The United States Food and Drug Administration has the power to order companies to remove potentially dangerous food items from retailer shelves. However, according to a recent report from The New York Times, the FDA may be dragging its feet a bit—leaving consumers at risk for dangerous food-borne illnesses.
Federal investigators examined the process by which the FDA orders food manufacturers to remove items from the market. There were approximately 1,557 recalls on food items from 2012 to 2015. The Department of Health and Human Services studied 30 of these recalls.
The agency discovered that the FDA did not always look into food-related hazards as quickly as they should. In some cases, the FDA also did not confirm that the companies started the recall process quickly enough. Both shortcomings put the general public at risk.
On average, food manufacturers took 57 days after the FDA was advised of food-borne hazards to issue recalls. One recall took almost a year—303 days—to begin.
George Nedder, who serves as an assistant regional inspector general for the Department of Health and Human Services, led the investigation. He commented, “Each and every day is important, because every day the product remains on the shelf, consumers are potentially at risk for serious illness or death.”
The FDA governs the production and distribution of almost all of the food in the United States. For example, it is primarily responsible for overseeing almost all processed food items in the country. When it comes to meat and poultry items, the Department of Agriculture handles the recalls.
Roughly 48 million people suffer food-borne illnesses every year in the United States. In this group, 3,000 individuals will die and 128,000 must be hospitalized.
The majority of food recalls are voluntarily issued by manufacturers. In some cases, a company approaches the FDA to report adulteration, mislabeling, or contamination. In others, the FDA goes to a food manufacturer after it receives word of a food-related hazard from a third party, such as a state agency.
In recent months, recalls have been announced for biscotti that contained undeclared nuts, apple slices that were contaminated with listeria, and adobo sauce that was contaminated with salmonella.
In the report, several weaknesses in the FDA’s process were noted. For example, “deficiencies in FDA’s oversight of recall initiation, monitoring of recalls,” and in tracking and compiling recall information. Additionally, hazards were not always investigated promptly.
In June of 2016, the inspector general released an “early alert memorandum” that stated “consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.”
The inspector general noted the following concerning findings:
- It took 165 days for the FDA to recall nut butters that were potentially contaminated by salmonella
- It took 151 days for the FDA to recall hazelnuts that were suspected of salmonella contamination
- It took 82 days to recall a batch of frozen spinach that potentially had high cadmium levels
- It took 27 days to recall cooked duck eggs that contained a bacterium that causes botulism. According to the World Health Organization, botulism toxins are one of the most deadly substances in existence.
Representative Rosa L. DeLauro (D-CT) said, “The latest OIG report confirms what we have known for years. The FDA’s response to food recalls is both slow and inadequate.”
Scott Gottlieb is the Commissioner of the FDA. He explained that the FDA had taken the June 2016 report seriously and had begun working toward improving its response times. Dr. Gottlieb noted that most food recalls are initiated within 4 days of a reported issue. However, Nedder disputed this statement.
Dr. Gottlieb said, “Our ability to affect a recall in a timely fashion is a core consumer protection function of the FDA. If we’re not executing that well, then we’re not fulfilling our mandate.”
Dr. Gottlieb said that the FDA now has a group of senior staff members who review complicated claims and try to speed up the agency’s response.
Though the numbers for food-borne illnesses have remained steady for several years, they are still a serious threat. For example, in 2016, the campylobacter infections were lower in 2016 as compared to the 2013 – 2015 period. However, other infections, such as those from Yersinia, Cryptosporidium, and Shiga toxin-producing E. coli (STEC) increased.
In 2011, President Obama signed the Food Safety Modernization Act. The Act was to provide additional authority over food companies to the FDA. For example, the 2011 law provided the FDA with the power to issue mandatory recalls if a company did not issue a voluntary recall after receiving such a request. The FDA has only used this power on two occasions.
Public Citizen is an advocacy group that was founded by Dr. Sidney Wolfe. He commented that, several years after the Food Safety Modernization Act was signed into law, the FDA should be doing better. He said, “The kinds of things that the inspector general has found are things that might be excusable in the first couple of years. But not seven years into it.”
The FDA has admitted that it faces several challenges. Douglas Stearn is the director of the agency’s office of enforcement and import operations. He said, “We work cooperatively with industry in the overwhelming number of cases. At the same time, we are very dependent on what a firm tells us. Sometimes we do not get all the information we need, and sometimes the information provided is not accurate.”
Food manufacturers may face liability for selling dangerous products
Food manufacturers have a duty to provide products that are safe for consumption. If they sell products that contain dangerous contaminants, they could be liable if consumers become ill.
These lawsuits are known as products liability lawsuits. In a products liability suit against a food manufacturer, the claimant must show:
- The claimant consumed the food item
- The food item was contaminated or otherwise caused illness
- The claimant was injured
- The contamination directly caused the claimant’s injuries
Each of these elements must be proven for the claimant to prevail and recover damages in a products liability lawsuit.
Causation is especially complex in food contamination cases. After all, how does one prove that a food item, as opposed to a virus or other illness, caused symptoms? Proving causation requires consultations with experts and individuals in the food industry. Therefore, if you or someone you know may have been injured by a contaminated food item, it is important to seek the assistance of an experienced attorney as soon as possible. Your attorney will research multiple avenues to determine what contaminant you ingested and will pursue several avenues of recovery to maximize your damages award.
Without an attorney’s assistance, you may unknowingly forfeit legal rights and lose the right to recover damages. There are deadlines in place that limit how long claimants have to file a claim.
Call Parker Waichman LLP today to schedule your free consultation
At Parker Waichman LLP, we are experienced in products liability claims against the food industry. We hold companies accountable when they injure consumers. To schedule your free consultation with our legal team, call 1-800-YOURLAWYER (1-800-968-7529).
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