FDA Tackles Observational Studies In Draft Health Claims Guidance
This article was originally published in The Tan Sheet
"Scientific conclusions from observational studies cannot be drawn about a relationship between a food component and a disease," FDA concludes in draft guidance for health claim petitioners
You may also be interested in...
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
Attorney Jonathan Emord continues his effort to force FDA to allow more expansive qualified health claims for nutritional supplements with two petitions relating to the capability of selenium and antioxidant vitamins to reduce the risk of site-specific cancers
A group promoting greater access to alternative medicines says FDA's proposed evidence-based review system for industry to evaluate health claims poses "grave consequences" for consumers seeking options to medication for their health care