FDA sends warning letter to CVS over ‘unapproved’ pink eye drops

In a letter to CVS Health CEO Karen Lynch, the FDA wrote: “This letter is to advise you that the U.S. Food and Drug Administration reviewed your website at the Internet address www.cvs.com in July 2023. The FDA has observed that your website offers ‘CVS Health Pink Eye Relief Drops’ for sale in the United States. Based on our review, this product is an unapproved new drug…This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. In addition, please note that unapproved new drugs are subject to refusal of admission into the United States, and such products may be subject to detention without physical examination.”