FDA recently posted a March 5, 2021 Warning Letter to Panther James LLC for the manufacture of untreated juices without a Hazard Analysis and Critical Control Point (HACCP) plan and the required 5-log reduction of the pertinent microorganism that are required under the Juice HACCP regulations at 21 CFR Part 120.  The same violations were the subject of a February 1, 2019 Warning Letter involving Apple Lemon Ginger, Beet #1, Beet #2, Beet #3, Green #1, Green #2, Green #3, Green #4, Carrot Orange Beet, Ginger Shot, Turmeric Shot, Immunity Potion and other juices manufactured at the company’s Berkley, MI facility and sold onsite and at its four retail establishments in the Detroit metro area, as well as distributed wholesale, under the “DROUGHT” brand name, to non-related business entities.

While noting that the exemption from Juice HACCP for a “retail establishment” does not apply here because juice from Panther James’ Berkley facility is sold to other business entities, FDA explains that if it was exempt from Part 120 and not also exempt from registering as a food facility, it would be subject to the preventive control requirements of 21 CFR Part 117, which would require essentially the same food safety plan and hazard control measures as Juice HACCP.  Additionally, FDA’s letter explains how the different definition of “retail food establishment” under Part 117, as compared to “retail establishment” under the Juice HACCP regulations, means that the Berkley facility would not fall within the retail food establishment exemption from the requirement to register, even if sales to outside businesses were eliminated.

FDA’s recent action highlights how the Agency’s regulations allow only very limited exemptions from the requirement for a 5-log reduction of the pertinent microorganism in juices.  Although it is difficult to gauge the likelihood of further FDA enforcement action against DROUGHT juices, where no illnesses have been reported and no pathogens have been detected, any products that FDA has determined are not prepared, packed, or held in compliance with Juice HACCP, are presumed by law to be unsafe (adulterated per se).