Real Salt Lake’s kit sponsor, LifeVantage, has been given a warning by the Food and Drug Administration over their use of scientific and medical claims on their packaging — and the FDA is saying LifeVantage is illegally selling “cancer treatments.”
The warning letter, sent April 17, says that the FDA determined that LifeVantage’s “Protandim NRF2 Synergizer” is defined as a drug because of claims made by the organization that indicate it is intended for “use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”
The claim in the letter is that Protandim NRF2 Synergizer “fails to bear adequate directions for its intended use,” and that the diseases LifeVantage claims are treated with the product are “not amenable to self-diagnosis or treatment without ... a licensed practitioner.” Because of that, they say that adequate directions for safe use of the product can’t be written.
The letter details several of the claims found, which include, but are not limited to, claims that the drug can aid in fighting cancer of multiple types, including skin cancer, breast cancer, ovarian cancer and others; prevent tumor growth, and prevent diabetes.
LifeVantage indicates on their website that Protandim is a dietary supplement, not a drug.
Real Salt Lake’s partnership with LifeVantage started in October 2013 with a long-term front-of-jersey sponsorship deal. In July 2015, Real Salt Lake owner Dell Loy Hansen was reported by the Securities and Exchange Commission to have bought 5.1 percent of LifeVantage Corporation.
UPDATE: A LifeVantage spokesperson provided this statement from Darren Jensen, LifeVantage CEO.
At LifeVantage we pride ourselves on our science-based approach to product development. We proactively consult with distinguished FDA experts to ensure our promotional materials and websites adhere to FDA regulations. We will respond to the FDA in a timely fashion and make any changes needed to further ensure our compliance.