Tag: FDA Warning Letter

Cronobacter in infant formula: getting to the “root” of the problem

On August 30, 2023, the US Food and Drug Administration (FDA) issued formal Warning Letters to three manufacturers of powdered infant formulas: ByHeart, Inc., Reckitt/Mead Johnson Nutrition, and Perrigo Wisconsin, LLC.

That same day, the FDA released the redacted content of those Warning Letters to the public.

The letters reflected the agency’s concern that the companies had not established “ …a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment…”

According to the information contained in the Warning Letters, all three companies had a history of Cronobacter sakazakii contamination in the production environment, with occasional positive finished product samples. And all three companies failed, in the FDA’s estimation, to conduct a thorough “root cause analysis” to determine and correct the source of their contamination issues.

Case-by-case overview

Although the general conclusions reached by FDA investigators were similar for all three companies, each situation presented its own challenges. 

ByHeart, Inc. 

The FDA conducted its inspection of ByHeart’s Pennsylvania manufacturing subsidiary from December 21, 2022, through February 17, 2023. The operation, located at 61 Vanguard Drive, Reading, PA, manufactured an infant formula base product that was subsequently blended and packaged at a third-party contract manufacturing facility.

In October 2022, the company learned that a powdered infant formula product manufactured during a continuous production campaign at the facility from July 13, 2022, through August 23, 2022 and blended and packaged from September 15, 2022 through October 7, 2022, had tested positive for Cronobacter sakazakii.

The company’s “root cause analysis” blamed the positive result on lab error on the part of a third-party laboratory. A detailed review of the laboratory’s protocols and records found no basis to support such a conclusion.

A separate infant formula base mix that was manufactured on August 24, 2022, also tested positive for the pathogen.

This contamination event was blamed on a failure to follow specified cleaning and sanitation procedures following maintenance work and valve repair. 

Cronobacter sakazakii also was found in multiple locations in the production environment from July 25, 2022 through August 27, 2022, all of which were attributed to “…isolated events such as facility repairs, using an ineffective sanitizer, or ineffective cleaning frequency.”

In it’s Warning Letter, the FDA emphasized that the company’s root cause analyses were inadequate and did not get to the root of the problems. For example, ByHeart could have—should have, in the agency’s opinion—carried out whole genome sequencing (WGS) on the various Cronobacter sakazakii cultures in order to determine whether or not the same strain was consistently present in the production plant.

Perrigo Wisconsin, LLC

The FDA’s inspection of Perrigo’s Eau Claire, Wisconsin, manufacturing facility took place from March 6 through April 26, 2023.

On four separate occasions prior to and during the FDA inspection, the company found Cronobacter sakazakii in samples of its spray-dried infant formula manufactured during the period from October 2022 through April 2023.

The company blamed the contamination variously on probable cross-contamination betwen the dryer environment and the product contact equipment, packaging line downtime due to multiple scoop jams during production, and potential contamination introduced into the packaging line during increased dry cleaning interventions.

The FDA took exception to Perrigo’s root cause analysis in each case, pointing out that the company had not thoroughly investigated the source of the contamination. In addition, the agency expressed its disapproval of the company’s sanitation protocols and practices, stating:

“The detection of C. sakazakii in your facility across multiple independent inspections is significant in that it demonstrates your sanitation procedures have been inadequate to significantly minimize or prevent the presence of C. sakazakii in your facility.”

Reckitt/Mead Johnson Nutrition

The FDA Warning Letter detailed outstanding issues at two separate manufacturing plants: Zeeland, Michigan (inspected from February 7, 2023, through February 23, 2023) and Wanamingo, Minnesota (inspected from November 28, 2022 through January 9, 2023).

As was the case for Perrigo and ByHeart, FDA investigators found evidence of multiple reports of Cronobacter sakazakii in both finished products and environmental swab samples at both manufacturing plants

The FDA was once again unhappy with the manufacturer’s response to the Cronobacter-positive findings, stating, “Upon receiving notification of this result, you failed to conduct an independent root cause analysis or investigation and you did not evaluate whether other products may have been impacted by this contamination event.”

Root cause analysis

Cronobacter sakazakii is a common presence in the environment, and can be found in soil, surface water, mud, grains, rotting wood, bird droppings, and food. 

The microbe is relatively harmless to most people, but can cause severe illness, often leading to death in susceptible individuals, especially in preterm, low-birthweight, immunocompromised, and/or infants under than 28 days of age.

