Free Speech About Science Act April 2010

NMR News: Volume 3, Issue 4, April 2010 FREE SPEECH ABOUT SCIENCE ACT RIGHT ON TARGET WITH CONSUMER NEEDS By: Latesha Richards, Marketing Coordinator April 2010 Last month, on March 23, 2010, Representatives Jason Chaffetz (R-UT) and Jared Polis (D-CO) introduced the “Free Speech about Science Act” to Congress. This bill, if passed, would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) so as to allow legitimate scientific research to be freely distributed to the public about foods and dietary supplements. It would essentially give dietary supplement and food manufacturers the right to cite scientific research studies from well-respected, peer-reviewed scientific journals on product labels that claim health benefits. Among some of the ideas that this short bill argues for are: 1. To amend the “Misbranded Food” section of FFDCA (Section 403(r)): that claims for food can be made if the claim is based on legitimate scientific research. 2. To amend subparagraph 3C to allow food claims along with allowing the public to understand what is being said in the claim and the “relative significance of such information in the context of a total daily diet,” must be stated in a manner (a) where “an accurate balanced summary of such research,” is presented (b) where the claim includes 1

NMR News: Volume 3, Issue 4, April 2010 a citation to the research, and (c) where the claim discloses the parties that funded the research. (p4, lines 1-12) 3. To add a definition of “legitimate scientific research” to indicate the types of scientific research that can be cited, i.e. in vitro, in vivo, in animals, or in humans that is (a) is “conducted [according] to sound science,” (p4, lines 20-21) (b) has received acceptance by a scientific or medical panel, and has been published in its entirely as an accurate, balanced review or summary in a peer-reviewed article, textbook, scientific publication or a recognized federal publication. (p4, lines 22-25 and p5, lines 1-10) 4. To amend subparagraph 6A of the FFDCA, which would include an allowance for mitigation, cure, treatment, or prevention claims to be made for dietary supplements concerning a specific disease or class of diseases. In order to make such a claim, the manufacturer must have (a) substantiation that is truthful and not misleading, (b) a disclosure stating that the statement has not been evaluated by the Food and Drug Administration, (c) and the claim must include a citation to the research and the parties that funded such research. (p6, lines 12-24 and p7, lines 1-4) Bill right on target with consumer trends Apart from this seemingly controversial issue posed by this bill, concerning statements for dietary supplements made with vitamins, minerals, herbs or other similar substances, that claim to diagnose, mitigate, treat, cure or prevent a specific disease or class of diseases, without needing significant scientific agreement or FDA approval, the provisions made in this bill are 2

NMR News: Volume 3, Issue 4, April 2010 one step forward in the right direction. As consumers embrace better nutrition and healthier lifestyles, products that provide information on product efficacy that is up-to-date and easily understood are required. The bill states that “Americans want access and have a right to access legitimate scientific information about foods and dietary supplements to ensure informed decisions about diet and health care (p2, lines 9-12)…Providing access to scientific information promotes self-responsibility, thereby empowering Americans to exercise independent judgment in caring for themselves and ultimately reducing health care costs and improving quality of life.” (p2, lines 20-24) Consumers demand more meaningful information from food and dietary supplement manufacturers because they believe in the value of dietary supplements. Access to scientific research, as required by this bill, will be a powerful tool that will meet demands and drive consumer confidence. As the healthcare landscape has evolved to include more self-care and awareness, the provisions in this bill are very fitting for today’s smart and savvy consumer. To access the bill, go here: http://frwebgate.access.gpo.gov/cgi- bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h4913ih.txt.pdf About Nutraceutical Medical Research: Nutraceutical Medical Research, LLC is a premiere contract research organization dedicated to substantiating your product or ingredient claims and efficacy with clinical research. We provide medical writing services which include product 3

NMR News: Volume 3, Issue 4, April 2010 brochures, literature reviews and journal publication. Our goal is to partner with natural product, cosmeceutical and pharmaceutical companies to help them establish efficacy and safety of their products using evidence-based approaches. Contact NMR at 1-914-220-8325 or email info@nutraceuticalmedicalresearch.com. 4

Free Speech About Science Act April 2010

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