Recently, I have had several personal experiences with the Food and Drug Administration (FDA) regarding my business, Fry’s Food and Drug LLC. My business is a franchise of another company that serves similar foods, namely, KFC. When the federal government came to determine if the franchise agreement between the franchisor, Fried chicken and its subsidiary corporation was legal, they were careful to note that this specific franchise arrangement did not affect the legal liability of KFC under the Monopoly Laws. Specifically, the FDA cited that the arrangement did not change the legal relationship between KFC and its franchisees under existing law, such that if a harmed party ever suffered damages as a result of having eaten at one of KFC’s restaurants, then KFC could be held responsible. The FDA did not believe that this holding should extend to the drug dealings between KFC and its various distributors, including its current owner, Simon Thomas.
It seems that the FDA may have overlooked one important consideration: when issuing their opinion, namely that the Food and Drug Administration’s hold on KFC ought to apply to all companies that directly or indirectly contract with the food industry, such as KFC. The FDA holds that a manufacturer of food intended for consumption ought to ensure that all ingredients are approved for human consumption before distributing any pharmaceuticals through any distribution channels, even if the distribution channels happen to be operated by KFC. This includes distributing drugs directly to the pharmaceutical company’s intended customers. The FDA maintains that distribution channels of drugs need to adhere to all federal safety requirements and that company assets must be secure from damages or losses sustained as a result of negligence or intentional misconduct. Because Simon Thomas was primarily a distributor, rather than a manufacturer of food meant for human consumption, it seems likely that the FDA overlooked this possibility in reaching its opinion that KFC should have been held liable for actions undertaken by a distributor rather than a manufacturer.
Although Simon Thomas was ultimately found not to be a manufacturer of drugs: it should be noted that he did supply drugs to KFC at his own expense and had an interest in the food industry. If KFC can be held responsible for distributing drugs to the customer that they personally order when ordering meals from KFC, then what about all of the other food industry distributors that receive food through distributors and suppliers and do not make personal deliveries? The Food and Drug Administration is correct that distributors and suppliers must exercise reasonable care in determining the suitability of any ingredients in food for human consumption. But according to the FDA’s own regulations, if a manufacturer is found to have subcontracted that responsibility to another person, that manufacturer is guilty of “fraudulent conduct.”
So whether the FDA intended to hold Mr. Thomas accountable for what he did or not: the fact is that they did. And that is why it is so important when manufacturing drugs and food products that you properly complete the entire labeling and manufacturing process. You want to make sure that everything as it is manufactured meets all applicable federal, state, and local requirements. Otherwise you run the risk of being found in violation of the law and this could severely damage your company’s reputation in the food manufacturing and distribution industry.
Mr. Thomas could have easily avoided: this unfortunate situation by simply having all of his employees sign a code of conduct prior to being hired by Fries’ Food and Drug division. This would have prevented him from hiring someone who violated either state or federal law during the manufacturing process. It is also quite possible that the Food and Drug Administration would not have brought about such a drastic action against Mr. Thomas; especially considering that this is their job.
It is not the Food and Drug Administration’s responsibility to police the food industry: They simply are responsible for following the law when it comes to manufacturing and distributing drugs and food for human consumption. A good faith effort on the part of the FDA will go a long way toward ensuring that all company’s manufacturing and distributing responsibility for actions taken are held in check and in order.
A drug found to be dangerous because it was improperly manufactured could cause injury or even death. Please think on this.
