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FDA FINALLY PUBLISHES GMPS: DOESN'T MISS CHANCE TO SLAP INDUSTRY
Location: BlogsMarc Ullman FYI Blog    
Posted by: marc 6/25/2007 2:00 AM
More than 12 years after the passage of DSHEA, FDA has finally published the Dietary Supplement GMPs. At the same time, as it has done at almost every turn, the Agency has taken the opportunity to slap the industry in the face.
Over 12 years in the making, the dietary supplement GMPs have finally emerged from the FDA. Setting aside questions such as “how is it possible that it could take more than a decade to produce this regulation?” this is certainly a welcome development. At first blush, the final regulation appears to have accepted many of the industry’s comments on the preliminary draft, moving away from an inflexible requirement of constant lab testing at every step of the manufacturing process. The final regulation appears to allow for a reasonable amount of flexibility for dietary supplement manufacturers to develop GMPs that work for them, so long as there is a valid basis for the procedures that are adopted. Overall, the GMP regulation which includes an extensive discussion of the need for documenting all steps of the quality control process, clearly takes the approach of “if something is not in writing, it did not happen”.

At the same time as it issued the GMPs, FDA published a Consumer Update touting the release of the GMPs. In that publication, FDA once again has taken a gratuitous slap at the industry, proclaiming that “some supplements pose health risks. They may contain harmful ingredients or be improperly manufactured or handled”.

When FDA issues regulations or takes an enforcement action against any other class of goods, the Agency goes to great pains to assure the public that the broad class of goods is of generally high quality and deserving of consumer confidence. Why do supplements deserve this kind of negative “special treatment”? In case you don’t think it matters, just look at the mainstream media reporting about the new regulation which almost invariably asserts: a) until now supplements were unregulated; b) that the new regulations were finally promulgated as the result of pressure by so-called consumer advocacy groups such as Center for Science in the Public Interest; or c) both of these supposed facts.

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