Confusion over NDA and/or Monographs
Hi, I’ve been curious about aromatherapy products, labeling and what is or isn’t considered a drug. My current product is a leather care product, which is fairly benign, but I’m interested in branching into pet care products as well, including a magnesium oil sore muscle rub and a product that can be used on cannon crud dermatitis in equines. So these products would have a therapeutic or drug claim. The plan is to add active ingredients such as magnesium chloride, willow bark extract, etc. mild ingredients that have therapeutic claims. Would I need to get premarket approval for these or can I simply list certain ingredients as “active” ingredients on the label? I contacted the FDA, but since they are intended for animal use, I was advised to contact the Veterinary Section of the FDA. I sent them email, but they never got back to me. Does anyone know if product claims like “relax muscles, or soothes irritated skin, require an NDA or if you only need to list the active ingredients on the label? I’m just a small hand crafter. Thanks in advance.
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