The Trouble with Ashwagandha: A Sourcing Journey

 

As long-time herbalists and Ayurvedic practitioners we can safely say that Ashwagandha is our favorite herb. If we could only take one herbal supplement personally it would be Ashwagandha. We have grown, harvested, extracted, and used Ashwagandha throughout our 30 plus year journey in this industry. So, when we founded Bold Botanica, the first product we set out to make was a high-quality, potent Ashwagandha extract in a capsule. However, we did not anticipate the many challenges of sourcing this highly beneficial and popular herb.

 

Sales are Booming

 

Ashwagandha, an herb which has been used for thousands of years in Ayurveda, India’s traditional system of medicine, has experienced a spike in popularity in the last five years. Sales in 2023 are estimated to be at least $280 million in the US and $670 million globally. Ashwagandha ranked as the top four or five bestselling herbs in the US mainstream and natural channels, respectively. Especially during and since the pandemic, sales of Ashwagandha jumped by 50% as consumers looked for alternative remedies to help calm stress and enhance sleep.  This growth in demand has also placed strain on the supply chain.

 

Journey to India

 

Ashwagandha has been revered in Ayurveda for over 4,000 years and India is still the world‘s largest producer of Ashwagandha.  With over 10,000 hectares of land under cultivation, India produces at least 8,500 tons of Ashwagandha annually. And like China, because of its long history of traditional herb use, India specializes in extraction methods and the manufacture of standardized powdered extracts. In fact, unlike here in the US where botanical supplements have an adversarial relationship with the pharmaceutical industry, many pharmaceutical companies in India have an herbal division and heavily invest in herbal research and development.  Also, just to note, while there are over 500 suppliers of botanical extracts in India, there may be only a handful of manufacturers in the US that make botanical extract powders (there are more that make liquid extracts and raw powders), and none that we know of is making an Ashwagandha extract powder. Therefore, the majority of Ashwagandha powdered extracts are manufactured in India.

 

Extract Solvents

 

As any herbalist knows, one of the most widely used extract solvents is water and alcohol; a combined hydroalcoholic solvent can extract a wide range of active constituents. A liquid extract is the starting point to manufacture powdered extracts. However, India has a very complicated relationship with alcohol which impacts its herbal extract manufacturing. India has a long history of prohibition of alcohol, dating back to the principles of Gandhi. Prohibition is a part of the Indian Constitution and has created a very complex bureaucracy of laws and regulations that vary by state, and some states still have outright bans on the sale of alcohol. Therefore, most botanical extract manufacturers have been forced to use other solvents, such as methanol (wood alcohol), ethyl acetate, N-butanol, hexane, and others which are more toxic than natural ethanol.  Even if chemical solvents can be removed, there is still the possibility that traces remain in the final ingredient, and use of these solvents has a negative impact on the environment.  For years, it was impossible to find powdered extracts made with ethanol. Fortunately, there are now some companies in India that are able to acquire ethanol to use in their manufacturing process.  At Bold Botanica, we seek out suppliers that only use water and/or ethanol to make their extracts.

 

Certified Organic and Pesticides

 

Like many cultures, for millennia farmers in India practiced natural or organic farming methods. It was after World War I, that chemical pesticides and synthetic fertilizers were introduced, and the “Green Revolution” of the 60s cemented India’s dependency on chemical inputs. Interestingly, the organic movement has its roots in India. One of the primary founders of organic farming movement was a British scientist, Sir Albert Howard, who spent 25 years in India, studying traditional farming practices, including composting, and wrote about them in his 1943 book, “An Agricultural Testament”. Howard’s work inspired American businessman and publisher, Jerome Rodale, who founded the Rodale Institute which has been and continues to be a leader in promoting organic farming in the US.

 

Fast-forward to the early 1990s, as the intensive use of chemicals degraded soil health, India began to see a movement towards organic farming. Today India is one of the world’s top producers of certified organic crops. It is not without challenges. Indian agriculture is a patchwork of small land-holdings, most organic farms are less than 10 acres. It is costly for small farms to become certified organic and most need assistance from the government, collectives, or manufacturers.  Organic farms are often bordered by conventional farms, sharing the same irrigation water. Cross contamination is difficult to prevent. Also, many are unaware that while the US and other countries began to phase out use of leaded fuel in the '70's and '80's, India did not ban leaded fuel until 2000. So, although it is possible to find quality certified organic botanicals in India, there continue to be issues with pesticide and heavy metal residue.

 

And when it comes to manufacturing a certified organic botanical extract, until recently these could only be made with water as a solvent. As difficult as it has been to access natural ethanol, certified organic ethanol has been almost completely unavailable in India. It is only in the past few years that a handful of producers are starting to manufacture it. 

