(Silver Spring, MD, October 26, 2005) -- In a sign that the Food and Drug Administration's (FDA) final rule for current good manufacturing practice (cGMP) for dietary supplements is imminent, the Office of Management and Budget (OMB) has recorded that it has received the final rule for review. In the normal course of federal rulemaking, this should be the last step before actual publication of the rule, which can now be expected within the next 90 days.
“The dietary supplement industry has been advocating for the completion of this regulatory process for more than a decade,” commented AHPA President Michael McGuffin. “AHPA worked closely with other trade associations to provide meaningful comments to FDA to assist in the development of a final rule that assures high quality products, but does not stray too far into a pharmaceutical model.”
In its posting on October 25, OMB noted that FDA proposed cGMP regulations for dietary ingredients and dietary supplements on March 13, 2003. Their notice states that the proposed rule was published “to establish the minimum cGMPs necessary to ensure that, if firms engage in activities related to manufacturing, packaging, or holding dietary ingredients of dietary supplements, they do so in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements.” OMB also observed that FDA “also proposed to require manufacturers to evaluate the identity, purity, quality, strength, and composition of their dietary ingredients and dietary supplements,” and that the proposed rule “also responds to concerns that such regulations are necessary to ensure that consumers are provided with dietary supplement products which have not been adulterated as a result of manufacturing, packing, or holding, e.g., which have the identity and provide the quantity of dietary ingredients declared in labeling.”
AHPA’s most recent communication on the issue of cGMP for supplements was addressed to acting FDA Commissioner Andrew von Eschenbach. MD, on October 4, 2005. In this correspondence AHPA repeated complaints about inaccurate statements that accompanied the proposed rule in 2003 and requested that FDA “adopt an overall tone that is respectful of the regulated industry and focused on the value and the quality of the final rule.”
“We should be guardedly optimistic that FDA, under their current leadership, has heard AHPA’s message, and will refrain from misleading the public in any way,” added McGuffin.
In preparation for the publication of the new cGMP for dietary supplements, AHPA’s Education Committee has already planned a series of six teleseminars that will address each section of these regulations. The series will start early in 2006 and will be offered to AHPA members at a discounted fee. AHPA staff will design the content of these teleseminars so that each provides relevant training to key personnel in manufacturing facilities, in accordance with the expectation that such training will be required under the cGMP. Though dates have not yet been set, it is not too early to express your interest by contacting Robin Gellman at [email protected].
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org