Analysis and Op-Ed

Although the names sound as though they belong on the letterhead of a law practice, or of an accounting firm, Abbott Nutrition, Ferrero International, and Strauss Group are three distinct companies, located in North America, Europe, and the Middle East, respectively.

Each of these companies is currently managing multinational product recalls.

And two of the recalls have been associated with outbreaks of foodborne disease.

Strauss – Elite Chocolate

On April 19, 2022, Strauss notified Israel’s Ministry of Health that routine testing had revealed the presence of Salmonella “in the manufacturing area” of the company’s Nof HaGlil’ production facility.

The factory manufactures a range of Elite brand chocolate products, and also supplies chocolate to other food processors.

The Ministry of Health instructed Strauss to conduct more extensive tests on its finished products, raw materials, and production environment.

On April 21, 2022, using a rapid test, Strauss found indications of Salmonella in some raw material.

It took an additional three days to confirm these preliminary positive results, during which time no warning was issued to the public. Nor, as far as we can tell, was any product put on hold.

On April 24, 2022, once the preliminary results had been confirmed, Strauss initiated a recall of multiple Elite chocolate products, explaining that Salmonella had been discovered in the production line at the company’s Nof HaGlil’ manufacturing plant. Samples of chocolate used as an ingredient for other products also tested positive for Salmonella.

On April 25, 2022, Unilever Israel recalled multiple ice cream products that contained chocolate supplied by Strauss.

On April 27, 2022, more than one full week after first reporting the presence of Salmonella in the production plant, Strauss expanded its recall to include all expiration dates of all products manufactured by Elite’s chocolate factory, including Elite cakes, Elite wafers, cereal energy bars, chocolate-coated energy rice crisps, bubble gums and taffy candies.

The company has suspended operations at the manufacturing facility while it conducts and investigation into the cause and source of the contamination and carries out an intensive cleaning and sanitizing of the production area.

In addition to being sold throughout Israel, products manufactured in the Nof HaGlil’ facility were exported to multiple countries, including Australia, Austria, Canada, France, Germany, Hungary, Italy, Netherlands, New Zealand, Poland, Romania, Spain, United Kingdom and United States.

Although Israel’s Ministry of Health has not announced any indications of an outbreak linked to the recalled chocolates, The Jerusalem Post reported that a 10-year-old boy was diagnosed with Salmonella on April 27th after being admitted to hospital with severe dehydration as a result of extensive vomiting and diarrhea.

Ferrero – Kinder chocolate products

On December 15, 2021, Ferrero detected Salmonella on the surface and in residual raw materials samples taken from buttermilk tanks in its Arlon, Belgium manufacturing facility.

The company did not notify the Belgian food safety authority of this finding until early April 2022.

Instead, Ferrero suspended production, destroyed the affected semi-finished product, carried out a deep cleaning of the entire line, and resumed production. Finished product manufactured on the line was released for distribution following negative test results.

Additional samples tested in January 2022 also were positive for Salmonella, including two samples from two buttermilk tanks, recorded on January 11th.

As before, the company suspended production, deep-cleaned the line and gradually resumed production.

On February 17, 2022, the UK reported a cluster of monophasic Salmonella Typhimurium cases to the European Centre for Disease Control (ECDC).

Between January 5th and February 8th, Ferrero had submitted nine Salmonella cultures to an Italian lab for serological and molecular typing.

Four of those cultures were a match for the outbreak strain.

By April 8, 2022, the ECDC had received reports of 150 cases from nine EU countries and the UK.

Most of the cases were in children less than ten years of age, and many of the children were hospitalized.

On April 8th, the Belgian food safety authority withdrew its production authorization for Ferrero’s Arlon manufacturing facility, announcing that it could not rely on the information the company had been providing.

That same day, Ferrero recalled all of the Kinder chocolate products manufactured in the Arlon facility.

As of April 19th, the number of cases had risen to 187 cases in 11 EU countries and the UK.

On April 22, 2022, the company expanded its recall to include additional products.

Abbott Nutrition – Powdered infant formula

It could be argued that Strauss’s delay in recalling its chocolate products was relatively minor and without any significant impact on public health.

It is more difficult to justify a similar argument in the case of Ferrero.

Had the company destroyed the finished products impacted by its buttermilk contamination rather than testing and releasing, a multi-national Salmonella outbreak most likely would have been avoided.

Yet, Ferrero’s actions pale in comparison to the situation at Abbott Nutriton’s Sturgis, Michigan production facility, as alleged in a whistleblower complaint lodged with the FDA last October.

According to the whistleblower, company management has been falsifying records, shortchanging preventative maintenance, skimping on sanitation, and turning a blind eye to microbiological problems in the plant.

While we have only the whisteblower’s word for many of the allegations, some of what he or she has reported has been substantiated in the FDA’s Establishment Inspection Reports from September 2019 and September 2021, and in the Inspectional Observations (FDA Form 483) documented during the January – March 2022 investigation of the Sturgis facility, as described in earlier eFoodAlert posts.

FDA actions vis-a-vis Abbott Nutrition

The apparent ease with which Abbott allegedly pulled the wool over the eyes of FDA inspectors during the 2019 and 2021 inspections is troubling, to say the least.

Even though the inspectors were advised during the September 2021 plant visit of consumer complaints of Salmonella infections associated with Abbott products, they did not carry out any independent environmental sampling during the course of their plant visits. Instead, they relied on the company’s reports of how the complaints were investigated and deemed to be unsubstantiated.

Reports of equipment maintenance also were taken at face value, as were sanitation records.

Coincidentally, while the FDA inspectors were on site at Abbott in September 2021, the agency was alerted to the first of four confirmed reports of Cronobacter sakazakii in an infant who had been fed an Abbott powdered infant formula.

The following month, on October 20, 2021, the whistleblower complaint was submitted to the FDA.

The agency did not get around to interviewing the whistleblower until late December, and the FDA did not begin its in-depth investigation into the operations of Abbott’s Sturgis facility until January 31, 2022.

By then, two additional reports of Cronobacter-infected infants and one report of a Salmonella-infected infant had been lodged with the FDA.

Before the completion of the January – March 2022 Abbott inspection, a fourth Cronobacter-infected infant was identified.

TWO OF THE FOUR CRONOBACTER-INFECTED INFANTS DIED.

What next for food safety?

Had Ferrero been living up to its responsibility to produce safe food, there would have been no outbreak of Salmonella Typhimurium in Europe and the UK.

Had Abbott been living up to its responsibility, the four infants would not have become infected with Cronobacter, and the parents of the two dead babies would have been spared a lifetime of grieving.

Likewise, had the FDA lived up to its responsibilities, Abbott’s behavior might have come to light at least two years ago, and the company would have been brought to heel.

There is no excuse for Ferrero, for Abbott Nutrition, or for the FDA.

It is time for food companies who flout good manufacturing practices and who put consumers at risk to pay for their malfeasance.

And it is past time for the US Congress to take a good, long, hard look at the way in which food safety is overseen in the United States.

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Learn more about Salmonella in chocolate and Cronobacter sakazakii in infant formula in TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures, now available in digital, print and audiobook editions.