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Medical Foods |  |
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Medical Foods(MF) Claims vs. Drug Claims By statutory and regulatory definition, product claims must be explicitly different for medical foods (MF) versus drugs. Generally, MF claims reference the “dietary management” or “distinctive nutritional requirements” of a particular disease, whereas drug claims reference “curing, treating, preventing or mitigating”a disease or the effects or symptoms of a particular disease. For example, a MF may claim the dietary management of the metabolic processes of osteoarthritis, whereas a drug may claim the reduction of osteoarthritis pain. A MF must meet the distinctive nutritional requirements of a disease through dietary management, whereas a drug may address any aspect of a disease or its treatment or prevention. Claims for both MFs and drugs must be supported by solid scientific and clinical data. Their formulas
and efficacy must be established by medical determination. |
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