Dietary Supplement Business in USA
Hi everyone,
I’m in the process of launching a supplement brand for USA Market. As I know according to the law all responsibility for supplement quality is on the Brand Owner's Company (not on manufacturer), and according to DSHEA 21 U.S.C. § 350b(a) all ingredients that are used in formula if they are not ODI (Old dietary supplements or “grandfathered” dietary ingredient ) are considered to be New Dietary Ingredients and so far should have FDA NDI number. If any of the ingredient in the whole formula have not confirmed regulatory status it is considered as adultered and FDA can restrict all commodities from sales.
I'm confused because as I contact with USA manufacturers (GMP certified with FDA registration) - all of them don't provide any information about quality of ingredients, don't provide any regulatory status for ingredients, no NDI/GRAS or other reasonable reply.
May be I'm mistaken and ask for documents are don't needed for sales in USA?
I would be happy to hear the opinions of experts already in the business: how do you handle the issue of verifying the quality of your formula?
I also realize that this is a sensitive matter, and if no one wants to share their experience, I understand that too.