WASHINGTON-US Senator Mitt Romney (R-UT) today urged US Food and Drug Administration (FDA) Commissioner Califf and US Department of Agriculture (USDA) Secretary Vilsack to address the shortage current use of infant formula and prevent future threats to infant health. In the letter, he stressed that the FDA and USDA have a dual responsibility to ensure a safe formula and prevent supply shortages in the event of a crisis, and he highlighted his concern about the lack of action to mitigate. the current shortage. Romney also pointed to how the recall has sent formula prices skyrocketing for many American families who are already struggling due to high levels of inflation.
“I am writing to ensure that the federal government takes all available steps to get to the bottom of an increasingly urgent national infant formula shortage, including the possible link to multiple infant deaths,” said Senator Romney. “The responsibility rests with the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) to protect the health of infants by ensuring that they have access to infant formula that is safe and, in times of crisis, to initiate contingency plans to alleviate life-threatening shortages of infants across the country.Given the serious implications of the current shortage on child health, I am deeply concerned at the apparent lack an effective mitigation strategy and I urge both agencies to act as quickly as possible to resolve this situation safely.
“In addition to the urgent urgency to investigate the cause of death and apply lessons learned to future Food and Drug Administration (FDA) inspections of infant formula manufacturers, we are extremely concerned about shortages of infant formula that has been affecting American families since the essential closure of the Sturgis facility,” Romney continued. “The recall and closure are impacting the affordability and availability of infant formula – several retail chains are limiting the number of products per purchase to manage inventory and desperate families are facing skyrocketing costs via third-party vendors.Infant formulas are also not easily interchangeable: some infants develop allergies or sensitivities, and some infants need specific formulas based on other medical conditions.It is essential that the FDA incorporate redundancies and robust supply chain analysis to prevent future life-threatening shortages.
The full text of the letter can be found below.
Dear Commissioner Califf and Secretary Vilsack:
I am writing to ensure that the federal government takes all available steps to get to the bottom of an increasingly urgent national shortage of infant formula, including the possible link to multiple infant deaths. It is the responsibility of the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) to protect the health of infants by ensuring that they have access to safe infant formula and, if crisis, to initiate contingency plans to alleviate life-threatening shortages of infants across the country. Given the serious implications of the current shortage on child health, I am deeply concerned about the apparent lack of an effective mitigation strategy and urge both agencies to act as quickly as possible to resolve this situation safely. security.
Between the risk of ingesting contaminated formula and the risk of malnutrition due to an inability to receive said formula, the FDA is in an extremely difficult position to protect the health of the infant. I appreciate the FDA’s efforts to support case-by-case release of essential products, but the pace of release is much slower than the demand felt in our country. In its attempt to balance the safety of contaminated products and safe infant development with access to formula, the FDA achieves neither of these objectives. I, and millions of families across the country, look forward to hearing the status of your investigation into powdered infant formula manufactured at Abbott Nutrition’s facilities in Sturgis, Michigan, the impact of the voluntary recall on critical access for infants with special dietary needs; and the role of our federal agencies in monitoring and access to infant formula.
To date, four adverse events and tragically two deaths have reportedly been associated with Abbott Nutrition powdered infant formula at this facility. In either case, Cronobacter sakazakii infection may have contributed to the cause of death, given that the bacteria was found at the facility during an inspection from January 2022 to March 2022. Cronobacter diseases are rare but can be fatal to infants. According to the Centers for Disease Control and Prevention, the bacteria can spread to the production site if contaminated raw materials are used to make formula or if formula powder comes in contact with a contaminated surface. I am alarmed to see documented cases of indescribable contamination on September 24, 2021, and inadequate sample testing to prove formula products met microbiological quality standards in 2019. This documentation suggests that the FDA’s routine inspection authority is insufficient to meet consumer safety demands, but its hammer of near facility closures is causing a ripple effect across the country.
In addition to the urgent urgency to investigate the cause of death and apply lessons learned to future Food and Drug Administration (FDA) inspections of infant formula manufacturers, we are extremely concerned about formula shortages. babies who have been affecting American families since the essential closure of the Sturgis facility. The recall and closure are impacting the affordability and availability of infant formula – several retail chains are limiting the number of products per purchase to manage inventory and desperate families are facing skyrocketing costs by the through third-party vendors. Infant formulas are also not easily interchangeable: some infants develop allergies or sensitivities, and some infants need specific formulas based on other medical conditions. It is critical that the FDA incorporate redundancies and robust supply chain analysis to prevent future life-threatening shortages.
A better understanding of FDA and USDA authorities will help us address the current shortage more quickly and prevent future threats to infant health. We respectfully request your responses to the following questions:
- Please describe in detail the cost/benefit analysis that the FDA undertakes to protect consumers from potentially contaminated products versus a lack of product access?
- Please provide a full update on the status of the investigation, the estimated timeframe for its completion, coordination efforts with other federal agencies, including the USDA, and any other authorities that may be necessary to help address the shortage of preparations.
- Please describe in detail the FDA’s consumer complaint review process, including the average time it takes to review and investigate a complaint, the time it took to link the three Cronobacter sakazakii complaints received by the FDA, and the number of full-time equivalents supporting the FDA in this work.
- The FDA is not required on Form 483 to document every case of questionable materiality or other objectionable conditions. During the inspection of the Sturgis facility from September 20, 2021 to September 24, 2021, did FDA investigators find any other sightings of questionable significance at the time of the inspection that were excluded from the report form 483? If so, why were these observations excluded? Did the FDA notify field investigators of the first child consumer complaint received on September 20, 2021 before the end of the inspection period from September 20, 2021 to September 24, 2021?
- In Form 483 dated September 24, 2021, observers noted on September 20, 2021, “the Processing Operator did not disinfect or change his gloves after touching non-food contact surfaces; immediately afterwards he touched food contact surfaces, including the inside of the potassium chloride ingredient bag […]. In addition, the exposed wrists of the Operator […] have been observed entering inside the Potassium Chloride ingredient bag while collecting ingredients.
- When FDA investigators identify clear cases of contamination, what immediate steps are taken to ensure the products do not leave the facility?
- What measures were taken during this inspection to ensure that the contaminated products observed did not leave the establishment?
- I understand that the FDA notifies company management immediately after the inspection is concluded to discuss the observations. Did this discussion take place as a result of this inspection? If so, is it reasonable to conclude that Abbott Nutrition had knowledge of contamination or potential contamination on or immediately after September 24, 2021?
- Between September 24, 2021 and December 18, 2021, the FDA received three additional consumer complaints. A follow-up inspection of the facilities did not begin until January 31, 2022. Why did the FDA take 44 days to initiate a follow-up inspection?
- Section 412(c)(1) of the federal Food, Drug, and Cosmetic Act requires companies manufacturing or distributing new infant formula to register with the FDA ninety days prior to market the said formula.
- On average, how many new infant formula submissions does the FDA receive in a year?
- What percentage of new submissions come from companies that already have infant formula on the market? What percentage of submissions come from new market entrants?
- To what extent does the FDA analyze new and existing infant formula submissions to discern diversity in global ingredient sources and nutrient profile (single-source versus complementary formula nutrition)?
- The impact of the voluntary recall affects families of all income levels, although the pain is particularly acute for those cared for by the special Supplemental Nutrition Program for Women, Infants and Children (WIC); For 23 states and the District of Columbia, Abbott Nutrition is the sole supplier to WIC.
- Please describe to what extent the USDA is re-evaluating its single-source WIC contract model, including offering multi-source contract options or shorter contract terms.
- To what extent is the FDA working with Abbott Nutrition to move products from safe release on a case-by-case basis to extended release, particularly for infants with certain metabolic and gastrointestinal diseases and allergies?
We respect and appreciate the hard work of your agencies in monitoring the current infant formula crisis, but we also cannot afford to waste time finding a solution. Please provide us with a response to this urgent request by May 24, 2022.