Quesion1: According to the CFR, if a component is part of an ingredient that is a dietary supplement, can the component be considered a dietary supplement as well?
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Question 2: Does the component that meets the definition per 21 CFR 101.3, need to also file an NDI or is it exempt as a component of an ingredient that is already in the food supply?
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Question 3: What section of the CFR states that it is exempt from NDI if the component must not have been marketed as a dietary supplement before October 15, 1994?
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Question 4: Does the CFR allow a concentrate of a food prior to October 15, 1994, to be marketed as a conventional food without any premarket notification?
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Question 5: If I do an extract of broccoli, where the concentrate is 80% niacin, can It be marketed as a food?
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Question 6: Is an ingredient that is GRAS "General Recognied As Safe" can be marketed as a food according the the CFR?
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Question 7: Can a GRAS ingredient be both a conventional food and at specific concentrations be also a drug?
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