Is Ashwagandha FDA Approved?

Updated on February 23, 2024
 by — reviewed by Jason Williams, PhD (Contributor: George Collins / Editor: Yoko Hill)
An article discussing the FDA approval status of the herbal supplement Ashwagandha.

Is Ashwagandha FDA-approved?

When it comes to natural remedies for stress relief and anxiety relief, one herb that has gained popularity is Ashwagandha. Also known by its scientific name, Withania somnifera, ashwagandha has been used for centuries in Ayurvedic medicine for its adaptogenic properties. 

This powerful herb is believed to help the body adapt to stress and promote overall well-being. 

But has Ashwagandha been FDA-approved? 

Let’s explore the FDA’s role in supplement approval and whether Ashwagandha has received the agency’s stamp of approval.

Understanding Ashwagandha and Its Uses

Ashwagandha is a traditional Ayurvedic medicine that is native to India. It belongs to the Solanaceae family and is often referred to as “Indian ginseng” or “winter cherry.” 

Ashwagandha is classified as an adaptogen, a group of herbs that are believed to help the body cope with stress and improve resilience. 

Not only does Ashwagandha extract help relieve anxiety and stress, but these supplements also provide many other health benefits when used correctly and consistently.

If you’re looking for a way to counteract the stress of a high-paced lifestyle, then 100% natural Ashwagandha supplements could be the answer you’re looking for!

These high-quality Ashwagandha supplements are manufactured in FDA-approved facilities to ensure the best quality and safety of use for optimal wellness.

Here are some key potential health benefits of Ashwagandha:

  1. Stress Relief: Ashwagandha has been shown to reduce the levels of cortisol, a stress hormone, in the body. By balancing cortisol levels, it can help stimulate stress reduction and promote a sense of calmness.(1)
  2. Anxiety Reduction: Ashwagandha has anxiety-reducing properties and can help manage symptoms of generalized anxiety disorder. It works by modulating neurotransmitters in the brain and promoting relaxation. By reducing stress and anxiety, Ashwagandha promotes well-being and relaxation.  
  3. Insomnia Treatment: Ashwagandha may aid in improving sleep quality and reducing insomnia symptoms. It has a calming effect on the body and mind, promoting restful sleep and reducing sleep disturbances.
  4. Immune Support: Ashwagandha has immune-boosting properties that can help strengthen the body’s defenses against infections and diseases. It provides immune system support by balancing the immune response and promoting overall health. This means Ashwagandha could help prevent illness and boost vitality.(2)
  5. Anti-inflammatory Effects: Ashwagandha contains compounds that have anti-inflammatory properties, which can help reduce inflammation and pain in the body. This makes it beneficial for individuals with inflammatory conditions like arthritis.(3)
  6. Cognitive Function: Ashwagandha has been found to enhance cognitive function and improve memory. It can help boost mental clarity, focus, and overall brain health.(4)
  7. Energy and Vitality: Ashwagandha is believed to increase energy levels and improve physical performance. It can help reduce fatigue and enhance stamina, making it popular among athletes and individuals looking to improve their energy levels.
  8. Hormonal Balance: Ashwagandha has been used to regulate hormones and support reproductive health. It may help balance hormones in the body and improve fertility in both men and women. It has been known to boost testosterone levels by up to 14.7%.(5)
  9. Anti-aging Properties: Ashwagandha is considered an anti-aging herb due to its ability to reduce oxidative stress and promote cellular regeneration. It may help slow down the aging process and improve overall vitality.(6)
  10. Mood Enhancement: Ashwagandha has mood-enhancing effects and may help alleviate symptoms of depression. It can improve mood and promote a sense of well-being.

Note: Research has shown that Ashwagandha may have potential benefits for these conditions, but more studies are needed to establish its effectiveness.

FDA’s Role in Supplement Approval

The FDA, or the Food and Drug Administration, plays a crucial role in regulating various products, including dietary nootropic supplements.

However, it’s important to note that the FDA does not have the authority to approve dietary supplements for safety and effectiveness, nor does it approve their labeling before they are marketed. This is an authority that they only have with exclusively medical substances.

This distinction is crucial and stems from the Dietary Supplement Health and Education Act (DSHEA) of 1994, which defined the category of dietary supplements and established guidelines for their regulation.

Under the DSHEA, a dietary supplement is defined as a product intended for ingestion that contains a dietary ingredient intended to supplement the diet. This includes ingredients such as vitamins, minerals, herbs, amino acids, and more.

Dietary supplements can be found in various forms, such as pills, capsules, liquids, and powders. However, for a product to be classified as a dietary supplement, it must be labeled as such.

Unlike drugs, which require extensive pre-market approval by the FDA, dietary supplements are placed in a special category under the general umbrella of foods. This means that manufacturers of dietary supplements are not required to provide the FDA with evidence of safety and effectiveness before marketing their products. However, there are exceptions to this rule.

If a dietary supplement contains a new dietary ingredient that is not present in the food supply in an unaltered form, the manufacturer or distributor must submit a notification to the FDA at least 75 days before introducing the product into interstate commerce.

This notification should include the basis for concluding that the new dietary ingredient will be reasonably expected to be safe.

