In its continuing efforts to inform its members and the industry at large about best practices regarding solvents in dietary supplements, the American Herbal Products Association (AHPA) has amended its existing guidance policy on residual solvents in herbal extracts. The amendment, approved by AHPA's Board of Trustees in July, prohibits the use of class 1 solvents and amends the policy concerning the use of acetic acid when it is present in liquid extracts formulated to contain vinegar or acetic acid.
The amended guidance policy states that Class 1 solvents "are not appropriate for use, and should not be used, in the manufacture of herbal extracts." The existing policy previously set International Conference on Harmonization (ICH) class 2 and class 3 solvent limits for herbal extracts.
Class 1 solvents include benzene; carbon tetrachloride; 1, 2-dichloroethane; 1, 1-dichloroethene; and 1, 1, 1-trichloroethane, according to ICH.
AHPA develops guidance policies to advance its mission to promote responsible commerce in herbal supplements. These policies address a variety of labeling and manufacturing issues and reflect the consensus of AHPA's members and its Board of Trustees. Unlike AHPA's trade recommendations, compliance with AHPA's guidance policies is not a condition of membership. Nevertheless, AHPA encourages its members and non-member companies to adopt each of these policies in the interest of establishing consistent and informed trade practices.
"The previous AHPA policy did not explicitly exclude class 1 solvents as ICH makes exemptions for their use in drug manufacture when no other solvents can be used," said Steven Dentali, Ph.D., AHPA's chief science officer. "AHPA's Standards Committee, which recommended the new policy to the board, wanted to make it clear that these solvents have no place in the manufacture of herbal extracts due to their unacceptable toxicity or status as an environmental hazard. Most of the solvents listed are not used in the manufacture of herbal extracts; AHPA acted to harmonize with the broadly accepted ICH guidelines."
Dentali also stated that the AHPA Standards Committee "also recognized that some liquid extracts should have an exemption for acetic acid residues when they are formulated with acetic acid or vinegar--which contains acetic acid--in the same way that the earlier guidance policy exempted residual ethanol when it is used as a component in the manufacture of liquid extracts."
Interested parties can view the revised guidance policy on residual solvents here. Scroll down to "Guidance on Residual Solvents in Extracts."
About the American Herbal Products Association
The American Herbal Products Association is the national trade association for and the voice of the herbal products industry. AHPA is comprised of domestic and foreign companies doing business as growers, processors, manufacturers, and marketers of herbs and botanical and herbal products, including foods, dietary supplements, cosmetics, and non-prescription drugs. Founded in 1982, AHPA's mission is to promote the responsible commerce of herbal products. www.ahpa.org.