Leading Obesity Groups Call for FDA Regulation of ‘Medicinal’ and ‘Curative’ Dietary Supplements

Leading Obesity Groups Call for FDA Regulation of ‘Medicinal’ and ‘Curative’ Dietary Supplements

Citing a new study linking use of dietary supplements to more than 23,000 emergency room visits each year, four leading obesity research, treatment, and prevention groups have issued a joint scientific position statement, entitled “Dietary Supplements Sold as Medicinal or Curative for Obesity,” recommending that dietary supplements claiming curative or medicinal qualities for weight loss be made subject to review and approval by the U.S. Food and Drug Administration (FDA).

The co-signatories — The Obesity Society, Obesity Action Coalition, Obesity Medicine Association (formerly the American Society of Bariatric Physicians), and Academy of Nutrition and Dietetics — note that while up to 30 percent of U.S. adults have reportedly used a dietary supplement for weight loss, with annual spending on such products of close to $2 billion, there is limited regulation of dietary supplement claims. The groups maintain that the regulatory status quo is promoting a dangerous health environment, and are calling for reform of the 1994 Dietary Supplement Health and Education Act (DSHEA) to provide the FDA and the Federal Trade Commission (FTC) with increased regulatory authority and funding to protect the public from false claims of safety and efficacy regarding dietary supplements. They contend that all publicly available dietary supplements sold or advertised for weight loss should have randomized, double-blinded, placebo-controlled studies of appropriate magnitude and rigor, and sufficient duration to support both safety and claimed efficacy. They also argue that if a dietary supplement is marketed as being curative or medicinal, it should be categorized as a drug and subject to FDA enforcement.

The co-signatory groups acknowledge that there may be efficacious dietary supplements and non-prescription prevention and treatment strategies, and that as science-based groups with the best interest of the public in mind, they are committed to taking a public position on specific treatment and prevention modalities, and strategies, when data are available that show sufficient evidence for both safety and efficacy. However, they say there is a major need for long-term data showing proven benefits, safety and effectiveness of dietary supplements for weight management.

Given the need to equip patients and physicians with evidence-based health care options, the groups call for adequate funding support for the FDA and the FTC, and for reform of the Dietary Supplement Health and Education Act (DSHEA) in order to develop standard guidelines and tools to regulate promotion of dietary supplements with medicinal or curative claimed effects, specifically as it pertains to weight loss or weight management.

Observing that the FDA justifiably requires a very careful scrutiny of weight loss drugs for safety and efficacy, the co-signatories contend that to provide similar scrutiny for nutritional supplements that claim weight loss benefits, appetite suppression or thermogenesis, the FDA and FTC should receive adequate funding and the DSHEA should be modified to enable greater FDA and FTC regulatory capacity to protect the public from any false claims in this regard. They also recommend that health care providers be strongly discouraged from engaging in entrepreneurial activities in which they directly profit from prescription of non-FDA approved weight-loss remedies where both safety and efficacy have not been proven.

The groups contend that when consumers buy dietary supplement products with weight-loss claims not based on evidence, pursuant harm can go beyond financial losses, and may include: 1) exposure to unsafe ingredients from 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. Moreover, they observe that dietary supplements with misleading and unsubstantiated claims may detract consumers from evidenced-based interventions and treatments, such as FDA-approved medications, metabolic and bariatric surgery, and commercial intensive lifestyle intervention programs with proven safety and efficacy.

StevenSmith“While we acknowledge that there may be effective dietary supplements on the market, there is a clear need for long-term data showing the benefits, safety and effectiveness for these unregulated treatments claiming weight management,” says Steven R. Smith, MD, past-president of The Obesity Society (TOS), and Chief Scientific Officer at Florida Hospital, Orlando.

A TOS release notes that in 2013, the American Medical Association joined many other leading organizations in recognizing obesity as a disease, including the National Institutes of Health (1998), the Social Security Administration (1999), the Centers for Medicare and Medicaid Services (2004), The Obesity Society (2008), and the American Association for Clinical Endocrinology (2012). With weight loss recognized as a treatment for obesity, TOS observes that according to FDA, dietary supplements should not make claims that their products will diagnose, treat, cure, or prevent any disease. Legally, only FDA-approved drugs can make those claims. However, under the current DSHEA, dietary supplement companies are not required to provide pre-market data for the safety and claimed efficacy, or evidence that label claims are not false or misleading to consumers.

“The current regulatory approach to protect Americans from the harms of dietary supplements is simply not working,” Dr. Smith maintains. “Inaction should not be an option in response to the 23,000 people each year who find themselves in emergency rooms as a result of unregulated, unsafe and ineffective products. Americans deserve better and we’ve come together to propose a solution.”

In addition to the regulatory recommendations, the groups propose that health care 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 on the DSHEA and the roles of FDA and FTC in safety and claims monitoring of supplements promoted for the purpose of weight loss.

Dietary supplement use, as well as proven treatments for obesity and weight loss, will be discussed in several sessions at the upcoming ObesityWeek conference, taking place at the Los Angeles Convention Center in Los Angeles, California, November 2–6, 2015. ObesityWeek is the premier, international event focused on the basic science, clinical application, prevention and treatment of obesity. TOS will also be hosting its Annual Meeting at the conference, and for the third year, attendees will unveil new research, discuss emerging treatment and prevention options, and network and present. You can connect and share with ObesityWeek on Twitter and Facebook, or by using #OW2015.

Sources:
The Obesity Society
Obesity Action Coalition
Obesity Medicine Association (formerly the American Society of Bariatric Physicians)
Academy of Nutrition and Dietetics
ObesityWeek conference

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