nx_supp_claims.nx

nx_supp_claims.nx -- SUPPLEMENT GTM SUITE / LABEL CLAIMS rung. Classifies a marketing sentence as a lawful structure/function claim or an unlawful disease claim, because that line is where supplement companies actually get warning letters -- more often than for the formula itself. THE LAW IN ONE SENTENCE. A supplement may say what an ingredient does to the normal structure or function of the body. The moment it says the product diagnoses, mitigates, treats, cures or prevents a DISEASE, it is making a drug claim, and an unapproved drug claim makes the product an unapproved drug -- 21 CFR 101.93(g) sets out the criteria this implements. THE PAIRS THAT MATTER, and they are closer than they look: LAWFUL "helps maintain healthy cholesterol levels already in normal range" UNLAWFUL "lowers cholesterol" (implies treating hypercholesterolemia) LAWFUL "supports healthy sexual function" UNLAWFUL "treats female sexual arousal disorder" UNLAWFUL "works alongside your antidepressant to fix SSRI side effects" -- this one is doubly bad: it is a disease claim AND an AUGMENTS-A-THERAPY claim under 101.93(g)(2)(viii). THAT LAST CASE IS WORTH SAYING PLAINLY: the framing "famously used to treat antidepressant-induced sexual dysfunction", which is how ginkgo is usually described in this category, CANNOT go on a label. The underlying research may be perfectly real -- the sentence is still a drug claim. NATURAL STATES ARE NOT DISEASES. FDA is explicit that menopause, pregnancy, aging and adolescence are normal life stages, so "for the relief of hot flashes associated with menopause" is a lawful structure/function claim while "for the treatment of osteoporosis" is not. A classifier that flagged "menopause" as a disease term would be wrong in a way that costs real, lawful marketing -- so the lexicon carves them out explicitly. FAIL-CLOSED, AND DELIBERATELY SO. A sentence with no disease trigger but also no recognisable structure/function frame returns NEEDS_REVIEW, not OK. This organ can retire the easy calls; it cannot replace counsel, and pretending otherwise would be the expensive kind of wrong. Grounding (cited; researcher-groundable): fda_21cfr101_93_structure_function_vs_disease_claims fda_21cfr101_93_g_2_disease_claim_criteria