How does the FDA regulate dietary supplements?: A comprehensive guide to nutrition diet and oversight

October 13, 2025 •

5 min read

Since the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, the number of dietary supplements on the market has increased nearly twentyfold. This growth has brought increased scrutiny to the question of how does the FDA regulate dietary supplements?, a process that differs significantly from drug oversight and places the primary responsibility for safety on manufacturers.

Quick Summary

The regulation of dietary supplements is primarily governed by the Dietary Supplement Health and Education Act of 1994 (DSHEA), which classifies them as a category of food. Manufacturers are responsible for ensuring their products are safe and accurately labeled before marketing. The FDA's role is largely post-market, focusing on enforcement of labeling claims, product quality through Current Good Manufacturing Practices (cGMPs), and tracking serious adverse events reported by manufacturers.

Key Points

Post-Market Regulation: Unlike drugs, dietary supplements do not require FDA premarket approval for safety or effectiveness; the FDA largely regulates them after they are on the market.
Manufacturer Responsibility: The burden of ensuring a dietary supplement is safe and labeled truthfully falls primarily on the manufacturer or distributor.
Good Manufacturing Practices (cGMPs): FDA regulations mandate cGMPs for manufacturing, packaging, and holding supplements to ensure product quality, purity, and composition.
New Dietary Ingredient (NDI) Notification: For ingredients not on the market before 1994, manufacturers must submit a safety notification to the FDA before selling the product.
Adverse Event Reporting: Manufacturers are required to report serious adverse events to the FDA, and consumers can also voluntarily submit reports.
Labeling and Claims: Manufacturers are responsible for substantiating any structure/function claims they make and must use a mandatory disclaimer.

Understanding the Regulatory Framework: DSHEA

The foundation of modern dietary supplement regulation in the United States is the Dietary Supplement Health and Education Act (DSHEA) of 1994. This law defined dietary supplements and established a unique regulatory framework, treating them as a category of food rather than as drugs. The core of DSHEA places the burden on manufacturers and distributors to ensure their products are safe and labeled in a truthful and non-misleading way before marketing. In contrast to the rigorous premarket approval process for drugs, dietary supplements do not require FDA approval for safety or efficacy before being sold to the public. This framework means the FDA’s role is largely one of post-market enforcement, where they can take action against unsafe or misbranded products already on the market.

The Critical Distinction: Supplements vs. Drugs

A key aspect of understanding dietary supplement regulation is recognizing the difference between how the FDA treats supplements versus prescription and over-the-counter drugs. This distinction fundamentally shapes the level of government oversight and manufacturer responsibility.

Drugs: Require extensive premarket approval from the FDA. This involves clinical trials to prove both safety and efficacy for a specific medical use. The FDA reviews all data before a drug can be marketed.
Dietary Supplements: Do not require premarket approval from the FDA. Manufacturers are responsible for their own safety and labeling, but do not need to prove efficacy through clinical trials. A supplement may contain ingredients with strong biological effects, but manufacturers cannot market them to treat or cure diseases.

New Dietary Ingredients: The Premarket Notification Process

While premarket approval is not required for most supplements, there is an exception for products containing a “New Dietary Ingredient” (NDI). An NDI is an ingredient not marketed in the U.S. before October 15, 1994. For these ingredients, manufacturers must submit a notification to the FDA at least 75 days before introducing the product to market.

The NDI notification must provide evidence that the ingredient is “reasonably expected to be safe” under the recommended conditions of use. This is not an approval process, but rather a safety notification that allows the FDA to review the submitted evidence. An incomplete or missing notification can cause the FDA to deem the product adulterated.

Ensuring Quality and Purity with Good Manufacturing Practices (cGMPs)

To ensure the quality, identity, purity, strength, and composition of dietary supplements, the FDA established Current Good Manufacturing Practice (cGMP) regulations in 2007, outlined in 21 CFR Part 111. These rules require manufacturers to control and document their processes for producing, packaging, labeling, and holding dietary supplements. This helps prevent contamination and ensures that a product contains what the label claims it contains.

Compliance with cGMPs covers a wide range of operational aspects, including:

Personnel Qualifications: Training and qualifications for employees involved in manufacturing.
Facility and Equipment: Maintaining a clean, sanitary environment to prevent contamination.
Production and Process Controls: Implementing and documenting specific procedures for manufacturing.
Quality Control: Testing raw materials and finished products to confirm identity, purity, and composition.
Handling of Complaints: Establishing procedures for managing customer complaints and returned products.

