GMPs could force manufacturers to clean-up

By Clarisse Douaud

- Last updated on GMT

Related tags: Dietary supplement industry, Dietary supplement, Andrew shao

On Friday, the US Food & Drug Administration (FDA) issued the
final rule on Good Manufacturing Practices (GMPs), which some say
is the most important regulatory development for the dietary
supplement in over a decade.

A statute of the 1994 Dietary Supplements Health and Education Act (DSHEA), GMP legislation has been the missing link in governance of the dietary supplement industry. The legislation is set to provide standards specific to this industry for inspectors to check for purity, safety and legality in manufacturing. While the road has been long for these requirements to become legislation, the road may be arduous still for those manufacturers that have not been using food GMPs as a point of reference to date. "For those companies not adhering to food GMPs already, this will be a major wake-up call,"​ Andrew Shao, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), told NutraIngredients-USA. Dietary supplement trade associations have been involved in the process of bringing GMPs to life, insofar as providing comments and input to FDA. While many were nervous as to what the regulations would look like when finally issued, it seems the result has been met with approval. "For the most part we're pretty happy,"​ Daniel Fabricant, vice president of scientific and regulatory affairs for the Natural Natural Products Association (NNFA), told NutraIngredients-USA. "This is going to be good for industry." ​ And all across the board, there is a sense of relief that after about 13 years, GMPs are finally here. "It's a strong regulation, but not overly burdensome to the industry,"​ said Shao. The main difference between food GMPs and the new ones for the dietary supplement industry is that over and above checking for sanitary and consistent products, the new GMPs also ensure purity, identity and strength of composition. "Now third party certification will become more and more important,"​ said Fabricant. Also, because the new GMPs put the burden solely on the manufacturer, the outcome may well be that there is increased pressure from these very manufacturers on what they expect of their suppliers. "There's going to be some upstream pressure from manufacturers to raw material suppliers,"​ said Fabricant "Their vigilance should be now that much more increased,"​ added Shao. According to the associations, the FDA did take into account their suggestions. For instance, emphasis has now been placed on quality in process, and not just at the end of the production line, as well as testing for the identity of incoming ingredients. "I think the agency did a pretty good overview of making clear what the requirements are,"​ said Shao. The effective date of the interim GMP rule is August 24, 2007. FDA is making allowances for small businesses by giving them extra time to comply. As such, there is a three-year phase-in for small businesses. Those companies with more than 500 employees will have until June 2008 to comply, while those companies with less than 500 employees have until June 2009 to comply. Finally, those with fewer than 20 employees have until June 2010 to comply with the regulations. "For the responsible companies in the industry, they've probably been doing this for over ten years,"​ said Shao. "It should really be a minor adjustment."

Related topics: Regulation

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