Even if you're not on a diet, you've no doubt seen advertisements for products promising to help you lose weight and shed unwanted pounds. Whenever you come across one of these products, it's very likely the product is marketed as a "dietary supplement" and not as a drug or medication. This distinction is important because the US Food and Drug Administration has to approve all prescription drugs, but dietary supplements do not need any such approval.
Weight Loss Supplements
When a manufacturer wants to sell a dietary supplement, it must ensure that the product contains only dietary ingredients and is intended for consumers to ingest orally, according to the FDA. The weight-loss supplement can contain ingredients such as plants, vitamins, minerals, enzymes and amino acids, but cannot contain a drug or other controlled medication or substance.
FDA Approval
The FDA does not approve any dietary supplement, regardless of whether it is intended as a weight-loss product. A weight loss supplement manufacturer has a duty to ensure the product is safe, but it does not have to register the product nor get any government approval before it sells it to the public. However, a dietary supplement manufacturer must include specific information on the product's informational label, including the ingredients used, the name of any plant or botanical used and the contact information for the manufacturer, packer or distributor, according to the Office of Dietary Supplements.
Disclaimers
Many dietary supplements that purport to aid people with weight loss come with a disclaimer that states "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." The law that governs dietary supplements, called the Dietary Supplement Health and Education Act, or DSHEA, requires manufacturers to include this disclaimer whenever it makes a claim about a product's ingredient and its effect on the body. The manufacturer has to ensure that it makes a truthful statement, and the FDA has no role in approving such statements.
Dietary Medications
Unlike supplements, the FDA has to approve all medicines and drugs before a manufacturer can sell them in the United States. According to the Weight Control Information Network, a service of the National Institutes of Health, the FDA has approved a variety of obesity medications, most of which are available only with a prescription. As of May 2011, orlistat, sold under the brand name Alli, is the only approved weight-loss medication available over-the-counter, or without a prescription.
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