Guidance for Industry Helps FDA (Mostly) Win First Amendment Case on Health Claims

May 1, 2011

After more than 15 years of related cases in the larger matter of The First Amendment v. Dietary Supplement Health Claims, FDA mostly won one. And its winning card? Knowing that the courts will not, and cannot, independently assess whether the scientific evidence provided to FDAto support a health claim for a dietary supplement constitutes “credible evidence.”