AHPA offers cleaning tips to prepare for cGMPs

Related tags Ahpa Dietary supplement Food and drug administration Fda

With the finalization of the cGMPs (Good Manufacturing Guidelines)
for the dietary supplement industry scheduled for this winter, the
American Herbal Products Association (AHPA) has decided to preempt
any problems which could arise from the increased need to produce
clean and safe products.


The AHPA will hold a tele-seminar later this year for members of the industry to help them establish processes to care for and control raw materials "from the field to order fulfillment"​.

This event is not hanging off an increase in problems with herbal cleanliness, "but is inspired by the increasing commitment to quality control in our industry,​ said a spokesperson for the association. "The AHPA is fulfilling a need for information and thereby heading off problems,"​ she added.

The cGMPs, which the FDA announced earlier this month are due to be completed by the winter, focus heavily on cleanliness and make numerous references to the use of "clean unadulterated components"​ and "clean and sanitary conditions"​.

The AHPA seminar will therefore focus on raw material cleanliness, specifically microbial load, pesticide levels and heavy metals.

"Even organic suppliers and buyers need to know the acceptable levels and analytical means to test their products for microbes and heavy metals, which are taken up by the plants from the soil,"​ said the AHPA spokesperson.

Recent reactions

The AHPA, together with the Council for Responsible Nutrition (CRN), and the National Nutritional Foods Association (NNFA), spent much of 2003 and the beginning of this year recommending changes to the FDA's proposed cGMPs to ensure the dietary supplement industry will not suffer under new guidelines.

The AHPA expressed its disappointment at the beginning of August when the FDA again failed to set a specific date for the introduction of the revised cGMPs.

Michael McGuffin, president of the AHPA, told NutraIngredientsUSA​ at the time that he was disappointed that Dr Lester Crawford, acting FDA commissioner, had not been more specific in his timing, though he was glad that the government body now planned to update cGMPs for food and drugs, as well as supplements.

"For a long time we have been saying the cGMPs for all sectors should be revised,"​ said McGuffin. "However, we are disappointed that the FDA continues to drag its feet over this matter. We will certainly not see the guidelines before December and it then all depends on who wins the elections - if Kerry wins everything will shut down until January,"​ he added.

Past proposals

Proposals for the cGMPs were published last March and prompted numerous concerns in the industry. Trade associations individually submitted extensive comments last year addressing the proposed regulation and then in January 2004 these three groups cooperated together.

They all believe the rule should apply to both dietary ingredients and to dietary supplements, as FDA had proposed, provided that the final rule itself is modified to offer a more realistic framework for the entire industry.

They suggested written procedures for numerous manufacturing practices, consistent with the same suggestions made by the industry groups in a proposal submitted to FDA in 1995.

They have also requested that a statement of product shelf life should appear on product labels.

"Our three organizations were able to sort out all of our differences and arrive at a consensus position that provides an excellent model for appropriate GMP for dietary supplements, by shifting from the agency's emphasis on exhaustive and unnecessary finished product testing to more appropriate attention to ensuring the quality of the raw materials and processes used in manufacturing,"​ said McGuffin.

"We believe that this document will assist the agency in its preparation of a rigorous but reasonable final rule,"​ added Annette Dickinson, president of CRN.

The recommendations re-addressed many details that were identified in the proposed rule and in the original comments but they focused on issues that were either absent in FDA's proposed rule or in sharp contrast to industry needs.


The AHPA will hold two tele-Seminars on 21 October and 4 November. Interested parties should contact Natasha Hall at the AHPA​ via email at nhall@ahpa.org or telephone (301) 588-1171, ext 106.

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