Dietary supplements are a popular way for many to boost their nutrient intake, but understanding their regulation is crucial. In the United States, the Food and Drug Administration (FDA) plays a key role in overseeing these products to ensure public safety. This article provides an overview of how the FDA regulates dietary supplements, also known as Dietary Food Supplements, and offers valuable resources for consumers and industry stakeholders.
The FDA’s oversight of dietary supplements is managed by the Human Foods Program’s Office of Food Chemical Safety, Dietary Supplements, and Innovation. This office coordinates efforts to regulate both finished dietary supplement products and dietary ingredients. It’s important to note that dietary supplements are regulated under a different set of rules compared to “conventional” foods and drug products.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers and distributors are responsible for ensuring their dietary supplements are safe and properly labeled before they reach the market. They must evaluate their products to meet the requirements of the Federal Food, Drug, and Cosmetic Act, as amended by DSHEA and FDA regulations. This means companies cannot legally market adulterated or misbranded dietary supplements. The FDA’s role is to take action after a product is on the market if it is found to be adulterated or misbranded.
For those seeking the latest updates and actions concerning dietary supplements, the FDA provides a dedicated resource:
What’s New in Dietary Supplements
This section offers constituent updates, press releases, warning letters, and information on recalls, keeping you informed about current regulatory actions.
To delve deeper into specific ingredients and substances in dietary supplements, the FDA offers this directory:
Information on Select Dietary Supplement Ingredients and Other Substances
Here, you can find a compilation of FDA actions and communications related to particular ingredients, helping you make informed choices.
If you encounter an issue with a dietary supplement, it’s important to know how to report it. The FDA provides clear guidance for this:
How to Report a Problem with Dietary Supplements
This resource explains how consumers, healthcare providers, and others can report complaints or concerns. It also includes guidance for manufacturers and distributors on adverse event reporting.
For consumers looking for general information and education on using dietary supplements safely and effectively, the FDA offers a comprehensive consumer section:
Information for Consumers on Using Dietary Supplements
This section includes consumer updates, educational materials, and links to information from other relevant agencies, empowering consumers to use dietary supplements knowledgeably.
Supplement Your Knowledge Dietary Supplement Education Initiative
For industry professionals involved in manufacturing, distributing, or selling dietary supplements, the FDA provides essential resources and guidance:
Information for Industry on Dietary Supplements
This section offers resources for new dietary ingredient notifications, structure/function claim notifications, applications, guidances, regulations, and other crucial information for industry compliance.
For direct inquiries or further information, you can contact the FDA’s Office of Dietary Supplement Programs:
Office of Dietary Supplement Programs, HFS-810
Food and Drug Administration
5001 Campus Dr
College Park, MD 20740
Email: [email protected]
For general food and cosmetic information, you can also reach FDA’s Food and Cosmetics Information Center at 1-888-SAFEFOOD (1-888-723-3366).
By providing these resources and maintaining regulatory oversight, the FDA helps ensure that dietary supplements are safe and properly labeled, contributing to consumer protection and informed decision-making in the realm of dietary food supplements.
