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FDA dietary supplement regulation

Groups call for FDA regulation of dietary supplements

Approximately 30% of US adults report using a dietary supplement for weight loss, contributing to the nearly US$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

Four leading obesity research, treatment and prevention groups have issued a joint scientific statement recommending dietary supplements for weight loss claiming curative or medicinal qualities be subject to review and approval by the FDA. To do so, the groups call for the reform of the 1994 Dietary Supplement Health and Education Act (DSHEA), providing FDA and the Federal Trade Commission (FTC) the increased regulatory authority and funding to protect the public from false claims of safety and efficacy of dietary supplements.

The statement reads: “All publicly available dietary supplements sold or advertised for weight loss should have randomised, double blinded, placebo-controlled studies of sufficient duration to support both safety and claimed efficacy. These randomised controlled trials should be of appropriate magnitude and rigor. If a dietary supplement is marketed as curative or medicinal it should be categorised as a drug and subject to enforcement by FDA.”

“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,” said Dr Steven R Smith, The Obesity Society (TOS) past-president and Chief Scientific Officer at Florida Hospital, Orlando, FL.

Approximately 30% of US adults report using a dietary supplement for weight loss, contributing to the nearly US$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. According to the statement, the harm can go far beyond financial losses, including:

  • exposure to unsafe ingredients including drugs removed from the market or compounds not adequately studied in humans;
  • exposure to products tainted with prescription drugs, and;
  • deleterious response to products that may include increased blood pressure, cardiac arrhythmias, stroke, seizure and even death

In 2013, the American Medical Association joined the many other leading organisations 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). While weight loss is recognised as a treatment for obesity, 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,” added Smith. “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.”

Even for consumers struggling with their weight who seemingly do not experience direct harm from the purchase of dietary supplements, the groups say, “misleading and unsubstantiated claims 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.”

In addition to the regulatory recommendations, the groups proposed steps to help healthcare providers address the dangers with patients:

  • 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.
  • 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.

TOS’s Advocacy and Public Affairs Committees led the development of the statement over a six-month period, adhering to a rigorous, scientific process and review of existing peer-reviewed research. In addition to TOS, signatories include the Obesity Action Coalition, the Obesity Medicine Association, and the Academy of Nutrition and Dietetics.

To read the full statement, please click here

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