It is, therefore, incumbent upon manufacturers of powdered infant formulas to take every possible step to ensure that their products are not contaminated with this potentially dangerous microbe.

In principle, any finding of Cronobacter sakazakii in the production environment or finished infant formula should trigger what is known as a “root cause analysis”—a systematic and intensive effort to find the source of the contamination and to make the necessary corrections before proceeding with additional production.

In practice, what ByHeart, Mead Johnson, and Perrigo did was to treat the symptoms rather than diagnose and correct the problem.

For example, in some instances, the companies responded to the finding of Cronobacter by performing an intensive cleaning and sanitizing without first carrying out environmental sampling to determine where in the production or packaging environment the microbe was lurking.

The sanitation effort provided a temporary solution, but did not prevent a recurrence of the contamination. Effectively, this approach treated the symptoms, rather than eliminating the source(s) of the contamination.

In its trilogy of Warning Letters, the FDA emphasized that a proper root cause analysis must be comprehensive and complete in order to be of value in determining the source of a contaminant. 

Only once the source has been identified correctly can a long-term, effective solution to the problem be put into effect.

What next for infant formula safety?

In its August 30, 2023, news release announcing the Warning Letters, the FDA pledged its commitment to ensuring the safety of powdered infant formula, stating,

“The FDA will continue its regulatory oversight and engagement with industry to enhance infant formula safety, including continuing to conduct annual inspections of infant formula facilities, maintaining a dialogue with infant formula manufacturers on these issues, and furthering prevention-based research and activities.”

It behooves all manufacturers of powdered infant formula to do their part to maintain safe and sanitary production environments and to take all precautions necessary for the production of pathogen-free products, especially as these products are destined for the nourishment of a highly susceptible population.

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Darwin’s drags feet on pet food recall request—again

Arrow Reliance, Inc., doing business as Darwin’s Natural Pet Products (Darwin’s), has delayed acting on a request from the US Food and Drug Administration (FDA) to initiate a recall of three Salmonella-contaminated raw pet foods.

This information is contained in an August 16, 2023 FDA Advisory cautioning pet owners not to feed their pets certain lots of Darwin’s Natural Pet Products raw cat and dog food.

The FDA issued its advisory out of concern that pet owners might feed the contaminated products to their pets, warning that the Salmonella-contaminated products, “…pose a significant risk to human and animal health.”

The following three products, all of which have tested positive for Salmonella, were listed in the FDA notice:

  • Darwin’s Natural Pet Products Natural Selections Chicken Recipe with Organic Vegetables for Dogs, Lot 9774, manufactured on Jun 13, 2023.
  • Darwin’s Natural Pet Products Natural Selections Chicken Recipe for Cats, Lot 9795, manufactured on Jun 28, 2023.
  • Darwin’s Natural Pet Products Natural Selections Chicken Recipe for Cats, Lot 9830, manufactured on Jul 19, 2023.

Not for the first time

Darwin’s has a troubled history dating back as far as 2016 with both the FDA and the Washington State Department of Agriculture (WSDA).

in 2016, the WSDA found Salmonella in a sample of a Darwin’s raw dog food.

In 2017, the FDA found both Salmonella and Listeria monocytogenes in a sample of Darwin’s dog food after a consumer complained that the product had made her dog ill.

In 2018, the FDA alerted the public to a “pattern of contamination” in Darwin’s raw pet foods after the agency found Salmonella, Listeria monocytogenes, and E. coli O128 in samples of the company’s products.

During a multi-day inspection of the company’s manufacturing facility in 2018/2019, the FDA found Salmonella and Listeria monocytogenes in the production environment, and also recovered Salmonella from finished product samples.

In 2022, in a follow-up to yet another consumer complaint, the FDA found two different Salmonella serotypes in samples of a Darwin’s cat food.

The inspections conducted in 2017/2018 and in 2022 both resulted in the issuance of a formal Warning Letter to the company.

In its response to the 2022 Warning Letter, obtained in response to a Freedom of Information Act request, the company simply refused to correct any of the violations listed in the letter.

Voluntary recalls and FDA Cautions/Advisories

In 2016/2017, Darwin’s quietly recalled several products, advising its customers of the recalls via direct email messages.

In March 2018, the company recalled four additional products after the FDA found Salmonella, Listeria monocytogenes, and/or E. coli O128 in samples of the items.

