Dietary Supplement GMPs Expected to be Published in June 2007; Will FDA Pull a “Switcheroo”?

May 21, 2007

The Office of Management and Budget (“OMB”) recently gave clearance for FDA to publish final regulations on current good manufacturing practices (“GMPs”) for dietary supplements.  The dietary supplement GMPs are expected to appear in the Federal Register in June 2007, which is over four years after they were proposed in March 2003.  Upon hearing the news, Sen. Orrin Hatch (R-UT) exclaimed “Finally!”  Sen. Hatch is one of the principal authors of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”).  DSHEA gave FDA the authority to write dietary supplement GMPs.

The key question, given that over 4 years have passed since the publication of the proposed rule, will be whether the final rule has changed so much from the proposed rule that the regulation could be subject to legal challenge.  If the changes are significant, the final dietary supplement GMPs could be challenged under the Administrative Procedure Act for a lack of notice if the final GMPs are not a “logical outgrowth” of the proposed GMPs.  As the U.S. Court of Appeals for the District of Columbia Circuit stated in its 2005 opinion in Envtl. Integrity Project v. EPA, “we have refused to allow agencies to use the rulemaking process to pull a surprise switcheroo on regulated entities.”  There is some indication, however, that the rule may be published as an “interim final rule” permitting further comments and changes, which would likely avoid legal challenges.   The rule is purported to be part of a 1,300-page document.  No wonder it took more than 4 years to get them written!

By Cassandra A. Soltis