The U.S. Food and Drug Administration sent warning letters Tuesday to LifeVantage Corp (NASDAQ: LFVN) and 13 other companies engaged in the illegal sale of more than 65 products purported but unproven to prevent, diagnose or treat cancer.
The regulatory agency listed LifeVantage’s Protandim NRF2 Synergizer among an assortment of pills, creams, oils, drops, syrups, teas and diagnostic technology fraudulently marketed to heal people and animals.
However, LifeVantage CEO Darren Jensen rejected the FDA’s conclusions.
“LifeVantage does not claim that any of our products prevent, diagnose, treat or cure cancer in any marketing materials or labeling,” Jensen said through the company’s public relations firm. “In fact, the citations in the FDA’s letter are not claims regarding LifeVantage products. We proactively consult with distinguished FDA experts to ensure our promotional materials and websites adhere to FDA regulations. We have responded to the FDA and will make any changes needed to further ensure our compliance.”
The other unapproved products, the safety and efficacy of which remain undemonstrated, have been distributed on websites and social media sites in violation of the Federal Food, Drug and Cosmetic Act.
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” Douglas Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs, said in a press release. “We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work.”
Meanwhile, the FDA requested corporate responses delineating correction strategies and threatened legal action for failed compliance, ranging from product seizure to criminal prosecution. The Administration is currently aggregating reports of the products’ adverse effects by healthcare professionals and consumers through its MedWatch system.
The recent issue compounds an enduring problem in the American health sector, which has warranted more than 90 FDA letters in the last decade to terminate the distribution of fraudulent products.
LifeVantage had initially dropped 8 percent on the news but had fully recovered and was trading up 5.4 percent Thursday from its opening Tuesday rate.
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