(Silver Spring, MD, November 7, 2005) -- Effective January 1, 2006, AHPA’s Herbs of Commerce, 2nd edition, will be officially incorporated into federal regulations on labeling of botanical ingredients in dietary supplement, when a direct final rule published in 2003 goes into effect.
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. The rules also allow dietary supplement product labels to omit the Latin binomial of herbal ingredients listed in Herbs of Commerce, 2nd edition, whereas 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 (St. Louis Code) is identified as an authoritative reference.
Because the second edition of Herbs of Commerce includes almost 1,500 more species than the first edition (2,048 separate species as opposed to 550), many ingredients presently used on labels will now be able to be identified by their common names instead of their Latin binomials.
“It's gratifying that FDA incorporated AHPA’s good work to set standards for labeling,” stated Michael McGuffin, AHPA’s president. “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.”
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; the latter must under go a safety review by FDA.
AHPA’s first edition of Herbs of Commerce, published in 1992 as self-governing guidance to reduce confusion associated with labeling botanical ingredients, established a single “standardized” common name for each listed herbs. The document was incorporated by reference in 1997 as FDA initiated rulemaking to implement the Dietary Supplement Health and Education Act of 1994. The second edition was published in 2000 and edited by McGuffin in collaboration with three of the country's preeminent experts on botanical nomenclature: Drs. John Kartesz, Albert Leung, and Arthur Tucker.
The direct final rule is on AHPA’s website: http://www.ahpa.org/03_0828_DirectFinalRule_HoC2.pdf. Herbs of Commerce, 2nd edition, may be purchased from AHPA’s website at: http://www.ahpa.org/bookstore.htm (AHPA members price is $39.99; non-member companies pay $99.99).
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org