FDA warns Utah-based LifeVantage, Sunstone about cancer treatment claims
Two Utah-based companies were warned by the U.S. Food and Drug Administration on Tuesday to correct violations of the Food, Drug and Cosmetic Act.
LifeVantage Corporation and Sunstone, Inc. were flagged by the agency for selling products without FDA approval that fraudulently claim to prevent, diagnose, treat or cure cancer. Twelve other companies were similarly warned, the FDA said in a press release.
The FDA sent a warning letter dated April 17 to LifeVantage, based in Sandy, for a product called Protandim NRF2 Synergizer, which the FDA said is fraudulently marketed as a drug.
On its website, LifeVantage says Protandim “activates survival genes.”
According to the FDA, LifeVantage claims the drug protects users from UV radiation and inflammation, staves off diseases like diabetes and Alzheimer’s, reduces high blood pressure and protects against carcinogens.
Additionally, the FDA said that LifeVantage’s product is misbranded because it fails to bear adequate directions for its use.
In a statement, LifeVantage CEO Darren Jensen said the company “does not claim that any of our products prevent, diagnose, treat or cure cancer in any marketing materials or labeling. In fact, the citations in the FDA’s letter are not claims regarding LifeVantage products.”
Jensen said the company has responded to the FDA and will make “any changes needed to further ensure our compliance.”
LifeVantage is a publicly traded company which sells Protandim under a multi-level-marketing structure. It describes itself as a “burgeoning science-based nutraceutical company dedicated to helping people achieve healthy living through a combination of scientifically validated products and an attractive business opportunity.”
LifeVantage has been a major sponsor of Real Salt Lake, a major league soccer team in Salt Lake City, and its logo is featured prominently on players’ jerseys.
The other Utah-based recipient of the FDA’s April 17 warning letter was Sunstone, Inc., based in Pleasant Grove. The FDA warned its operator, Einar Bjarnson, that the company’s website was violating federal law by introducing unapproved and misbranded drugs into interstate commerce.
Listing examples of Sunstone’s violations, the FDA cited a brand of tea that, online, promised, “has been used for cancer, cancer prevention, AIDS, diabetes…”
A topical creme sold on Sunstone’s website was said to be “traditionally used for cancer, and as a broad-spectrum internal and external antimicrobial to treat bacterial and fungal infections.”
In addition, the FDA tagged several dietary supplements sold through Sunstone that were mislabeled and unapproved by regulators, including Colloidal Silver Spray, Chelated Boron, Fermented Yeast Culture and Circulatory Detox & Support Syrup, and Plague Buster Syrup, among others.
Sunstone’s website features a disclaimer saying the FDA has not evaluated products or statements on its site. Sunstone representatives had not responded to media requests at press time.
The companies have 15 working days to respond in writing to the FDA detailing steps they’ll take to correct the violations. Failure to do so would risk asset seizure and other legal consequences, the FDA said.


