FDA Identifies "Fatal Flaws" That Block Approval Of Health Claims
This article was originally published in The Tan Sheet
Executive Summary
FDA likely will refuse new health claims applications if petitioners fail to provide relevant studies in healthy humans that evaluate the relationship between the substance and the disease, an agency official says
You may also be interested in...
Omega-3 Petition Outcome Will Reveal FDA Biomarker Stance
A citizen petition for omega-3 cardiovascular health claims is the first since the Institute of Medicine in 2010 recommended a framework to assess biomarkers for supplement health claims. The petition also will show whether FDA changed its thinking about supplement claims, says former FDA dietary supplement programs head Bill Frankos.
Omega-3 Petition Outcome Will Reveal FDA Biomarker Stance
A citizen petition for omega-3 cardiovascular health claims is the first since the Institute of Medicine in 2010 recommended a framework to assess biomarkers for supplement health claims. The petition also will show whether FDA changed its thinking about supplement claims, says former FDA dietary supplement programs head Bill Frankos.
ODS Expects Positive Impact On Industry From Promoting Supplement Science
The National Institutes of Health's Office of Dietary Supplements does not operate to promote supplement products, but shares a common interest with industry that can help spur businesses' growth - disseminating information and improving research, says ODS Director Paul Coates