The FDA does not regulate dietary supplements.

Regulation

In 1994, the Dietary Supplement Health and Education Act  became law, amending the Federal Food, Drug, and Cosmetic Act. DSHEA created a new regulatory framework for the safety and labeling of dietary supplements.

FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of dietary supplements. The Federal Trade Commission (FTC) regulates advertising, including infomercials for supplements and most other products sold to consumers. The U.S. Postal Inspection Service has laws that regulate the advertising and promotional material you receive in the mail.

Under DSHEA:

• Dietary supplements are classified as foods and are assumed to be safe. They are subjected to limited regulatory oversight.
• Manufacturers do not need to register with the FDA or get FDA approval before producing or selling dietary supplements.
• Manufacturers are responsible for ensuring that dietary supplements are safe before they are marketed. A new dietary ingredient requires a pre-market review for safety. Otherwise, no law or regulation requires a firm to disclose information about the safety or benefits of its products.
• The manufacturer is not required to include warnings, precautions, or side effects on product labels.
• The FDA must prove that a dietary supplement is unsafe before it can take action to restrict the product's use or remove it from the marketplace. 
• Manufacturers are not required to record, investigate, or forward to the FDA any reports of injuries or illnesses that may be related to the use of its products.

Because the FDA has limited resources for analyzing the composition of food products, it focuses first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe, fraudulent, or in violation of the law.
 
In 2004, American Medical Association (AMA) Trustee Ronald M. Davis, MD, told Congress, "Because existing law treats dietary supplements as foods, many consumers think they are safe. Many consumers believe these products have been approved by the government, when in fact they have not. Ephedra, for example, was on store shelves long after the risks of heart attack, stroke, seizure, and death were well documented. It took the FDA seven years to ban ephedra because DSHEA makes it difficult for the FDA to prove that a dietary supplement is unsafe. Yet, other dietary supplements such as bitter orange contain ephedra-like substances and are still available to consumers."

Labeling

FDA regulations require dietary supplement labels to include the following information:

• Descriptive name of the product, stating that it is a supplement
• Name and place of business of the manufacturer, packer, or distributor
• Supplement Facts panel, which identifies each dietary ingredient contained in the product
• Ingredients list beneath the Supplement Facts panel, which includes all other ingredients

Manufacturers may make the following claims for their products:

• Amount of a nutrient or dietary substance in a product
• Intended benefits of using the product
• Links between a food substance and disease or a health-related condition

Nutritional supplements cannot claim to treat specific conditions. A supplement promoted on its labeling as a prevention, treatment, or cure for a specific condition would be considered an unapproved - and thus illegal - drug.

Different requirements generally apply to each type of claim, as described in more detail on the FDA web site. For example, with certain claims, DSHEA requires the label disclaimer: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."