Decoding the FDA: Why Doesn't the FDA Approve Supplements?

October 16, 2025 •

4 min read

According to a 2018 CBS News report, an analysis of an FDA database found nearly 800 warnings for dietary supplements containing unapproved, dangerous ingredients over a ten-year period. This statistic highlights the critical issue many consumers don't understand: why doesn't the FDA approve supplements? The answer lies in a fundamental difference in regulatory classification, with significant implications for nutrition and safety.

Quick Summary

The FDA does not approve dietary supplements for safety or efficacy before they are sold because they are regulated as food, not drugs, under the DSHEA framework. Manufacturers are responsible for product safety and labeling, while the FDA's oversight is primarily focused on post-market enforcement.

Key Points

Different Regulation: The FDA does not approve dietary supplements because they are legally classified and regulated as a category of food, not as drugs, under the DSHEA.
Post-Market Enforcement: The FDA's role is largely reactive, focusing on enforcing safety and proper labeling after a product is on the market, instead of granting pre-market approval.
Manufacturer Responsibility: The burden of proof for a supplement's safety and truthful labeling lies with the manufacturer, who must ensure their products comply with all regulations.
No Disease Claims: Supplements cannot legally claim to diagnose, cure, mitigate, or treat diseases. Permitted claims, such as those about a product's effect on body structure or function, must carry an FDA disclaimer.
Voluntary Certification: Consumers can seek third-party certification from organizations like USP or NSF to gain quality assurance, but these are voluntary and not required by the FDA.
Consumer Diligence is Key: Due to the limited pre-market oversight, consumers must exercise caution and research supplements, look for quality seals, and consult healthcare professionals.

The Fundamental Regulatory Divide: Foods vs. Drugs

In the United States, the Food and Drug Administration (FDA) operates on a vastly different set of rules for drugs and dietary supplements. This distinction is the core reason why doesn't the FDA approve supplements in the same way it does prescription medications. The key piece of legislation governing this is the Dietary Supplement Health and Education Act (DSHEA) of 1994, which formally categorized dietary supplements under the umbrella of foods.

For pharmaceutical drugs, the path to market is long and arduous, requiring extensive pre-market testing and FDA approval. Manufacturers must conduct rigorous clinical trials to prove that their product is both safe and effective for its intended use before it can be sold to consumers. In stark contrast, DSHEA does not require supplement manufacturers to prove a product's safety or efficacy to the FDA before selling it.

The DSHEA Framework: Post-Market Responsibility

Under the DSHEA framework, the responsibility for ensuring a dietary supplement is safe and properly labeled falls directly on the manufacturer. The FDA's role shifts from a proactive pre-market gatekeeper to a reactive, post-market enforcer. This means that the FDA only intervenes after a product is already on the market and evidence emerges that it is unsafe or misbranded. This places the burden of proof on the FDA to demonstrate a product's risk, rather than on the manufacturer to prove its safety. If a supplement is found unsafe, the FDA can take action, but this reactive approach means potentially harmful products can reach consumers.

Quality Control and New Dietary Ingredients

Manufacturers must follow Current Good Manufacturing Practices (cGMPs) to ensure product quality and prevent contamination. For new dietary ingredients (NDIs) not marketed before October 15, 1994, manufacturers must submit a safety notification to the FDA at least 75 days before marketing. This is a notification, not an approval, and FDA review resources are limited.

Regulation of Labeling and Claims

Supplement labels cannot make claims to diagnose, treat, cure, or prevent any disease; doing so reclassifies the product as an unapproved drug. They can make "structure/function" claims, describing the ingredient's role in the body, but these must include a disclaimer stating the FDA has not evaluated the claim and the product is not intended to treat diseases. The FTC primarily monitors the truthfulness of advertising and marketing claims.

Navigating the Supplement Market Safely

Due to the FDA's reactive role, consumers should research products, look for independent third-party certification seals (like USP or NSF), and consult healthcare professionals before taking supplements. It's also important to be wary of disease-related claims and report any adverse reactions.

Here are some tips for consumers:

Do your research: Understand the supplement's ingredients, potential benefits, and risks.
Consult a professional: Talk to your doctor, registered dietitian, or pharmacist before taking any new supplement, especially if you take other medications.
Report adverse events: If you experience a negative reaction, report it to both the manufacturer and the FDA.
Be wary of claims: Critically evaluate any health claims, and remember that disease-curing claims are prohibited for supplements.
Check for third-party testing: Look for a quality seal from an independent organization to ensure what's on the label is in the bottle.

Conclusion

The reason why doesn't the FDA approve supplements stems from the DSHEA of 1994, which regulates them as food, not drugs. This results in a post-market enforcement model rather than a pre-market approval process. While manufacturers are responsible for safety and the FDA has enforcement power, consumers must be diligent in making informed choices. Understanding these regulations is key when considering supplements. For more information, visit the FDA's official page on dietary supplements.

Comparison of Drug vs. Supplement Regulation


Feature	Pharmaceutical Drugs	Dietary Supplements
Pre-Market Approval	Required - Manufacturers must prove safety and effectiveness before selling.	Not Required - Manufacturers are responsible for ensuring safety; no FDA approval needed before marketing.
Burden of Proof	Manufacturer must prove product is safe and effective for its intended use.	FDA must prove the product is unsafe to remove it from the market.
FDA Role	Extensive review and approval of products, clinical trial data, and labeling before marketing.	Primarily post-market enforcement, including inspecting facilities and responding to adverse event reports.
Labeling/Claims	Strict regulation on all labeling and claims, which must be approved by the FDA.	Structure/function claims permitted with a mandatory disclaimer; disease claims are prohibited and would classify the product as a drug.
Mandatory Reporting	Manufacturers must report all serious adverse events related to their products.	Manufacturers must report any serious adverse events to the FDA.

Frequently Asked Questions

No, the FDA does not approve dietary supplements for safety or efficacy before they are sold to the public. The only exception is for new dietary ingredients (NDIs), which require a notification submission to the FDA 75 days before marketing, but this is not an approval process.

Since the FDA does not pre-approve supplements, consumers can look for seals of quality assurance from independent third-party organizations like USP or NSF International. This indicates that the product was properly manufactured and contains the ingredients listed on the label, but does not guarantee safety or effectiveness.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 is the law that established the regulatory framework for supplements. It classifies them as foods, not drugs, and places the responsibility for safety on manufacturers, with the FDA's oversight being primarily post-market.

No, supplement companies are limited in the types of claims they can make. They can make 'structure/function' claims (e.g., 'supports bone health'), but cannot claim to diagnose, cure, or prevent a disease. The Federal Trade Commission (FTC) monitors advertising claims for truthfulness.

After a supplement is on the market, if the FDA finds it to be unsafe or misbranded, it has the authority to take action. This can include asking the company to voluntarily recall the product or taking legal action to have it removed from the market.

Current Good Manufacturing Practices (cGMPs) are a set of guidelines established by the FDA that dietary supplement manufacturers must follow. They cover a range of requirements to ensure a product's identity, purity, strength, and composition, and to prevent contamination.

The Federal Trade Commission (FTC) is primarily responsible for regulating the advertising of dietary supplements, while the FDA is responsible for labeling and safety concerns. The two agencies share jurisdiction over supplement marketing.

Yes, there are risks. Without a pre-market review for safety and effectiveness, supplements can contain undisclosed, unsafe, or ineffective ingredients. Risks include contamination, interactions with medications, and unproven claims.