Structure/function vs. disease claims
This article was originally published in The Tan Sheet
Executive Summary
CDER is leading an agency-wide working group of roughly 20 people, including reps from CFSAN, the Office of Policy and the Office of Chief Counsel, that will develop a guidance on structure/function vs. disease claims, FDA says in a Feb. 29 letter to the dietary supplement community clarifying appropriate contacts for questions on the structure/function claims final rule. CDER has lead responsibility on disease/non-disease distinctions; correspondence should be directed to the Executive Secretariat, Executive Operations HFD-6, at (301)-594-5468. Contact point at CFSAN, which oversees the rule's implementation and enforcement, is the Division of Compliance & Enforcement within the Office of Nutritional Products, Labeling & Dietary Supplements at (202)-205-5229