[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
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]
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