Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm339538
Timestamp: 2019-02-16 11:44:14
Document Index: 752130265

Matched Legal Cases: ['§ 352', '§ 331', '§ 321', '§ 321', '§ 355', '§ 355', '§ 331', '§ 352', '§ 352', '§ 201', '§331']

Medsnoscript 2/11/13
TO: Alexander Chepurnoy
Severny Av 10 B1 1 Apt 101
St. Petersburg, Saint Petersburg 3691
sandylabs@gmail.com
The United States Food and Drug Administration (FDA) recently reviewed your website “www.Medsnoscript.com” and has determined that your website offers products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, your website offers unapproved and misbranded new drugs for sale in violation of sections 502(a), 502(f)(1), 503(b)(1), and 505(a) of the FD&C Act [21 U.S.C. §§ 352(a), 352(f), 353(b), and 355(a)]. Introduction of such products into interstate commerce, including importation into the United States, is prohibited under sections 301(a) and 301(d) of the Act [21 U.S.C. §§ 331(a) and 331(d)]. We request that you immediately cease marketing violative drug products to United States consumers.
The oseltamivir phosphate you offer for sale through your website is a drug within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or it is intended to affect the structure or function of the body. This product is also a new drug as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)], because it is not generally recognized as safe and effective for the labeled uses. No approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] are in effect for generic Tamiflu products. Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates section 505(a) of the FD&C Act [21 U.S.C. § 355(a)], which is prohibited under section 301(d) of the FD&C Act [21 U.S.C. § 331(d)]
This drug is misbranded pursuant to section 502(a) of the FD&C Act [21 U.S.C. 352(a)] because the labeling is false or misleading. Your firm’s website and promotional labeling for this product misleads the consumer to believe that the product they are purchasing is an FDA approved drug product. Additionally, because the above mentioned drug are intended for the treatment of conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use this product safely for the intended uses. Consequently, the labeling fails to bear adequate directions for the intended uses, causing the drug to be misbranded under 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)]. Because “Generic Tamiflu” offered for sale on your website lacks a required approved application, it is not exempt from the requirements of section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] as described in Title 21 of the Code of Federal Regulations (21 CFR) § 201.115. The introduction or delivery for introduction into interstate commerce of a misbranded drug product is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. §331(a)].