FDA tells another online retailer to stop selling unapproved popular weight-loss drugs
The US Food and Drug Administration has sent a warning letter to the owners of www.ozempen.com, instructing the company to stop selling products that they claim are semaglutide drugs. The diabetes management drugs have become hugely popular as weight-loss products, but the agency says the company’s unapproved versions could harm users.In a letter dated 24 June, the FDA told the owners of Ozempen.com, which according to their website is based in Burlington, VT, that their semaglutide drug products are unapproved and misbranded and that they should stop selling them immediately.
“Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight,” FDA said in its letter. “Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.”
“Accordingly, FDA requests that www.ozempen.com cease offering any unapproved and misbranded drugs for sale to U.S. consumers,” the agency added. “This is critical to protect the public from harm.”
FDA noted that the company sells 4mg and 8mg semaglutide pens that it claims contain the same active ingredient as brand-name drugs, including Ozempic, Rybelsus, and Wegovy, but cheaper. It noted that there are approved injectable semaglutide products that require prescriptions, but the agency has no approved drug applications for a 4mg or 8mg injectable semaglutide pens.
In addition to the concern that the company has circumvented the FDA's premarket review requirements, FDA is also concerned that without oversight, the drugs may not include proper use instructions and may be marketed without patients being told about the risks associated with their use.
"FDA‐approved semaglutide products bear a boxed warning, commonly referred to as a ‘black box warning,’ which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life‐threatening adverse effects," said FDA. "The boxed warning addresses the risk of thyroid C‐cell tumors."
“Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended use,” the agency added. “Consequently, the labeling for these drugs fails to bear adequate directions for use, causing them to be misbranded.”
Semaglutide has gained immense popularity over the past year as a weight-loss drug, and as a result several unauthorized companies have popped up to cash in on its popularity. Since October 2023, FDA has issued at least six warning letters to companies and websites for marketing semaglutide without proper FDA oversight, including warning letters to websites semaspace.com, gorillahealing.com and dashpct.com.
The owners of ozempen.com have 15 days to respond to FDA’s warning letter.
Warning letter
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