The American Herbal Products Association (AHPA), Silver Spring, MD, wants the FDA to focus on several areas that will help the dietary supplement industry comply with regulations that cover new good manufacturing practices (GMPs), adverse event reporting, and new dietary ingredient (NDI) safety reviews. AHPA submitted its comments in early September in response to the FDA’s request for input on the program priorities in the coming year at the Center for Food Safety and Applied Nutrition (CFSAN). According to AHPA, the dietary supplement industry faces two major new regulatory requirements, as does the agency: (1) a final rule on current good manufacturing practice (cGMP) for manufacturing, packaging, labeling and holding dietary supplements, which was released this past June; and (2) the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a new law requiring serious adverse event reports (AERs) associated with dietary supplements and over-the counter (OTC) drugs be submitted to the FDA, which goes into effect this December. In its comments, AHPA requested that CFSAN ensure that sufficient agency resources are available to the industry so it can comply with both of these new requirements.

Further, citing FDA’s “FY 2007 Report to Stakeholders,” which was issued in June and listed a number of CFSAN program priorities, AHPA requested that CFSAN disclose how it identifies dietary supplement ingredients and products that raise safety problems, and that the agency act consistently and promptly to enforce against companies that sell products containing ephedra, which are illegal.

AHPA noted that while the agency generally meets its statutory requirement to review NDI pre-market notifications within 75 days, the agency should ensure that resources are provided so that requirement is always met. The FY 2007 Report to Stakeholders also listed CFSAN’s intention to develop a new rule and guidance on what information should be filed with an NDI notification, a requirement established by DSHEA. In the absence of agency guidance on how to comply with this safety review for new ingredients, AHPA produced its own interim guidance document.