FDA WARNING_LETTER - Health Center for Better Living, Inc.

The FDA issued a Warning Letter to Health Center for Better Living, Inc. following a review of their website, www.hcbl.com. The FDA determined that several products, including "Green Tea Capsules," "Lycopene," "Melatonin," "Omega 3-6-9," "Omega 3," "Prostate Support," "Selenium," and "Turmeric," are promoted with therapeutic claims that cause them to be unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. These claims, which include preventing cancer, lowering cholesterol, aiding cardiovascular disease, treating arthritis, and inducing sleep, establish the products' intent for use in the cure, mitigation, treatment, or prevention of disease. Consequently, these products are considered "new drugs" [21 U.S.C. § 321(p)] and are illegally marketed without prior FDA approval as required by section 505(a) of the Act [21 U.S.C. § 355(a)]. Furthermore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because their labeling lacks adequate directions for use. The FDA requires the firm to take prompt action to correct these violations and prevent recurrence, notifying the agency within fifteen working days with documentation of corrective steps. Failure to comply may result in enforcement actions, including product seizure and injunctions.