GMPs due some time in winter
priority being to finalize the GMP (Good Manufacturing Guidelines)
for the dietary supplement industry by the winter.
This announcement was greeted with mixed emotions by one of the industry bodies, which has worked hard to make sure the FDA takes notice of industry concerns when drawing up the new guidelines.
Michael McGuffin, president of the American Herbal Products Association (AHPA) told NutraIngredientsusa that he was disappointed that Dr Lester Crawford, acting FDA commissioner, had not been more specific in his timing, but glad to see that the government body was looking at updating GMPs for food and drugs, as well as supplements.
"The FDA is working to ensure that the latest, science-based current good manufacturing practices (cGMPs) are in place to help ensure product quality across all industries FDA regulates," said Crawford.
"We are disappointed that the FDA continues to drag its feet over this matter," said McGuffin. "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."
However, there was something positive for him to take away from Crawford's speech.
"Yesterday, we saw a different GMP message, with supplements being placed in a broader context", he said. "For a long time we have been saying the GMPs for all sectors should be revised."
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 GMP to ensure the industry does not suffer under new guuidelines.
In February, the organisations suggested alterations, which they said would make them a more 'reasonable' assessment of product quality.
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 suggest 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.
Michael McGuffin, AHPA's president, said: "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."
"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 focus on issues that were either absent in FDA's proposed rule or in sharp contrast to industry needs.
