FDA Consent Decree Calls for Retention of Food Labeling Expert

February 8, 2013

By Ricardo Carvajal

FDA announced a somewhat unusual consent decree for permanent injunction in which a manufacturer of fruit and juice products agreed to retain a labeling expert (among other experts) to ensure compliance with applicable FDA regulations.  In part, the government alleged that the juice products were misbranded because they were labeled as “natural” and “100% natural” even though they contained “chemical additives such as sodium benzoate, and artificial colorants Yellow #5 and Red #40.”  The product labels were further alleged to bear impermissible nutrient content claims.  The government also alleged that the products were adulterated due to failure to comply with cGMP and HACCP requirements.  These were alleged to be repeat violations.

Under the terms of the consent decree, the manufacturer and its president (Defendants) are permanently enjoined from marketing food “unless and until… Defendants retain, at Defendants’ expense, an independent person or persons (the “Labeling Expert”)… who by reason of background, experience, education, and training is qualified to review Defendants’ labeling and ensure that all such labels are in compliance with the applicable FDA regulations.”  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.