Recent FDA Warning Letters Issued

In April of 2104, the FDA published nine warning letters to various food manufacturers. A warning letter is the FDA’s primary method of notifying manufacturers that they are not in compliance with the administration’s Current Good Manufacturing Practice, the Federal Food, Drug, and Cosmetic Act or other regulations. The warning letter is usually the first serious action taken after an inspection has uncovered violations serious enough to take action.

FDA Enforcement

Some of the violations uncovered in the April letter included unacceptably high levels of drugs in animals for slaughter, unacceptably high levels of pesticide residue on produce, unacceptably high levels of toxins produced by molds and unsanitary working conditions and food storage conditions. These violations all pose health risks to any consumer who may eat the contaminated product.

The FDA is hoping that a warning letter will trigger voluntary compliance actions. In general, the letter outlines the specific violations and instructs the company to correct the violations within a certain period. If the company fails to correct the violations, the FDA will administer actual penalties. The FDA will usually follow the warning letter with an additional inspection to see if the company has restored compliance. Further legal actions can include fines and recalls up to the closure of the facility that is handling or processing the contaminated food items.

Warning Letters and the Public

Warning letters can still have serious consequences for manufacturers because they are published publicly and can greatly affect the company’s ability to do business, find new clients and sell additional products. A warning letter also provides legal leverage for a consumer who may have been harmed due to contaminated foods.

Many consumers who suffer due to a serious food poisoning or food borne illness can use strict product liability laws to their advantage if they choose to file a lawsuit to reclaim damages for their injuries or illness. Food-borne illness can cause serious injury, large medical bills or even death if not promptly treated. Children and the elderly are especially susceptible to food-borne illnesses.

Under the concept of strict product liability, consumers must only prove that the food they ate was contaminated and that the contamination led to their illness or injury. Since contamination can happen at any stage of food production, a case will attempt to trace that food back along its entire production path. If that path leads to a company or facility that has been issued an FDA warning letter, grounds for a successful lawsuit against that firm increase dramatically.

Warning letters protect both consumer and producers from the more serious consequences of contaminated food by bringing issues to public attention and giving producers a chance to clean up their act and hopefully avoid more serious consequences.