|
by Mark Blumenthal
In most cases, the ideal way to regulate an industry is for that industry to regulate itself. Since 1992 the American Herbal Products Association (AHPA) has taken the initiative for self-regulation in one of the most important areas of the herb trade, the names used for herb materials used in teas, dietary supplements, and other commercial products.
In 1992 AHPA published Herbs of Commerce, a listing of about 550 of the most widely used herbs in the North American market with their “standardized common name” (SCN) and the corresponding Latin binomial for each entry. 1 The intention was to develop uniform common names used for herb materials and finished products. The first edition was published as self-governing guidance for AHPA members to reduce confusion associated with labeling botanical ingredients. This standardization of common names is at the root of efforts to ensure quality and safety of botanical products. The 1992 document was incorporated by reference in 1997 as FDA initiated rulemaking to implement aspects of the Dietary Supplement Health and Education Act of 1994 (DSHEA). 2
In 2000, AHPA revised this list to more than 2,000 species found in the U.S. marketplace with its Herbs of Commerce, 2nd edition. 3 Effective January 1, 2006, the second edition will be incorporated officially into federal regulations dealing with the labeling of botanical ingredients in dietary supplement. This official recognition was originally announced by the Food and Drug Administration (FDA) in the Federal Register in 2003. 4
Title 21 of the Code of Federal Regulations, Part 101.4(h) (21 CFR 101.4(h)) requires that the common or usual name of botanical ingredients in dietary supplements be consistent with the names standardized in the second edition of Herbs of Commerce. 2 The rules also allow dietary supplement product labels to omit the Latin binomial of herbal ingredients listed in Herbs of Commerce, 2nd edition when the AHPA SCN is used; otherwise, the Latin name is required to identify all other herbal ingredients. In addition, when Latin names are used, they must conform to internationally accepted nomenclature rules, and the 2000 edition of the International Code of Botanical Nomenclature (ICBN, or St. Louis Code) is identified as an authoritative reference. 5
As noted above, the second edition of Herbs of Commerce contains significantly more listings that the original 1992 edition: there almost 1,500 more species than the first edition (2,048 separate species as opposed to 550). Thus, according to AHPA, “many ingredients presently used on labels will now be able to be identified by their common names instead of their Latin binomials.” 6
AHPA’s president Michael McGuffin stated, “It’s gratifying that FDA incorporated AHPA’s good work to set standards for labeling. We strive to work in this way with the regulatory agencies: credible experts in the field provide valuable and authoritative information to the regulator and the regulator then adopts and endorses this information as policy.” 6
AHPA has also urged FDA to recognize Herbs of Commerce, 2nd edition, as an authoritative resource to differentiate between old dietary ingredients and new dietary ingredients (NDIs, i.e., dietary ingredients that were not sold as foods or dietary supplements prior to the passage of DSHEA on October 15, 1994). NDIs are required to be subject to a safety review by FDA with the prospective seller submitting documentation of safety at least 75 days before the date of the proposed initial sale of the NDI. AHPA asked the FDA to recognize the second edition of Herbs of Commerce in its Public Comments to FDA regarding to FDA’s proposed regulations on NDIs on February 1, 2005. (The American Botanical Council [ABC] also independently suggested to FDA that Herbs of Commerce, as well as some lists of old dietary ingredients compiled by other industry groups, be recognized as an official list of old dietary ingredients, the lack of which causes confusion in the industry as to whether a potentially novel botanical ingredient must undergo an NDI review.)
ABC published an article on this subject in HerbalGram in 2003 after FDA announced the new policy.7 The direct final rule from the Federal Register is posted on AHPA’s website: http://www.ahpa.org/03_0828_DirectFinalRule_HoC2.pdf. Herbs of Commerce, 2nd edition is available to AHPA members from the AHPA online bookstore, http://www.ahpa.org/bookstore.htm, for $39.95. Non-AHPA members can purchase the book from the ABC Herbal Education Catalog on ABC’s website at http://www.herbalgram.org/bookcatalog/product.asp?p=136; item # B475; $95.00).
References
1. Foster S. Herbs of Commerce. Austin TX: American Herbal Products Assn., 1992.
2. Title 21. Code of Federal Regulations, Part 101.4(h).
3. McGuffin M, Kartesz JT, Leung AY, Tucker AO. American Herbal Products Association’s Herbs of Commerce, 2nd ed. Silver Spring, MD: American Herbal Products Association, 2000.
4. FDA. Food labeling: Ingredient labeling of dietary supplements that contain botanicals. Docket no. 2003N-0346. (Food and Drug Administration). Federal Register 68 (167):51693-51704. August 28, 2003. Available at: http://www.ahpa.org/03_0828_DirectFinalRule_HoC2.pdf.
5. Greuter W (ed.). International Code of Botanical Nomenclature (St. Louis Code) 2000, adopted by the International Association for Plant Taxonomy at the XVI International Botanical Congress. Königstein, Germany: Koeltz Scientific Books; 2000. Available online at http://www.bgbm.fu-berlin.de/iapt/nomenclature/code/SaintLouis/0000St.Luistitle.htm.
6. AHPA. Herbs of Commerce, 2nd edition, Becomes Law of the Land for Labeling [press release]. Silver Spring, MD: American Herbal Products Assn., Nov. 7, 2005.
7. Blumenthal M. FDA publishes rule to incorporate AHPA’s Herbs of Commerce in herb labeling. HerbalGram. 2003;60:66. Available at: http://www.herbalgram.org/herbalgram/articleview.asp?a=2601.
|