In a statement, CRN president and chief executive officer Steve Mister welcomed final implementation of the controversial and much-amended rule and urged the Food and Drug Administration to put strength in the arm of the regulation by getting out into the field and performing ‘483’ inspections.
“Industry worked hard to get GMPs and we now expect FDA to make complete use of the standards by holding the industry to them,” Mister said.
“Full implementation of the GMPs, coupled with FDA attention to industry compliance, will help to weed out bad actors from our legitimate industry and assure that consumers are being protected.”
However, the FDA’s policing of the Good Manufacturing Practice regulation is complicated by resourcing issues, although inspections and funds available for further inspections have risen under the Obama administration.
The re-introduction of the Dietary Supplement Implementation and Enforcement Act of 2010 is upping the ante for increased FDA funding, but how much traction the Bill is likely to gain in Congress is uncertain.
“The legislation, recently introduced by Senators Tom Harkin (D-Iowa) and Orrin Hatch (R-Utah), would provide FDA with resources over five years to aid in its enforcement of DSHEA, including ensuring manufacturing facilities are in compliance with GMPs by conducting inspections,” CRN said.
As of April, the FDA had conducted about 40 ‘483’ inspections which highlighted problems such as insect and rodent activity in storage areas; lack of batch data; lack of identity testing and failure to qualify vendors.
Historic
Mister praised industry efforts in lobbying for appropriate GMP rules, which kicked in for the largest companies in June 2008 and mid-sized firms in June 2009. Now the whole dietary supplements manufacturing industry is bound by the rules.
“This is a historic day for the dietary supplement industry and its consumers,” said Mister. “Full implementation of the GMP regulations that we fought so hard for should put to rest any skepticism that our industry is not regulated. Clearly, there are stringent manufacturing standards that our entire industry must adhere to and we expect that after three years of preparation for implementation, manufacturers are prepared to embrace GMP compliance as another illustration of an industry committed to its consumers.”
CRN was unavailable for further comment at the time of publication.