[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR71.37]

[Page 365]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 71_COLOR ADDITIVE PETITIONS--Table of Contents
 
              Subpart B_Administrative Action on Petitions
 
Sec. 71.37  Exemption of color additives for investigational use.

    (a) A shipment or other delivery of a color additive or of a food, 
drug, or cosmetic containing such a color additive for investigational 
use by experts qualified to determine safety shall be exempt from the 
requirements of section 402(c), 501(a), or 601(e) of the act, provided 
that the color additive or the food, drug, or cosmetic containing the 
color additive bears a label which states prominently, ``Caution--
Contains new color additive--For investigational use only.'' No animals 
used in such investigations, or their products, such as milk or eggs, 
shall be used for food purposes, unless the sponsor or the investigator 
has submitted to the Commissioner data demonstrating that such use will 
be consistent with the public health, and the Commissioner, proceeding 
as he would in a matter involving section 409(i) of the act, has 
notified the sponsor or investigator that the proposed disposition for 
food is authorized. Any person who contests a refusal to grant such 
authorization shall have an opportunity for a regulatory hearing before 
the Food and Drug Administration pursuant to part 16 of this chapter.
    (b) The person who introduced such shipment or who delivers the 
color additive or a food, drug, or cosmetic containing such an additive 
into interstate commerce shall maintain adequate records showing the 
name and post-office address of the expert to whom the color additive is 
shipped, date, quantity, and batch or code mark of each shipment and 
delivery for a period of 2 years after such shipment and delivery. Upon 
the request of a properly authorized employee of the Department, at 
reasonable times, he shall make such records available for inspection 
and copying.