What Does the FDA Say About Ashwagandha? Understanding Regulation and Safety

October 5, 2025 •

4 min read

Unlike prescription medications, dietary supplements like ashwagandha are not subject to pre-market approval by the U.S. Food and Drug Administration (FDA) for safety or effectiveness. This means that while the FDA regulates the manufacturing and labeling of these products, it does not certify that they are safe or that they work as claimed before they are sold to the public.

Quick Summary

The FDA does not approve dietary supplements like ashwagandha for efficacy or safety before they enter the market. Instead, it enforces regulations on manufacturers regarding labeling, safety, and manufacturing quality, and issues warnings for non-compliance or fraudulent claims.

Key Points

No FDA Approval: The FDA does not approve ashwagandha or any other dietary supplement for safety or efficacy before it is sold.
Manufacturer Responsibility: The burden lies with manufacturers to ensure the safety and accurate labeling of their ashwagandha products.
Post-Market Enforcement: The FDA monitors the market and takes action against companies for improper claims, manufacturing violations, or safety issues after a product is introduced.
FDA Warning Letters: The FDA has issued warning letters to companies selling ashwagandha for making unproven health claims, such as treating COVID-19.
Rare Side Effects: Rare but serious side effects like liver injury have been reported through the FDA's adverse event system.
Contraindications: Ashwagandha is not recommended for pregnant or breastfeeding women and those with certain medical conditions like thyroid disorders or hormone-sensitive prostate cancer.
Third-Party Testing is Key: Consumers should look for third-party verification (e.g., USP, NSF) to confirm a product's quality, purity, and composition.
Drug Interactions: Consult a healthcare provider, as ashwagandha can interact with various medications.

The FDA's Regulatory Approach to Dietary Supplements

The U.S. Food and Drug Administration (FDA) regulates dietary supplements under a different framework than prescription and over-the-counter drugs. The Dietary Supplement Health and Education Act (DSHEA) of 1994 established this system, placing the primary responsibility for ensuring a product's safety and labeling accuracy on the manufacturer. The FDA does not review dietary supplements, including ashwagandha, before they are marketed. Instead, it has a post-market role, monitoring for safety issues after products are already on shelves and taking action against companies that violate regulations.

Key aspects of FDA regulation for ashwagandha and other supplements:

No Pre-Market Approval: Manufacturers are not required to provide evidence of safety or efficacy to the FDA before selling an ashwagandha supplement.
Manufacturer Responsibility: The company is responsible for ensuring their ashwagandha product is safe and accurately labeled.
Good Manufacturing Practices (CGMP): The FDA enforces regulations requiring manufacturers to follow specific quality standards to ensure product identity, purity, and composition.
Claims: Claims made about ashwagandha's health benefits, like treating a disease, are highly regulated. Products that make unproven therapeutic claims are considered unapproved new drugs and are subject to FDA enforcement.
Adverse Event Reporting: The FDA maintains a system for tracking adverse events related to dietary supplements. Consumers and healthcare professionals can report issues, which the FDA can use to identify potential safety problems.

FDA Enforcement Actions Related to Ashwagandha

Although the FDA does not pre-approve supplements, it actively enforces regulations to protect consumers. This often involves issuing warning letters to manufacturers for various violations, many of which have involved ashwagandha products.

Types of FDA warning letters seen with ashwagandha products:

Making False or Misleading Claims: The FDA has sent warning letters to companies for marketing ashwagandha with unproven claims, such as treating or preventing COVID-19. Products marketed with these claims are classified as unapproved new drugs.
Violations of Good Manufacturing Practices: In some cases, the FDA has inspected manufacturing facilities and found violations of Current Good Manufacturing Practices (CGMP). These violations can lead to concerns about product contamination, potency, or purity.
Selling Unregistered Products: The FDA has issued advisories against purchasing unregistered food and supplement products containing ashwagandha.

Ashwagandha's Safety Profile and the FDA

Research suggests that ashwagandha is generally safe for short-term use (up to 12 weeks), but information on long-term safety is limited. The FDA's post-market surveillance has identified some potential safety concerns, which are important for consumers to consider. Cases of liver injury and thyroid issues have been reported, although these are considered rare.

