The Department of Health and Human Services (HHS) and the FDA announced last October that the rule had been forwarded to the Office of Management and Budget for review. This, said the American Herbal Products Association, meant that the rule should have been published within 90 days. OMB is the last step in the rule-making process.
Such 'imminent' action was not forthcoming however and after eight months of languishing in the OMB, the HHS/FDA has now announced a forecast date for publication of the final ruling: December 2006.
The announcement has been met with some skepticism by the industry, with Michael McGuffin, president of AHPA, saying: "This is not the first time that we have been told that the final rule would be completed by December - but the year keeps changing. If past is prologue, maybe it's time to look for another answer and evaluate a self-regulatory approach in the absence of timely completion of this important rulemaking."
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.
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.
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.
The new projection was included in the April 24 semiannual agenda of "potential rule-making" published in the Federal Register, which also included four other initiatives with direct implications for the dietary supplements industry, including a review of the existing rules for use of the terms "high potency" or "antioxidant" on labels of conventional food and supplements, finalizing guidance for rules on qualified health claims for food and supplements, prohibiting the use of specific cattle materials in food and supplements to limit the risk of mad-cow disease (BSE), and prohibiting the sale of food, including supplements, that contain elk or deer-derived products exposed to chronic wasting disease.