Do i need fda approval for marketing herbal medicines in us?

Question

we are manufacturing and marketing herbal medicines in India, what are the requirements for marketing herbal medicines in US?

is it really necessary to seek fda approval for the same?

Answer 1

Na, most herbal type stuff (like that found at "GNC") is not FDA approved.

Then again I've been up all night so my brin isn;t really functioning correctly right now... but thing to do would be to check the FDA website

Answer 2

Herbal supplements still have to be approved by FDA that they are what they say on the label.  You will have to provide testing (analysis) data to the FDA, otherwise they can force you to recall it and pay fines.

Answer 3

If you make specific health claims and you call it medicine, it needs to be FDA approved.