[Federal Register Volume 73, Number 41 (Friday, February 29, 2008)]
[Notices]
[Page 11095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-3912]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0131]


Frozen Concentrate for Lemonade Deviating From Identity Standard; 
Temporary Permit for Market Testing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
temporary permit has been issued to Florida's Natural Growers, to 
market test a product designated as ``Frozen Concentrate for Lemonade 
3+1 Ratio'' that deviates from the U.S. standard of identity for frozen 
concentrate for lemonade. The purpose of the temporary permit is to 
allow the applicant to measure customer acceptance of the product, 
identify mass production problems, and assess commercial feasibility.

DATES: This permit is effective for 15 months, beginning on the date 
the permit holder introduces or causes the introduction of the test 
product into interstate commerce, but not later than May 29, 2008.

FOR FURTHER INFORMATION CONTACT:  Loretta A. Carey, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2371.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 130.17 concerning 
temporary permits to facilitate market testing of foods deviating from 
the requirements of the standards of identity issued under section 401 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341), FDA is 
giving notice that a temporary permit has been issued to Florida's 
Natural Growers, a division of Citrus World, Inc., 20205 U.S. Highway 
27N, Lake Wales, Florida 33853.
    This permit covers limited interstate marketing tests of products 
identified as ``Frozen Concentrate for Lemonade 3+1 Ratio'' that 
deviate from the U.S. standard of identity for frozen concentrate for 
lemonade (21 CFR 146.120) in that the frozen concentrate for lemonade 
is a 3 + 1 fold dilution with a 56[deg] Brix (measure of concentration 
of sugars in juice) rather than the 48[deg] Brix as required in the 
standard. When diluted according to directions that appear on the 
label, the test product contains not less than 0.70 grams of acid per 
100 milliliters and not less than 10.5 percent by weight of soluble 
solids. The test product meets all the requirements of the standard 
with the exception of the 3 + 1 fold dilution. The purpose of this 
temporary permit is to test the product throughout the United States, 
in order to allow the applicant to measure customer acceptance of the 
product, identify mass production problems, and assess commercial 
feasibility.
    This permit provides for the temporary marketing of a total of 
20,000 cases per year of 12 x 32 ounce cartons (240,000 cartons). The 
total fluid quantity covered by this application is 227,100 liters 
(60,000 gallons). The test product will be manufactured at Florida's 
Natural Growers, a division of Citrus World, Inc., located at 20205 
U.S. Highway 27N, Lake Wales, Florida 33853. Florida's Natural Growers 
will distribute the test product throughout the United States. The 
information panel of the labels must bear nutrition labeling in 
accordance with 21 CFR 101.9. Each of the ingredients used in food must 
be declared on the label as required by the applicable sections of 21 
CFR part 101. This permit is effective for 15 months, beginning on the 
date the permit holder introduces or causes the introduction of the 
product into interstate commerce, but not later than (see DATES).

    Dated: February 25, 2008.
Barbara Schneeman,
Director, Office of Nutritional Products, Labeling and Dietary 
Supplements, Center for Food Safety and Applied Nutrition.
[FR Doc. E8-3912 Filed 2-28-08; 8:45 am]
BILLING CODE 4160-01-S