EvaPharmacy recently received a Warning Letter from the United States Food and Drug Administration (“FDA”), Office of Drug Security, Integrity and Recalls regarding products available for sale to consumers in the United States on its websites. The FDA requested that EvaPharmacy take prompt action and notify the FDA within ten business days of receipt of the letter regarding the corrective action that will be implemented to remediate the violations and prevent future violations. Specifically, the FDA stated that EvaPharmacy violated marketing laws by (i) making unapproved new drugs available for sale; and (ii) selling FDA-approved drugs directly to consumers who do not have valid prescriptions for such drugs. According to the FDA, these actions misbranded the drugs in violation of the Food, Drug, and Cosmetic Act.
The day after the Warning Letter to EvaPharmacy, the FDA announced that it shut down and seized products from 1,677 illegal pharmacy websites with assistance from the U.S. Attorney’s Office for the District of Colorado. During the operation, nicknamed Operation Pangea VI, the FDA targeted websites selling unapproved and potentially dangerous prescription medicines that could pose significant public health risks. The FDA also worked with international regulatory and law enforcement agencies to seize over $41 million worth of illegal medicines.