New Brunswick, NJ—Natreon Inc., the maker of Sensoril ashwagandha, based here, has filed a lawsuit against Ixoreal Biomed Inc., Los Angeles, CA, maker of KSM-66 ashwagandha and its parent company Shri Kartikeya Pharma, Ltd., Hyberadad, India, for false advertising, unfair competition and trade libel, among other counts. The complaint was filed on September 30 and levels several serious allegations against Ixoreal and its ashwagandha product.
The complaint alleges that Ixoreal falsely represents KSM as an extract, citing its use of phrases on their website such as “highest concentration full-spectrum extract” and “root-only extract,” while independent testing showed that KSM had low aqueous solubility compared to Sensoril (35% compared to 90%). Plant extracts, explains the complaint, are more soluble in water than plant powders and KSM’s low solubility can be indication of a substantial presence of root powder. Testing also showed the presence of Lignin in at least one KSM product, indicating that it is substantially root powder rather than a full extraction.
This is significant, states the complaint, because ashwagandha extracts cost nearly five times more to produce than ashwagandha root powder. Besides false advertising, Natreon considers this unfair competition because if Ixoreal is in fact manufacturing an inferior product, selling it for a cheaper price than competitors while also claiming to be a superior product, it is unfairly undercutting other ashwagandha ingredients such as Sensoril. According to the complaint, Natreon did lose clients to KSM “for their ashwagandha needs based on Defendants’ false and misleading statements about KSM in conjunction with its lower prices.”
This is also where Natreon alleges that Ixoreal has committed trade libel against them. According to the complaint, in an effort to extoll the virtues of their root-only ashwagandha extract, Ixoreal negatively portrayed the use of ashwagandha leaves in extractions from other manufacturers with the term “adulteration” such as in “[KSM-66] uses ONLY the roots with no adulteration by leaves.” Natreon interprets this as defamation and trade libel against them because their process for manufacturing Sensoril, using both roots and leaves is protected by U.S. Patent numbers 7,318,938 and 6,713,092, meaning they are the only ashwagandha maker that uses leaves.
The complaint also alleges that Ixoreal implies the use of leaves is less safe because of their “high levels of Withaferin A,” an undesirable cytotoxic withanolide. However, independent testing by Natreon showed that Sensoril contains negligible amounts of Withaferin A. While KSM also had negligible amounts, the complaint claims Withaferin A levels in KSM were greater than Sensoril. An earlier version of the complaint, which has since been amended, alleged that KSM had overly high levels of Withaferin A, but closer inspection by Natreon revealed this was incorrect.
Perhaps the most serious allegation leveled against Ixoreal in the complaint is that KSM-66 contains undeclared milk allergens. This is a public health issue that FDA has no tolerance for and could result in the recall of many product formulations containing KSM. The complaint alleges Ixoreal does not disclose on their website, labels or Certificate of Analysis the presence of dairy, but that independent tests showed elevated levels of b-lactoglobulin dairy allergen and casein allergen in KSM-66 itself and KSM-containing products, some of which exceeded 13.5 parts per million. While some finished product containing KSM disclose the presence of dairy, many of those tested that contained dairy allergens did not disclose said allergens or incorrectly claimed dairy-free status.
When WholeFoods reached out to Ixoreal for comment, Kartikeya Baldwa, the firm’s director called the allegations baseless. “[The allegation that KSM is not a full extraction] is simply astonishing because KSM-66’s extraction facility is one of the most heavily audited and inspected in the industry,” he explained. “KSM-66’s process and composition have led it to achieve the highest number of quality seals and certifications, now totaling 22, including those involving stringent GMP inspections like USP, UL-NPA, NSF, WHO.”
With regard to their disclosure of dairy allergens, Baldwa said, “KSM-66 comes in multiple variants, customized to the needs of the manufacturers, among them is a milk-pretreated variant and a milk-free variant…We not only communicate to every customer about the two variants when they contact us to buy KSM-66, we also provide them an appropriate allergen statement (based on the variant they use)…That we are trying to conceal the milk allergens, as the lawsuit seems to suggest, is flatly incorrect.” Further, he characterized this complaint as part of a “history of litigious bullying,” explaining that Natreon previously threatened legal action against his firm in 2011 and 2013, but withdrew those allegations.
When contacted by WholeFoods, Natreon confirmed filing this complaint and previously sending Ixoreal cease and desist letters for disparaging its products. However, Sanni Raju, president of the firm stated that Natreon stands behind those previous letters as well as the content of this complaint.