We have shared many articles about the highly regulated pharmaceutical industry. Still, we don’t often think about all the other products the FDA may periodically come across through inspections that we don’t categorize as pharmaceuticals. A well-known natural ingredient toothpaste brand needed to make swift changes when the FDA accused the toothpaste maker of bacteria-tainted water supply after a said inspection.

Tom’s of Maine, received a warning letter from the FDA after several of their toothpaste formulas in which water is used for processing were found to contain “multiple types of bacteria including those linked to infections of the blood, lungs and eyes. Since water is a major ingredient in many of Tom’s over-the-counter products, the company must institute a robust, pharmaceutical-grade water system that they can “control, maintain and monitor.”

Manufacturers should be prepared for swift action to bring their organization back into compliance. Tom’s brought in water specialists to evaluate their water systems and implement additional safeguards to ensure they are meeting the FDA’s requirements.

While this scenario doesn’t specifically involve labeling issues, if the potentially contaminated product made it out to the consumer, the need to locate and recall the items would be of utmost importance. Having a reliable labeling solution to quickly identify affected lots and properly dispose of the product is essential to minimize supply chain interruptions and brand reputation. Pragmatyxs can help companies find the best solution based on their specific product and business needs.