Fact Sheet: Dietary Supplements as Regulated Products
CHPA supports the regulatory authorities governing dietary supplement manufacturing, labeling, and marketing and works to ensure the availability of safe dietary supplements.
Today’s consumers are taking greater responsibility for their own healthcare. 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 these products 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)?
FDA has primary responsibility for regulating dietary supplements 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 or makes a claim that the product can treat, cure, or prevent a disease
- Take action against dietary supplements that pose "a significant or unreasonable risk of illness or injury"
- 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 (Current 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
- 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 bottom line...There is a regulatory system for dietary supplements in the United States.