FDA WARNING_LETTER - alpharoyalpharmacy.com - September 02, 2020

On September 2, 2020, the FDA issued a Warning Letter to www.alpharoyalpharmacy.com for offering unapproved new drugs and misbranded opioids for sale to U.S. consumers, violating sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act. The FDA highlighted the public health crisis of opioid addiction and the risks of unapproved drugs, which lack safety and effectiveness assurances and may be contaminated or counterfeit.

Specifically, the website offered "tramadol 225 mg tablets manufactured by Royal Inc," claiming it treats moderate to severe pain. This product is an unapproved new drug under section 201(p) and 505(a) of the FD&C Act, as no FDA-approved applications are in effect for it. FDA-approved tramadol carries a "black box warning" due to risks like addiction, abuse, respiratory depression, and neonatal opioid withdrawal syndrome.

Furthermore, the tramadol product is misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson, as it is a prescription drug requiring professional supervision. The website also offered tramadol without requiring a prescription, violating section 503(b)(1) and 301(k) of the FD