While the FDA does not approve dietary supplements before they are marketed, it does have the authority to enforce regulations and ensure that dietary supplement manufacturers comply with quality standards. Manufacturers are required to follow current good manufacturing practices, which help ensure the identity, purity, quality, strength, and composition of dietary supplements.

The FDA may conduct inspections, review regulatory submissions, and investigate adverse event reports to identify any violations.

The labeling of dietary supplements is also subject to FDA regulations. Dietary supplement labels are required to include the product name, a statement indicating that it is a dietary supplement, the name and address of the manufacturer, nutrition labeling in the form of a Supplement Facts panel, a list of other ingredients, and the net quantity of contents.

Claims made on dietary supplement labels are also regulated, with different requirements for health claims, structure/function claims, and nutrient content claims.

In summary, the FDA has the responsibility to regulate and enforce regulations for dietary supplements. While it does not have the authority to approve dietary supplements before they reach the market, it ensures that manufacturers comply with quality standards and labeling requirements.

The Difference Between FDA Approval and FDA Regulation

While dietary supplements like ashwagandha are not FDA-approved, they are still subject to FDA regulation. The FDA regulates the manufacturing, labeling, and advertising of dietary supplements to ensure they meet certain quality standards. These regulations include:

  • Good Manufacturing Practices (GMP): Manufacturers must follow specific guidelines for production, testing, and labeling to ensure the quality and consistency of their products.
  • Labeling Requirements: Dietary supplement labels must contain accurate and truthful information about the ingredients, dosage, and any potential risks or side effects.
  • Adverse Event Reporting: Manufacturers are required to report any serious adverse events associated with their products to the FDA.

By regulating dietary supplements, the FDA aims to protect consumers and ensure that they have access to safe and accurately labeled products.

Is Ashwagandha FDA Approved?

Ashwagandha is not FDA-approved as a drug but is classified as a “botanical dietary supplement” by the Food and Drug Administration in the US. This implies that while it’s allowed for consumption, its quality and effectiveness are not scrutinized as rigorously as FDA-approved medications.

This means that ashwagandha manufacturers are responsible for ensuring the safety and quality of their products, but they do not need FDA approval before selling them.

It’s important to note that just because a dietary supplement is not FDA-approved does not mean it is unsafe or ineffective.

Potential Side Effects and Interactions of Ashwagandha

While Ashwagandha is well-tolerated, it may cause certain side effects in some individuals.

These side effects can include:

  • Upset stomach
  • Diarrhea
  • Nausea
  • Headaches

Additionally, Ashwagandha may interact with certain medications, including:

  • Immunosuppressants
  • Sedatives
  • Thyroid medications

Conclusion

In conclusion, while Ashwagandha is not FDA-approved, it is still a popular herbal supplement with a range of potential benefits.

It is well-tolerated and has helped many people to live their lives in a balanced lifestyle. Additionally, it also provides a way for fitness-or-die fanatics to naturally boost their testosterone levels for increased power in the gym! This powerful herb has many benefits to offer, and ongoing research is being done to determine the full extent of its value.

As a dietary supplement, it falls under FDA regulation, which ensures that manufacturers meet certain quality standards. However, it is crucial to exercise caution and consult with a healthcare professional before starting any new supplement, including Ashwagandha, to ensure safety and efficacy.


Sources, Studies, and Scientific Research
  1. Salve, Jaysing et al. “Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study.” Cureus vol. 11,12 e6466. 25 Dec. 2019, doi:10.7759/cureus.6466 
  2. Tharakan, Ajit et al. “Immunomodulatory Effect of Withania somnifera (Ashwagandha) Extract-A Randomized, Double-Blind, Placebo Controlled Trial with an Open Label Extension on Healthy Participants.” Journal of clinical medicine vol. 10,16 3644. 18 Aug. 2021, doi:10.3390/jcm10163644 
  3. Sikandan, Abudubari et al. “Ashwagandha root extract exerts anti‑inflammatory effects in HaCaT cells by inhibiting the MAPK/NF‑κB pathways and by regulating cytokines.” International journal of molecular medicine vol. 42,1 (2018): 425-434. doi:10.3892/ijmm.2018.3608 
  4. Xing, Dante et al. “Effects of Acute Ashwagandha Ingestion on Cognitive Function.” International journal of environmental research and public health vol. 19,19 11852. 20 Sep. 2022, doi:10.3390/ijerph191911852 
  5. Lopresti, Adrian L et al. “A Randomized, Double-Blind, Placebo-Controlled, Crossover Study Examining the Hormonal and Vitality Effects of Ashwagandha ( Withania somnifera) in Aging, Overweight Males.” American journal of men’s health vol. 13,2 (2019): 1557988319835985. doi:10.1177/1557988319835985 
  6. Kelgane, Sunil B et al. “Efficacy and Tolerability of Ashwagandha Root Extract in the Elderly for Improvement of General Well-being and Sleep: A Prospective, Randomized, Double-blind, Placebo-controlled Study.” Cureus vol. 12,2 e7083. 23 Feb. 2020, doi:10.7759/cureus.7083 
chevron-down