---
title: "What are the FDA's general requirements for health claims on food labels? Answer in under 100 words. Cite only eCFR (www.ecfr.gov) sources."
canonical: https://www.m-i-n-d.ai/minds/nutrition/fda-health-claim-requirements
jurisdiction: "US Federal"
last_verified: 2026-08-27
license: CC BY 4.0 — https://creativecommons.org/licenses/by/4.0/
attribution: "Source: MIND (m-i-n-d.ai)"
---

# What are the FDA's general requirements for health claims on food labels? Answer in under 100 words. Cite only eCFR (www.ecfr.gov) sources.

Under 21 CFR 101.14, the FDA permits health claims on food labels only when significant scientific agreement supports the substance-disease relationship. Foods must meet disqualifying nutrient thresholds (13.0g fat, 4.0g saturated fat, 60mg cholesterol, or 480mg sodium per RACC), contain 10% or more of the RDI/DRV for vitamin A, vitamin C, iron, calcium, protein, or fiber, and provide nutrition labeling per 21 CFR 101.9 or 21 CFR 101.36.

## Validity and Eligibility

Under 21 CFR 101.14(c), the FDA authorizes a health claim only when significant scientific agreement among qualified experts, based on the totality of publicly available scientific evidence, supports the claim. Under 21 CFR 101.14(b), the substance must be associated with a disease or health-related condition for which the U.S. population or an identified subgroup is at risk.

## General Labeling Requirements

Under 21 CFR 101.14(d), health claims must be complete, truthful, and not misleading; based on conclusions in subpart E regulations; and consolidated in one place without intervening material. A reference statement (e.g., 'See attached pamphlet for information about calcium and osteoporosis') may appear on the principal display panel. Nutrition labeling must accompany any health claim: 21 CFR 101.9 for conventional foods, 21 CFR 101.10 for restaurant foods, or 21 CFR 101.36 for dietary supplements.

## Prohibited Claims

Under 21 CFR 101.14(e), no health claim may be made unless it is specifically provided for in subpart E, conforms to all general and specific provisions, and does not exceed disqualifying nutrient levels. Claims are not permitted for products represented for infants or toddlers under 2 years of age, except as specifically provided for in subpart E (e.g., iron claims for infants).

## Exemptions

Under 21 CFR 101.14(f), infant formulas subject to 21 U.S.C. § 350a(h) and medical foods defined under 21 U.S.C. § 360ee(b)(3) (Orphan Drug Act) are exempt from these requirements. Under 21 CFR 101.14(a)(5), diseases resulting from essential nutrient deficiencies, such as scurvy and pellagra, are excluded from the definition of 'disease or health-related condition.'

## Disqualifying Nutrient Levels

Per 21 CFR 101.14(a)(4), foods exceeding these levels per RACC are disqualified from bearing a health claim unless an exception is provided in subpart E.

## Nutrient Content Thresholds for Eligibility

Under 21 CFR 101.14(e)(6), foods (other than dietary supplements) must contain 10% or more of the RDI or DRV for vitamin A, vitamin C, iron, calcium, protein, or fiber per RACC prior to any nutrient addition.

## Sources

- [1] U.S. National Archives, Electronic Code of Federal Regulations — 21 CFR 101.14 — Health claims: general requirements · https://www.ecfr.gov/current/title-21/section-101.14 · as of 2026-08-27
- [2] U.S. National Archives, Electronic Code of Federal Regulations — 21 CFR 101.36 — Nutrition labeling of dietary supplements · https://www.ecfr.gov/current/title-21/section-101.36 · as of 2026-08-27