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Living Foods LLC was cited for marketing three unapproved products: Bion+Plus Silver Ozone and ZeoHeal (both drugs) and Relax Far Infrared Ray Sauna (a medical device). The company's website contained disease claims that established these products as drugs or devices requiring FDA approval or clearance, which had not been obtained. The products were being sold without the required scientific data demonstrating safety and effectiveness, in violation of the Federal Food, Drug, and Cosmetic Act sections 301(d) and 505(a).