Published: 29 February 2024
Disclaimer: Always seek the guidance of your doctor or other qualified health professionals with any questions you may have regarding your health or a medical condition. If you are thinking of using ashwagandha, talk to your doctor first.
Have you heard about Denmark’s surprising decision to ban ashwagandha? Many were confused by the news back in April 2023. But the Danish Veterinary and Food Administration’s position is crystal clear: ashwagandha’s sale within the country is now strictly prohibited.
Denmark’s regulatory position against ashwagandha in dietary supplements seems to be rooted in prudence and supported by a report published by the Technical University of Denmark (DTU) Food Institute in 2020.
The ban on ashwagandha was deemed necessary due to a lack of available information on its safe consumption levels. Meanwhile, ashwagandha continues to rise in popularity in countries such as India, the United States, Germany and the U.K.
So what about these claims? Was Denmark’s decision to ban ashwagandha justified, or should it be regarded as an excessive measure? Before delving into the arguments presented by the DTU report, let’s first provide an overview of both the health claims and negative experiences associated with ashwagandha.
Did you know? Back in March 2023, the hashtag #ashwagandha racked up over 675 million views on Tik-Tok.
Ashwagandha’s Health Claims
For those unfamiliar with ashwagandha, the latter is essentially a shrub from the nightshade family that can be found in various regions like Asia, Africa, the Middle East, and southern Europe.
Ashwagandha is known scientifically as Withania somnifera but it is also commonly referred to as winter cherry. Its use has been a staple of traditional Indian medicine for nearly 3000 years.
According to Mikulska et. al. (2023), “the name “Ashwagandha” is derived from the word “ashwa”, meaning horse. It is believed that after consuming the root, one gains powers similar to that of a horse. The second part of the name “gandha,” means fragrance and refers to the characteristic smell of the fresh root of the plant.
Ashwagandha is often referred to as “Indian ginseng” due to its adaptogenic qualities, reminiscent of those found in ginseng. The roots are usually the most used part of the plant. However, ashwagandha’s therapeutic uses can also involve its leaves, flowers, and fruits.
Regarding ashwagandha in Ayurvedic medicine, some of the most popular health claims include:
- Reducing stress and anxiety
- Improving quality of sleep
- Enhancing memory, concentration and mood
- Improving male fertility
- Reducing inflammation
- Lowering blood sugar
- Helping to stimulate the thyroid
- Improving the immune system
- Increasing endurance, muscle strength and recovery
- Improving heart health
- Helping with chronic pain and improves muscle spasms
- Reducing some menopause symptoms
Negative Experiences with Ashwagandha
Ashwagandha has been connected to several potential drawbacks. For instance, numerous social media users have reported experiencing anhedonia while using the herb. Anhedonia is characterized by the inability to feel pleasure, often resulting in a lack of interest or enjoyment in activities that were previously enjoyable.
Some individuals have also reported experiencing various side effects when consuming high doses of ashwagandha. These may include headaches, nausea, upset stomach, diarrhea, vomiting and sleepiness. In rare instances, ashwagandha has also been linked to liver problems, including severe liver failure
It is also worth noting that ashwagandha is not recommended for people on immune-suppressing medication, sedatives, anti-seizure medications or blood thinners. It also should be avoided in combination with medication used to treat high blood pressure, diabetes or any thyroid hormone medication.
The Report Behind Denmark’s Ban
The DTU report, conducted for the Danish Veterinary and Food Administration (DVFA), raises alarming concerns regarding ashwagandha’s potential impact on thyroid and sex hormones. It also flags the herb’s potential to induce abortions and impact various bodily functions including the metabolism, the immune system and the central nervous system. By highlighting the uncertainties surrounding ashwagandha’s use, the report emphasizes the need for continued research and careful regulation.
The 29-page document starts by highlighting the presence of two key groups of substances in the root of Withania somnifera: steroid lactones (also known as withanolides) and alkaloids. However, as the study progresses, it acknowledges the challenge of identifying the specific substances within ashwagandha responsible for reported effects.
Additionally, the report points out the unreliability of certain measurement methods employed in clinical studies, particularly those showing minimal to no adverse effects. It also sheds light on the absence of crucial details in some clinical studies regarding how extracts are produced and which parts of the plant are used.
