FDA Keeps Door Open To Help Observational Studies Work For Health Claims
This article was originally published in The Tan Sheet
Executive Summary
FDA says in a final guidance that observational studies alone are insufficient support for health claims, but the agency also says it is interested in making it easier for those studies to support claims
You may also be interested in...
First Day Children’s Multivitamin Needs ‘Good Fit’ Studies To Support Hyperactivity Claims
First Day Life discontinues claims its children’s multivitamin could help with attention issues and hyperactivity during a review by the National Advertising Division, which reminded the firm that studies in support of claims must not only be competent and reliable but also a “good fit.”
FDA Veers From Guidance In Some Supplement Health Claim Decisions – Court
FDA made unreasonable demands with disclaimers for proposed qualified health claims for vitamin C and vitamin E to reduce the risk of cancer, according to a court ruling.
Omega-3 Probe Underscores FTC Standard For Claims Substantiation
FTC's widespread review of omega-3 fatty acid supplement claims reminds firms they must support claims with "competent and reliable scientific evidence," a standard stakeholders argue is unclear and at times impractical