Oxford Selling Unapproved, Misbranded Covid Items: FDA

FDA says Oxford Medical Instruments USA, Carlsbad, CA, is selling through a Web site salt inhaler products intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. An 8/11 Warning Letter says the agency has determined that the products are misbranded unapproved new drugs.

“We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of Covid-19,” the letter says.

Oxford was told to respond with a list of specific actions taken to correct the violations and a timetable for completion if the actions need more than 48 hours. The company also was told to immediately cease making any claims that its products can prevent, treat, or cure human diseases since there is no reliable scientific evidence, including well-controlled human studies, to support any such claims.