This concern is exemplified in the findings of Björnsson et al. 2020 which documented five cases of liver damage among individuals consuming dietary supplements with ashwagandha. These cases, spanning across three men and two women aged 21-62 from Iceland and the USA, occurred after intake of 450 to 1350 mg per day. However, the study’s lack of detail regarding which part of the plant was used and how it was prepared makes it difficult to fully grasp its findings, especially in the context of herbal medicine.
One of the most notable concerns raised in the DTU report pertains to the potential impact of ashwagandha root on hormone levels in men. Experimental studies conducted on rats indicated that the root could affect male reproduction, influencing sex hormone levels and mating behaviors.
Among the cited papers are two studies looking at the effects of aqueous extracts from the ashwagandha leaf. These concluded that this type of supplementation could affect the hormone system in young rats, causing both male and female rats to reach sexual maturity earlier than usual. The report also showcases animal studies looking at reduced sperm quality and reduced fertility after dosing with plant parts other than the root.
Lastly, the issue of potential abortions underscores the need for more information on how ashwagandha root may affect pregnancy and potentially induce termination. The report notes the absence of experimental studies to establish safe dosage levels for preventing abortion and references the World Health Organization’s advice against ashwagandha use during pregnancy and breastfeeding due to safety concerns.
Ultimately, Denmark’s decision to ban ashwagandha from its shelves was driven by DTU’s inability to ascertain a safe minimum consumption level free from risks.
Critics Speak Out
While Denmark’s decision appears cautious, it faces significant pushback due to its reliance on a report that overlooks key factors and relies on incomplete evidence.
For one, the credibility of the ban is questioned as it relies on a report that overlooks numerous well-conducted studies published since May 2020, addressing both effectiveness and safety.
Moreover, according to a comprehensive review published by World Ashwagandha Council in 2023, DTU’s risk assessment fails to properly distinguish between different parts of the plant and indiscriminately investigates the potential of other plant parts in experimental studies.
The World Ashwagandha Council remarks: “Since the conclusion in the DTU report is that there can be a safety concern with root, the safety evaluation should therefore focus on root extracts only. An important aspect since studies on other parts of the plants will most certainly lead to different conclusions on safety, which may be incorrect and seriously misleading.”
In Ayurvedic tradition, it’s recognized that the aerial parts of the plant, such as the leaves and stems, have higher concentrations of withaferin A, withanone, and alkaloids than the root. Therefore, they’re primarily intended for external use, with internal use being uncommon.
DTU’s report is also criticized for heavily leaning on animal studies and neglecting to differentiate results based on extraction methods.
Most of the animal studies cited in the report utilize ethanol or methanol extracts of W. somnifera. However, many people believe that water-extracted ashwagandha is preferable due to its traditional use and perceived better results.
The report does, however, mention a 2015 paper that looked into an aqueous extract of W. somnifera. This double-blind, placebo-controlled trial spanned 8 weeks and involved 57 healthy men aged 15-50 years. Results eventually showed increased testosterone levels and muscle strength with ashwagandha supplementation, with no serious side effects reported.
As for the evidence in the report regarding ashwagandha’s potential effects on hormones and fertility, it is claimed to lack clarity and strong support. Indeed, the absence of well-designed trials supporting these claims is surprising. It appears the decision is influenced more by a lack of clear understanding about how the plant extract affects the human body than by concrete evidence.
It is also worth noting that dosage plays a vital role, with many referenced studies employing excessively high doses of ashwaganda.
Last but not least, regarding the claims of spontaneous abortion, it’s important to note that as far as I’m aware, the DTU report did not present any clinical evidence of ashwagandha actually causing abortions.
While it’s understandable to argue that Denmark’s decision to ban ashwagandha was precautionary, the report’s lack of substantial nuance certainly raises questions about the thoroughness of the decision-making process.
Growing Clinical Trials
Over the last couple of years, there has been a notable increase in the number of scientific papers on ashwagandha. However, clinical data remains limited, which may explain why most major government agencies have yet to take action on this particular issue.
