FDA faces another QHC complaint
This article was originally published in The Tan Sheet
Executive SummaryTea for Health marketer Fleminger Inc. challenges FDA's policy on qualified health claims for dietary supplements. The 1complaint filed June 1 in U.S. District Court for the District of Connecticut alleges the agency violated Fleminger's First Amendment rights by prohibiting truthful statements in its QHC regarding green tea and incidence of breast and prostate cancers. The complaint comes after a ruling in a separate case found FDA's 2009 decision to deny proposed QHCs linking selenium to reduced risk of site-specific cancers failed the First Amendment standard established in the 1999 Pearson v. Shalala decision (2"The Tan Sheet" June 7, 2010). According to Fleminger's lawsuit, FDA required the firm to use the QHC language the agency wrote, risk enforcement action if it used its own language, or make no claim at all. The Trumbull, Conn., firm argues FDA failed to apply the "least restrictive means of preventing any alleged deception of consumers." FDA denied Fleminger's QHC application in 2007, denied a petition for administrative review in 2008 and issued a February 2010 warning letter to the firm (3"The Tan Sheet" March 8, 2010)
You may also be interested in...
A BLA filing for Zynteglo in beta-thalassemia is expected in the second half of 2020 instead of the first half, but the first commercial patient in the EU will be treated in the first half of this year.