March 7, 2016
Office of Dietary Supplement Programs
Food and Drug Administration
5100 Paint Branch Pkwy
College Park, MD 20740
RE: The Obesity Society Supports Creation of ODSP, Offers Scientific Expertise
Dear Director Durkin,
As President of The Obesity Society (TOS), the leading professional society with a focus on obesity science and treatment, I am writing to express our support for the recently established Office of Dietary Supplement Programs (ODSP). Today, 30% of U.S. adults report using a dietary supplement for weight loss, contributing to the nearly $2 billion a year spent on these products. Many dietary supplements have no evidence to support the weight-loss claims made on labels and in advertising. The harm can go far beyond financial losses, including: 1) exposure to unsafe ingredients including drugs removed from the market or compounds not adequately studied in humans; 2) exposure to products tainted with prescription drugs, and; 3) deleterious response to products that may include increased blood pressure, cardiac arrhythmias, stroke, seizure and even death.
We acknowledge that there may be efficacious dietary supplements and recognize the need to equip healthcare providers and the public with evidence-based dietary supplement options. In October 2015, TOS and our partners took a public position on dietary supplements sold and advertised with medicinal or curative claims with the release of a Position Statement entitled “Dietary Supplements Sold as Medicinal or Curative for Obesity” (policy and press release), in which we recommend healthcare providers:
- Be aware of the lack of credible evidence for efficacy and safety of many supplements promoted for the purpose of weight loss.
- Query patients who desire to accomplish weight loss regarding their use of dietary supplements for this purpose.
- Advise patients who desire to accomplish weight loss of the limited evidence supporting the efficacy and safety of many supplements and the lack of oversight by government agencies regarding the claims made about such supplements.
- Be educated about the Dietary Supplement Health and Education Act (DSHEA) and the roles of FDA and FTC in safety and claims monitoring of supplements promoted for the purpose of weight loss, as well as the limitations and lack of oversight by these government agencies.
- Avoid engaging in entrepreneurial activities in which they may directly profit from the prescribing of non-FDA approved weight-loss remedies where both safety and efficacy have not been proven.
Therefore, we are pleased about the potential promise of the ODSP and support the need for the ODSP to be adequately funded and empowered to protect the public from any false claims regarding efficacy and safety of dietary supplements. TOS would also support collaborative reform of the DSHEA in order to develop standard guidelines and tools to regulate the promotion of dietary supplements with medicinal or curative claimed effects, specifically as it pertains to weight loss or weight management.
TOS is optimistic that the creation of this new office will lead to a healthier environment for the consumer and the entire healthcare system, including manufacturers of evidence-based dietary supplements. We are pleased to offer our support and expertise to ODSP, as needed, and hope you will call on us for future collaboration.
Penny Gordon-Larsen, PhD, FTOS
President, The Obesity Society