FDA WARNING_LETTER - www.buycodeine.us - May 05, 2025

On May 5, 2025, the FDA issued a Warning Letter to www.buycodeine.us for unlawfully selling unapproved and misbranded drugs to U.S. consumers over the internet. The FDA's review of the website revealed violations of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

The website was found to be introducing unapproved and misbranded opioid drug products and Schedule II stimulants, posing significant public health risks due to the opioid epidemic and the high potential for abuse and diversion of stimulants. Specific examples include "Toseina" (codeine phosphate hemihydrate oral solution) and "Ritalina" (methylphenidate hydrochloride tablets). These products are considered unapproved new drugs because no FDA-approved applications are in effect for them, violating sections 301(d) and 505(a) of the FD&C Act.

Furthermore, these drugs are misbranded under section 502(f)(1) of the FD&C Act because their labeling lacks adequate directions for use, as they are prescription drugs not safe for layperson self-treatment. The website also offers these prescription drugs without requiring a prescription, violating section 503(b)(1) and 301(k) of the FD&C