FDA WARNING_LETTER - Florida Fruit Juices, Inc. - April 29, 2011

On April 6-29, 2011, the FDA inspected Florida Fruit Juices, Inc., identifying serious violations of 21 CFR Part 101, the Food Labeling regulation. This resulted in four products being misbranded under Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act).

Violations include: 1. **(b)(4) product:** Misbranded because the "Fortified with vitamins" claim on the label is inappropriate for a sugary beverage with no juice, violating 21 CFR 101.54(e)(ii) and 21 CFR 104.20(a). 2. **(b)(4) product:** Misbranded due to incorrect nutrition facts format (21 CFR 101.9). Specific issues include: * Calories (37) not expressed to the nearest 5-calorie increment. * Sodium (87 mg) not expressed to the nearest 5-milligram increment. * Percent Daily Value for trans fat declared, despite no established daily reference value. * Failure to meet bolding requirements for nutrition labels. * Saturated fat and trans fat not indented. * "Not a significant source of" statement incorrectly lists nutrients declared on the label. * "PHENYLKETONURICS: CONTAINS