Any treatment offered for sale in the United States must get FDA
approval. I can't speak to the regulations in Canada. Not all products
need to be completely defined, but they will certainly ask how you insure
that each and every lot is safe and effective.
On 16 Jul 1995, Lim Pohyam wrote:
> From the discussions generated from Jay's PCR note, I wonder if a treatment
> regime for alcoholics should get FDA approval to be sold in the US or
> Canada? We have been approach to try FDA approval for a Chinese herbal cure
> for alcoholism. My main concern is that some herbal components may not be
> defined in specific terms. Could anyone tell me?