The American Herbal Products Association (AHPA), Silver Spring, MD, is reviewing the U.S. Consumer Product Safety Commission’s (CPSC) request for comments regarding the “Consumer Product Safety Improvement Act of 2008” (CPSIA), which requires that products subject to a consumer product safety rule include a Certificate of Compliance when shipped in commerce. For dietary supplement manufacturers, products subject to this rule are those that contain more than 250 mg of elemental iron and are required to be in childproof closures. The CPSIA is directed mainly at children’s products; however, the provision also applies to certain dietary supplements containing iron.

AHPA’s board of trustees has also adopted a new trade recommendation indicating use of the word “extract” in the labeling of herbal ingredients is not used to describe dehydrated plant materials that have not been subject to additional processing other than size reduction (i.e., cutting, milling, etc.). AHPA also adopted an interim guidance specification under current GMPs for quantitative limits of certain heavy metals that may be present in herbal supplements, including 10 units per gram/day of arsenic, 4.1 of cadmium, 10 of lead and 2 of methylmercury. Lastly, AHPA recommends that manufacturers and marketers of non-liquid dietary supplements establish specifications under current GMPs for microbiological limits, which include: total aerobic plate count: 107 colony forming units/gram; total yeasts and molds: 105 colony forming units/gram; total coliforms: 104 colony forming units/gram; salmonella: absent in 10 grams; Escherichia coli: not detected in one gram.