FDA WARNING_LETTER - RxCash.Biz

The FDA issued a Warning Letter to RxCash.Biz for offering unapproved and misbranded opioid products for sale to U.S. consumers, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act), specifically sections 301(a), 301(d), 503(b), and 505(a). This is particularly concerning given the U.S. opioid epidemic. The inspection identified that products, such as tramadol, are unapproved new drugs under section 201(p) and 505(a) of the FD&C Act, lacking FDA approval and the associated safety and effectiveness assurances. For instance, the tramadol offered lacks the critical "black box warning" present on FDA-approved versions, which addresses severe risks like addiction, respiratory depression, and neonatal opioid withdrawal syndrome. Furthermore, these drugs are misbranded under section 502(f)(1) of the FD&C Act because their labeling fails to bear adequate directions for use by a layperson, as required by 21 CFR 201.5. As prescription drugs, they are not safe for use without professional supervision. The firm's actions cause the introduction of misbranded drugs into interstate commerce, violating section 301(a). The FDA emphasizes the inherent risks of unapproved drugs, which may be contaminated, counterfeit, or contain incorrect ingredients. RxCash.Biz must immediately cease selling violative drugs and respond within 10 working days, detailing corrective actions and prevention measures, or face potential regulatory actions like seizure or injunction.