The Dietary Supplement Health and Education Act (DSHEA) of 1994, which amended the Federal Food, Drug, and Cosmetic Act, transformed FDA’s authority to regulate dietary supplements. Under DSHEA, FDA is not authorized to approve dietary supplements for safety and effectiveness before they are marketed. In fact, in many cases, firms can lawfully introduce dietary supplements to the market without even notifying FDA. Since DSHEA was enacted, the dietary supplement market has grown significantly. For example, the number of products has expanded nearly twenty times since 1994.

Dietary supplements play a role in the comprehensive care plan for many Americans. For example, some dietary supplements can help improve or maintain overall health and help provide adequate amounts of essential nutrients that the body needs to function. Because taking supplements can also involve health risks, FDA advises consumers to be informed and talk to their doctor, pharmacist, or other healthcare professional before deciding to purchase or use a dietary supplement. FDA is committed to protecting the public by identifying and removing unsafe and illegal products from the market and ensuring that products marketed as dietary supplements are safe, well-manufactured, and accurately labeled.

The following are resources and important information for you and your family about dietary supplements.

Consumer Updates

Timely and easy-to-read articles on product approvals, safety warnings, and other health information.

• Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You
• Mixing Medications and Dietary Supplements Can Endanger Your Health
• More Consumer Updates related to Dietary Supplements…

Alerts for Consumers

• Public Health Alert Concerning Dietary Supplements Containing Cesium Salts
• Public Health Alert Concerning Nopalina Flax Seed Powder and Nopalina Flax Seed Capsules and Salmonella Contamination
• FDA Advises Consumers to Stop Using Certain Life Rising Dietary Supplements

Recalls, Warnings, and Health Fraud

• Recalls, Market Withdrawals, & Safety Alerts
• ORA District and Headquarters Recall Coordinators
• Warning Letters
• Medication Health Fraud
• Health Fraud Product Database
• Health Fraud Scams

FDA Resources for You

• How to Report a Problem with Dietary Supplements
• Dietary Supplement Products & Ingredients
• What’s New in Dietary Supplements
• Label Claims for Conventional Foods and Dietary Supplements
• Let’s Talk Dietary Supplements (Video)

Additional Dietary Supplement Information from Other Agencies

National Institutes of Health

• Dietary Supplement Health Information (NIH-ODS)
• Dietary Supplement Fact Sheets (NIH-ODS)
• Botanical Dietary Supplements (NIH-ODS)
• Using Dietary Supplements Wisely (NIH-NCCIH)
• How To Evaluate Health Information on the Internet (NIH-ODS)
• Video on Thinking About Taking a Dietary Supplement (NIH-ODS)
• Dietary and Herbal Supplements (NIH-NCCIH)
• Herbs at a Glance (NIH-NCCIH)
• Dietary Supplements (MedlinePlus)

U.S. Department of Agriculture

• Nutrition.gov (online federal government information on nutrition, including dietary supplements)

Federal Trade Commission

FDA and FTC work together to regulate dietary supplement claims. FTC regulates the advertising of dietary supplements and specifically reviews the truth and accuracy of claims made in dietary supplement advertising and marketing.

• Dietary Supplements: An Advertising Guide for Industry

National Academies of Sciences, Engineering, Medicine

• The Food and Nutrition Board establishes principles and guidelines of adequate dietary intake; issues publications such as “Dietary Reference Intakes: Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline.

U.S. Department of Defense

• Operation Supplement Safety provides dietary supplement information for the military community, leaders, healthcare providers, and DoD civilians.