It has been ruled in the US Court of Appeals that a tomato farmer from South Carolina cannot recover damages for an emergency, erroneous FDA food-safety warning that was aimed at tomatoes, when it was later found to be imported peppers that were at fault.
The ruling on Dec 2nd by the US Court of Appeals for the Fourth Circuit stated that the Food and Drug Administration (FDA) is not to be held liable for the financial damages that farmers suffer due to them issuing emergency but erroneous warnings regarding food safety.
The tomato farmer sought to claim over $15 million in damages under the Federal Tort Claims Act, following a warning issued by the FDA regarding an outbreak of Salmonella Saintpaul bacteria from contaminated tomatoes. It later transpired that the cause for the outbreak was imported contaminated peppers from Mexico.
Protecting public health
The court ruling supported the FDA in its issuing of emergency food safety warnings that are based on initial information and provided to protect public health. To rule against the FDA in this case would open the floodgates for any injured companies seeking compensation against the FDA, for anything other than perfect accuracy. The FDA must feel able to issue warnings against contamination that could protect consumers against serious or even fatal illnesses, that only a timely warning can avert.
FDA 510k clearance submission
The FDA has many areas to oversee in order to protect the public with regards to food and drug safety. New products must be reviewed by the FDA and cleared before they are allowed on the market. Specialist providers such as http://www.fdathirdpartyreview.com/ help companies to expedite their 510k submissions, which can reduce time to market by as much as 100 days. This beneficial fast track process can help companies achieve their targets and financial success by getting their products to market before their competitors.
The FDA has broad discretion in the issuing of food safety warnings, as laid out by the Food, Drug and Cosmetic Act. The Food Safety Modernization Act was signed by President Obama in January 2011, providing a sweeping overhaul of the laws regarding food contamination. Public health is at the forefront of the bill, giving the FDA the power to issue warnings as and when it feels appropriate.