FDA WARNING_LETTER - www.tob-one.com

The FDA issued a Warning Letter to www.bestcheapmedsonline.com after reviewing its website and determining it offers misbranded and unapproved new drugs for sale, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The website sells unapproved new drugs, including Januvia 25 mg (Sitagliptin Phosphate), Sildigra 100 mg (Sildenafil Citrate), Exermet GM, Galvus, Nuzide, and Triexer. These products are considered drugs under section 201(g) of the FD&C Act due to their intended use for disease diagnosis, cure, mitigation, treatment, or prevention (e.g., diabetes mellitus, erectile dysfunction). They are also new drugs under section 201(p) as they are not generally recognized as safe and effective for their labeled uses, and no approved applications under section 505 of the FD&C Act are in effect for them. Their introduction into interstate commerce violates section 505(a) and is a prohibited act under section 301(d).

Additionally, the website sells misbranded drugs. Januvia was purchased without a prescription, despite its labeling requiring one, violating section 503(b)(1) and constituting a prohibited act under section 301(a). Both Januvia and Sildigra are misbranded under section 50