Key parts of notice from the FDA:
“FDA’s Center for Veterinary Medicine (CVM) has completed its review of this shipment and determined these products are intended to mitigate, treat, or prevent disease, or intended to affect the structure or function of the body of animal, they are drugs within the meaning of section 201(g)(1)(B) and (C) of the FD&C Act. These products are not the subject of an approved new animal drug application, abbreviated new animal drug application, conditionally approved new animal drug application, or index listing; the products are unapproved new animal drugs.
These products must be exported or destroyed under Customs supervision within 90 days from the date of this notice, or within such additional time as the Division Director of Custom specifies. Failure to do so may result in destruction of the products. Distribution of the products may result in their seizure and/or injunction or criminal prosecution of persons responsible for their distribution.”
At this time we do not know if the manufacturer will be able to work with the FDA to get the products allowed or approved. But this is the current situation and we will update here in the Blog as we know anything.
This block is for All 3 Dermacton products including the shampoo bar and Ultrasalve.