41-point refutation of the FDA’s press release on Abbot Infant formula shortage

Note: This article has been updated with additional refutations.

Below is the FDA’s May 10, 2022 press release regarding the infant formula shortage which is seething with lies, misdirection, and contradiction. In bold are refutations and citations.

FDA Press Release

Today, the U.S. Food and Drug Administration is providing an update on its work to increase the availability of infant and specialty formula products.

• The FDA is not capable of increasing availability; it is not a producer of infant formula.
• The FDA prompted the recall; decreasing availability of formula
• The FDA advised consumers to dispose of existing formula 2/17/22; further reducing availability of formula

On Feb. 17, the agency warned consumers not to use certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan facility, and Abbott initiated a voluntary recall of certain products. Since that time, the agency has been working with Abbott and other manufacturers to bring safe products to the U.S. market.

• Bogus warning (“warned consumers”). Both CDC and FDA investigated Abbott. FDA found no Cronobacter sakazakii or Salmonella in product. CDC concluded its investigation with no findings of a link between Abbott formulas and infant illnesses.
• Unsubstantiated claims (“working to bring safe products”)

“We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their inability to do so. We are doing everything in our power to ensure there is adequate product available where and when they need it,” said FDA Commissioner Robert M. Califf, M.D. “Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA. Our teams have been working tirelessly to address and alleviate supply issues and will continue doing everything within our authority to ensure the production of safe infant formula products.”

• Unsubstantiated claims (“working tirelessly”)
• The FDA failed to acknowledge its own contribution to the shortage. In recent months, it directed the confiscation and destruction of high quality infant formula from Europe, shut down associated businesses, and advised consumers to dispose of the formula. The FDA is now contradicting themselves by approving that same European formula and disregarding their own, largely arbitrary, restrictions.
• The FDA failed to acknowledge that, under its watch, formula production has been consolidated to four producers which represent 90% of the marketplace. Abbott represents 40% of the marketplace. The FDA has failed to facilitate a diverse marketplace of suppliers. Its oversight has resulted in a monopolistic and dangerous environment which is vulnerable to shortages (precisely the opposite of the stated goal of “ensuring the availability”.

Prior to the voluntary recall of several infant formula products produced at the Abbott Nutrition facility, the FDA was working to address supply chain issues associated with the pandemic including those impacting the infant formula industry. The FDA continues to take several significant actions to help increase the current supply of infant formula in the U.S.

• Unsubstantiated claims (“FDA was working to address supply chain issues”)
• Misleading / dubious claim (“issues associated with the pandemic”). The current shortage is significantly a result of the Abbot recall for Cronobacter concerns (not a pandemic related shutdown). However, the supply had already been experiencing intermittent shortages prior to the Abbott shutdown.
• The FDA failed to acknowledge that this press release is 2 months after the Abbott recall. The FDA failed to provide immediate response to Abbott which would have enabled them to resume operations quickly.

In fact, other infant formula manufacturers are meeting or exceeding capacity levels to meet current demand. Notably, more infant formula was purchased in the month of April than in the month prior to the recall.

• Since the FDA advised consumers to destroy the Abbott formula, justified or not, the FDA caused the increased purchases (reducing available supply).

Leveraging all of the tools at its disposal to support the supply of infant formula products, the FDA is:

Meeting regularly with major infant formula manufacturers to better understand their capacity to increase production of various types of infant formulas and medical foods.

• FDA’s admission of their ignorance of manufacturing is frightening
• FDA imposed meetings do not produce formula

The infant formula industry is already working to maximize their production to meet new demands.

• This is not a credit to the FDA. This is a credit to producers adapting to a difficult environment imposed by the FDA.
• Update 6/1/22: Producers stated they anticipated the impacts of the shutdown of the Abbott plant in Sturgis from the beginning. They immediately increased their capacity to the maximum months ago and communicated the problem widely. The current shortage is despite the best efforts of the industry to address the shortage that would be caused by the FDA.

Efforts already underway by several infant formula manufacturers include optimizing processes and production schedules to increase product output, as well as prioritizing product lines that are of greatest need, particularly the specialty formulas.

• Formula is a multi billion dollar industry. The FDA’s suggestion that formula makers have not already optimized their processes is ludicrous.
• This is not a credit to the FDA. This is a credit to producers adapting to a difficult environment imposed by the FDA.

Helping manufacturers bring safe product to the market by expediting review of notifications of manufacturing changes that will help increase supply, particularly in the case of the specialized formulas for medical needs.

• The FDA admits they are most helpful by getting out of the way
• The FDA admits that it has not optimized its own processes and has imposed unnecessary delay on producers (which in this case has contributed to a shortage)

Monitoring the status of the infant formula supply by using the agency’s 21 Forward food supply chain continuity system, combined with external data. 21 Forward was developed during the pandemic to provide a comprehensive, data-backed understanding of how COVID-19 is currently impacting food supply chains.

