[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR570.6]

[Page 486]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 570--FOOD ADDITIVES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec.  570.6  Opinion letters on food additive status.

    (a) Over the years the Food and Drug Administration has given 
informal written opinions to inquirers as to the safety of articles 
intended for use as components of, or in contact with, food. Prior to 
the enactment of the Food Additives Amendment of 1958 (Pub. L. 85-929, 
Sept. 6, 1958), these opinions were given pursuant to section 402(a)(1) 
of the Federal Food, Drug, and Cosmetic Act, which reads in part: ``A 
food shall be deemed to be adulterated if it bears or contains any 
poisonous or deleterious substance which may render it injurious to 
health''.
    (b) Since enactment of the Food Additives Amendment, the Food and 
Drug Administration has advised such inquirers that an article:
    (1) Is a food additive within the meaning of section 201(s) of the 
act; or
    (2) Is generally recognized as safe (GRAS); or
    (3) Has prior sanction or approval under that amendment; or
    (4) Is not a food additive under the conditions of intended use.
    (c) In the interest of the public health, such articles which have 
been considered in the past by the Food and Drug Administration to be 
safe under the provisions of section 402(a)(1), or to be generally 
recognized as safe for their intended use, or to have prior sanction or 
approval, or not to be food additives under the conditions of intended 
use, must be reexamined in the light of current scientific information 
and current principles for evaluating the safety of food additives if 
their use is to be continued.
    (d) Because of the time span involved, copies of many of the letters 
in which the Food and Drug Administration has expressed an informal 
opinion concerning the status of such articles may no longer be in the 
file of the Food and Drug Administration. In the absence of information 
concerning the names and uses made of all the articles referred to in 
such letters, their safety of use cannot be reexamined. For this reason 
all food additive status opinions of the kind described in paragraph (c) 
of this section given by the Food and Drug Administration are hereby 
revoked.
    (e) The prior opinions of the kind described in paragraph (c) of 
this section will be replaced by qualified and current opinions if the 
recipient of each such letter forwards a copy of each to the Department 
of Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine, Office of Surveillance and Compliance (HFV-200), 
7500 Standish Pl., Rockville, MD 20855, along with a copy of his letter 
of inquiry, on or before July 23, 1970.
    (f) This section does not apply to food additive status opinion 
letters pertaining to articles that were considered by the Food and Drug 
Administration to be food additives nor to articles included in 
regulations in this Subchapter E if the articles are used in accordance 
with the requirements of such regulations.

[41 FR 38644, Sept. 10, 1976, as amended at 54 FR 18281, Apr. 28, 1989; 
57 FR 6476, Feb. 25, 1992]

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