By Jacqueline Jacques, ND
For a PDF version of this article, please click here.
Everyone has seen the ads and the amazing promises they make: Lose 30 Pounds in 30 Days! Safe, Natural and Effective! Melt Away Fat and Cellulite! Never Diet Again! The promises of pills, patches, elixirs and creams that will lead to safe, effortless weight-loss are everywhere. The dietary supplement industry has long made millions off of the weight-loss consumer – and the worse the problem gets, the more products there are waiting to offer their magic.
According to AC Neilson, in 2005 alone, U.S. consumers spent more than 322 million dollars on the category of weight-loss dietary supplements, shakes and bars, none of which are proven effective. A recent survey conducted by the Obesity Society (NAASO) concluded that more than two-thirds of Americans believe that dietary supplements sold for weight-loss must be tested for safety and efficacy. They also found that those with a serious need to lose weight were more willing to purchase and use these products than engage in medical programs that have been evaluated for safety and efficacy.
Can Dietary Supplements Really Help with Weight-loss?
There are many natural products that have been studied for weight-loss, but few, if any, have been studied to the degree of diet, drugs and surgery. The best-studied dietary supplement by far for weight-loss was Ephedra, which has been banned in the U.S. since 2003 for safety reasons. Others, by and large, are folk remedies, or substances that, while they may hold some promise, have not been adequately evaluated to demonstrate that they are either safe or effective. This is not to say that none are somewhat effective or that they may not help some people, only that there is not enough evidence to make claims for them.
These remedies go by many names. Some are nutrients like chromium; others herbs like hoodia, guarana, magnolia or kelp; there are food extracts from tea, beans and barley; even hormones like DHEA. Some claim to accelerate fat burning, others to target specific areas of fat, still others claim to suppress appetite. And while there may be pieces of truth in any of this, often companies are simply aiming to sell hope to those who are desperately seeking to find a solution to being affected by excess weight or obesity.
Why can companies market these products?
In the U.S., it is relatively easy to bring a dietary supplement to market. Unlike drugs, dietary supplements do not have to go through clinical trials; they do not have to be proven safe or effective for anything.
As far as safety goes, the FDA currently treats dietary supplements more like foods than drugs. Safety does not have to be established in clinical trials, but is assumed because the products are dietary (just like you do not need to demonstrate the safety of bananas). Companies selling dietary supplements are ultimately responsible for their safety; the FDA is responsible for demonstrating that a product is unsafe before it can restrict use or recall the product from the market.
It is currently not required for manufacturers or distributors of dietary supplements to collect or report adverse events to the FDA. Consumers or health professionals can file voluntary Adverse Event Reports (AERs) through Med Watch (www.fda.gov/medwatch).
The issue of claims made about dietary supplements is perhaps most irritating to physicians and confusing to consumers. Ads, especially for weight-loss products, seem to make remarkable claims. How can they do that?
Quite simply, a great deal of the advertising for dietary supplements is illegal – companies simply bank on not being caught, or on making enough money before they do get caught that the fines will pale in comparison to profits.
The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) technically work together to regulate what is said about dietary supplements. Where the FDA has primary jurisdiction over things that are on the product – the label, the packaging, inserts and appended literature – the FTC has oversight of everything else such as commercials, Internet marketing, print media, catalogs, testimonials and direct marketing materials.
The issue of claims made about dietary supplements is perhaps most irritating to physicians and confusing to consumers. Legally, a dietary supplement cannot be used to, or claim to diagnose, cure, mitigate, treat or prevent a disease – substances that do this, or claim to do so, are drugs by definition.
As stated above, the FDA and the FTC both have some oversight over claims, packaging and label information. However, it seems that between these two agencies they still struggle to maintain control over inconsistent, unproven and just plain false information being distributed to consumers. This problem has clearly been compounded by the Internet, which we now know is used by approximately 16 percent of the U.S. adult population to seek information on health.
In the September 17, 2003 issue of the Journal of the American Medical Association, Morris and Avorn of Harvard Medical School conducted a survey of health claims made on the Internet about the most common dietary supplements. The reviewers looked at 443 Web sites and applied FDA criteria to classify claims as “disease” or “non-disease” in nature. Of the surveyed sites, 76 percent were retail sites either selling products or directly linked to a vendor. Of this 76 percent, 81 percent (338 sites) made one or more health claims, with 55 percent of these claiming to treat, prevent, diagnose or cure specific diseases.
