AHPAs Annotated Final Rule Provides Guidance for cGMP

(July 19, 2007, Silver Spring, MD) Understanding 21 CFR 111 — the newly-published final rule on current good manufacturing practice (cGMP) for dietary supplements — is easier with insight and guidance from the American Herbal Products Association (AHPA).

AHPA recently produced a cGMP educational tele-seminar that brought industry and legal experts together with Vasilios Frankos, PhD, the director of the Food and Drug Administration’s Division of Dietary Supplements. Supporting material for the seminar included AHPA’s Annotated Final Rule on Dietary Supplement cGMP, which links key points and comments found in FDA’s preamble to the final rule to each specific section of 21 CFR 111 to which it applies.

“I really believe that anyone in the dietary supplement industry should read the whole preamble as it provides context and explains the logic behind the rule,” commented Dr. Frankos. “AHPA’s annotated version provides a good synopsis of the preamble and makes understanding the rule much easier.”

A transcript of the seminar and all supporting documents — including AHPA’s Annotated Final Rule – are available for purchase on AHPA’s online bookstore at http://www.ahpa.org/Default.aspx?tabid=68#GMP0.

The preamble to the final rule, and the additional preamble to an accompanying interim final rule, provide details that are critical to understanding how companies will need to comply with the new cGMP. For example, the final rule requires that specifications be established and met for the quality, strength and composition of dietary ingredients and finished dietary supplements. These terms, however, are not defined in the rule itself, but the preamble discloses FDA’s intended meanings for each.

“It will be essential for companies to understand FDA’s thinking as they work to implement these new regulations,” noted Michael McGuffin, AHPA’s president and the author of AHPA’s Annotated Final Rule. “Our document and the transcript of the AHPA tele-seminar provide tools that will clarify many of the details that must be addressed to come into compliance with this cGMP.”

“This seminar was definitely very relevant and worthwhile,” said one participant, Travis Borchardt, director of corporate quality systems at Enzymatic Therapies. “Whenever you can have a conversation with FDA officials and hear their interpretation of the regulations, it’s very valuable. “

Questions addressed by the seminar’s speakers covered such topics as:

distribution and/or importation of finished products,

importing raw materials,

testing raw materials,

FDA inspections, and

how the rules affect herbal practitioners and acupuncturists.

“We’ve attended all of AHPA’s educational events since they started offering them over the past few years,” said Jim Grant, regulatory compliance officer at Gaia Herbs. “The speakers are always knowledgeable, and AHPA’s expert staff is especially helpful and accessible. This seminar on the GMPs helped clarify the key points of the new rule.”

Based on feedback from its members, AHPA will hold further cGMP seminars focused on those parts of the regulations that generate the most questions and concerns.

* Compliance in the new GMPs for dietary supplements varies according to company size. A company of 500+ employees must comply by June 25, 2008. Smaller companies must comply by 2009 or 2010, depending on the number of employees.


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. Website: www.ahpa.org.

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