However, Darwin’s has not always been compliant with the FDA’s recall requests. As a result, the agency has released a total of four Cautions or Alerts for pet owners, including the most recent Advisory issued on August 16, 2023.

  • February 13, 2018:- FDA Investigates Pattern of Contamination in Certain Raw Pet Foods Made by Arrow Reliance Inc., Including Darwin’s Natural Pet Products and ZooLogics Pet Food
  • March 26, 2019:- FDA Cautions Pet Owners Not to Feed Their Pets Three Lots of Darwin’s Natural Pet Products Raw Dog Food Due to Salmonella
  • August 5, 2022:- FDA Cautions Pet Owners Not to Feed Certain Lots of Darwin’s Natural Pet Products Due to Salmonella
  • August 16, 2023:- FDA Advisory: Do Not Feed Certain Lots of Darwin’s Natural Pet Products for Dogs & Cats Due to Salmonella

What will happen next?

The FDA has multiple enforcement tools in its arsenal. However, the most effective ones also tend to be the most difficult to implement.

When the FDA classified the results of its 2022 inspection at Darwin’s as “Official Action Indicated,” the tool it turned to was a formal Warning Letter, in which it set out a list of the violations observed during the course of the inspection and the company’s (lack of) substantive response to the requested corrections. The agency gave Darwin’s the standard fifteen (15) business days in which to respond with either proof of corrections or a written plan for making them.

Darwin’s simply declined to comply.

As this most recent FDA Advisory demonstrates, the Warning Letter was completely ineffective.

Mandatory Recall

The FDA has the authority under the Food Safety Modernization Act to mandate a recall of a contaminated product that it believes to represent a hazard to human or animal health. It has exercised this authority sparingly over the years, preferring to obtain voluntary compliance on the part of a manufacturer.

Mandating a recall is not a trivial exercise. It requires several administrative steps, and can only be undertaken with the approval the FDA Commissioner, and after the company has been given written notice and one last chance to initiate a voluntary recall. At any stage in the administrative/notification process, there is a risk that the company will choose to seek an injunction to block the FDA’s action.

Suspension of Federal Food Facility Registration

Under the Food Safety Modernization Act, all food facilities under the FDA’s jurisdiction must register with the FDA and renew their registration every two years.

The FDA has the authority to suspend a food facility’s registration, effectively shutting down its activities, if, “…food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals…”

While this would appear to be a very effective tool, Darwin’s has never registered with the FDA as a food facility, claiming that its direct sales business model and the fact that it does not distribute through a third party exempts the company from this requirement.

As indicated in the 2022 Warning Letter, the FDA disagrees with the company’s interpretation.

Request For Injunction—The Nuclear Option

When a company demonstrates a pattern of behavior that flouts the laws and regulations under which every member of its industry is required to operate and declines repeatedly to comply with those laws, the ultimate tool in the regulatory arsenal is to petition the Court to order compliance.

The FDA was forced to follow this path in 2021 when faced with egregious acts of non-compliance on the part of Bravo Packing, Inc., a New Jersey-based producer of raw foods for companion animals and exotic (zoo) animals.

This is a costly and time-consuming process, and is viewed by the agency as a last resort.

What Darwin’s customers need to know

The FDA Advisory offers the following advice to pet owners who may have purchased one of the recalled products.

  • If you have any of the Darwin’s Natural Pet Products Natural Selections cat or dog foods listed above, stop feeding it to your pets and throw it away in a secure container where other animals, including wildlife, cannot access it. 
  • Consumers who have had this product in their homes should clean refrigerators/freezers where the product was stored and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, litter boxes, toys, floors, and any other surfaces that the food or pet may have had contact with. Clean up the pet’s feces in places where people or other animals may become exposed. Consumers should thoroughly wash their hands after handling the product or cleaning up potentially contaminated items and surfaces.

How to report a pet illness

There is no animal equivalent to the CDC. There is no mandatory reporting of animal illnesses. The FDA relies on voluntary reporting of pet illnesses by pet owners and veterinarians in order to spot potential outbreaks of animal illnesses due to contaminated pet food.

People who think their pets have become ill after consuming contaminated pet food should first contact their veterinarians. Veterinarians who wish to have pets tested for Salmonella may do so through the Veterinary Laboratory Investigation and Response Network (Vet-LIRN Network) if the pet is from a household with a person infected with Salmonella. 

The FDA encourages consumers to report complaints about pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.

