New Jersey-based Natreon, Inc., supplier of ayurvedic ingredients including Sensoril ashwagandha, filed a lawsuit against Ixoreal Biomed Inc. (California) and its parent company, Shri Kartikeya Pharma, Ltd. (India) on September 30.
Natreon’s allegations include unfair competition, trade libel, defamation, and interference with economic relations, among others. An initial filing stated that Ixoreal Biomed’s KSM-66 contained hazardous Withaferin A levels, but was ultimately modified. The recent allegations state that the defendant is making false representations about KSM, specifically that it is a plant extract, not derived from root powder, pointing to various statements on IxoReal’s website, such as describing KSM as the “highest-concentration extract on the world market,” and an “ashwagandha extract.”
Natreon noted that plant extracts are known to have higher solubility in water than plant powders. Independent testing showed that that Sensoril has an aqueous solubility of over 90 percent as opposed to KSM, which measured at about 35 percent, indicating that the product contains more root powder. The lawsuit also cites that ashwagandha extract costs almost five times more to produce, compared to ashwagandha root powder. Natreon said it considers price cutting and falsely touting KSM-66 as a superior product unfair competition.
The trade libel and defamation allegations originated from Ixoreal’s accusations that Natreon’s use of ashwagandha leaves created an adulterated product. According to the plaintiff, Sensoril’s process of using both ashwagandha roots and leaves is protected by U.S. Patents 7,318,938 and 6,713,092.
Kartikeya Baldwa, Ixoreal’s director, told Nutrition Industry Executive that on November 7, they filed a lawsuit and cross-complaint against Natreon and NutraGenesis (Vermont), which details their practices, such as commanding a high margin of price over the cost basis, severely distorting patent claims, approaching Ixoreal in 2013 to join forces in an implicit collusion, and presenting false identities to get access to its research and marketing material.
This cross-complaint also states that Natreon and NutraGenesis make unsupported claims concerning Sensoril’s health benefits, such as suppressing food cravings, speeding workout recovery time, increasing metabolism and others.
In addition, Natreon’s lawsuit alleges that Ixoreal KSM products contain undeclared milk allergens. Jeff Lind, vice president of sales and marketing with Natreon, stated that, initially through independent labs, five products showed the presence of dairy allergens. Since then, 11 products have been added—Natreon has notified the FDA of all 16 products testing positive for dairy allergens, according to Lind. Declaring it a public health risk, Natreon recommended that the defendants issue a voluntary recall of these products and urged that products containing KSM-66 be tested immediately.
“We at Natreon stand by everything that’s alleged against IxoReal,” Lind said.