FDA Monographed item for OTC medication
So I have been going round and round, and getting nowhere fast trying to list our new OTC product. Over 2 months now. The active ingredient meets the FDA OTC Monograph requirement, but I keep getting rejected saying "You need a prescription for you product". We have appealed, and gone under a secondary review, but have been told the same thing. I cannot get anyone from the Enforcement Team to speak to me. I sent our label (highlighted) and a copy of the FDA monograph (highlighted) clearly showing this is an OTC product. What other actions can I take?
FDA Monographed item for OTC medication
So I have been going round and round, and getting nowhere fast trying to list our new OTC product. Over 2 months now. The active ingredient meets the FDA OTC Monograph requirement, but I keep getting rejected saying "You need a prescription for you product". We have appealed, and gone under a secondary review, but have been told the same thing. I cannot get anyone from the Enforcement Team to speak to me. I sent our label (highlighted) and a copy of the FDA monograph (highlighted) clearly showing this is an OTC product. What other actions can I take?
9 replies
Glenn_Amazon
Greetings @Seller_pZaQIOwjrzHfD,
Thanks for reaching out with your concerns with your product. In my experience one of the common reasons products indicate prescriptions because the description of the product and the Drugs and drug paraphernalia policy. I'd like to review to see what I can offer to escalate this issue. Can you please reply with your most recent Seller Support Case on this issue for my review? Thank you for your understanding.
-Glenn
