[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR170.17]

[Page 11]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 170_FOOD ADDITIVES--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 170.17  Exemption for investigational use and procedure for obtaining 
authorization to market edible products from experimental animals.

    A food additive or food containing a food additive intended for 
investigational use by qualified experts shall be exempt from the 
requirements of section 409 of the Act under the following conditions:
    (a) If intended for investigational use in vitro or in laboratory 
research animals, it bears a label which states prominently, in addition 
to the other information required by the act, the warning:

    Caution. Contains a new food additive for investigational use only 
in laboratory research animals or for tests in vitro. Not for use in 
humans.

    (b) If intended for use in animals other than laboratory research 
animals and if the edible products of the animals are to be marketed as 
food, permission for the marketing of the edible products as food has 
been requested by the sponsor, and authorization has been granted by the 
Food and Drug Administration in accordance with Sec. 511.1 of this 
chapter or by the Department of Agriculture in accordance with 9 CFR 
309.17, and it bears a label which states prominently, in addition to 
the other information required by the Act, the warning:

    Caution. Contains a new food additive for use only in 
investigational animals. Not for use in humans.
    Edible products of investigational animals are not to be used for 
food unless authorization has been granted by the U.S. Food and Drug 
Administration or by the U.S. Department of Agriculture.

    (c) If intended for nonclinical laboratory studies in food-producing 
animals, the study is conducted in compliance with the regulations set 
forth in part 58 of this chapter.

[42 FR 14483, Mar. 15, 1977, as amended at 43 FR 60021, Dec. 22, 1978]