Today’s consumers are taking greater responsibility for their own health care. A prime example of this growing trend is the increased use of dietary supplement products in the United States. However, while consumers understand the benefits of taking dietary supplements to promote overall wellness, they may not fully understand the U.S. government’s role in ensuring that the products they take are safe.

Did you know that . . . dietary supplements are considered a subset of foods under federal law and are therefore regulated by the U.S. Food and Drug Administration (FDA) and the U.S. Federal Trade Commission (FTC)? In fact, FDA and FTC work closely together to ensure their enforcement efforts with respect to dietary supplements are consistent to the fullest extent feasible

FDA has the primary responsibility for safety issues and has the authority to:

• Stop any company from selling a dietary supplement that is toxic or unsanitary.
• Stop the sale of a dietary supplement that makes false or unsubstantiated claims on its labeling.
• Take action against dietary supplements that pose "a significant or unreasonable risk of illness or injury."
• Stop any company from making a claim that a product cures or treats a disease.
• Stop a new dietary ingredient from being marketed if the agency does not receive enough safety information in advance.
• Require dietary supplements meet strict manufacturing requirements (Good Manufacturing Practices), including regulations for potency, cleanliness, and stability.
• Require companies to register with the agency.
•  Inspect certain records and require companies to keep them for two years.

FTC has primary responsibility for claims in advertising and has the authority to:

• Enforce laws outlawing "unfair or deceptive acts or practices" to make sure consumers are truthfully informed.
• Challenge and stop advertising that is not adequately substantiated.
• Investigate complaints or questionable trade practices.
• Negotiate a consent order, or proceed through an FTC process that results in a cease and desist order to change or fix promotion practices.
• Stop false advertisements or other violations of the FTC Act, the law governing trade practices.
• Seek civil penalties for violations of trade regulation rules or violations of cease and desist orders.

Information required on dietary supplement labels includes:

• Statement of identity (e.g., "ginseng").
• Net quantity of contents (e.g., "60 capsules").
• The statement: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." (If claims describing the role of a dietary supplement on a structure or function of the body are made.)
• Directions for use (e.g., "Take one capsule daily").
• Supplement Facts Panel (lists serving size, amount, and dietary supplement ingredients).
• Other ingredients, in descending order of predominance.
• Name and place of business of the manufacturer, packer, or distributor.

THE BOTTOMLINE . . . There is a regulatory system for dietary supplements in the United States