GMP inspections show ‘consistent fundamental failures’: Israelsen, UNPA
The Food and Drug Administration (FDA) has increased the number of GMP inspections over the last few years. Only seven GMP inspections occurred in 2008, which increased to 34 in 2009, 84 in 2010. As of September 13 of this year, there have been 145 inspections, according to FDA data.
Warning letters from the agency have followed: Indeed, last week we reported on two warning letters in November for alleged dietary supplement cGMP violations.
The agency has also hinted at increased enforcement. At the recent Council for Responsible Nutrition’s (CRN) conference in Rancho Palos Verdes in California, FDA’s Dr Daniel Fabricant told attendees, “I cannot talk about what the future holds but I do think we are going to do more than just hand out paper.”
Threat vs reward ratio
Speaking with NutraIngredients-USA, Israelsen, executive director of United Natural Products Alliance (UNPA), described the GMP issue as a “topic of disappointment”.
“There is a general low level of GMP compliance,” he said. “This could be economic in terms of the cost to implement, or it could be that the threat versus reward ratio is not balanced.”
One issue could be the small numbers of “informed and competent staff”, and the high turnover of staff in the QA-QC industry, he added.
Numerous GMP training course are held at various industry events, and they are usually well attended, but while Israelsen supports such initiatives he notes that many “don’t have the rigor to get into problem solving areas”.
Despite the demands of the job and the increased FDA scrutiny, progress on GMPs is occurring “year on year”, he said.
Spiking
While many GMP violations cite adulteration, Israelsen said that the motivation to adulterate has “nothing to do with GMPs”.
“It is an illegal enterprise, and the intention is to hide the fact that they have added it [the adulterant].”
UNPA is one of several trade associations to support and help under-write the recently announced non-profit collaboration to address adulteration of botanical dietary ingredients, led by the American Botanical Council, American Herbal Pharmacopoeia, and University of Mississippi’s National Center for Natural Product Research.
NDI
Israelsen confirmed that UNPA was putting the final touches to its comments to the new dietary ingredient (NDI) draft guidance.
For insights on NDI comments from other industry stakeholders, see the accompanying articles on today’s NutraIngredients-USA.
