Web Site Illegally Selling Semaglutide Products: FDA

FDA says the Web site www.ozempen.com is introducing into interstate commerce misbranded and unapproved new drugs, specifically semaglutide products. A 6/24 Warning Letter says there are “inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory standards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that ozempen.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers. This is critical to protect the public from harm.”

The Web site was told to respond with a description of specific steps taken to address any violations and prevent their recurrence, with copies of related documentation and a schedule for completing the corrections.