(September 6, 2007) — American Herbal Products Association (AHPA) is encouraging the Food and Drug Administration (FDA) to focus on several areas that will help the dietary supplement industry comply with regulations that cover new good manufacturing practices, adverse event reporting, and new dietary ingredient safety reviews. The association’s comments were submitted to FDA earlier this week 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).
The dietary supplement industry faces two major new regulatory requirements, as does the agency: a final rule on current good manufacturing practice (cGMP) for manufacturing, packaging, labeling, and holding dietary supplements, which were released this past June, and the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a new law requiring serious adverse event reports associated with dietary supplements and over-the counter 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 ensure that industry can comply with both of these new requirements promptly.
Citing FDA’s “FY 2007 Report to Stakeholders,” which was issued in June 2007 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.
“It is not apparent that enforcement against dietary supplements that contain ephedrine alkaloids is, in fact, an agency priority. There are numerous products that are readily available on the Internet that are marketed as dietary supplements and that purport to contain ephedrine alkaloids,” AHPA wrote.
AHPA noted that while the agency generally meets its statutory requirement to review new dietary ingredient (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 the Dietary Supplement Health and Education Act of 1994. In the absence of agency guidance on how to comply with this safety review for new ingredients, AHPA produced its own interim guidance document.
“In the interest of minimizing duplication of efforts and the use of agency resources, and of accelerating the completion of guidance for industry on NDI regulations, AHPA encourages FDA to incorporate any or all of the existing AHPA guidance as may be appropriate,” AHPA wrote.
Further, AHPA urged CFSAN to ensure that dietary supplement regulations are generated only by CFSAN and not other centers within the agency that have no jurisdiction. This comes from AHPA noting that the FDA office that focuses on prescription drugs, the Center for Drug Evaluation and Research (CDER), had issued a document in 2006 stating that it planned to develop guidance on “labeling dietary supplements for women who are or could be pregnant.” In its comments, AHPA requested that “appropriate personnel at CFSAN communicate with appropriate personnel at CDER to request that CDER refrain from any further activity in developing labeling guidance of any sort for dietary supplements.”
AHPA’s comments are available on the association’s website at: http://www.ahpa.org/Portals/0/pdfs/07_0904_AHPAComments_CFSAN2008Priorities.pdf.
The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade—comprised of the finest growers, processors, manufacturers and marketers of herbal products—our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Celebrating our 25th anniversary in 2007! Website: www.ahpa.org.