The American Herbal Products Association has submitted comments to the US Food and Drug Administration, urging it to assist the dietary supplement industry in complying with good manufacturing practices, adverse event reporting, and new dietary ingredient safety regulations. The Maryland-based association was responding to calls for input from the FDA's Center for Food Safety and Applied Nutrition.
"The dietary supplement industry faces two major new regulatory requirements, as does the agency: a final rule on current good manufacturing practice 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," AHPA stated.
FDA resources needed to be directed to the area to assist industry in complying with the new regulations, AHPA said. CFSAN should disclose how it identifies dietary supplement ingredients and products that raise safety problems, and must continue to act against products containing the illegal ingredient, ephedra.
In regard to ephedra, AHPA stated: "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."
The AHPA had produced its own guidance in regard to new dietary ingredient safety regulations. "In the interest of minimising 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.