Nutrition 2000 – FDA Warning Letter

The FDA issued a Warning Letter to Nutrition 2000 after reviewing their website, http://www.nutrition2000.com. The agency determined that several products, including "Cesium and Potassium Combo," "Curcumin," "Men's Prosta-Life," "PC Hope," "Platinum," "Protocel Formula 23," "Protocel Formula 50," and "Surcan," are promoted with therapeutic claims that cause them to be unapproved new drugs under Sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (21 USC 321). These claims, which include intentions for the cure, mitigation, treatment, or prevention of disease, violate the Act. The products are not generally recognized as safe and effective for their promoted uses and lack prior FDA approval as required by Section 505(a) (21 USC 355(a)). Furthermore, these products are misbranded under Section 502(f)(1) (21 USC 352(f)(1)) because their labeling fails to bear adequate directions for use. Nutrition 2000 is required to take prompt action to correct these violations and prevent recurrence. They must notify the FDA in writing within fifteen working days, detailing corrective steps, prevention plans, documentation, and a timeframe for completion. Failure to comply may result in enforcement actions, including product seizure and injunctions.