Premarket notifications of new dietary ingredients - A ten-year review

Food and Drug Law Journal

Volumn 59, Issue 2, 2004, Pages 229-244+ii

  McGuffin, Michael ^a   Young, Anthony L ^b  

^a American Herbal Products Association   (United States)

^b Law Firm of Kleinfeld Kaplan Becker LLP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACAMPROSATE; ANDROSTENEDIONE; ASTAXANTHIN; CONJUGATED LINOLEIC ACID; DRUG; FUCOIDIN; HORMONE; IDEBENONE; IRON; IRON PROTEIN SUCCINYLATE; PLANT EXTRACT; RELAXIN; RESVERATROL; SWEETENING AGENT; VINCAMINE;

DIET; DIET SUPPLEMENTATION; EXTRACT; FOOD AND DRUG ADMINISTRATION; LAW; MARKET; PLANT; REVIEW;

CHEMISTRY, PHARMACEUTICAL; CONSUMER PRODUCT SAFETY; DIETARY SUPPLEMENTS; DRUG APPROVAL; DRUG LABELING; FORECASTING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 3242741058     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (18)

1. Pub. L. No. 75-717, 52 Stat. 1040 (1938), as amended 21 U.S.C. §§ 301-397 (2000).
2. Pub. L. No. 85-929, 72 Stat. 1784 (1958) (codified at 21 U.S.C. § 348 (1999)).
3. 21 U.S.C. § 321(s) (FDCA § 201(s)).
4. Pub. L. No. 94-295, 90 Stat. 539 (1976).
5. Pub. L. No. 103-417, 108 Stat. 4325 (1994).
6. Pub. L. No. 103-417, § 8, 108 Stat. at 4331-32 (1994).
7. Pub. L. No. 103-417, § 8, 108 Stat. at 4331-32 (codified at 21 U.S.C. § 350(b)(c) (FDCA § 413(a))).
8. When DSHEA was enacted, the House and Senate sponsors of the legislation wanted to make sure that the legislative history of this new law would be minimal and controlled. Thus, a "Statement of Agreement" accompanied the law when it was enacted in both the Senate and House. One part of the Statement is pertinent to new dietary ingredients: "In Section 413(a)(1), added by section 8, the term 'chemically altered' does not include the following physical modifications: minor loss of volatile components, dehydration, lyophlization [sic], milling, tincture or solution in water, slurry, powder, or solid in suspension." 140 CONG. REC. H11,179 (daily ed. Oct. 6, 1994).
9. Pub. L. No. 103-417, § 8, 108 Stat. at 4331-32 (codified at 21 U.S.C. § 350(b)(c) (FDCA § 413(a))).
10. See FDA Docket No. 95S-0316, 75-Day Premarket Notifications for New Dietary Ingredients, available at http://www.fda.gov/ohrms/dockets/dockets/ 95s0316/95s0316.htm (last accessed May 11, 2004).
11. 62 Fed. Reg. 49,886 (Sept. 23, 1997) (codified at 21 C.F.R. § 190.6).
12. The authors were informed on January 5, 2004, that FDA had received 190 notices as of August 22, 2003-the last date on which FDA's files had been updated. FDA also stated that it updates its files every 90 days. This article addresses only those files available in the docket as of the date of its submission for publication.
13. The total of 29 examples in this paragraph exceeds the number of cases because two of these submissions were cited both for drug claims and for nonconformity to the dietary ingredient definition.
14. A novel extract of a common ingredient arguably can be described as a "new dietary ingredient," and there have been submissions for new dietary ingredients that are identified as novel extracts of common plants (e.g., a polyphenolic extract of evening primrose (Oenethera biennis)). None of the examples identified here, however, provided any information to suggest that they were anything other than simple ethanolic extracts, traditionally prepared.
15. AMERICAN HERBAL PRODUCTS ASS'N, HERBS OF COMMERCE (2d ed. 2000). This document is a compilation of input received from herbal marketers and experts who were asked, in 1995, to identify all of the plants that were marketed in the United States prior to the passage of DSHEA. Because there was no effort to verify this input, however, the text disclaims any identity as a definitive reference to substantiate either presence in, or absence from, the market, and should be considered as only one source of information.
16. George W. Bush, State of the Union Address (Jan. 20, 2004), available at http://www.whitehouse.gov/news/releases/2004/01/20040120-7.html (last accessed June 21, 2004).
17. Pub. L. No. 103-417, § 3, 108 Stat. at 4327 (codified at 21 U.S.C. § 321(ff)(1)(A)-(F) (FDCA § 201(ff)(1)(A)-(F))).
18. Food and Drug Administration, White Paper, Health Effects of Androstenedione (Mar. 11, 2004), available at http://www.fda.gov/oc/whitepapers/ andro.html (last accessed May 11, 2004).