September 2007

AHPA seeks further guidance on regulations

The American Herbal Products Association (AHPA) submitted comments to the Food and Drug Administration (FDA) to encourage the FDA to focus on several areas that will help the dietary supplement industry comply with regulations covering current good manufacturing practices (cGMP), adverse event reporting, and new dietary ingredient safety reviews.

The comments were presented in response to the FDA’s request for input on 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 CFSAN: a final rule on cGMPs 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 adverse event reports associated with dietary supplements and over-the-counter drugs be submitted to the FDA. The act goes into effect this December.

In its comments, AHPA requested CFSAN ensure sufficient agency resources are available to make certain the industry can comply with these new requirements.

Citing FDA’s “FY 2007 Report to Stakeholders,” which was issued in June and listed a number of CFSAN program priorities, AHPA requested 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 new dietary ingredient (NDI) pre-market notifications within 75 days, the agency should ensure resources are provided so the 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.

Further, AHPA urged CFSAN to ensure dietary supplement regulations are generated only by CFSAN and not other centers within the agency that have no jurisdiction.

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