Are any herbal supplements FDA-approved? The Truth About Regulation

October 13, 2025 •

3 min read

Millions of Americans use herbal supplements annually, but a fundamental misconception persists regarding their safety and oversight. The answer to 'are any herbal supplements FDA-approved?' is no, because the FDA does not have the authority to approve these products for safety or effectiveness before they are sold.

Quick Summary

This article explains why herbal supplements are not subject to FDA pre-market approval, detailing the regulatory framework established by the Dietary Supplement Health and Education Act (DSHEA). It clarifies the distinction between supplements and drugs, outlines the FDA's post-market role, and provides consumer guidance.

Key Points

No FDA Approval for Supplements: Herbal supplements are classified as dietary supplements and do not receive pre-market FDA approval for safety or efficacy, unlike pharmaceutical drugs.
Post-Market Enforcement: The FDA's role is largely reactive, focusing on inspecting manufacturing facilities and monitoring adverse event reports after products are on the market.
Limited Claims: Supplement manufacturers can make "structure/function" claims but cannot claim to diagnose, treat, or cure diseases. Labels must include a specific FDA disclaimer.
New Ingredient Notification: For ingredients not on the market before 1994, manufacturers must submit an NDI notification, but this is a review, not an approval, process.
Third-Party Testing: Consumers can look for seals from independent organizations like USP or NSF for quality and purity assurance, but these do not guarantee effectiveness.
Botanical Drugs vs. Supplements: A few botanical products have been approved as prescription drugs (e.g., Veregen, Mytesi) but underwent the full FDA drug approval process, unlike supplements.

The Fundamental Difference: Drugs vs. Dietary Supplements

Herbal supplements are legally classified by the FDA as dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which distinguishes them from conventional foods and pharmaceutical drugs. Unlike drugs, herbal supplements do not require FDA approval for safety and effectiveness before being marketed. Drugs must undergo extensive pre-market clinical trials, a requirement that does not apply to supplements.

The FDA's Limited Post-Market Oversight

The FDA's regulatory role for herbal supplements begins after they are on the market. The agency's authority focuses on ensuring products are not adulterated or misbranded. This includes:

Manufacturing Inspections: Checking facilities for compliance with current Good Manufacturing Practices (cGMPs) to ensure quality and prevent contamination.
Labeling and Claims Review: Reviewing labels and websites. Supplements can make "structure or function" claims (e.g., "supports bone density") but not disease claims (e.g., "treats osteoporosis"). Allowable claims require a disclaimer.
Adverse Event Monitoring: Manufacturers must report serious adverse events, which the FDA uses to identify potential safety risks. However, this is a reactive measure.

The New Dietary Ingredient (NDI) Notification Process

Manufacturers introducing a dietary ingredient not marketed before October 15, 1994, must submit a pre-market notification to the FDA. This NDI notification requires the manufacturer to provide a basis for concluding the ingredient is reasonably expected to be safe. However, this is a notification process, not an approval, and the FDA does not evaluate the product's safety.

The Rare Exception: FDA-Approved Botanical Drugs

A few botanical products have received FDA approval, but these are classified as prescription drugs, not dietary supplements. These botanical drugs, such as Veregen® (for genital warts), Mytesi™ (for HIV/AIDS-related diarrhea), and Filsuvez® (for Epidermolysis Bullosa), met the same rigorous safety, efficacy, and quality standards as any other conventional drug.

Comparison: FDA-Regulated Drugs vs. Herbal Supplements


Aspect	FDA-Regulated Drugs	Herbal Supplements (Dietary Supplements)
Pre-Market Review	Mandatory FDA approval for safety and efficacy.	No FDA pre-market approval required.
Burden of Proof	Manufacturer must prove safety and efficacy before selling.	FDA must prove the product is unsafe after it's on the market.
Efficacy Claims	Can claim to treat, cure, or prevent a disease.	Can only make "structure/function" claims, not disease claims.
Labeling	Strictly regulated, must list all active and inactive ingredients.	Requires a "Supplement Facts" panel and a specific disclaimer for structure/function claims.
Quality Control	Strict manufacturing practices verified by FDA.	Follows current Good Manufacturing Practices (cGMPs), but third-party testing is optional.

Conclusion: Navigating a Non-Approved Market

No herbal supplements are FDA-approved for safety and effectiveness in the same way as prescription drugs. The primary responsibility for product safety and quality lies with the manufacturer, with the FDA's oversight occurring after products are on the market. This regulatory framework, established by DSHEA, means consumers face potential risks like contamination, undisclosed ingredients, or misleading claims. Consulting a healthcare professional before using any herbal supplement is crucial, especially for those with existing health conditions or taking other medications. Seeking products with third-party testing seals from organizations like USP or NSF can offer additional assurance of quality and purity. However, these seals do not guarantee safety or effectiveness. Consumer diligence and professional health advice are essential for safe supplement use.

Link to FDA's dietary supplement information for official regulatory updates and consumer information.

Frequently Asked Questions

Herbal supplements are not FDA-approved because they are legally classified as dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994. This legislation exempts them from the rigorous pre-market safety and efficacy testing required for pharmaceutical drugs.

The FDA's regulation of herbal supplements is primarily post-market. The agency can inspect manufacturing facilities for compliance with cGMPs, review labels for inappropriate claims, and take action against products that are found to be unsafe, adulterated, or misbranded after they are sold.

The NDI (New Dietary Ingredient) notification is a pre-market safety notification required for ingredients not marketed before October 15, 1994. Manufacturers must submit safety data for FDA review, but it is not an approval process, and the FDA does not evaluate the product's safety.

No, an herbal supplement cannot claim to treat, diagnose, cure, or prevent any disease. It can only make "structure/function" claims, such as "supports healthy immune function," and must include a specific disclaimer stating it has not been evaluated by the FDA.

An herbal supplement is sold to support overall health without therapeutic claims, while a botanical drug is intended to diagnose, treat, or prevent a disease. Botanical drugs must go through the strict FDA drug approval process, unlike herbal supplements.

To increase confidence in a product's quality, look for independent third-party verification from organizations like USP or NSF. However, this only assures that the contents match the label and are free of certain contaminants; it does not guarantee effectiveness or safety.

Before taking any herbal supplement, you should consult a healthcare professional. They can help you understand potential risks, including side effects and interactions with other medications, and determine if the supplement is appropriate for your health needs.

If an herbal supplement is found to be unsafe after it is on the market, the FDA can take enforcement action, which may include asking the manufacturer for a voluntary recall or taking action to remove the product from the marketplace.