Understanding the Regulators: Does the EPA regulate the labeling of dietary supplements?

October 14, 2025 •

4 min read

Over 75% of American adults report having taken a dietary supplement, a market valued in the billions. When it comes to ensuring the accuracy of product information, a common misconception is to ask, "Does the EPA regulate the labeling of dietary supplements?" The answer is no; this responsibility falls to other federal agencies.

Quick Summary

The Environmental Protection Agency (EPA) does not regulate the labeling of dietary supplements. That role is primarily handled by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), with the FDA overseeing product labeling and the FTC focused on advertising claims.

Key Points

Misconception Clarified: The EPA does not regulate the labeling of dietary supplements; that role is handled by the FDA and FTC.
FDA's Role: The FDA oversees the safety and labeling of dietary supplements after they are marketed, meaning manufacturers are responsible for compliance.
FTC's Role: The FTC polices the advertising and marketing claims for dietary supplements, ensuring they are truthful and substantiated.
EPA's Limited Involvement: The EPA's only direct regulatory interaction with dietary supplements involves their disposal as hazardous waste from healthcare facilities, not their labeling for consumer use.
EPA (Ingredient) vs. EPA (Agency): Confusion may arise from the omega-3 fatty acid eicosapentaenoic acid (EPA), but the FDA, not the EPA agency, regulates its claims on supplement labels.
Post-Market Enforcement: Unlike prescription drugs, dietary supplements do not require FDA approval before they are sold, placing a higher burden on manufacturers and requiring consumer vigilance.

The Truth About Dietary Supplement Regulation

Many consumers are confused about which government agency oversees the vast dietary supplement market. While the Environmental Protection Agency (EPA) does have a role related to pharmaceuticals, its authority does not extend to the day-to-day regulation of dietary supplement labeling. The primary responsibility for ensuring truthful and accurate supplement labeling rests with the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). Understanding the distinct responsibilities of each agency is crucial for consumer protection.

The Food and Drug Administration (FDA)

The FDA is the key regulatory body for dietary supplements in the U.S., operating under the framework established by the Dietary Supplement Health and Education Act of 1994 (DSHEA). Unlike with prescription drugs, manufacturers of dietary supplements do not need to obtain FDA approval before marketing their products. Instead, the FDA's oversight is primarily focused on post-market enforcement. This means manufacturers are responsible for ensuring their products are safe and that their labels are truthful and not misleading.

The FDA's key responsibilities include:

Establishing Good Manufacturing Practices (GMPs): The FDA sets and enforces regulations for how supplements must be manufactured, packaged, and stored to ensure quality.
Reviewing New Dietary Ingredients (NDIs): For supplements containing new ingredients, manufacturers must notify the FDA at least 75 days before marketing and provide evidence supporting the safety of the new ingredient.
Taking Action Against Misbranded or Adulterated Products: The FDA has the authority to remove products from the market if they are found to be unsafe or if their labeling is false or misleading.
Reviewing Labeling Claims: While manufacturers can make certain claims (e.g., structure/function claims), the FDA reviews these to ensure they are substantiated.

The Federal Trade Commission (FTC)

In conjunction with the FDA, the FTC plays a critical role by regulating the advertising of dietary supplements. The FTC enforces federal law, which requires all advertising to be truthful, not misleading, and supported by competent and reliable scientific evidence. This is an important distinction from the FDA's labeling oversight, and the two agencies often collaborate.

Key areas where the FTC takes action include:

Combating Deceptive Advertising: The FTC has brought numerous law enforcement actions against companies making unsubstantiated or fraudulent claims in their advertisements, infomercials, and websites.
Regulating Online Claims: With the rise of e-commerce, the line between "labeling" and "advertising" has blurred. The FTC and FDA now scrutinize online claims, with the FTC often taking the lead on substantiation review for advertising claims.

The EPA's Actual Regulatory Scope

The EPA's mission focuses on protecting human health and the environment. It registers pesticides and disinfectants, such as those used to kill viruses and bacteria on hard surfaces in hospitals or homes. The EPA regulates products applied to the environment, not products ingested by the body.

However, a specific EPA rule concerning the disposal of hazardous waste pharmaceuticals does apply to some dietary supplements. In 2019, the EPA finalized regulations for managing hazardous waste pharmaceuticals at healthcare facilities, including retail pharmacies. Under this rule, a dietary supplement that qualifies as a hazardous waste when disposed of is subject to EPA regulations, which is a very different type of oversight than labeling control.

Clearing Up the Confusion: The EPA vs. EPA (Eicosapentaenoic Acid)

Some confusion may arise from the acronym "EPA" itself. Eicosapentaenoic acid, or EPA, is a type of omega-3 fatty acid found in fish oil and supplements. The FDA, not the EPA, regulates the qualified health claims that can be made on the labels of supplements containing EPA.

Regulatory Comparison: FDA, FTC, and EPA


Feature	FDA (Food and Drug Administration)	FTC (Federal Trade Commission)	EPA (Environmental Protection Agency)
Primary Function	Post-market oversight of supplement safety and labeling.	Regulates the truthfulness and accuracy of supplement advertising.	Protects human health and the environment; regulates pesticide and hazardous waste disposal.
Approval Required Before Sale?	No, for most supplements; manufacturers must ensure safety.	No, but claims must be substantiated before they are made.	Yes, for registering pesticides, but not for supplement labeling.
Area of Focus	Product labeling, ingredients, manufacturing practices (GMPs), and product safety.	Advertising and marketing materials, including online claims.	Disinfectants on surfaces and the proper disposal of hazardous waste pharmaceuticals, including some supplements.

A Note on Consumer Vigilance

Because dietary supplements are not subject to pre-market approval for safety or efficacy, consumers must be vigilant. Checking for third-party certifications from organizations like NSF International can provide additional confidence that a product contains what its label claims and is free from certain contaminants. The ultimate responsibility lies with the manufacturer to follow the law, but consumers should stay informed and report concerns to the FDA.

Conclusion

To be clear, the EPA does not regulate the labeling of dietary supplements. That regulatory authority is divided between the FDA, which oversees product labeling, and the FTC, which governs advertising claims. While the EPA's influence on the supplement industry is minimal and pertains mainly to waste disposal, the FDA and FTC are constantly working to enforce regulations and protect consumers from misbranded or misleading products. This regulatory framework places a significant burden on manufacturers to ensure compliance but leaves consumers with the responsibility to be informed and cautious. By understanding the roles of these different agencies, consumers can make more knowledgeable decisions about the supplements they choose to use.

Here is an authoritative source on the topic.

Frequently Asked Questions

The U.S. Food and Drug Administration (FDA) is the primary agency responsible for regulating the labeling of dietary supplements.

The EPA's involvement is very limited. It regulates the disposal of hazardous waste pharmaceuticals, which can include some dietary supplements, but it does not regulate their labeling for consumer use.

The Federal Trade Commission (FTC) regulates the advertising claims for dietary supplements, ensuring they are truthful and not misleading.

No, dietary supplements generally do not need FDA approval before they are marketed. The manufacturer is responsible for ensuring the product's safety and labeling are compliant with the law.

The FDA regulates the content and claims on the product label, while the FTC regulates the claims made in advertising and marketing materials.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 gives the FDA the authority to regulate dietary supplements and makes manufacturers responsible for the safety and accurate labeling of their products.

The EPA is a U.S. government agency (Environmental Protection Agency). EPA is also the abbreviation for eicosapentaenoic acid, an omega-3 fatty acid found in supplements, whose claims are regulated by the FDA, not the EPA agency.