CGMPs 'expected within 90 days'
long-awaited final rule on current good manufacturing practices
(cGMP), which has now been forwarded to the Office of Management
and Budget for review.
According to the American Herbal Products Association (AHPA) this means that the rule should be published within the next 90 days. OMB is the last step in the rule-making process.
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 news that they are imminent will be welcomed by many in the industry who believe that DHSEA is a good law that will effectively ensure the safety and quality of dietary supplements when properly enforced.
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.
"AHPA worked closely with other trade associations to provide meaningful comments to FDA to assist in the development of a final rule that assures high quality products, but does not stray too far into a pharmaceutical model," said AHPA president Michael McGuffin.
One factor that is believed to have contributed to the delay is the lack of a permanent FDA commissioner. Lester Crawford was acting commissioner the 12 months prior to July 2005, when he was voted into the role for good, and prior to that between February and November 2002.
But Crawford announced his resignation in September, just two months into the permanent role. Andrew von Eschenbach, MD, is now acting commissioner.
At the beginning of this month AHPA wrote to von Eschenbach asking that FDA adopt a 'respectful' tone in its final rule, and seeking assurances that it will not assurances that when it is published, FDA will not repeat the "errors and misrepresentations" that occurred when the proposed rule was first published in 2003.
"We should be guardedly optimistic that FDA, under their current leadership, has heard AHPA's message, and will refrain from misleading the public in any way," said McGuffin.
In an interview with NutraIngredients-USA.com earlier this 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.
The challenge, he said, would be in reporting these practices. 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.
The CRN criticized the 2003 draft guidelines as placing too much emphasis on testing, which verifies quality but does not impact standards at source, and not enough on safety.
APHA plans to hold a series of teleseminars to train key personnel in manufacturing facilities in the cGMPs.