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PET FOOD IS A RISKY BUSINESS

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FDA warns Darwin’s in follow-up to sick cat complaint

The US Food and Drug Administration (FDA) has issued a stern warning to Arrow Reliance Inc. (doing business as Darwin’s Natural Pet Products), following what the agency referred to as an “inadequate” response to violations of the Food Drug and Cosmetics Act (FD&C Act) documented during an August-September 2022 inspection.

The inspection was carried out in response to a consumer complaint received by the FDA, in which the consumer reported that a Darwin’s cat food had caused illness in three kittens. The consumer provided documentation that a stool sample from one of the kittens tested positive for Salmonella.

Background

On July 8, 2022, the FDA was contacted by a consumer who complained that Darwin’s cat food had made her three kittens ill.

The FDA collected unopened packages of the suspect food from the consumer and found Salmonella in two samples.

With the Salmonella-positive results in hand, the FDA urged Darwin’s to initiate a recall of the contaminated products.

The company refused, and the FDA advised Darwin’s that the agency would issue a public caution.

On July 29, 2022, Darwin’s filed a request in federal court for a temporary restraining order to prevent the FDA from releasing information about the contaminated products to the public.

The court rejected the company’s request, and on August 5, 2022, the FDA finally was able to issue a caution to pet owners, advising them not to feed certain Darwin’s cat foods to their pets due to Salmonella contamination.

On August 23, 2022, the FDA began an inspection of Darwin’s manufacturing facility and, on September 30, 2022, handed a completed list of Inspectional Observations (FDA Form 483) to the company.

The company’s Director of Quality replied to the list of observations on October 14th.

What Darwin’s claims

Darwin’s claims that its Salmonella-contaminated raw pet foods are not adulterated, because (a) the microbe is not an “added substance,” and (b) it is up to the FDA to demonstrate that the Salmonella is present at a level that makes it “ordinarily injurious” to the intended consumer.

In its filing for the temporary restraining order, the company made reference to USDA enforcement policies for Salmonella and questioned why it should be acceptable for the pathogen to be present in raw poultry, beef and other meats for human consumption, but not in pet food.

Unresolved issues

1. Adulterated Animal Food

The FDA collected and analyzed unopened samples from the complainant.

One of the samples contained Salmonella Typhimurium, a serotype well known to cause both human and animal illness.

A second sample contained both Salmonella Typhimurium and Salmonella Kentucky, another serotype known to cause disease.

A third sample collected during the inspection of Darwin’s manufacturing facility also yielded Salmonella Typhimurium.

Because Salmonella can cause serious–sometimes fatal–illness in humans and in animals, the FDA considers the presence of the microbe at any level to be hazardous if the food is meant to be consumed without cooking.

Therefore, the three lots of Salmonella-contaminated cat food were adulterated within the meaning of the FD&C Act, according to the Warning Letter.

2. Use of an Unapproved Food Additive

In 2021, the FDA expressed its concern to Darwin’s regarding the company’s use of peroxyacetic acid (PAA) as an additive to control pathogens in its raw pet foods, as the chemical was not “generally recognized as safe” (GRAS) for the intended use.

During the 2022 inspection, the FDA observed that PAA was still being added to the pet foods, and that the company had increased the level of PAA to a concentration significantly higher than the recognized maximum safe level for its use in any food.

The FDA was unable to find any scientific data to indicate that the concentration of PAA incorporated into Darwin’s pet foods was safe for dogs or cats to consume.

The agency also reviewed documentation of a third-party lab study, undertaken on Darwin’s behalf, to validate the ability of PAA to control pathogens in the company’s raw pet foods. The FDA concluded that the level of pathogen control demonstrated during the study was inadequate to ensure a pathogen-free state in the company’s finished products.

3. Food Facility Registration

Under the FD&C Act, Darwin’s is required to register with the FDA as a “food facility.”

The company has long insisted that it supplies its products directly to customers and, as a “retail food establishment,” is exempt from this mandate.

However, Darwin’s ships the majority of its products to customers through third-party warehouses rather than directly from its manufacturing facility. Therefore, the company does not meet the definition of “retail food establishment” under the FD&C Act.

What happens next?

The company was given fifteen (15) working days to respond to the issues raised in the Warning Letter.

In the absence of a satisfactory response, the FDA may undertake legal action, including the possibility of seizure of products and/or seeking an injunction against the company.

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