A weekly live web event dedicated to issues related to international trade. Links used during the stream: PERSONAL PROTECTIVE EQUIPMENT (PPE) Martin K. Behr’s Presentation Slides: https://drive.google.com/file/d/11YS4dLl68etjWETIJ4di1XR50YqFVJJ9/view?usp=sharing FDA’s PPE dedicated page: https://www.fda.gov/industry/importing-covid-19-supplies/information-filing-personal-protective-equipment-and-medical-devices-during-covid-19 CBP News: https://www.cbp.gov/newsroom/local-media-release/500000-counterfeit-n95-masks-seized-chicago-cbp CBP Dedicated COVID page: https://www.cbp.gov/newsroom/coronavirus…
“Substance” is defined as “a specific food or component of food, regardless of whether the food is in conventional food form or a dietary supplement that includes vitamins, minerals, herbs, or other similar nutritional substances.” Id. at (a)(2)
“Disease” or health-related condition means damage to an organ, part, structure, or system of the body such that it does not function properly. Id at (a)(4).
FDA Guidance Document, Guidance for Industry: FDA’s Implementation of Qualified Health Claims, How are health claims different from statements about dietary guidance? (May 2006)
If statement describes structure/function and therefore requires disclaimer. 21 C.F.R. § 101.93.
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(r)(6)) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading.