Dietary Supplements Sold as Medicinal or Curative for Obesity

Dietary Supplements Sold as Medicinal or Curative for Obesity

October 2015

Co-signatories: Obesity Action Coalition, Obesity Medicine Association (formerly the American Society of Bariatric Physicians), Academy of Nutrition and Dietetics

 

Overview of Position

All publicly available dietary supplements sold or advertised for weight loss should have randomized, double blinded, placebo-controlled studies of sufficient duration to support both safety and claimed efficacy. These randomized controlled trials should be of appropriate magnitude and rigor. If a dietary supplement is marketed as curative or medicinal it should be categorized as a drug and subject to enforcement by US Food and Drug Administration (FDA) (1).

The undersigned obesity groups acknowledge that there may be efficacious dietary supplements and non-prescription prevention and treatment strategies. As science-based groups with the best interest of the public in mind, we 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. There is a major need for long-term data showing the benefits, safety and effectiveness of dietary supplements for weight management.

Given the need to equip patients and physicians with evidence-based healthcare options, we support adequate funding for FDA and the Federal Trade Commission (FTC) and reform of the Dietary Supplement Health and Education Act (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.

 

Recommendations

FDA justifiably requires a very careful scrutiny of weight loss drugs for safety and efficacy. To provide similar scrutiny for nutritional supplements that claim weight benefit, appetite suppression or thermogenesis, FDA and FTC should receive adequate funding and the DSHEA should be modified to enable the FDA and FTC greater regulatory capacity to protect the public from any false claims regarding efficacy and safety of dietary supplements.

Healthcare providers should:

  • 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 (2, 3).
  • 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.

Healthcare providers are strongly discouraged from engaging in entrepreneurial activities in which they directly profit from the prescribing of non-FDA approved weight-loss remedies where both safety and efficacy have not been proven.

 

Background and Statement of the Problem

There is increased attention on obesity as a critical public health problem, heightened public recognition of the health risks caused by obesity, and the declaration of obesity as a disease by multiple medical and professional societies. Diet and exercise are difficult to sustain, and so the public is highly motivated to seek alternative remedies such as dietary supplements for weight loss (4).

A dietary supplement is “a product intended to supplement the diet and may include a vitamin, mineral, herb or botanical, an amino acid, or a concentrate, metabolite, constituent, extract, or combination” (5).

Up to 30% of U.S. adults have reportedly used a dietary supplement for weight loss with annual spending close to $2 billion (4,6,7). However, there is limited regulation of dietary supplement claims, hence promoting a dangerous health environment (8,9).

Under the 1994 Dietary Supplement Health and Education Act (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 (4,10).

The FDA and FTC have different roles with respect to dietary supplements. Under DSHEA, dietary supplement firms are responsible for maintaining records of safety and efficacy; however, for a new ingredient not sold in the US prior to DSHEA, a “pre-market review for safety data” is required (1). The DSHEA prevents FDA from pre-market regulation of claims, but firms must notify the agency of a claim prior to its use and indicate on its packaging, “FDA has not evaluated the claim” (1). Post-marketing, the FDA monitors adverse event reports of dietary supplements, label claims, package inserts, and accompanying literature, including websites for false or misleading information (11). The FTC has the authority to regulate advertising in print media, on the radio and in TV commercials, through mail and the Internet that make weight-loss claims without evidence (11). The lack of integrated regulation places the burden on the FDA and FTC to prove a claim is unsubstantiated rather than mandating companies to provide evidence of safety and claimed effectiveness.

Often ambiguous language that avoids the scrutiny of the FTC and FDA is used to claim, without scientific evidence, that dietary supplements increase energy, decrease appetite, activate fat burning and suppress cravings. In addition to these misleading practices, there are examples where companies illegally add pharmaceuticals to dietary supplements (12).

Consumers buy weight-loss products and many with no evidence to support weight-loss claims. In the specific case of weight-loss dietary supplements not based on evidence, the harm can go beyond financial losses. These 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 (12).

Finally, dietary supplements with 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.

 

References

1) Q&A on Dietary Supplements. US Food and Drug Administration Website. http://www.fda.gov/Food/DietarySupplements/QADietarySupplements/default.htm#FDA_role. Updated on March 20, 2014. Accessed on April 8, 2015.

2) Tips for Dietary Supplement Users: Making Informed Decisions and Evaluating Information. US Food and Drug Administration. Available at: http://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm110567.htm. Accessed on April 8, 2015.  

3) Food Facts from the US Food and Drug Administration. Dietary Supplements: What You Need to Know. US Food and Drug Administration Website. http://www.fda.gov/downloads/Food/DietarySupplements/UCM240978.pdf.

4) Dietary Supplements for Weight Loss. Fact Sheet for Health Professionals. National Institutes of Health. Office of Dietary Supplements Website. http://ods.od.nih.gov/factsheets/WeightLoss-HealthProfessional/#en8. Reviewed April 5, 2015. Accessed April 11, 2015.

5) Dietary Supplement Health and Education Act of 1994. US Food and Drug Administration website. Available at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/ucm148003.htm#sec3. Accessed on April 8, 2015.

6) JL Pillitteri. Use of Dietary Supplements for Weight Loss in the United States: Results of a National Survey. Obesity. 2008;16(4)790-796.

7) RL Bailey, JJ Gahche, PE Miller, PR Thomas, and JT Dwyer. JAMA Intern Med. 2013;173(5):355-361. 

8) Tainted Weight Loss Products. Public Notifications. US Food and Drug Administration Website. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234592.htm. Updated March 26, 2015. Accessed on April 1, 2015.

9) Sensa and Three Other Marketers of Fad Weight-Loss Products Settle FTC Charges in Crackdown on Deceptive Advertising. Sensa to Pay $26.5 Million for Consumer Refunds. US Federal Trade Commission Website. https://www.ftc.gov/news-events/press-releases/2014/01/sensa-three-other-marketers-fad-weight-loss-products-settle-ftc. Published January 7, 2014. Accessed April 11, 2015.

10) Frequently Asked Questions (FAQ): Regulatory Information. National Institutes of Health. Office of Dietary Supplements website. Available at http://ods.od.nih.gov/Health_Information/ODS_Frequently_Asked_Questions.aspx#Regulatory. Accessed on April 8, 2015.

11) Federal Trade Commission. Dietary Supplements: An Advertising Guide for Industry. https://www.ftc.gov/tips-advice/business-center/guidance/dietary-supplements-advertising-guide-industry#b

12) Beware of Products Promising Miracle Weight Loss. US Food and Drug Administration website. Available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm246742.htm. Accessed April 21, 2015.

This statement is furnished for general information purposes only. It does not constitute the practice of medicine, nor should it be relied upon for dealing with a specific medical or health condition. Please consult a qualified medical professional for advice about a specific situation.