FDA Takes its Time to Brush Aside an APA Challenge

November 25, 2008

By James P. Ellison

In a November 10, 2008 response posted on November 24, 2008, FDA denied an April 27, 2005 Citizen Petition challenging a March 29, 2005 Interim Final Rule increasing Color Additive Certification Fees as violating the FDC Act and the Administrative Procedure Act (APA), because notice and comment rulemaking was required under the law.
FDA's response rejected the argument by the International Association of Color Manufacturers that notice and comment rulemaking was required, citing the APA's "contrary to public interest" exception to the general rule requiring notice and comment rulemaking.

While the question of whether FDA should proceed with an interim final rule, a direct final rule, a direct final rule in tandem with a proposed rule, or simply a proposed rule–in this case specifically or in connection with rulemakings generally–raises potentially interesting APA questions, one cannot help but feel that the writing was on the wall in connection with this issue as the increased fees have been in effect for over 3 and 1/2 years.  Those who are intrigued by agency decisions concerning publication of rules may want to stay tuned to see how FDA proceeds in connection with its next Color Additive Certification Fee increase, which given the delay in responding to this Citizen Petition, may be just around the corner.

Categories: FDA News