FDA WARNING_LETTER - LCW, INC. - November 30, 2014

The FDA conducted an inspection of LCW, Inc. (dba uFresh Center and LDF) on October 15, 2014, and subsequently reviewed product labeling and the firm's website, www.ufreshcenter.com. This review revealed serious violations of the Federal Food, Drug, and Cosmetic Act. Several products, including "uFresh," "Super Ganoderma," and "uLiver Pro," are promoted with therapeutic claims (e.g., cure, mitigation, treatment, prevention of disease) on their labels, flyers, and website. These claims cause the products to be unapproved new drugs under section 201(g)(1)(B) of the Act. As they are not generally recognized as safe and effective, they are also considered "new drugs" under section 201(p). Introducing these new drugs into interstate commerce without prior FDA approval violates sections 505(a) and 301(d). Furthermore, certain products are misbranded under section 502(f)(1) because they are intended for conditions not amenable to self-diagnosis and treatment, thus lacking adequate directions for use for laypersons. Introducing misbranded drugs into interstate commerce violates section 301(a). The firm must take prompt action to correct these violations and notify the FDA in writing within 15 working days, detailing corrective steps and documentation. Failure to comply may result in legal action, including seizure and/or injunction.