FDA WARNING_LETTER - Pacific Standard Distributors, inc - January 31, 2014

The FDA issued a Warning Letter to Mr. Vladimir after reviewing www.modifilan.com in January 2014, concerning the product "Modifilan." The FDA determined that the website promotes "Modifilan" with therapeutic claims that establish it as a drug under section 201(g)(1)(B) of the Act, intended for the cure, mitigation, treatment, or prevention of disease. Examples of claims include treating cancer, cardiovascular diseases, high blood sugar, cholesterol, radiation sickness, and inflammatory conditions, supported by scientific data, testimonials, and metatags. Consequently, "Modifilan" is considered a "new drug" under section 201(p) because it is not generally recognized as safe and effective for its intended uses. Introducing such an unapproved new drug into interstate commerce violates sections 505(a) and 301(d) of the Act. Furthermore, the product is misbranded under section 502(f)(1) because its labeling lacks adequate directions for use for laypersons, as its conditions are not amenable to self-diagnosis and treatment. Introducing a misbranded drug into interstate commerce is a violation of section 301(a). The firm is required to take prompt action to correct these violations and notify the FDA within fifteen working days, detailing corrective steps and recurrence prevention. Failure to comply may lead to legal action, including seizure and injunction.