FDA Warning Letter to an Online Illegal Ozempic Seller
(Thursday, October 19, 2023)
Earlier this month, the FDA issued a Warning Letter to an online pharmacy selling a generic version of GLP-1 analog, semaglutide, and in the process highlighted the limitations of such FDA actions for online pharmacies selling illegal products. So long as the consumers are willing to risk buying products online from dubious companies, the FDA is helpless.
Occasionally, the FDA issues such Warning Letters to companies that seemingly exist only in the ether. Online pharmacies sell drugs and biological products for the same drug at a fraction of the price, even under prescription. For drugs such as the GLP-1 analogs, which are legally sold under brand names Ozempic, Mounjaro, and Rybelsus, the shortage of the legal drug, limitation of insurance coverage, and hype in the market contribute to them being attractive targets for fake counterfeits and illegal copies. Add to that the limited consequence of the FDA’s action, allowing such pharmacies to openly flout the laws.
Just like the previous such cases, the pharmacy targeted by the FDA this time has many non-compliance observations but the FDA does not even know the name of the owners of the website, so the letter is addressed to the website URL. The letter lists a series of violations and asks the website to stop selling the drugs. The website promptly removed the drugs listed by the FDA and stayed in business. This is the second website this month with a similar Warning Letter. It should be noted that there are no fines or other punitive actions that we know of, and not even the names of the individuals behind this website are known publicly. It seems the FDA is not even sure if the company is based in the US, although the website lists an address in Florida where it seems to be running out of a fitness store.
It is easy to blame the FDA for the futility of such actions but there is not much else for FDA to do other than blocking the sales on such websites and educating consumers. But ultimately, it is on the consumers to educate themselves about such websites and do their due diligence.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC