Course:FNH200/Projects/2023/Infant Formula

Introduction

Empty shelves due to Infant Formula shortage

In recent times, the safety and availability of infant formula have emerged as pressing concerns for millions of households across the U.S. and Canada. Abbott Nutrition, the leading infant formula manufacturer and supplier, was at the epicenter of this crisis. The alarming detection of the bacterium Cronobacter sakazakii in the Sturgis, Michigan facility necessitated a sweeping recall from three of its most recognized brands: Similac, Alimentum, and EleCare. This urgent action, culminating in the facility's shutdown, followed the heart-wrenching deaths of nine infants, purportedly connected to the tainted formula. The ramifications were profound, given the indispensable nature of infant formula as a human milk substitute, especially for those relying on it, including infants allergic to cow milk. While the COVID-19 pandemic had already strained the supply chain, the recall deepened the crisis, resulting in a severe shortage and subsequent hospitalizations of numerous children. Canada grappled with its formula concerns. Although the Canadian Food Inspection Agency (CFIA) typically oversees bilingual food labeling, the scale of a related recall spurred Health Canada to step in. Implementing an "interim policy," Canada imported infant formulas globally. However, given the recency of the recall, more research must be done on the specifics of relaxed ingredient restrictions under this policy.

Infant Fatalities Linked to Abbott Nutrition’s Infant Formula

Abbott Nutrition's recalled Infant Formula products

Between December 1, 2021, and March 3, 2022, the US Food and Drug Administration (FDA) received nine reports of infant deaths linked to powdered infant formula manufactured by Abbott Nutrition in Sturgis, Michigan. Among these cases, two fatalities were related to a Cronobacter sakazakii outbreak reported by the Center for Disease Control (CDC), impacting four individuals. Additionally, two deaths were attributed to Salmonella. Alongside these reported deaths, consumer complaints detailed 25 incidents categorized as “life-threatening illness/injury” and 80 classified as “non-life-threatening illness/injury.” Symptoms included fever (31 babies), vomiting (42 babies), diarrhea (47 babies), and blood in the stool (6 cases).

Cronobacter sakazakii naturally occurs in the environment and can thrive in dry foods, such as powdered formulas and starches, as noted by the CDC. Canadian authorities cautioned that formula containing Cronobacter sakazakii "may not show signs of spoilage in appearance or odor but can still lead to illness." They also highlighted that the bacterium can cause “rare bloodstream and central nervous system infections” linked to severe intestinal issues and blood poisoning, particularly in newborns. Early indicators of Cronobacter infection in infants under 1 year old include fever, crying, reduced energy, and compromised feeding.

The FDA determined that Abbott Nutrition's plant in Sturgis, Michigan, failed to implement measures to prevent product contamination during manufacturing. The FDA inspection unveiled inadequate maintenance of surfaces in contact with the formula, instances of standing water, and improper handwashing practices among employees handling the formula. Notably, FDA testing found Cronobacter sakazakii on a piece of equipment called a "scoop hopper," which holds the plastic scoops placed inside baby formula cans, and on the floor around product dryers.

Processing

Flow chart detailing steps of (A) Wet Mix + Spray Drying Method (B) Dry Mix Method (C) Wet Mix & Dry Mix Method.

Infant formula is produced by two methods, the dry mix process, and the wet mix with spray drying process. The dry mix process involves mixing powder ingredients in a blender and filtering them through a sieve to create an infant formula of uniform consistency. The wet mix process involves several steps of preparation and heating of the wet mix, homogenization, evaporation and finally spray drying. It is important to note that the wet mix method involves heating of the wet mix which ensures pathogenic bacteria are destroyed to protect consumers from contamination, a process the dry mix method lacks. In the dry mix process, the microbial safety of the product relies on the microorganisms present in the ingredients before processing. However, the dry mix method doesn’t use water in processing which prevents additional microbial introduction.

The Cronobacter sakazakii outbreak in the infant formula recall could have been due to improper heat treatment. If the infant formula was created through the dry mix method, no heat treatment would have occurred to eliminate pathogenic microorganisms that were originally in the raw ingredients like Cronobacter sazakii that thrive in such environments. Cronobacter sakazakii could have also survived after heat treatment in the wet mix process if not done at a high enough temperature or enough length of time. Furthermore, human intervention in the operating process of the formula production could have introduced Cronobacter sakazakii with improper hand sanitization and unwell workers. Moreover, microbial introduction could have occurred even after heat treatment of bacteria through the surfaces of machines such as homogenizers, evaporators, and the spray dryer used in the remaining steps of formula production.

Canadian Regulations

Canadian regulations governing infant food formula are outlined in Division 25 Section B, comprehensive guidelines established under the Food and Drug Regulations and enforced by Health Canada, safeguarding Canadians' health. Division 25 Section B focuses on infant formula and human milk fortifiers, ensuring nutritional adequacy and safety. These regulations encompass formulation, labeling, packaging, and quality control, with manufacturers adhering to stringent quality assurance protocols to minimize contamination risks and ensure consistent quality. Health Canada mandates rigorous laboratory testing and certification procedures for infant food formulas to meet nutritional and safety standards before sale. Health Canada collaborates with the Canadian Food Inspection Agency for enforcement, including inspections and imposing penalties or recalls for non-compliance. Following an assessment, a minister may authorize or not authorize a product and request additional information from the manufacturer.

On February 17th, 2022, Canadian Food Inspection Agency recalled powdered infant formula from Abbott's Sturgis, Michigan facility. The temporary closure of this facility affected infant formula, human milk fortifiers, and metabolic product supplies for Canada and other countries. Health Canada acknowledges potential shortages and recommends Canadian Food Inspection Agency's enforcement discretion for specific products, including both hypoallergenic and regular infant formulas, imported to alleviate the shortage. These products meet foreign standards but may not fully align with Canadian criteria in Part B, particularly Division 24 and 25, and Part D of the Food and Drug Regulations. For example, out of the 64 approved imported products, three labeled as ready-to-feed infant formula would be classified as human milk fortifiers in Canada. Healthcare providers will be provided preparation instructions, along with the formula, to administer the product according to Canadian human milk fortifier guidelines listed in Division 25 Section B of the Food and Drug Regulations, enforced by Health Canada. Human milk fortifiers enhance human milk's nutrients, aiding premature or medically needy infants' growth. human milk fortifiers must be used under medical guidance, often in hospital settings.

Licensed importers must promptly notify Health Canada and Canadian Food Inspection Agency of food safety concerns. This discretion is proposed until December 31, 2024. Pre-2024 imports can be sold until their shelf-life ends. Health Canada may extend this period to mitigate shortages. Both Health Canada and Canadian Food Inspection Agency prioritize public health, addressing challenges arising from facility closures.

Enforcement Discretion in Labelling Requirements

Canadian nutritional facts label template in French

Canadian infant formula must follow the labeling requirements under the Food and Drugs Act (FDA), the Food and Drug Relations (FDR), The Canadian Food Inspection Agency (CFIA), specific requirements of the Safe Food for Canadians Act (SFCA), and the Safe Food For Canadians Regulations (SFCR) which apply to all pre-packaged foods sold in Canada despite the level of trade. Although the CFIA is responsible for bilingual food labeling under section 5 of the food and drug regulations, in 2022, Health Canada requested enforcement discretion for specific labeling and composition requirements due to a forced formula recall from a large manufacturing plant in the United States. The enforcement discretion allowed infant formulas to be imported to Canada through an "intern policy" that did not enforce bilingual labeling.

Health Canada made the enforcement discretion request concerning labeling and importation requirements for products listed under CFIA's Appendix A. Food items listed under Appendix A only partially comply with Canadian regulatory requirements despite being manufactured to a relatively equal standard and approved for sale by foreign regulatory authorities. The CFIA's discretion applied to labeling food additives; nutrient material used as an ingredient; vitamins, minerals, and amino acids; agricultural chemicals; food packaging and material composition; drugs administration to animals that may be consumed as food. Since Canada does not have a domestic infant manufacturer, the interim policy was in effect from December 15, 2022 – December 31, 2024, to minimize the health risk the infant formula shortage posed to vulnerable Canadians.

Canadian nutritional facts label template in English

Potential Exam Questions

Question 1

Question: Please choose the correct word to fill in the blank. There are two methods to produce infant formula, the dry mix process and the wet mix process with spray drying. The wet mix process involves ______ to destroy pathogenic microorganism in milk (and protect customers from contamination) in comparison with the dry mix process.

A. Thermal processing

B. Freezing

C. Refrigeration

D. Dehydration

The Answer: A (Thermal processing)

Explanation: Fluid milk products are commonly spray-dried into powder form, but the dehydration process (spray drying) does not kill microorganisms nor inactive enzymes. Milk is a low-acid food that is susceptible to growth of pathogenic microorganisms as well as to spoilage by microbes and enzymes, so additional processes or approaches such as thermal process is needed for better preservation of milk powder.

Question 2

Question: On February 28, 2022, Abbott Nutrition recalled one of the infant formula products after a report of the death of an infant with a Cronobacter sakazakii infection. What could be the potential cause of the contamination of Cronobacter sakazakii in the manufacturing process of the infant formula?

A. Inadequate maintenance of the machine

B. Improper handwashing practices

C. Improper heat treatment

D. All of the above

The Answer: D (All of the above)

Explanation: In fact, the FDA inspection unveiled Inadequate maintenance of the machine (A) and Improper hand washing practices at the manufacturing plant (B). Improper heat treatment (C) could also have caused inadequate elimination of pathogenic microorganisms.

Explanation as to why these questions should be on the exam: Preservation methods are important concepts we have learned about in FNH 200, and Q1 can familiarize ourselves with them. Q2 is based on a true case, so it would truly test the student's ability to apply their knowledge to real life examples.