Legal Definition
The term dietary supplement--
“(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);
(2) means a product that--
(A) (i) is intended for ingestion in a form described in section 411(c)(1)(B)(i) [21 USCS § 350(c)(1)(B)(i)]; or
(ii) complies with section 411(c)(1)(B)(ii) [21 USCS § 350(c)(1)(B)(ii)];
(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and
(C) is labeled as a dietary supplement; and
(3) does--
(A) include an article that is approved as a new drug under section 505 [21 USCS § 355] or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f) [21 USCS § 342(f)]; and
(B) not include--
(i) an article that is approved as a new drug under section 505 [21 USCS § 355], certified as an antibiotic under section 507 [21 USCS § 357], or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or
(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this Act [21 USCS §§ 301 et seq.].
Except for purposes of sections 201(g) and 417 [21 USCS §§ 321(g) and 350f], a dietary supplement shall be deemed to be a food within the meaning of this Act.” [21 USCS §§ 301 et seq.].
21 USCS § 321
Legal Definition list
- Dietary Law
- Dietary Guidelines for Americans
- Diesel Engine
- Diem Clausit Extremum
- Diebus Dominicis Mercari, Judicari Vel Jurari Non Debet
- Dietary Supplement
- Difference between first and second degree murder
- Difference in Conditions Coverage
- Different Campus [Education]
- Different Cause of Action
- Different-Department Rule
Related Legal Terms
- Child Supplementary Aids and Service
- Commodity Supplemental Food Program [CSFP]
- Dietary Guidelines for Americans
- Dietary Law
- Efficacy Supplement [Food and Drugs]
- Federal Supplement
- Federal Supplemental Benefits - FSB
- Medicare Supplement Insurance
- Medicare Supplemental Insurance
- Original Bill in the Nature of a Supplemental Bill
