FDA WARNING_LETTER - Twin Falls Bio Tech, LLC

The FDA issued a Warning Letter to Twin Falls Bio Tech, LLC, following a November 2014 review of their website (www.arisitol.com) and product literature for "Arisi-Tol." The FDA determined that the product is promoted for conditions that cause it to be an unapproved and misbranded drug under the Federal Food, Drug, and Cosmetic Act. Therapeutic claims, such as reducing cancer cell growth, treating arthritis, and alleviating pneumonia symptoms, establish Arisi-Tol as a drug intended for the cure, mitigation, treatment, or prevention of disease [21 U.S.C. § 321(g)(1)]. Since the product is not generally recognized as safe and effective for these uses, it is considered a "new drug" [21 U.S.C. § 321(p)] that lacks the required prior FDA approval [21 U.S.C. § 355(a), § 331(d)]. Additionally, Arisi-Tol is misbranded because it is offered for conditions not amenable to self-diagnosis, and its labeling fails to provide adequate directions for use by a layperson [21 U.S.C. § 352(f)(1)]. The introduction of such unapproved and misbranded drugs into interstate commerce violates the Act [21 U.S.C. § 331(a)]. Twin Falls Bio Tech, LLC, must take prompt action to correct these violations and notify the FDA in writing within 15 working days, detailing corrective steps and timelines, to avoid further regulatory action like seizure or injunction.