FDA WARNING_LETTER - The American Bottling Company, Inc. - March 13, 2012

On March 8-13, 2012, the FDA inspected The American Bottling Company, Inc.'s manufacturing facility in Irving, TX, revealing serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). This renders their lemon and lime juices adulterated under Section 402(a)(4) of the Food Drug and Cosmetic Act.

Key violations include: 1. **Inadequate 5-log reduction control:** The HACCP plan for ReaLemon and ReaLime 100% Lemon/Lime Juices lacks controls to ensure a 5-log reduction of *Listeria monocytogenes*, the pertinent microorganism. Microbial verification studies provided only evaluated *Salmonella* and *E. coli O157:H7* and did not identify critical factors (Brix, acidity, temperature, preservatives, holding time) for achieving the 5-log reduction. 2. **Missing hazards in HACCP plan:** The HACCP plan does not list *Listeria monocytogenes*, metal inclusion from (b)(4) processes, or undeclared allergens/food intolerance substances (specifically sodium metabisulfite) as reasonably likely hazards. While current labels declare sulfites, the HACCP plan lacks ongoing control measures or critical limits to ensure these declarations appear on labels.

The company is responsible for prompt corrective action to prevent recurrence. Failure to comply