FDA Consent Decree Requires Jonlly Fruits to Retain a Labeling Expert

Last month, the FDA entered into a consent decree with Jonlly Fruits, Inc. and its president prohibiting the Puerto Rican company from distributing adulterated beverage products with false claims.  Besides the issue of adulteration, the FDA found that Jonlly’s juice products were misbranded because:

(1) their labels claim that the products are ‘natural,’ and ‘100% natural juice,’ even though the labeling and product formulation sheets indicate that the products contain chemical additives such as sodium benzoate, and artificial colorants Yellow #5 and Red #40″;

(2) their labels bear nutrient content claims, such as “Light,” “100% Vitamin C,” “Rich in Calcium,” “No Sugar,” but the products bearing these claims do not meet the requirements set forth in FDA’s regulations, 21 C.F.R. Part 101.23; and

(3) they fail to bear the common or usual name of the food.

Notably, the consent decree, signed by Judge Gustavo A. Gelpi of the U.S. District Court for the District of Puerto Rico, requires Jonlly to retain an independent “labeling expert” to review Jonlly’s labels and submit a report ensuring that they are in compliance with applicable FDA regulations.  The framework for resolving the serious violations found by the FDA also require  Jonlly to hire sanitation and HAACP experts to provide reports and corrective-action plans, and auditors to monitor the company over a period of years. 

See the FDA press release is here.

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