The Council for Responsible Nutrition (CRN), Washington, D.C., noted that all dietary supplement manufacturers—from largest to smallest—are now legally bound to comply with dietary supplement-specific good manufacturing practices (GMPs) as the regulation goes into full effect today.

With the third and final phase-in of the law, small dietary supplement firms (those with less than 20 employees) now join large and mid-sized companies in the legal requirement to be GMP-compliant.

“This is a historic day for the dietary supplement industry and its consumers,” said Steve Mister, CRN’s president and CEO. “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 also encourages FDA to ensure that the industry is meeting GMPs by conducting 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,” Mr. 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.”

CRN and its member companies also reaffirm their support for the Dietary Supplement Implementation and Enforcement Act of 2010, which calls for additional funds for FDA to fully implement and enforce the Dietary Supplement Health and Education Act (DSHEA) of 1994. 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.