Weight Loss Dietary Supplements Need To Be Regulated
Approximately 30% of adults in the US report using dietary supplements for weight loss, contributing to nearly US$2 billion a year on these products. However, many supplements have no evidence to support 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. In order to protect the public from false claims of safety and efficacy of dietary supplements the groups are calling for the reform of the 1994 Dietary Supplement Health and Education Act (DSHEA) to provide the FDA and the Federal Trade Commission (FTC) with increased regulatory and funding.
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 marked as curative or medicinal it should be categorised as a drug and subject to enforcement by the 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.
According to the statement, the harm can go 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
While weight loss is recognised as a treatment for obesity, according to the 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. Currently under the 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.
Consumers struggling with their weight who do not experience direct harm from the purchase of dietary supplements, the groups say, “misleading and unsubstantiated claims detract consumers from evidence-based interventions and treatments, such as FDA-approved medications, metabolic and bariatric surgery and commercial intensive lifestyle intervention programmes 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.
Source: The Bariatric News Wednesday 21st October 2015