FDA WARNING_LETTER - www.xsteroids.com - September 10, 2020

The FDA issued a Warning Letter to www.xsteroids.com for offering unapproved and misbranded opioid products, specifically "OxyNorm" (oxycodone), for sale to U.S. consumers via their website. This violates sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The products are deemed "unapproved new drugs" under sections 201(g) and 201(p) because they are intended to affect body function or treat disease but lack FDA approval for safety and effectiveness. No approved applications exist for "OxyNorm" under section 505(a).

Furthermore, the products are "misbranded" under section 502(f)(1) because they lack adequate directions for use by a layperson. As prescription drugs, they require supervision by a licensed practitioner and are not amenable to self-diagnosis or treatment. The absence of U.S. approval also means they are not exempt from misbranding requirements.

The FDA emphasizes the significant public health risk posed by the easy availability of unapproved and misbranded opioids, especially given the opioid epidemic. Such drugs may be contaminated, counterfeit, or contain incorrect active ingredients.

www.xsteroids.com is required to immediately cease offering violative drugs for sale to U.S