FDA WARNING_LETTER - kubapharm.com - April 12, 2022

The FDA and DEA issued a Warning Letter to www.kubapharm.com on March 30, 2022, for unlawfully selling Schedule II stimulants, including amphetamine products, to U.S. consumers over the internet. The website violates the Ryan Haight Online Pharmacy Consumer Protection Act (RHA) by distributing, dispensing, and advertising controlled substances without the required modified DEA registration (21 U.S.C. § 841(h) and § 843(c)). Additionally, the site introduces misbranded amphetamine drug products into interstate commerce, violating sections 301(a), 301(k), and 503(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, it offers prescription drugs like "Adderall" without requiring a prescription, which misbrands the drug and jeopardizes patient safety. These actions pose significant public health risks due to the high potential for abuse and dependence of Schedule II stimulants and the inherent dangers of unregulated, potentially counterfeit or contaminated drugs. The company must notify DEA and FDA within 15 working days of corrective actions taken to address all violations and prevent recurrence. Failure to comply may result in further legal action, including contacting domain registrars, seizure, injunctions, and civil or criminal proceedings.