Proposed Food Labeling Changes May be Hard for Pharmaceuticals to Swallow

By Peter M. Jaensch –

On March 23, 2010, Congressman Jason Chaffetz (R-UT) introduced H.R. 4913 – the Free Speech About Science Act of 2010.  The bill proposes several amendments to FDC Act § 403(r) concerning the misbranding of foods, which would have the effect of expanding authority to include disease and health-related condition claims in the labeling of some foods and dietary supplements.  According to Rep. Chaffetz, “[t]he bill allows the producers of healthy foods and dietary supplements to cite legitimate scientific studies on the health benefits of their products.”

H.R. 4913 creates a new subsection of FDC Act § 403(r)(3) to permit food labeling to include disease and health-related condition claims, notwithstanding certain existing limitations, where the claim is based on “legitimate scientific research,” provides a balanced summary of the research, and is written in a way that enables the public to understand it.

The bill also reformats and adds a new subsection to FDC Act § 403(r)(6) permitting claims “to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases” in labeling for dietary supplements where the claim is based on “legitimate scientific research,” is truthful and not misleading, and explicitly disclaims prior evaluation by FDA. Such changes would permit food and dietary supplement manufacturers to make claims similar to those typically made for drug products, without subjecting them to the same degree of oversight or requiring the same depth of scientific analysis.

For both food and dietary supplements, H.R. 4913 requires that the claim must cite to the research source and identify parties funding the research.

H.R. 4913 also precludes the Secretary of Health and Human Services from taking any action to restrict the dissemination of the information that “is not false or misleading on legitimate scientific research” in connection with food sales.

The amendments largely turn on the basis in “legitimate scientific research,” which the bill defines as “scientific research” that is performed “in vitro, in vivo, in animals, or in humans,” is conducted in accord “with sound scientific principles,” has been “evaluated and accepted by a scientific or medical panel,” and has been published in a peer-reviewed article or book, recognized textbook, peer-reviewed scientific publication or any U.S. Government publication.

The bill is co-sponsored by Rep. Jared Polis (D-CO), and was referred to the House Committee on Energy and Commerce.