Issue: 69 Page: 60-61
Herb Industry Self-Regulation Initiative on Common Names for Herbal Ingredients Becomes Federal Law in January
by Mark Blumenthal
HerbalGram. 2006; 69:60-61 American Botanical Council
Herb Industry Self-Regulation Initiative on Common Names for Herbal Ingredients Becomes Federal Law in January
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 the Food and Drug Administration (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 US 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 supplements. This official
recognition was originally announced by the 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; the 2000 edition of the International Code of Botanical
Nomenclature (ICBN, or St. Louis Code) is
identified as an authoritative reference.5
The second edition of Herbs of Commerce contains almost 1,500 more species than the original
1992 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 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 Web site:
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 Web site at
http://www.herbalgram.org/bookcatalog/product.asp?p=136 (item # B475) for
$95.00.
References
1. Foster S. Herbs of Commerce. Austin TX: American Herbal Products Association;
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. Accessed December 2,
2005.
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. Koigstein, Germany: Koeltz Scientific Books; 2000.
Available at:
http://www.bgbm.fu-berlin.de/iapt/nomenclature/code/SaintLouis/0000St.Luistitle.htm.
Accessed December 2, 2005.
6. AHPA. Herbs of Commerce, 2nd edition, Becomes Law of the
Land for Labeling [press release]. Silver Spring, MD: American Herbal Products
Association; November 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. Accessed December
2, 2005.
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