 

In addition to the challenges already listed, in 2021 the USDA ended its agreement with the government of India to accredit its own organic certifying agency.  The USDA set in place new rules that imports from India must be certified by 3^rd party USDA approved agencies and added more stringent documentation requirements for certified organic shipments.  Although the USDA gave a window of 18 months to comply, many famers and manufacturers in India are still in the process of fully implementing these rules, as well as the new USDA Strengthening Organic Enforcement (SOE) regulations implemented in March of this year.  These requirements, which should increase oversight and quality of organic imports, also create an extra layer of cost and bureaucracy for Indian manufacturers and has at least temporarily reduced the availability of certified organic botanical extracts from India.

 

 

What is “gravimetric”? Questionable Testing Methods

 

Another challenge in sourcing our favorite botanical is the testing for a group of compounds in Ashwagandha called withanolides.  As with all of our products, we wanted to create a potent product with therapeutic amounts of the plant’s bio-actives. There are many bio-actives in Ashwagandha however the ones most commonly tested for, and to which the primary beneficial health results are attributed to, are withanolides. There are at least 35 different withanolides making testing methods complex.

 

In our search for extracts we found that manufacturers were using many different testing methods which made comparisons difficult. Some use a mysterious method called gravimetric which is not really used outside of India.  Others have developed their own “proprietary” HPLC testing methods meant to capture as many withanolides as possible which boost their withanolide numbers. We don’t completely discount these methods however if the method is proprietary it cannot be used to compare results evenly across multiple extracts or products.  Therefore, until the United States Pharmacopeial Convention (USP) updates its method, USP-43 via HPLC (formerly USP-40 or 41) remains the current universal or standardized industry method. Because this method accounts for only 10 withanolides, it under-represents total withanolide content. 

 

During our research in developing Bold Ashwagandha Plus, we used this method to test over a half dozen extracts. We expected lower markers, however we were surprised by the wide range of results. We found that some extracts that are being promoted as being highly potent, actually contained very little activity. We use the USP-43 testing method to determine which extract materials to use in our products and for our receiving and finished product testing to ensure our product meets our label claim for withanolide content.  Although this method results in a lower number, we believe in playing on a level playing field.

 

Adulteration

 

Due to the high demand for Ashwagandha root and subsequent higher costs, the issue of adulteration has become a concern in the international market. Testing of commercially available Ashwagandha root extracts have found that adulteration with undeclared and less costly leaf and aerial parts has become quite common. Some studies indicate the occurrence could be as high as 80%. To clarify, adulteration only occurs when the inclusion of aerial parts is undeclared and over 2%. There are many, including ourselves, who believe in using the leaf as well as the root. The leaf contains many of the same bio-actives as the root. Although some argue otherwise, the leaf has also been used traditionally and research shows that whole plant or leaf extracts are beneficial as well as safe. We include both root and leaf extracts in our product. However, this must be declared on the certificate of analysis (COA) from our suppliers, if a COA from a supplier states their material is root only, and it tests for leaf, it will fail identity testing. 

 

Test Result: Fail

 

At Bold Botanica, our high-quality products are manufactured at third-party certified cGMP facilities in the USA. We perform all the FDA required testing to verify ingredient identity, purity and strength. We have sourced many botanical extracts from around the world and have had very few quality issues. Until Ashwagandha.  Over the last few years, we have tested about a dozen Ashwagandha extracts, and the majority have failed. They failed testing for identity, withanolide content, heavy metals, and pesticides.

 

The Bold Difference

 

At Bold Botanica, some of the challenge in sourcing we inflict on ourselves. We are extremely selective and have high standards for our ingredients. We prefer to use certified organic whenever possible.  We care about how our extracts are made. We only use extracts made with water and alcohol. We try to avoid carriers or excipients, and if we are unable to avoid this, we look for non-corn based excipients.  We also do not rely on proprietary testing methods or a supplier’s COA, we conduct our own testing for bio-active content, in this case USP-43.

 

With Ashwagandha, we are still in search of our unicorn: a certified organic extract, extracted with certified organic ethanol, with a standardized withanolide content, tested via USP 43, and that will pass all of our other testing. We thought we had found it, we ordered a custom batch which took six months to produce, only to have it fail pesticides at the last stage. Until then, our Bold Ashwagandha Plus includes a powerful standardized root and leaf extract, produced using water and ethanol, to achieve 10 mg of withanolides per capsule. And we balance this with a certified organic root extract, water extracted, to provide a full spectrum of bio-actives. Bold Ashwagandha Plus is also amplified with Amla and Holy Basil for a powerful triple adaptogenic combination.  This is a product we believe in, and it was certainly worth the wait to get it right.

 

Alena Miles, Bold Botanica Co-Founder and Brand & Sustainable Sourcing Manager, has a diverse history in the natural products industry in marketing, global sourcing, product development, and her true passion, organic herb farming.