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The FDA’s position, stated explicitly in warning letters, is that RUO disclaimers are “a ruse to avoid FDA scrutiny.” If a product is being marketed in a way that implies human use — through claim language, testimonials, dosing guidance, or the product category itself — the disclaimer is legally irrelevant
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12 Therefore, since folate status modulates both genetic stability and DNA methylation, these critical indices are determined by both dietary intake and the activity of a number of folate metabolism enzymes, many of which exist in polymorphic form
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