FDA is providing additional context about the amount of lead in testing results from cinnamon used as an ingredient in the recalled applesauce pouches and in testing results of the recalled pouches. As of December 26, the agency has received 82 confirmed complaints/reports of adverse events potentially linked to recalled product, up from 69 complaints as of December 19. Those impacted are between zero and 53 years of age.

In an interview published on December 14 in Politico, Jim Jones, FDA’s deputy commissioner for human foods, said the agency is still investigating the lead-tainted cinnamon applesauce pouches, but adds that, “so far all of the signals we’re getting lead to an intentional act on the part of someone in the supply chain and we’re trying to sort of figure that out.” The agency’s investigation into how the lead was added is ongoing, and it has not given a conclusion as of December 28.

FDA tested samples of the cinnamon collected from the Austrofoods manufacturing facility in Ecuador and used in the recalled applesauce pouches. The highest result was 5,110 parts per million (ppm), which was more than 2,000 times the level of 2.5 ppm being considered for bark spices.

In addition, the testing results previously reported for the sample of recalled WanaBana cinnamon apple puree pouch collected from Dollar Tree had a lead concentration of 2.18 ppm which, for context, is more than 200 times greater than the action level of 0.01 ppm that the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children.

FDA and state partners have tested at least 136 samples of non-cinnamon containing products and all have been negative for elevated lead levels. Of those, 11 are the Smoothie Mango Passionfruit Banana flavor of WanaBana purees, three of these samples are of the same lot that ARCSA originally reported as positive for lead, and FDA results were negative for elevated lead for all samples. In addition, FDA collected a sample of WanaBana Organic Mango Puree at import and sample results are negative for elevated levels of lead.

The CDC is working in collaboration with state and local health department to investigate the situation as well. CDC’s case definition for state partners includes a blood lead level of 3.5 µg/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit puree product after November 2022.  As of December 22, CDC has received reports of 73 confirmed cases, 157 probable cases, and 21 suspected cases for a total of 251 cases from 34 different states through their reporting structure. CDC and FDA have different data sources, so the counts reported by each agency will not directly correspond.

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The USDA is testing shipments of raw beef and ready-to-eat products from Brazil after reports revealed Brazilian inspectors allegedly were taking bribes to allow sales of tainted food.

This is obviously a concern to many as Brazil is one of the world’s largest beef and veal producers, totaling more than $13 billion in sales last year. The country is also one of the largest exporters of chicken and pork products. So, the fact that inspectors are being investigated for allegedly allowing tainted food to get through is a major concern to the U.S. and other countries who import Brazilian meats.

Agriculture Ministry investigators reported that they have evidence of at least 21 meat companies—including JBS SA and BRF SA, Brazil’s two biggest meat suppliers’—bribing government inspectors to approve sales and exports, even though the meat and poultry was spoiled or contaminated. As of March 27, 33 federal inspectors were under investigation.

Last August, the U.S. and Brazilian governments agreed to open up their respective markets to fresh beef exports, a window expected to boost Brazil’s shipments to the U.S. by $900 million in the year ahead. That could be greatly affected by the scandal.

None of the slaughter or processing facilities implicated in the Brazilian scandal have shipped meat products to the U.S., but the USDA’s Food Safety and Inspection Service (FSIS) has created additional steps to keep the food supply safe for American families and ease consumers’ minds.

FSIS has instituted extra pathogen testing of all shipments of raw beef and ready-to-eat products from Brazil to its already strict safety standards. The agency has also increased its examination all Brazilian products at ports-of-entry across the country.

“Keeping food safe for American families is our top priority,” Mike Young, USDA’s acting deputy secretary, said in an organizational release. “FSIS has strengthened the existing safeguards that protect the American food supply as a precaution and is monitoring the Brazilian government’s investigation closely.”

For the immediate future, the agency will indefinitely maintain its 100 percent re-inspection and pathogen testing of all lots of FSIS-regulated products imported from Brazil.

