The FDA has released a 41-page report on Effects of Strength of Science Disclaimers on the Communication Impacts of Health Claims. The report discusses consumer research FDA conducted to evaluate whether the agency's current approach, under its interim guidance, to communicate to consumers the strength of science underlying a qualified health claim is effective. FDA intends to use this research and other relevant consumer studies to evaluate its approach to qualified health claims on conventional foods and dietary supplements.
For dietary supplement manufacturers and suppliers, the issue of health claims has existed since Pearson vs. Shalala – the landmark case in which AAHF, with four other plaintiffs, sued the U.S. Food and Drug Administration and won. We sued the agency for violating the First Amendment as well as the Administrative Procedure Act by not allowing the dissemination of truthful, scientific information on dietary supplement labels, and by holding manufacturers to an undefined standard called "significant scientific agreement. We also raised this issue when we testified before Congress last year at a House Government Reform hearing entitled Ten Years After the Implementation of DSHEA: The Status of Dietary Supplements in the United States.
The FDA intends to use the findings from this research and other relevant consumer studies to evaluate its approach to qualified health claims for dietary supplements. Both unqualified and qualified health claims may be used now. To date, there are only 12 qualified health claims that can be used for conventional foods and dietary supplement labeling. For qualified health claims, the FDA issues letters of enforcement discretion when there is credible scientific evidence, in their view, to support a claim.
With an initial review of the report, we found the following of most interest.There was evidence that respondents' perceptions of product health benefits were not diminished by conveying greater scientific uncertainty for a claim. In some cases conveying more scientific certainty for a claim actually led to more negative perceptions of product health benefits. This overall pattern of results suggests important caveats on the possible effectiveness of strength of science disclaimers.
The FDA intends to hold a public meeting to discuss the study on Thursday, November 17th from 9:00 am to 4:30 pm at FDA's Wiley Building, 5100 Paint Branch Parkway, College Park, Maryland. The meeting will provide an opportunity for attendees to provide comment to FDA on the new research findings. Please visit the FDA website for more information and to download the report.
Don't forget to visit AAHF's online Action Center to contact your representatives on important health freedom bills.