The FDA responded to the House of Representatives letter requesting clarification on the implementation of the GMP's under DSHEA. The FDA intends to publish a proposed rule for dietary supplement good manufacturing practices (GMPs). In the letter they indicated that the publication of this regulation is one of their top priorities. Once the publication of the proposed rules is available, the FDA intends to allow a 90-day comment period after which the Agency will incorporate any relevant comments and proceed with preparing the final rule.
The intent is to publish the proposed rule near the middle of FY 2002, they(FDA) will review comments and prepare the final rule for publication by mid-FY 2003.
Read the full response, click here.