E8-3912. 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° Brix (measure of concentration of sugars in juice) rather than the 48° 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.