Labeling Regulations and Permissible Claims

Dietary supplement labels are required to contain specific information, including the ``Supplement Facts'' panel, which lists the ingredients and their amounts. Manufacturers are responsible for ensuring that all information and claims on the label are truthful and not misleading. There are three main types of claims that can be made:

Health Claims: These describe a relationship between a supplement ingredient and a reduction in the risk of a disease. They require FDA authorization and are not common.
Structure/Function Claims: These describe the role of a nutrient in affecting the normal structure or function of the human body (e.g., “calcium builds strong bones”). Manufacturers must have scientific evidence to substantiate these claims and must notify the FDA within 30 days of first marketing the product. The label must also include a mandatory disclaimer: “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.”.
Nutrient Content Claims: These describe the level of a nutrient in a product (e.g., “high in calcium”).

Post-Market Surveillance and Adverse Event Reporting

Despite the lack of premarket approval, the FDA actively monitors the safety of dietary supplements on the market through a post-market surveillance system. A crucial part of this system is the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which requires manufacturers, packers, and distributors to report any serious adverse events they learn about to the FDA.

Mandatory Reporting: Companies must report serious adverse events (e.g., hospitalization, death, life-threatening experience) within 15 business days of receiving the report.
Voluntary Reporting: Consumers, healthcare professionals, and others can voluntarily report adverse events via the FDA’s online Safety Reporting Portal (SRP). These reports help the FDA identify potential safety issues with supplements.

FDA's Enforcement Actions

If the FDA finds a dietary supplement to be unsafe, adulterated, or misbranded, it has the authority to take action to remove it from the market. Enforcement tools available to the agency include:

Issuing warning letters to companies.
Working with companies to conduct voluntary recalls of products.
Initiating seizures of products.
Pursuing legal action against firms or individuals.

The FDA's authority is constrained by the DSHEA framework, meaning it must prove a product is unsafe before it can be removed from shelves.

Regulation Comparison: Dietary Supplements vs. Prescription Drugs


Feature	Dietary Supplements	Prescription Drugs
Premarket Approval	No, unless it contains a New Dietary Ingredient, which requires a premarket notification.	Yes, requires extensive premarket testing and FDA approval.
Evidence of Safety	Manufacturer is responsible for ensuring safety; FDA must prove a product is unsafe.	FDA reviews evidence of safety submitted by the manufacturer as part of the approval process.
Evidence of Efficacy	No premarket requirement to prove effectiveness.	Required to prove efficacy for a specific medical condition during clinical trials.
Adverse Event Reporting	Mandatory reporting of serious adverse events by manufacturers.	Mandatory reporting for a wider range of adverse events.
Labeling	Manufacturer is responsible for truthful and non-misleading labels, with substantiation for claims.	FDA approves the drug's labeling, including indications, dosage, and warnings.

Conclusion

The FDA's regulation of dietary supplements is fundamentally different from its approach to drugs, a reality shaped by the DSHEA legislation. While the post-market enforcement model places significant responsibility on manufacturers for product safety and labeling, consumers must also exercise caution and informed judgment. The cGMP requirements ensure a baseline for manufacturing quality, but the lack of mandatory premarket efficacy testing means consumers should always consult a healthcare professional before incorporating new supplements into their nutrition diet. As the market for dietary supplements continues to grow, understanding the regulatory landscape is essential for making safe and healthy choices.

For more information, the FDA provides a dedicated resource page on dietary supplements. Dietary Supplements - FDA

Frequently Asked Questions

No, the FDA does not approve dietary supplements for safety or effectiveness before they are marketed. The responsibility for ensuring a product is safe falls on the manufacturer.

DSHEA is a 1994 law that created the regulatory framework for dietary supplements, defining them as a category of food and placing the primary responsibility for safety and labeling on the manufacturers.

cGMPs are regulations issued by the FDA that establish requirements for the production, packaging, labeling, and holding of dietary supplements. They ensure product quality, identity, purity, and strength.

An NDI notification is a submission to the FDA required for any supplement containing an ingredient not marketed in the U.S. before 1994. It must be submitted 75 days before marketing and demonstrate that the ingredient is reasonably expected to be safe.

Manufacturers are required to report serious adverse events to the FDA within 15 business days. Consumers and healthcare professionals can also voluntarily submit adverse event reports.

No, manufacturers cannot claim that a dietary supplement can diagnose, treat, cure, or prevent any disease. Any structure/function claims they make, such as 'calcium builds strong bones,' must be truthful and include a mandatory disclaimer.

The FDA can take post-market enforcement actions against unsafe or misbranded products. These can include issuing warning letters, initiating recalls, or pursuing legal action against the responsible firm.