[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.108]

[Page 162-163]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 101_FOOD LABELING--Table of Contents
 
          Subpart G_Exemptions From Food Labeling Requirements
 
Sec.  101.108  Temporary exemptions for purposes of conducting authorized food labeling experiments.

    (a) The food industry is encouraged to experiment voluntarily, under 
controlled conditions and in collaboration with the Food and Drug 
Administration, with and other formats for presenting nutrition and 
other related food labeling information that is consistent with the 
current quantitative system in Sec. Sec.  101.9 and 105.66 of this 
chapter.
    (b) Any firm that intends to undertake a labeling experiment that 
requires exemptions from certain requirements of Sec. Sec.  101.9 and 
105.66 of this chapter should submit a written proposal containing a 
thorough discussion of each of the following information items that 
apply to the particular experiment:
    (1) A description of the labeling format to be tested;

[[Page 163]]

    (2) A statement of the criteria to be used in the experiment for 
assigning foods to categories, e.g., nutrient or other values defining 
``low'' and ``reduced'';
    (3) A draft of the material to be used in the store, e.g., shelf 
tags, booklets, posters, etc.;
    (4) The dates on which the experiment will begin and end and on 
which a written report of analysis of the experimental data will be 
submitted to FDA, together with a commitment not to continue the 
experiment beyond the proposed ending date without FDA approval;
    (5) The geographic area or areas in which the experiment is to be 
conducted;
    (6) The mechanism to measure the effectiveness of the experiment;
    (7) The method for conveying to consumers the required nutrition and 
other labeling information that is exempted from the label during the 
experiment;
    (8) The method that will be or has been used to determine the actual 
nutritional characteristics of foods for which a claim is made; and
    (9) A statement of the sections of the regulations for which an 
exemption is sought.
    (c) The written proposal should be sent to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. The proposal should be clearly identified 
as a request for a temporary exemption for purposes of conducting 
authorized food labeling experiments and submitted as a citizen petition 
under Sec.  10.30 of this chapter.
    (d) Approval for food labeling experiments will be given by FDA in 
writing. Foods labeled in violation of existing regulations will be 
subject to regulatory action unless an FDA-approved exemption to the 
specific regulation has been granted for that specific product.
    (e) Reporting requirements contained in Sec.  101.108(b) have been 
approved by this Office of Management and Budget and assigned number 
0910-0151.

[48 FR 15240, Apr. 8, 1983, as amended at 59 FR 14364, Mar. 28, 1994; 62 
FR 15343, Mar. 31, 1997]