Structure/Function Claims vs. Disease Claims: Decoding Supplement Labels

by Jason J. Duke - Owner/Artisan

Fresh Content: December 11, 2025 16:51

Why can't a supplement say it "Cures" anything? Because it is illegal, not necessarily because it is untrue. The FDA mandates a specific linguistic architecture. We distinguish between Disease Claims (strictly forbidden for food) and Structure/Function Claims (the legal grammar of Cultivation). We do not look for medical promises on a food product; we look for functional support.

Conceptual diagram contrasting the crossed-out word CURES (Medical Model) with the glowing word SUPPORTS (Cultivation Model)
Figure 1: The Grammar of Cultivation. (Click to Enlarge) Left: The Forbidden Medical Claim. Right: The Permitted Functional Truth.

The Audit: The Three Tiers of Claims

Claim Type Definition (Legal Status) The Language Used Sovereign Example
Disease Claim Implies treatment or prevention of pathology. Illegal for supplements. "Treats," "Cures," "Prevents," "Mitigates," "Heals." "Vitamin C cures the flu." (REJECTED)
Structure/Function Describes effect on normal physiology. Legal (with disclaimer). "Supports," "Maintains," "Promotes," "Nourishes." "Vitamin C supports immune system function." (ACCEPTED)
Nutrient Content Describes the level of a nutrient. Legal (if true). "High potency," "Excellent source," "Free from." "Excellent source of Vitamin C (100% DV)."

1. Structure/Function: The Language of Physiology

Under DSHEA 1994, dietary supplements are permitted to make statements that describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function in humans. This is the "Grammar of Cultivation."

These claims focus on the maintenance of homeostasis and the potentiation of health, rather than the correction of a defect. For example, "Calcium builds strong bones" describes a structural impact. "Antioxidants maintain cell integrity" describes a functional impact. This language aligns with the Sovereign view of the body as a system to be stewarded, not a machine to be fixed.

2. Disease Claims: The Legal Trap

A "Disease Claim" is any statement that implies a product can diagnose, cure, mitigate, treat, or prevent a disease. In the eyes of the FDA, only a drug can make these claims.

If a supplement label says "Lowers Cholesterol" or "Relieves Arthritis Pain," the FDA classifies that product as an Unapproved New Drug. This regulatory binary creates a situation where a supplement may be scientifically proven to help a condition (e.g., Magnesium for migraine prevention), but cannot legally state that fact on the bottle. The Sovereign must learn to read between the lines: look for the physiological mechanism ("Relaxes vascular tension"), not the medical outcome.

3. The Disclaimer: The Line in the Sand

You have seen it on every bottle: "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."

This is not an admission of inefficacy. It is a Jurisdictional Boundary. It acts as the legal firewall between the category of Food and the category of Drug. It ensures that the consumer understands they are engaging in self-cultivation (Food/Nutrition), not medical intervention (Pharma). We do not view this as a warning label; we view it as a badge of honor that the substance remains in the public domain.

The Sovereign Reframe: Do not look for medical promises on a food product. Look for functional support. If a supplement claims to "Cure," it is lying or breaking the law. If it claims to "Nourish," it is speaking the truth of nature.

Codex IV: The Sovereign Navigator

You have decoded the claims. Now, learn to evaluate the science behind them: