FDA WARNING_LETTER - www.soma4ever.com - June 13, 2025

On June 13, 2025, the FDA issued a Warning Letter to www.soma4ever.com (Singapore) for unlawfully selling unapproved and misbranded drugs to U.S. consumers via their website. The FDA's review found the website introduces into interstate commerce unapproved and misbranded opioids (e.g., Tapentadol, Oxycodone, Tramadol), benzodiazepines (e.g., Alprazolam, Clonazepam, Diazepam, Lorazepam), and Schedule II stimulants (e.g., Amphetamine/Adderall).

These products are considered "new drugs" under the FD&C Act because they lack FDA approval for safety and effectiveness, violating sections 301(d) and 505(a). The website's claims, such as selling "FDA-approved medications" and various anxiety, insomnia, ADHD, and pain medications, were cited as evidence of drug intent.

Furthermore, the drugs are misbranded under sections 502(f)(1) and 503(b)(1) of the FD&C Act because they are prescription drugs requiring professional supervision, and the website offers them without a prescription, lacking adequate directions for layperson use. This also violates section 301(a) and 301(k).

The FDA emphasized the significant public health risks, including addiction, abuse, respiratory depression, and death, associated with these controlled substances