Dietary Supplement GMPs Stuck In Transition Limbo
This article was originally published in The Tan Sheet
Executive Summary
FDA's proposed rule establishing dietary supplement Good Manufacturing Practices appears to be caught amid the flood of activity surrounding the transition to a new presidential Administration.
You may also be interested in...
GMPs
"CFSAN's goal is to have [dietary supplement good manufacturing practices] published as a proposed rule by the end of the year," CFSAN Division of Compliance & Enforcement Director John Foret reports at Supply Side East conference May 9, conceding some factors are "beyond our control." Supplement GMPs again are under OMB review after being tied up with change of administrations earlier this year (1"The Tan Sheet" Jan. 29, p. 3)
GMPs
FDA returns proposed dietary supplement reg to OMB March 28, almost two months after proposal was withdrawn due to Bush Administration hold (1"The Tan Sheet" Jan. 29, p. 3). CFSAN Office of Nutritional Products, Labeling & Dietary Supplements Director Christine Lewis, PhD, recently told industry stakeholders long-awaited proposal will not deviate significantly from third-party certification program standards (2"The Tan Sheet" March 26, p. 5)
USP Supplement Certification Program Advisory Group Forming
A USP Industry Advisory Group of representatives from the pharmacopeia, FDA and industry will meet in March to begin finalizing the design of USP's dietary supplement quality certification program.