Weight-loss supplements purport to be a less-expensive and more natural option to taking off those extra pounds. However, it's important to understand the relationship between weight-loss supplements and the FDA---the regulatory authority otherwise known as the U.S. Food and Drug Administration---so you can assess the probability that your product is both safe and effective. Always talk to your treating physician before taking weight-loss supplements or any other supplement to address your health concerns.
Supplement Basics
Over-the-counter weight-loss supplements are considered dietary supplements, as defined by the Dietary Supplement Health and Education Act of 1994. A weight-loss supplement can contain any ingredient that's meant to supplement your diet, says the FDA. Vitamin pills and mineral supplements you take to make sure you get enough of a specific nutrient are dietary supplements. So are supplements that contain herbs, botanicals, amino acids, enzymes and organ tissues. Dietary supplements are taken by mouth and can be purchased in a number of forms, such as gelcaps, tablets, capsules, liquid extracts and even bars. Regardless of the weight loss supplement or its form, these fall under the general category of "foods"---not drugs.
FDA Role
When you see a new weight-loss supplement on the market, keep in mind that it has not been approved by the FDA for that particular purpose. Nor is there any assurance of your product's safety and efficacy, says the FDA. Manufacturers of weight-loss supplements take responsibility for making sure their product is safe for consumers. However, if the FDA discovers that a particular weight-loss supplement contains a dietary ingredient that's hazardous to your health or one that's tainted with active pharmaceuticals undeclared on the label, the agency can take action to make sure the product is removed from the shelves.
Problems with Supplements
Never assumed that if an over-the-counter weight loss supplement won't help you, it won't hurt you either, cautions the FDA. When used at high dosages, for a long period of time or with other medications and supplements, even the most "natural" weight-loss supplements can be hazardous to your health. Problematic for the FDA are tainted weight-loss supplements that contain potent prescription pharmaceuticals. The agency has found the following in over-the-counter weight-loss supplements: Sibutramine, fenproporex, fluoxetine, bumetanide, furosemide, phenytoin, rimonabant, cetilistat and phenolphthalein. Some of these drugs are experimental or have no clinical studies to prove their safety and efficacy, while others are potent medications used for serious health conditions, such as congestive heart failure, hypertension and epilepsy. By March 2009, the FDA had compiled a list of 70 nonprescription weight-loss supplements that were potentially harmful.
FDA Approved?
According to the Weight Control Information Network, the FDA has approved only 5 drugs for weight loss. Phentermine, diethylpropion and phendimetrazine are appetite suppressants that can be used for up to 12 weeks by adults, while sibutramine may be used for up to a year. Orlistat, both prescription and nonprescription, is a lipase inhibitor that prevents the absorption of dietary fat. This medication can also be used for up to a year. However, many weight-loss supplements contain natural ingredients that have no science behind them, and some have been removed from the consumer market entirely. Country mallow and ephedra have been deemed potentially unsafe by the FDA and banned; bitter orange supplements may also be unsafe, according to MayoClinic.com. Guar gum purportedly also works like the drug orlistat, and it's probably safe---and it's also probably ineffective, says MayoClinic.com.
Consumer Tips
False advertising claims made by weight-loss marketers present an ongoing problem for the Federal Trade Commission, the regulatory authority that makes sure advertising claims weight-loss supplement marketers make about their product are truthful and don't mislead the public. Be wary of supplements that promise an extraordinary amount of weight loss in a short period of time. Ignore personal testimonials you see on TV infomercials and Internet websites. If you get information about weight-loss supplements online, make sure the site is administered by a government agency, hospital or clinic, university or national organization, such as the American Heart Association.
References
- Office of Dietary Supplements: Frequently Asked Questions
- U.S. Food and Drug Administration: Overview of Dietary Supplements
- Weight Control Information Network: Prescription Medicatons to Control Obesity
- Federal Trade Commission: FTC Releases Report on Weight-Loss Advertising
- MayoClinic.com: Over-the-Counter Weight Loss Pills-Do They Work?
- U.S. Food and Drug Administration: Questions and Answers about FDA's Initiative Against Contaminated Weight Loss Products



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