I was wondering if anyone has had experience with the FDA and
transdermal (TD) nutritional supplement delivery. I have considerable time and resources invested in developing TD delivered vitamins. My questions and conversations with the FDA about regulations respective to TD and vitamins have produced usless double-talk. Any comments out there?

[would think that checking the history and references for drugs like theophiline would be helpful

jim



quote=DrDave]I was wondering if anyone has had experience with the FDA and
transdermal (TD) nutritional supplement delivery. I have considerable time and resources invested in developing TD delivered vitamins. My questions and conversations with the FDA about regulations respective to TD and vitamins have produced usless double-talk. Any comments out there?[/quote]

DrDave said:

I was wondering if anyone has had experience with the FDA and transdermal (TD) nutritional supplement delivery. I have considerable time and resources invested in developing TD delivered vitamins. My questions and conversations with the FDA about regulations respective to TD and vitamins have produced usless double-talk. Any comments out there?

Was involved with a project /company which produced TD theophyline awhile back and haven't kept up with the field but it could be that your task is as much to educate the regulators about things they're not up on in your quest for FDA approval and their history with similar products often has a lot to do with their attitudes. There is a lot of info on the FDA's thinking available on line also by looking on their homepg. for 483 's they have issued to similar companies.

jim