When the investigation was first announced last week, China, Chile, and Egypt were among the countries banning Brazilian meat, but have since lifted the suspensions. U.S. Senators Heidi Heitkamp of North Dakota and Jon Tester of Montana had also pushed for a U.S. ban, writing a letter to President Donald Trump urging him to suspend imports, citing “the reputation of U.S. beef producers whose meat is sold next to imported meat—now without mandatory country of origin labeling.”

The USDA noted a box of meat imported from Brazil is labeled as coming from Brazil only if it was sold to consumers in its original container, but it is not labeled if it is repackaged or reprocessed.

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The production or distribution of a contaminated product is every food manufacturer’s worst nightmare. In spite of state-of-the-art technology and best practices, no one is immune to the possibility of contamination resulting in adulterated food. The consequences can conclude with a possible FDA recall, damage to the company’s brand, and if someone is injured as a result of the contamination, multiple individual or class action lawsuits. Advance preparation for a possible contamination puts a food manufacturer in the best position to get ahead of harm to consumers and defend any potential liability.

For purposes of this article, assume the food manufacturer is following all steps possible to avoid contamination, including the requirements of the Food Safety Modernization Act and all best industry practices. Despite these efforts, what steps should be taken in anticipation of a possible recall or litigation and what steps should be taken when either occurs?

Advance Preparation
Being able to quickly respond to a possible contamination is critical. In the event of a Class I recall, action is required within 24 hours. In possible litigation, the question will always be raised whether the company acted as quickly and efficiently as possible to minimize danger to consumers.

Before anything goes wrong, identify a crisis management team. The team should be trained on how to respond to a scenario of a contaminated product and should hold drills to practice their response. Internally, the team should include key members of management, quality control, production and distribution. The team should also include outside individuals including a regulatory attorney, litigation attorney, and possibly a public relations firm. A regulatory attorney can assist in determining whether a recall is necessary and help coordinate with the FDA. A litigation attorney is a risk manager who will help to ensure that what the company does or says to address the crisis in the short term has limited ramifications on longer-term liabilities. A public relations firm helps to protect the company’s brand through the process. Each of these team members brings a unique perspective and a base of knowledge that in combination should be able to address the current crisis and minimize the risk of the crisis growing.

Meaningful recordkeeping procedures and maintenance of particular data will also shorten response time. Once a determination is made to issue a recall, the FDA will want to see a Recall Submission. The data sought in this submission is used to track where the contamination may have originated and where the contaminated products may have ended up. Regularly maintaining records in a way that parallels the data will allow for quicker response to the FDA and hasten the manufacturer to get its arms around the scope of the problem. A Recall Submission will ask for product information such as brand and generic names, model and catalog numbers, order numbers, product and packaging physical descriptions, intended uses, self-life, copies of all labeling, inserts, and directions. Submissions must also include various product codes such as lot or unit numbers, expiration dates, use-by dates and universal product codes. Information regarding the volume of the recalled product must be provided including the total quantity produced, dates produced, quantity distributed, and dates distributed. Additionally, information must be provided relating to distribution patterns such as the number of direct accounts sold to, geographic areas of distribution, a detailed list of consignees (including names, addresses, contact names, and phone numbers), and information on both “ship to” customers and “bill to” customers. While this list is not everything that must be submitted to FDA in a Recall Submission, it does include data and information that could be a part of regular recordkeeping procedures.

Recall Response
In the most serious circumstances, manufacturers are required to report to the FDA’s Reportable Food Registry within 24 hours of learning that a food presents a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals (Class I Recall). Where the probability becomes more remote and/or the potential impact less severe, the required response time may be somewhat longer, moving from hours to days (Class II Recall). The FDA has published guidelines helping to determine whether the contamination qualifies as a Class I or Class II. To report a contamination to the FDA, contact the local FDA District Recall Coordinator.

If a recall is warranted, a press release will issue, along with communications to both suppliers and customers. Although the first instinct might be to quickly send out a voluntary notice of recall, that strategy would not be prudent. It is best only one recall notice is published. To do that it is necessary in determining how broad the scope of the recall needs to be. Additionally, the FDA has very specific requirements for the format of an approved notice of recall. The Recall Coordinator will oversee and approve all recall notices. If the scope or the format is wrong, one or more subsequent recall notices will have to be issued—each time bringing more adverse publicity to the company.