The table below offers a summary of a few human clinical trials investigating the potential benefits and harms of this medicinal herb.
| Study Name (Date) | Type of study | Sample Size / Dosage | Results |
|---|---|---|---|
| “Clinical safety and tolerability evaluation of Withania somnifera (L.) Dunal (Ashwagandha) root extract in healthy human volunteers” by Vaidya et. al. (2024) | Non-randomized, open-label, single-treatment clinical study | Eighteen healthy male participants aged 18 to 60 / 500 mg of the WSE capsules twice daily for four weeks. Each capsule contained not less than 7.50 mg of total withanolides. | No adverse effects physically, hematologically, and biochemically. No irregularities were observed in liver, kidney, and thyroid functions. |
| “Medicinal herbs for the treatment of anxiety: A systematic review and network meta-analysis” by Zhang et. al (2022) | Meta-analysis | 29 trials were reviewed. | Ashwagandha had a significant effect on anxiety. The anxiety levels were measured using HAMA scores which is used to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. |
| “Effects of Acute Ashwagandha Ingestion on Cognitive Function” by Xing et. al. (2022) | Randomized, double-blind, placebo-controlled, crossover, and counterbalanced manner. | 13 healthy volunteers / Acute supplementation with 400 mg of of a proprietary ashwagandha root and leaves extract | Improved selected measures of executive function. Acute ingestion of ashwagandha helped sustain attention and increase short-term/working memory in healthy young adults. |
| “Effect of Ashwagandha (Withania somnifera) extract on sleep: A systematic review and meta-analysis” by Cheah et. al (2021) | Systemic Review & Meta-Analysis | Five randomized controlled trials containing 400 participants | Taking ashwagandha modestly improved sleep quality and total sleep time in adults when compared to placebo. Participants who took ashwagandha also fell asleep quicker. |
| “Safety of Ashwagandha Root Extract: A Randomized, Placebo-Controlled, study in Healthy Volunteers” by Verma et. al. (2021) | Randomized, double-blind, placebo-controlled, and parallel-group study | 80 healthy participants (40 males, 40 females) / 300 mg, twice daily, orally for 8 weeks. | Revealed that the consumption of Ashwagandha root extract for 8 weeks was safe in both males and females volunteers |
| “A double-blind, randomized, placebo-controlled trial on the effect of Ashwagandha (Withania somnifera dunal.) root extract in improving cardiorespiratory endurance and recovery in healthy athletic adults” by Tiwari et. al (2021) | Double-blind, randomized, placebo-controlled trial | Fifty healthy athletic adults were selected randomly and equally allocated to Ashwagandha and placebo groups/ 300 mg of Ashwagandha root extract capsules, twice daily, for 8-weeks. | Suggests that “ashwagandha root extract can successfully enhance cardiorespiratory endurance and improve the quality of life in healthy athletic adults”. |
| “Effects of Ashwagandha (Withania somnifera) on Physical Performance: Systematic Review and Bayesian Meta-Analysis” by Bonilla et. al. (2021) | Systematic review and meta-analysis | 13 studies | Ashwagandha supplementation was more efficacious than placebo for improving variables related to strength/power, cardiorespiratory fitness and fatigue/recovery in healthy men and female. |
| “Effect of an ashwagandha (Withania Somnifera) root extract on climacteric symptoms in women during perimenopause: A randomized, double-blind, placebo-controlled study” by Gopal et. al. (2021) | Randomized, double-blind, placebo-controlled study | 100 women with climacteric symptoms were randomly allocated to take either a placebo or ashwagandha / 300 mg of an ashwagandha root extract twice daily. | Found that for women during perimenopause who took ashwagandha had relieved mild to moderate symptoms such as hot flashes, anxiety and night sweating. |
| “Withania somnifera (Indian ginseng) in diabetes mellitus: A systematic review and meta-analysis of scientific evidence from experimental research to clinical application” by Durg et. al. (2020) | Systematic review and meta-analysis | 6 in-vitro, 13 pre-clinical and 5 clinical studies were included for systematic evaluation. | The results suggest the potential role of W. somnifera in managing diabetes mellitus. |
| “Adaptogenic and Anxiolytic Effects of Ashwagandha Root Extract in Healthy Adults: A Double-blind, Randomized, Placebo-controlled Clinical Study” by Salve et. al. (2019) | Prospective, randomized, double-blind, placebo-controlled study | 58 participants / 250 mg/day of ashwagandha and 600 mg/day of ashwagandha | Found a statistically significant decrease in stress levels and serum cortisol levels in participants taking ashwagandha (even at a lower dose of 250m per day) versus the placebo group. As for anxiety, its reduction was only significantly at a standard dose of 600 mg per day. |
