[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR1.21]



[Page 8]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 1_GENERAL ENFORCEMENT REGULATIONS--Table of Contents

 

                 Subpart B_General Labeling Requirements

 

Sec.  1.21  Failure to reveal material facts.



    (a) Labeling of a food, drug, device, or cosmetic shall be deemed to 

be misleading if it fails to reveal facts that are:

    (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.

    (b) Affirmative disclosure of material facts pursuant to paragraph 

(a) of this section may be required, among other appropriate regulatory 

procedures, by

    (1) Regulations in this chapter promulgated pursuant to section 

701(a) of the act; or

    (2) Direct court enforcement action.

    (c) Paragraph (a) of this section does not:

    (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, or cosmetics under the 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.