While the crisis management team, including regulatory counsel, is addressing the recall and working with the FDA, litigation counsel acts as a risk manager by providing input on how the steps taken and things said during the recall process will impact later potential litigation. What is said and done during the recall process may ultimately have to be explained to a jury.

Litigation Response
Litigation may result from the same contamination as gave rise to the recall. Litigation may also arise wholly independent of any previously known contamination. In either event, the first three steps are the same. First, contact litigation counsel, as there are deadlines by which a lawsuit must be answered after it is served. Second, put the insurance carrier on notice. If the carrier isn’t notified within a reasonable time, coverage may be denied. The insurance carrier may also have the right to demand the company use a particular attorney to defend the lawsuit. Third, a litigation hold must be put in place within the company. A litigation hold requires that documents, electronic data, or any type of evidence that might be relevant to the lawsuit be protected and not destroyed. Failure to do this could result in a court instructing a jury that it can infer there was damaging evidence in what was destroyed.

If the litigation arises without having first gone through the recall process, a thorough investigation needs to be done to determine whether or not a contamination occurred and if so, what caused it. An internal investigation should not begin until legal counsel is involved. If an investigation is done at the direction of counsel and “in anticipation of litigation,” the findings are protected by the attorney client privilege and work product doctrine. If counsel is not involved, all investigation and interviews are discoverable by the opposing party.

A lawsuit for injuries from an adulterated food product can be brought under a number of different theories of law. The two most frequent theories are negligence and strict liability. The particulars of both theories vary by state law. In negligence, the fault of the manufacturer is compared to the fault of the plaintiff and sometimes to the fault of others. Fault can be measured in part by showing failure to comply with industry standards, failure to use state-of-the-art, and failure to respond quickly when a contamination was discovered. Strict liability claims are much harder to defend. While state laws vary, in some states a manufacturer who puts an adulterated product into commerce is going to bear the liability regardless of its lack of knowledge of the contamination or its good faith efforts to prevent it from occurring.

Hazardous Products
The most difficult type of lawsuit to handle is one which claims that the food product caused injuries because it, or one of its ingredients, is hazardous to the health of consumers or food handlers, despite the fact neither the government nor the industry recognizes the product or ingredient as hazardous. These types of lawsuits gradually grow over time and must be managed long before the lawsuit actually occurs.

Initially, a scientist or doctor may issue a report that a particular food or food ingredient causes some type of injury or illness. Other scientists or doctors may dispute the initial claims. What should a food manufacturer do? If it undertook to change its formulas every time a rogue claim asserted some new medical harm, the company would be out of business. But as time goes by and the evidence both for and against the claimed hazard continues to grow, when will a jury ultimately say the manufacturer has enough “knowledge” that it should have taken steps to protect against the hazard? One can be certain that a plaintiff’s attorney will argue their client was injured because the manufacturer failed to take action based on that first rogue claim.

A reasonable person might assume if a manufacturer is producing food products in compliance with FDA regulations and industry standards, it should have no concern of civil liability. But in most states, compliance with the law and current industry standards provides only limited evidence that the food manufacturer was not negligent. It is still left to a jury to decide whether a “reasonable person” with the knowledge available to the manufacturer would have acted (or not acted) as it did.

To manage these particular types of claims, a manufacturer must monitor publically available information regarding its products and the ingredients in its products. When adverse reports are made public, the debate both for and against should be monitored. Industry standards and governmental guidelines should be followed. If evidence of hazard mounts or if others in the industry begin to react and restrict the use of the product, a decision whether to change course is necessary.

Hardee, a Polsinelli shareholder, has more than 25 years of litigation experience, representing clients in the food industry, toxic and mass tort litigation, product liability issues, business disputes, and transportation disputes. Reach her at khardee@polsinelli.com.

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