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

On August 31, 2020, the FDA issued a Warning Letter to www.roidsforce.com for offering unapproved new drugs and misbranded drugs for sale, specifically opioids, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The website introduces into interstate commerce products like "TAMOL-XX" (tramadol), which are considered new drugs under section 201(p) of the FD&C Act because they lack FDA approval for safety and effectiveness. This violates sections 301(d) and 505(a) of the FD&C Act.

Furthermore, these products are misbranded under section 502(f)(1) of the FD&C Act because they lack adequate directions for use by a layperson, as they are prescription drugs requiring professional supervision. The website also dispenses these prescription drugs without requiring a prescription, violating sections 301(a) and 301(k), and 503(b)(1) of the FD&C Act. The FDA emphasizes the significant public health risk posed by the online sale of unapproved and misbranded opioids, citing the opioid epidemic and the dangers of products that circumvent regulatory safeguards.

The FDA requires www.roidsforce.com to immediately cease offering violative drugs for sale to U.S. consumers. The company must notify the FDA in writing within 15 working days