Moreover, 52 percent of retail sites failed to include the mandated federal disclaimer for dietary supplement sales. Only 12 percent of sites provided any reference materials to support claims. Thus, the authors concluded that despite supposed FTC authority to regulate these materials, the current enforcement of claims (at least on the Internet) is quite poor and likely to mislead consumers.
By law, allowable claims for dietary supplements are supposed to meet both FDA and FTC criteria. The FDA offers general guidelines for structure-function claims, language for approved health claims (very limited), and required disclaimers (such as those that caution use in pregnancy and nursing).
The FTC further offers guidelines for advertising that are designed to assure that materials are truthful and not misleading in nature. They further require claims to be adequately substantiated by solid scientific data. The FTC laws even apply to personal or health professional testimonials – including those often amazing pictures showing miraculous weight-loss and body sculpting.
Specific Guidelines for Weight-loss Products
The FTC has had ongoing campaigns to halt false advertising in the weight-loss category since the mid-90s. To that effect, they have issued both advertising and consumer guides to try to diminish fraud. Generally, guidance for dietary supplements states that they should not claim or promote an ability to produce weight-loss in the absence of dietary restriction and exercise, and they should not claim weight-loss of greater than one to two pounds per week (the amount that can be claimed for diet and exercise alone).
The following chart outlines the most common supplements for weight-loss and the specifics for each product: Please click here for chart.
How Dietary Supplements are Defined
It helps to start by understanding what a dietary supplement is and is not. Dietary supplements were defined in 1994 by Congress under the Dietary Supplement Health and Education Act (DSHEA). Under DSHEA, a product is a dietary supplement if:
- It is intended to supplement the diet
- It contains dietary ingredients such as vitamins, minerals, herbs (other than tobacco), amino acids, other natural substances and/or their constituents
- It is ingested orally in the form of a pill, capsule, tablet or liquid
- It is labeled on the front panel of the product as a dietary supplement
- It was sold and marketed as a dietary ingredient before October 15, 1994 or has been approved by the FDA as a new dietary ingredient (NDI)
- Its intended use is as a dietary supplement, not as a food or a drug
As long as a substance meets these criteria, it can be sold to the public without being tested or investigated as is required for substances sold as drugs.
What Can you Do as a Consumer?
As a consumer, you need to be smarter than the companies that market to you. Let’s face it: if any of these companies had the real miracle cure for weight-loss we would not be facing obesity at near epidemic levels in our country. More likely than not, a major pharmaceutical company would snap up the product, and it would be making headlines. The miracle solution for obesity does not yet exist. The best proven long-term results are from weight-loss surgery, followed by diet and exercise, behavior modification and some pharmaceutical agents. That does not mean that some natural substance might not have value – but you should look critically before you buy.
The following are some resources that consumers can use to both evaluate dietary supplements and report fraud:
- http://ftc.gov/bcp/conline/edcams/ojo/cases_health.htm#weight– This Web site has a list of companies that have recently been cited for fraudulent weight-loss claims by the FTC.
- http://rn.ftc.gov/pls/dod – If you feel you have been the victim of fraud from a company marketing or selling weight-loss products or services, you can file a complaint here.
- www.ftc.gov/redflag – The homepage for the FTC’s Operation Red Flag. This informative site gives great information for both consumers and companies on how to avoid false advertising of weight-loss products and services.
- ods.od.nih.gov/index.aspx – The National Institutes of Health Office of Dietary Supplements. Contains a lot of information on popular dietary supplements and has an informative page on avoiding health fraud (http://www.fda.gov/fdac/features/1999/699_fraud.html)
- www.umm.edu/altmed – The alternative medicine database at University of Maryland Medical Center. This is one of the best on the Web. Evidenced-based reviewed articles on hundreds of natural ingredients.
- www.cfsan.fda.gov/~dms/supplmnt.html – The Office of Dietary Supplements at the FDA. You will find a page here of FDA warnings and advisories against dietary supplements, information on being a smart consumer, and the link to report an adverse event or reaction to a dietary supplement. You can also look at warning letter such as those issued to companies marketing Ephedra.
About the Author:
Dr. Jacqueline Jacques is a Naturopathic Doctor with more than a decade of expertise in medical nutrition. She is the Chief Science Officer for Catalina Lifesciences LLC, a company dedicated to providing the best of nutritional care to weight-loss surgery patients. Her greatest love is empowering patients to better their own health. Dr. Jacques is a member of the OAC Advisory Board.