Code of Federal Regulations Title 21. Food and Drugs § 21.1.21 Failure to reveal material facts

(1) Material in light of other representations made or suggested by statement, word, design, device or any combination thereof;  or

(2) Material with respect to consequences which may result from use of the article under:  (i) The conditions prescribed in such labeling or (ii) such conditions of use as are customary or usual.

(1) Regulations in this chapter promulgated pursuant to section 701(a) of the act;  or

(2) Direct court enforcement action.

(1) Permit a statement of differences of opinion with respect to warnings (including contraindications, precautions, adverse reactions, and other information relating to possible product hazards) required in labeling for food, drugs, devices, cosmetics, or tobacco products under the Federal Food, Drug, and Cosmetic Act.

(2) Permit a statement of differences of opinion with respect to the effectiveness of a drug unless each of the opinions expressed is supported by substantial evidence of effectiveness as defined in sections 505(d) and 512(d) of the act.