In a letter to the company dated July 10, but published yesterday, the FDA said an inspection of the firm’s facility in Irving, Texas revealed serious violations of Regulation 21, Code of Federal Regulations (CFR) Part 120, relating to juice hazard analysis and critical control points (HACCP).
“Your lemon and lime juices are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” FDA Dallas District director Reynaldo R. Rodriguez wrote to American Bottling Company president and CEO Larry Young (who is also DPS CEO and president).
Recounting “serious deviations” at the site, the FDA told the managers that the company must include control measures in its hazard analysis and HACCP plan to “consistently produce at a minimum, a five-log* reduction of the pertinent microorganism for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions”.
(*Log reduction relates to the relative number of live microbes eliminated: a 5-log reduction involves lowering the number of pathogenic microbes 100,000 fold)
These were required under 21 CFR 120, the FDA wrote, but the company’s plan for its ReaLemon 100% Lemon Juice and ReaLime 100% Lime Juice brands did not provide such controls in relation to Listeria Monocytogenes.
Only microbial verification studies relating to Salmonella and E.coli O157:H7 were evaluated, the FDA added, but “the pertinent microorganism in the juice from these concentrates is Listeria Monocytogenes”.
“In addition, the study did not evaluate or identify the critical factors necessary for achieving a 5-log reduction (i.e. specific Brix, acidity, temperature, preservatives), and the time of holding necessary for achieving a 5-log reduction.”
Alerting sensitive individuals
The FDA also warned the American Bottling Company that its HACCP plan did not include metal inclusion or undeclared allergens/food intolerances, since ReaLemon and ReaLime contained sodium metabisulfite.
Discussing the life threatening effects that could result from such intolerances, the FDA wrote: “A declaration of the presence of sulfites in the ingredient declaration is essential to alert sensitive individuals to its presence.
“While we recognize that your current labels contain such a declaration, there are no ongoing control measures or critical limits in your HACCP plan to assure that the declarations appear in the labels.”
Warning the firm that it was responsible for complying with federal law, the FDA instructed the plant’s managers to take prompt action to correct the violations and establish corrective procedures.
DPS had not responded to a request for comment as of October 4, regarding its reply to the FDA letter (subject to a 15-day deadline after receipt) and measures taken; despite a phone call and email approach, the FDA had also not replied to an information request.
Update (10/10/12): An FDA spokesman told BeverageDaily.com that the administration was in the process of reviewing the firm's response to the warning letter.