| Efficacy and Safety of Ashwagandha (Withania somnifera (L.) Dunal) Root Extract in Improving Memory and Cognitive Functions” by Choudhary et. al (2017) | Pilot study (prospective, randomized, double-blind, placebo-controlled study) | 50 adults / Ashwagandha-root extract (300 mg twice daily) for eight weeks. | Significant improvement in both immediate and general memory in adults with mild cognitive impairment who took 300 mg of ashwagandha-root extract twice a day. |
| “Body Weight Management in Adults Under Chronic Stress Through Treatment With Ashwagandha Root Extract” by Choudhary et. al. (2016) | Double-blind, randomized, placebo-controlled trial. | 52 subjects under chronic stress / 300 mg of ashwagandha, twice daily. Assessed at the start and at 4 and 8 weeks. | The outcome of this study suggests that Ashwagandha root extract can be used for body weight management in adults under chronic stress. |
| “Examining the effect of Withania somnifera supplementation on muscle strength and recovery: a randomized controlled trial” by Wankhede et.al. (2015) | Randomized, prospective, double-blind, placebo-controlled clinical study | 57 young male subjects (18–50 years old) with little experience in resistance training were randomized into treatment (29 subjects) and placebo (28 subjects) groups. / 300 mg of ashawagandha per day | After 8 weeks of resistance training, they found a significant increase in muscle mass and strength in the group who was supplemented with ashwagandha, thus suggesting that ashwagandha supplementation may be useful in conjunction with a resistance training program. |
| “Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Improving Sexual Function in Women: A Pilot Study” by Dongre et. al. (2015) | Pilot study, randomized, double blind, and placebo-controlled. | 50 female subjects aged 21–50. / 300mg twice daily for 8 weeks | Oral administration of HCARE may improve sexual function in healthy women. The results also suggest that ashwagandha root extract could be useful for the treatment of FSD. |
Most of these studies acknowledge limitations, such as small sample sizes and a lack of long-term data. Furthermore, the presence of several pilot studies isn’t adequate for reaching conclusive findings.
Looking ahead, researchers emphasize the importance of including diverse subject groups and exploring a wider range of dosage levels, sample sizes, and study durations. These steps are essential for improving future investigations and deepening our understanding of ashwagandha’s effects on the human body.
Note to consider when reviewing literature: Be aware of potential conflicts of interest, particularly in studies funded by companies involved in manufacturing the extract. Transparency regarding funding sources is essential for maintaining research integrity.
Final Thoughts
As it stands, ashwagandha’s safety remains a topic of ongoing debate. Denmark’s decision to exercise caution regarding ashwagandha is understandable. It’s indeed true that several studies draw conclusions from small subject pools or insufficient trial durations. These are undoubtedly valid points that warrant careful consideration in advancing the regulation and monitoring of ashwagandha supplements. However, the report underpinning this decision falls short on several fronts, lacking sufficient evidence to substantiate its main arguments.
So is ashwagandha innocent until proven guilty or guilty until proven innocent? For Denmark, it seems the latter is the case.
It’s important to note that not all supplement brands are created equal. Some may lack accurate information regarding the amounts of active ingredients or may even contain harmful substances like lead that aren’t listed on the label. Additionally, certain supplements fail to specify which parts of the plants were used in their production, a concerning lack of transparency given their intended human consumption.
In the grand scheme of things, regulation holds significant importance, particularly given the influence of prominent figures like Dr. Eric Berg, who promotes his own brands of ashwagandha to millions of YouTube subscribers. Many individuals may also seek guidance from popular science podcasts such as the widely-followed Huberman Lab.
No matter where you get your information, it’s important to do your homework and make informed decisions. Health decisions are serious business, so it pays to play it safe. After all, we’ve got only one body to take care of. When it comes to supplements like ashwagandha, where the terrain can be uncertain, it’s advisable to have a healthcare professional evaluate its suitability for you or address any underlying issues. Remember, your well-being is your greatest asset, so protect it at all costs.
