[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR71.37]
[Page 337-338]
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
[[Page 338]]
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.
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