Important safety considerations:

Contraindications: Ashwagandha is not recommended for pregnant or breastfeeding women. It should also be avoided by individuals with autoimmune disorders, hormone-sensitive prostate cancer, or thyroid conditions.
Drug Interactions: Ashwagandha may interact with several medications, including sedatives, immunosuppressants, thyroid hormones, and drugs for blood pressure or diabetes. Consultation with a healthcare provider is essential before starting ashwagandha, especially if taking other medications.
Side Effects: Reported side effects can include drowsiness, stomach upset, diarrhea, and nausea, particularly at high doses.

Quality Control: Beyond FDA Regulation

Because the FDA does not approve supplements, consumers must take extra steps to ensure product quality. The FDA does, however, enforce CGMP to ensure products are produced in a quality manner. To further mitigate risks, many manufacturers opt for independent, third-party testing. These organizations verify that the supplement contains what the label says and is free from contaminants. Reputable third-party testers include:

U.S. Pharmacopeia (USP)
NSF International
ConsumerLab.com

FDA Regulatory Framework: Supplements vs. Drugs


Feature	Dietary Supplement (e.g., Ashwagandha)	FDA-Approved Drug
Pre-Market Approval	NO. Manufacturers are not required to submit safety or efficacy data before marketing.	YES. Requires extensive clinical trials for safety, efficacy, and dosage.
Burden of Proof	Manufacturer is responsible for ensuring safety and labeling accuracy.	FDA must be satisfied with the evidence of safety and effectiveness provided by the manufacturer.
Health Claims	Prohibited from making claims to cure, treat, or prevent a specific disease. Structure/function claims are permitted but must be substantiated.	Approved for specific uses and claims based on clinical trial data.
Labeling	Must be truthful and not misleading. Includes a "Supplement Facts" panel.	Contains detailed information on dosage, side effects, and warnings, based on FDA review.
Adverse Event Tracking	Manufacturers must report serious adverse events to the FDA. Consumers can also report.	Extensive post-market surveillance is conducted by the manufacturer and the FDA.

Conclusion: Navigating Ashwagandha with FDA Knowledge

In summary, the FDA does not approve ashwagandha or other dietary supplements for safety or efficacy, but it does hold manufacturers accountable for their product's safety and labeling after they enter the market. This regulatory approach, which relies on manufacturer responsibility and post-market enforcement, highlights the importance of consumer vigilance. Shoppers should prioritize products with third-party verification to ensure quality and consult with a healthcare provider before taking ashwagandha, especially if they have pre-existing health conditions, are pregnant, or are taking other medications. While the FDA has not restricted ashwagandha like some other countries, it continues to monitor its safety profile and act against fraudulent claims or substandard manufacturing practices.

For more information on dietary supplement regulation, refer to the FDA's official website.

Frequently Asked Questions

No, ashwagandha is not an FDA-approved medication. It is sold as a dietary supplement, which is regulated differently than pharmaceuticals. The FDA does not evaluate dietary supplements for safety or effectiveness before they are marketed.

The FDA's role is to enforce regulations after an ashwagandha product is on the market. It holds manufacturers responsible for ensuring their product is safe and accurately labeled. The FDA can issue warning letters or take action against products that violate these regulations, for example, by making false health claims or failing to meet quality standards.

The FDA does not routinely test ashwagandha supplements for purity before they are sold. It enforces good manufacturing practices, but it is the manufacturer's responsibility to ensure the product's identity, purity, and quality. Consumers can look for third-party certifications like USP or NSF to provide an additional layer of quality assurance.

Yes, you can and should report any bad reactions or side effects from an ashwagandha supplement to the FDA. The FDA maintains an adverse event reporting system for dietary supplements that helps them identify potential public health concerns.

The FDA has issued warning letters regarding certain ashwagandha products, primarily due to violations related to improper labeling and unsubstantiated health claims. For example, the FDA has cited companies for making unproven claims that their products could treat or prevent diseases like COVID-19.

While the FDA does not issue specific advisories for supplements, health organizations informed by scientific data recommend caution. Based on reported safety concerns, women who are pregnant or breastfeeding, people with autoimmune disorders, and those with thyroid conditions are often advised to avoid ashwagandha.

An FDA-approved drug has undergone extensive testing for safety, efficacy, and proper dosage before it can be sold. In contrast, an ashwagandha supplement is not pre-approved, and the manufacturer is responsible for its safety and labeling. The FDA's involvement for supplements is primarily post-market.