The point is not that FDA approval is needed to market a nutricutical, it is not. The point is that you cannot call it a "treatment, cure or diagnosis" for any medical condition without FDA approval.
The question is, how limiting on revenue will this be in the short or long run?
The present situation regarding claims of efficacy for non FDA approved substances is ALWAYS associated with this caveat (copied from the web site advertising Diatroxal):
Neither this product or statements about it have been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
So, no matter what claims "appear" to be made in the body of the advertisements and other product descriptive material, this disclaimer presently shields these companies from charges of making false medical treatment claims.
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