‘Somewhat unusual’ FDA consent decree requires company to retain a labeling expert


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‘Somewhat unusual’ FDA consent decree requires company to retain a labeling expert
The FDA has issued a consent decree against a Puerto Rican beverage manufacturer that requires the company to retain a team of experts, including a food labeling expert, to ensure compliance with FDA regulations. 

The consent decree, signed by Judge Gustavo A. Gelpi of the U.S. District Court for the District of Puerto Rico on January. 17, 2013, prohibits Jonlly Fruits, Inc. (Jonlly), and its President, Bartolo Pérez Román from distributing of their fruit and juice products sold under Jonlly’s own label, as well as “Natural Tropic,” “Selectos,” and several other private-label brands.

The consent decree was described as “somewhat unusual”​ by Ricardo Carvajal from Hyman, Phelps & McNamara in the FDA Law Blog​.

“The Labeling Expert must review all of the labels and submit a written report to the Defendants and FDA.  The Defendants must also retain sanitation and HACCP experts,”​ wrote Carvajal.

Jonlly’s and its president have a “long history of violating the Federal Food, Drug, and Cosmetic Act (the Act), by failing to comply with current good manufacturing practice (cGMP) and the juice Hazard Analysis Critical Control Point (HACCP) regulations”​, according to statement from the FDA.

“Our investigators recently inspected the firm and, along with the labeling violations, found mold on a grinder, rust on a bottle-capping machine and rodents in the processing area,”​ said Melinda K. Plaisier, the FDA’s acting associate commissioner for regulatory affairs.

“Today’s aggressive enforcement action demonstrates that the FDA remains vigilant in protecting consumers from products that do not meet federal standards for food safety.”

Aggressive action

Justin Prochnow, a shareholder based in the Denver office of law firm Greenberg Traurig told FoodNavigator-USA that FDA has definitely gotten more aggressive with injunctions and consent decrees during the course of the last six months.

Other recent examples include Venus Pharmaceuticals, a NY-based dietary supplement company, that was hit with a consent decree in October 2012, and was required to engage an external GMP auditor to ensure compliance​.

Another dietary supplement company, Alternative Health & Herbs Remedies of Albany​, Oregon, was hit with an injunction around in October 2012. The terms of that injunction require product claims to be assessed by an expert before the FDA authorizes a resumption of operations.

“If FDA gets a response to a warning letter that it doesn’t like, then it’s going after the companies with injunctions and consent decrees,” ​said Prochnow. 

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