‘Unlawful Marketing’ Doesn't Establish Dietary Ingredients' Use Before Drug Approval Or Study
FDA explains thinking in a letter to Inner Mongolia Kingdomway Pharmaceutical after rejecting Chinese firm’s NDI notification for N-acetyl-L-cystein. Prior to its investigation as a drug, NMN wasn’t used in supplements available in US, “except unlawfully without an NDI notification.”
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Trade group contends FDA’s misuse of regulation prohibiting any substance studied or approved as a drug in US from being used as dietary ingredients undermines innovation in supplement industry and is detrimental to consumer choice and health.
Because FDA “suddenly changed its position and advised companies of its determination that NMN is excluded from the definition of a dietary supplement,” Rep. Jeff Duncan states, a public hearing “would be incredibly beneficial as the dietary supplement industry seeks clarity on the FDA’s actions.”
Perrigo doesn’t attempt to diminish significance of challenge to regain sales growth in formula market as it resets its plants. Analysts see formula business as only current impediment to stronger results.