Regarding TV4's feature on December 1, 2024:
The feature is based on the same information as the article in Svenska Dagbladet on October 14, 2024, i.e. on a report compiled by the HoA (Head of Food Safety agencies) - consisting of representatives from European food agencies.
The list includes 12 herbs/medicinal plants that may be evaluated by EFSA, including: piperine, silver saxifrage (cimicifuga), tribulus terrestris, holy basil (tulsi), St. John's wort, cinnamon, maca, curcumin and ashwagandha.
The problem is that the media has perceived the list as establishing that these herbs are harmful. This is not the case at all.
Instead, the list is based on medicinal plants that various European authorities have asked about.
Questions relating to, inter alia: - Interaction risks - side effects - What dose can be considered safe - and whether this can be influenced by: - Which plant part is used - Which extraction method is used - Abnormally high concentrations of a single substance - New production technology e.g. nanotechnology etc.
If the European Commission considers that there is a case for evaluating the herbs, EFSA (European Food Safety Authority) will be given the task. EFSA will then give all companies the opportunity to submit safety documentation. Unfortunately, this is a slow process that may take up to 3 years.
We welcome the report because the quality of herbal supplements in particular varies widely. This can affect both efficacy and safety.
But... the problem is that the media perceive the list as being harmful and therefore likely to be banned. Which is unlikely to happen. However, certain extraction methods or the use of certain plant parts may be banned or restricted.
That's why MedicineGarden only works with the world's most well-documented extracts.
Extracts that have repeated, well-designed and published studies on exactly the extract and in the amount contained in our capsules. Because then we know that our supplements are both safe and effective.
All the negative publicity surrounding ashwagandha in recent years has come from the same source. Denmark and the so-called DTU report.
- After a good dialog between DTU and the Indian Ministry of Health, doctors and professors, DTU has come to the conclusion that they should update their report. This is because the report uncritically drew negative conclusions about ashwagandharot - wrongly based on studies mainly on leaves, stem and berries - or the whole plant.
Traditionally, as in KSM66, only ashwagandha root is used because the above-ground parts may contain substances that are cytotoxic, have a negative effect on sperm and are liver irritants. Substances that are not found in KSM66 - the world's most widely sold, studied and certified ashwagandha.
KSM66 is the only company to have submitted a specific safety report to DTU.
The report presents efficacy and safety data from 36 human clinical studies.
This included a global, double-blind, placebo-controlled safety study of 1000 people.
A high-dose study of 2000 mg per day, and interim results of a 12-month safety study.
Of these studies, 13 focus on liver safety, 13 on the efficacy and safety of sex hormones, sexual desire and function, and five on thyroid efficacy and safety.
The report also included 13 animal safety studies.
This included a complete reproduction study in which both female and male animals received a dose equivalent to 200 times a normal dose. The animals received KSM66 (2000 mg/kg) during mating, pregnancy and lactation. A long-term study of 90 days was also included - again with a dose 200 times higher than the normal dose.
Conclusion: The safety report on KSM66 shows that there is no difference in safety between placebo and KSM66 - even at high doses for longer periods of time. However, there was a large difference in effectiveness between KSM66 and placebo.
Tom Johnsson, CEO - Founder and Quality Manager.
MedicineGarden AB - tom@medicinegarden.se - 0705-94 91 95
