The American Herbal Products Association (AHPA) recently expanded its Trade Recommendation about safety labeling to include Class 3 botanicals. Class 3 botanicals are those that pose significant health risks as defined by AHPA's Botanical Safety Handbook.
AHPA previously evaluated herbs sold in the U.S. marketplace and placed them into four classes:
Class 1: herbs which can be safely consumed when used appropriately;
Class 2: Herbs with use restrictions:
2a: external use only;
2b: contraindicated during pregnancy;
2c: contraindicated during lactation;
2d: Other contraindications (e.g., hypertension, diabetes, etc.);
Class 3: herbs that should be used only under the supervision of a qualified expert;
Class 4: herbs that cannot be classified because of insufficient information.
The Botanical Safety Handbook (1997) lists about 550 herbs in trade and their classifications. The handbook also provides specific cautionary language to be included on product labels.
Formerly, only products in Class 2b or 2c had labeling requirements under AHPA policy. Membership in AHPA is contingent upon meeting these standards, among others.
Effective October 2003, product labels on Class 3 herb should include the following label information: "To be used only under the supervision of an expert qualified in the appropriate use of this substance."
Product labels on Class 3 herbal ingredients must also include: proper use information, dosage, contraindications, potential adverse effects and drug interactions, and any other relevant information related to the safe use of the substance. In addition, products containing Class 3 herbal ingredients must be labeled "not for general retail sale" and should be marketed so as to prevent general retail sale.
If the manufacturing process sets aside the safety concern, a product that contains a Class 3 herb need not include the recommended label information.
Two examples of Class 3 herbs are belladonna or deadly nightshade (Atropa belladonna L., Solanaceae), mayapple or American mandrake (Podophyllum peltatum L., Berberidaceae).
The entire list of Class 3 herbs can be found on page 189 of The Botanical Safety Handbook, which is sold by the American Botanical Council (ABC catalog #B275) and AHPA.
[AHPA. Update New AHPA Trade Recommendation [press release]. 2002 April 23.]