Regarding the Svenska Dagbladet article 2024-10-14:
The summary below shows that this is not applicable to KSM66.
The article, based on a report by the Heads of Food Safety Agencies (HoA), points to possible risks associated with the consumption of 12 different ingredients. One of the extracts mentioned is ashwagandha. Below is a compilation of facts showing that the risks presented in the article are not applicable to KSM66 - the world's most studied root extract of ashwagandha. The information was communicated to SvD three weeks before publication.
1. The report that forms the basis for HoA's and Svenska Dagbladet's critical view of ashwagandha is the so-called DTU report from May 2019. A report that uncritically drew negative conclusions about root - based on studies of above-ground parts, especially leaves.
2. Leaves, berries and stem should not be used internally as they contain a number of substances known to be cytotoxic, to adversely affect sperm and to be liver irritants e.g. Withaferin A, Withanone, Tropin and Theophyllin. Substances not found in KSM66.
3. DTU's conclusions are thus correct - regarding leaves, stem and berries. However, to conclude from this that these negative results also apply to root is absolutely unscientific. DTU has completely disregarded the basic pharmacological requirement - that conclusions regarding risk and effect can only be drawn from the plant part studied.
The above is emphasized by the fact that DTU has not been able to show any serious side effects from the use of root - apart from occasional case reports on non-specific extracts. On the contrary, the majority of the studies on root referred to by DTU show normalizing effects on e.g. sex hormone and thyroid hormone. Something DTU has chosen to disregard.
DTU's assumption is therefore as wrong about ashwagandha root as it is about potatoes being a health risk because the leaf contains toxic substances (ashwagandha is a potato plant).
4. that ashwagandha root would have a negative effect on sex hormones as DTU claims is a misinterpretation of the facts. Ashwagandha root, unlike the above-ground parts, has been used as an aphrodisiac for thousands of years in Ayurveda. A traditional use that is well documented. On KSM66 alone, there are 13 published/completed double-blind, placebo-controlled studies, on both men and women, showing normalized/increased levels of sex hormone, semen and increased sexual desire.
5. The efficacy and safety of KSM66 has been demonstrated in 36 clinical studies (published or under peer review). In addition, a 12-month safety study of 300 participants and a global study of 1000 participants have been completed. In addition, 9 further studies are ongoing.
The adverse event rates in the KSM66 and placebo groups are similar, 3.4% for KSM66 and 4.13% for placebo. This shows that the risk of having an adverse reaction to KSM66 is no greater than that of placebo (inactive drug). All side effects were mild and transient.
The majority of studies used the 600 mg/day dose, except for the safety study where one group received 2000 mg KSM66/day.
In addition, there are 9 toxicological safety studies in animals - including a long-term study and a reproduction study where the animals received a dose 200 times higher than the normal dose. No adverse effects can be found on either hormones or organs.
6. KSM66 is one of the world's best-selling food supplements. Outside India, 2 billion daily doses are sold annually, equivalent to 32 million cans of 120 capsules each. No serious side effects have been reported.
Although the contents of leaf and root are very different, there are some common substances, including withanolides A and B. This, combined with the fact that leaves cost about 1/100th of a root, has led some companies to use leaves - without understanding the risks.
Using leaves in food supplements is a Western invention. In India, leaves are mainly used as fertilizer. However, there are serious products with root and leaf, such as Sensoril - which has removed the toxic substances.
- Several comprehensive safety reports on ashwagandha root have been completed, both by the Indian government (Ministry of Health) and by Ixoreal, the company behind KSM66.
- Two meetings have been held between Indian experts, scientists and toxicologists and representatives from the Danish Food Authority. One meeting was held in May and one in early October. The result of the meetings is that the Danish Food Agency has realized that their "risk assessment" is not properly carried out.
- The risk assessment that has caused all the suspicions about "harmful effects of ashwagandha root" is now called by the Danish Food Safety Authority "a preliminary report", a new final report will be finalized in December 2024.
Conclusion: A well-defined, full-spectrum extract of ashwagandha root is both effective and safe. This is proven in countless studies along with 3000 years of traditional use.
We are confident that DTU will also come to the same conclusion in its final report.
Tom Johnsson, CEO - Founder and Quality Manager.
MedicineGarden AB - tom@medicinegarden.se - 0705-94 91 95
