FDA Slams OTC Drugmaker for Exceeding Monograph

The FDA is calling out an OTC drugmaker for selling an asthma inhaler in an unapproved format that may not work for patients.

In a March 10 warning letter, the FDA’s Philadelphia District Office cited the online store, Dr. Natural Healing, for distributing an unapproved new drug, misbranding two products and relying on an untested method for drug delivery. The letter asked the company to respond within three weeks with a list of all corrective measures taken and documents corroborating those steps.

The agency highlighted one of the company’s epinephrine-based products, which is considered an unauthorized new drug because it does not conform to the FDA-approved monograph for OTC bronchodilators.