21 CFR 369.8
§ 369.8 Warning statements in relation to conditions for use.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 369.8, § 369.8 Warning statements in relation to conditions for use, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86773
- Permanent ID
ys:prov:86773@1- SHA-256
1e6c72a0094fda0a408e6682fe1b78ea6a03e3a1433ee61be75cf7168270462a
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
The mention in any warning or caution statement included in subparts A, B, and C of this part, of a disease condition does not imply a finding on the part of the Food and Drug Administration that any drug or device is efficacious in such condition; nor is any drug or device bearing labeling referring to such disease condition precluded from regulatory action under the applicable provisions of the act if such claim is considered to be misbranding.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.