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What to consider if the clinical trial substantiating your U.S. advertising claim is conducted in a foreign country.

Will the wrong trial design make your dietary supplement or functional food an unregistered drug?

The company says that AstraGin has been demonstrated in vitro, in vivo, and in humans to significantly promote and improve absorption of amino acids, glucose, and vitamins.

The Food and Drug Administration (FDA) must reconsider imposing the pre-market approval paradigm of food additives to dietary supplements as proposed in its New Dietary Ingredient (NDI) Draft Guidance, according to a commentary by the Council for Responsible Nutrition (CRN).