Tuesday, May 09, 2006

New cGMPs for dietary supplements set for Dec. 2006

The FDA publication of "current Good Manufacturing Practice" for dietary supplements has been set for the end of 2006, however they have stated these guidelines would be released before and have missed previous deadlines.

The cGMPs form part of the Dietary Supplements Health and Education Act (DSHEA), which was signed into law more than decade ago in 1994.

The hold-up over the guidelines has laid DSHEA open to criticism from those, particularly in the medical community, who would have dietary supplements subjected to the same rigorous approvals process as pharmaceutical drugs.

In an interview with NutraIngredients-USA.com early last year John Hathcock, VP for scientific and international affairs at the Council for Responsible Nutrition, said that the most of the council's members already adhere to manufacturing practices that are as good or better than what the FDA will require.

FreeLife is an excellent example of a dietary supplements firm that goes above and beyond required Good Manufacturing Processes, utilizing a 30-Step process before bringing any supplement to market which includes; scientific and background research, compatibility studies, pharmaceutical grade ingredients, pilot-scale blend and dosage studies, intense screening of raw materials, potency and content uniformity analysis, dissolution testing (for esnuring proper absorbancy by the body) and much more.

Hathcock believes that the FDA has "massively misjudged the economic cost for a company going through the process, especially in record-keeping". It estimates that a company will need to spend around $47,000 on compliance, depending on its size.

Nonetheless, Hathcock sees the cost as entirely necessary. "If you can't afford to make good products, you shouldn't be making products at all," he said, adding that one company that fails to comply gives the entire industry a bad name.

We agree!