KSM-66 is the world’s leading ashwagandha supplier and, thanks to its 37 clinical studies, battery of toxicological studies, and ongoing scientific research, it can provide brands with a full-spectrum, root-only ashwagandha extract that is both safe and effective.
August 30, 2023
Sponsored by KSM-66: Ashwagandha
The root of the ashwagandha plant contains the active molecules responsible for the plant’s health benefits, such as reducing anxiety, encouraging quality sleep, and aiding in mental focus. But as this plant’s popularity increases, the emergence of ashwagandha-based formulations that use the plant’s leaves and other aerial parts is on the rise, raising safety concerns and tarnishing the plant’s reputation.
This is an issue that the leading ashwagandha supplier, KSM-66, is meeting head-on, firmly addressing consumer concerns. It highlights that the majority – 246 of 247 – of independent published clinical trials today use only root-based formulations. KSM-66 has also published more than 37 clinical studies on ashwagandha root extract and has an additional 13 ongoing. Thanks to this due diligence, KSM-66 has won the trust of countless health and wellness brands around the world, such as Swedish nutraceutical firm MedicineGarden.
“KSM-66 [...] have performed and published gold standard studies focusing both on safety and efficacy,” says Tom Johnsson, co-founder and head of R&D at MedicineGarden, which uses KSM-66 ashwagandha in its products.
Describing KSM-66 as “serious brand builders”, Johnsson adds: “They realised the only way to convince authorities was to use solid science. The work KSM-66 are doing is clearly showing that a well-defined full spectrum root extract is not only effective but 100% safe.”
Traditional use of ashwagandha extract for 5,000 years has built up a wealth of knowledge confirming its effectiveness and safety, and ashwagandha root is an established part of Ayurvedic medicine.
In recent years, however, the power of modern science has been able to identify the specific reason behind ashwagandha’s health benefits: the presence of withanolides. These are the root’s main active molecule, which are said to give ashwagandha root extract its adaptogenic properties. Nevertheless, it is important to understand that withanolides are only one of many active compounds in ashwagandha. This is why brands should use not only a withanolide extract but a whole ashwagandha complex that accurately mimics the root.
KSM-66 has perfected a green chemistry manufacturing method that results in a full-spectrum ashwagandha extract, featuring all the health-giving active compounds and an optimum natural percentage of withanolides (5%).
“KSM-66 has developed a proprietary extraction method using only water, ” says Johnsson. “The extract mimics the root both in actives and in the ratio between the ingredients, meaning that traditional knowledge can be applied. When using solvents like ethanol and methanol, the ratio between the constituents changes along with the properties and safety. And this situation gets even more critical when other plant parts are added.”
It is crucial to note that not all ashwagandha bioactives are beneficial: withaferin A is one such substance that is cytotoxic. Some ashwagandha extracts have high withaferin A levels because certain manufacturers use ashwagandha leaves. KSM-66 extract is guaranteed to contain negligible levels of withaferin A, making it very safe for human consumption.
The challenge to supply high-quality ashwagandha is made more complex by the plant’s origins because bioactive levels vary depending on how the plant is grown and harvested. Additionally, it is important to know which country ashwagandha originates from since the plant is also grown outside of India in places such as Sri Lanka and the Middle East.
As Johnsson explains, manufacturers buy ashwagandha from middlemen without knowing its exact origins. This is worsened by a lack of a precise definition for the number of active substances found in the plant. Consequently, ashwagandha quality varies with a real risk of contamination.
“KSM-66 has solved this challenge by creating total vertical integration,” he says. “All roots spring from their own organic fields and the seeds used are genetically similar. From the fields, the dry roots are transported in their own trucks and all extraction is done on their own organic-certified production units. This means that the extract is homogeneous and guaranteed [to be] pure when it reaches the manufacturer. No other ashwagandha producer has equivalent quality assurance. To further increase safety, the entire process is certified via roughly 40 independent organisations.”
The final word on why only a well-defined root-extract should be used is a regulatory one. Some European countries like Poland and Hungary only allow the use of ashwagandha root and no leaves while, in 2021, the government of India issued an advisory against the use of ashwagandha leaves. It stated that “no substantial evidence and literature is available to endorse the efficacy of crude drug / extract of Withania somnifera leaves”.
The European Food Safety Authority (EFSA) currently has 11 pending health claims for ashwagandha all of which are root-based. Only two claims are for leaf-based extracts. In addition, the use of ashwagandha roots and root extracts are stated in global pharmacopoeia recommendations issued by the United States Pharmacopeia, World Health Organization (WHO), and European Medicines Agency (EMA, in process), amongst others.
Safety is paramount for suppliers, manufacturers, and consumers alike when it comes to ashwagandha root– but so too is efficacy. Consumers must feel the effect of the health product they are taking, or they will not buy it again. Thanks to its published and ongoing scientific research, KSM-66 has proven time and time again that it can guarantee the purity, quality, and efficacy of its product, continually holding up to the rigorous scrutiny of regulatory agencies and consumers worldwide.
