FDA WARNING_LETTER - Vitasalus, Inc.

The FDA issued a Warning Letter to Nu-Gen Nutrition, Inc., Vitasalus. Inc., and Equinox Products, LLC, following a review of their websites (e.g., www.cancerchoices.com, www.vitasalus.com). The agency determined that several products, including "Ocean Treasure Coral Calcium," "Colostrum," "Electrolyte Formula (Cantron)," "Ellagenol," "Squalamax," "Ultramarine Omega-3TM Virgin Salmon Oil Gelcaps," and "Ultramarine Shark Liver Oil," are promoted for conditions that cause them to be unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. Therapeutic claims observed on the websites, such as those related to cancer treatment, antiviral, and anti-inflammatory effects, establish the products' drug intent. These products are not generally recognized as safe and effective, classifying them as "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)], which require prior FDA approval. Furthermore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] due to a lack of adequate directions for use in their labeling. The letter cites website claims, scientific publication references, testimonials, metatags, and co-promotion with books as evidence of intended use. The firm is required to take prompt action to correct these violations and prevent recurrence, notifying the FDA within fifteen working days with documentation of corrective steps. Failure to comply may result in enforcement actions, including product seizure and injunctions.