Ashwagandha has become increasingly popular in recent years due to its potential health benefits, especially as a stress reliever and adaptogen. Nevertheless, the recent growing interest in ashwagandha has also raised concerns about its legality. In this article, we will discuss the legal standing of ashwagandha in different countries and the reasons for regulations and restrictions that can be put on it. Moreover, one should know why these regulations are important both to consumers and retailers.
WHAT IS ASHWAGANDHA?
Withania somnifera, commonly referred to as Ashwagandha or Indian ginseng is a small perennial shrub that grows in India and some areas of North Africa and the Middle East. It has been used for thousands of years in the traditional Ayurvedic medicine to relieve stress, promote vitality and foster general wellbeing[^1^]. Ashwagandha is considered an adaptogen, which means that it helps the body to adjust and cope with physical stressors as well as emotional ones[^2].
The main bioactive components of ashwagandha are withanolides, which have been demonstrated to exhibit several pharmacological properties such as anti-inflammatory antioxidant and neuroprotective activities[^3]. Some of the possible benefits associated with ashwagandha include reducing stress and anxiety, improving mental performance, and strengthening the immunity system among others .
ASHWAGANDHA: LEGAL POSITION IN THE WORLD
The use of ashwagandha is legal in some countries but not others and every country that permits it has its own regulatory body with specific rules and guidelines for the sale or consumption of this herbal supplement.
In the USA, ashwagandha is considered a dietary supplement and falls under FDA regulation[^5^]. The Food and Drug Administration does not demand that dietary supplements go through as stringent a testing and approval process as prescription drugs. Nevertheless, the manufacturers and distributors of ashwagandha are to be blamed for the safety and efficacy aspects.
According to the Dietary Supplement Health and Education Act (DSHEA) of 1994, ashwagandha is a legal dietary supplement in America only if it has proper labelling and does not claim any false or misleading health benefits[^6^].
Ashwagandha is a Natural Health Product (NHP) in Canada and falls under the regulatory control of Health Canada’s Directorate for Natural Health Products and Non-prescription Drugs [^7^]. For NHPs to be sold in the country, they must pass through Health Canada for approval and be issued with a Natural Product Number (NPN)[^8^]. The NPN can be applied to Ashwagandha products that comply with the standards of safety, efficacy and quality in Canada.
In the European Union (EU), ashwagandha is subject to the regulations of individual member countries, as there is no unified legislation on herbal supplements across the EU. Some countries, such as Germany and France, have stricter regulations and may require products containing ashwagandha to be registered as medicinal products[^9^]. In other countries, ashwagandha may be sold as a dietary supplement, as long as it complies with local regulations.
In the United Kingdom, ashwagandha is regarded as a food supplement that must be regulated by both the Food Standards Agency (FSA) and the Medicines and Healthcare Products Regulatory Agency (MHRA)[^10^]. In the UK, ashwagandha products used for food supplementation must also comply with safety, quality and labelling standards. Ashwagandha is legal to sell and consume in the UK so long as it meets these standards.
AUSTRALIA AND NEW ZEALAND
In Australia and New Zealand, ashwagandha is considered a complementary medicine that falls under the purview of Therapeutic Goods Administration (TGA) in Australia[^12] and MedSafe[^13] in New Zealand. Before they can be sold in these countries, complementary medicines should meet the safety, efficacy and quality standards. Ashwagandha is legal to sell and consume in Australia and New Zealand, however it must adhere to the regulatory requirements.
REASONS FOR REGULATION AND CONSTRAINT
There are various factors that can prompt countries to regulate or limit the distribution and consumption of ashwagandha, such as safety concerns, quality control issues, among other reasons.
Despite the fact that ashwagandha is usually considered safe when used properly, some people may develop side effects or interactions with other drugs[^12]. For instance, ashwagandha has been found to interfere with the action of medications for anxiety and depression or blood pressure; its use should be closely monitored in such instances[^13^]. Also, ashwagandha should be avoided by pregnant or nursing women because its safety during pregnancy and lactation is still unclear[^14].
QUALITY CONTROL ISSUES
Like other herbal supplements, the quality and purity of ashwagandha products can range significantly due to factors like source materials used in manufacturing processes or storage conditions[^15^]. There is a possibility that some ashwagandha products may be contaminated with heavy metals, pesticides or other harmful substances and pose threat to consumer safety[^16]. Regulatory agencies in different countries strive to guarantee the safety and quality of ashwagandha products through setting standards for manufacturing, labeling, and testing.
POTENTIAL FOR MISUSE
Although ashwagandha is usually safe when used according to the doctor’s instructions, there are risks of abuse or overconsumption that may cause side effects. Regulatory bodies may also limit the sale and promotion of ashwagandha products to reduce chances of misuse while ensuring that consumers have access to correct information on how these supplements should be used.
Overall, the legality of ashwagandha differs from country to country and each nation has its own regulation for safety, efficacy and quality control on products containing this herb. In almost all countries, ashwagandha is legal to sell and consume in the form of dietary supplements or natural health products and complementary medicines provided that they meet safety standards for quality assurance and labeling.
As a consumer, it is important to understand the laws governing ashwagandha in your country and pick quality products from reliable suppliers. Should you consider using ashwagandha to reap health benefits, it is recommended that a medical professional determines how much of the supplement one should take and verifies its safety, especially if taking medication or have other underlying conditions.
Retailers and manufacturers should be aware of the laws governing ashwagandha in their countries and ensure that these products are compliant with those regulations. This will go a long way in protecting the interests of consumers while at the same time maintaining public trust and confidence on herbal supplement industry.
- Mishra, L. C., Singh, B. B., & Dagenais, S. (2000). Scientific basis for the therapeutic use of Withania somnifera (ashwagandha): a review. Alternative Medicine Review, 5(4), 334-346.
- Panossian, A., & Wikman, G. (2010). Effects of Adaptogens on the Central Nervous System and the Molecular Mechanisms Associated with Their Stress—Protective Activity. Pharmaceuticals, 3(1), 188-224. https://doi.org/10.3390/ph3010188
- Dar, N. J., Hamid, A., & Ahmad, M. (2015). Pharmacologic overview of Withania somnifera, the Indian Ginseng. Cellular and Molecular Life Sciences, 72(23), 4445-4460. https://doi.org/10.1007/s00018-015-2012-1
- Chandrasekhar, K., Kapoor, J., & Anishetty, S. (2012). A prospective, randomized double-blind, placebo-controlled study of safety and efficacy of a high-concentration full-spectrum extract of ashwagandha root in reducing stress and anxiety in adults. Indian Journal of Psychological Medicine, 34(3), 255-262. https://doi.org/10.4103/0253-7176.106022
- U.S. Food and Drug Administration. (n.d.). Dietary Supplements. Retrieved from https://www.fda.gov/food/dietary-supplements
- U.S. Food and Drug Administration. (2015). Dietary Supplement Health and Education Act of 1994. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dietary-supplement-health-and-education-act-1994
- Health Canada. (n.d.). Natural Health Products. Retrieved from https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription.html
- Health Canada. (2016). Natural Health Products Regulations. Retrieved from https://laws-lois.justice.gc.ca/eng/regulations/sor-2003-196/FullText.html
- European Medicines Agency. (n.d.). Herbal medicines. Retrieved from https://www.ema.europa.eu/en/medicines/field_ema_web_categories%253Aname_field/Herbal
- Medicines and Healthcare products Regulatory Agency. (n.d.). Herbal medicines. Retrieved from https://www.gov.uk/government/collections/herbal-medicines-and-remedies