• The FDA admits the “21 Forward” data-backend is ineffective and did not prevent the shortage
• The shutdown of Abbot’s facility in Sturgis, MI was due to Cronobacter concerns (not coronavirus).
• Monitoring has no inherent value. A fire alarm is of no use if fire trucks arrive after the building is destroyed.

Compiling data on trends for in-stock rates at both national and regional levels to help understand whether the right amount of infant formula is available in the right locations, and if not, where it should go.

• The FDA is not a retailer and has no capacity to sell and distribute formula
• The largest retailers of infant formula, such as Walmart, Target, Costco, already have real-time and nationwide inventory counts which is vital for their respective businesses. We can be certain a spreadsheet produced by the FDA will have no value at best, or worse, may cause further misallocation of resources.
• Trend reports have no inherent value. A fire alarm is of no use if fire trucks arrive after the building is destroyed.

Expediting the necessary certificates to allow for flexibility in the movement of already permitted products from abroad into the U.S

• The FDA admits that it has imposed unnecessary delay on certificates (which in this case has contributed a shortage)
• Vague. It appears to indicate that the FDA does not allow flexibility in the movement of permitted products (which would contribute to the shortage)

Offering a streamlined import entry review process for certain products coming from foreign facilities with favorable inspection records.

• the FDA admits that its own actions (obstructing high quality formula from coming to the US and telling consumers to destroy that formula) has contributed to the shortage

Exercising enforcement discretion on minor labeling issues for both domestic and imported products to help increase volume of product available as quickly as possible.

• the FDA admits that its own actions (obstructing high quality formula for minor labeling issues) has contributed to the shortage

Reaching out to retailer stakeholder groups to request that their members consider placing purchase limits on some products in order to protect infant formula inventories for all consumers.

• Retailers already have incentive to impose limits during shortages and sales: otherwise risk losing the bulk of their customers to competitors.

Not objecting to Abbott Nutrition releasing product to individuals needing urgent, life-sustaining supplies of certain specialty and metabolic formulas on a case-by-case basis that have been on hold at its Sturgis facility.

• The FDA admits they are most helpful by getting out of the way
• The FDA has not demonstrated contamination of products produced at Sturgis.

In these circumstances, the benefit of allowing caregivers, in consultation with their healthcare providers, to access these products may outweigh the potential risk of bacterial infection.

• The FDA admits they are most helpful by getting out of the way
• The FDA provided no data to enable caregivers or healthcare providers to assess risk. How many containers of formula will be allowed? How many infants are expect to come in contact with the formula if it is allowed? How much contaminated formula has been found? Abbott states that no contaminated formula has been discovered.

The FDA is working to ensure health care provider associations and stakeholders understand information about the risks and benefits of pursuing this product.

• This is precisely what the FDA isn’t doing. It has not even provided information about the risks.
• Update 5/12/22: The FDA continues to associate Abbot with cronobacter contamination, despite the FDA’s own testing which found no cronobacter contaminated products. In this way, the FDA is misleading the public with misinformation and speculation.

It’s important to understand that only facilities experienced in and already making essentially complete nutrition products are in the position to produce infant formula product that would not pose significant health risks to consumers.

• This is a self-contradiction. Denying essential food poses a vitally significant health risk to infants.
• This is a self-contradiction. If the facilities were shut down for health reasons, they are not in a position to produce healthy formula.
• Unsubstantiated claim. For example, they failed to provide evidence showing make-your-own-formula-at-home to be inherently unsafe.

The FDA established an Incident Management Group to continue coordinating longer-term activities, which is focused on working with other major infant formula manufacturers to increase supply and helping to ensure that production of infant formula products can safely resume at Abbott Nutrition’s Sturgis facility, among other activities.

The agency continues to advise against making infant formulas at home and encourages caregivers to work with their child’s health care provider for recommendations on changing feeding practices, if needed.

• Unsubstantiated claim. For example, they failed to provide evidence showing make-your-own-formula-at-home to be inherently unsafe.
• Changing feeding practices does not create additional formula
• This advise furthers the shortage and therefore contradicts the FDA’s previous statements that they are working to reduce the shortage.

The FDA will continue to dedicate all available resources to help ensure that infant formula products remain available for use in the U.S. and will keep the public informed of progress updates.

• Self-contradiction. The press release was written precisely because formula products are not available

President Joe Biden’s Statement

When asked about possible steps to prevent the formula shortage, Biden responded that authorities could only have been more effective:

“if we’d been better mind-readers, I guess”
— President Joe Biden May 13, 2022

However, the shortage was a predictable result of the Abbot facility shut down and did not require mind-reading. Abbott is 40% of the US formula supply and had been shut down for three months at the time of the question. The FDA also had advanced warning through reports on Abbott (9/20/2021 to 2/24/2022); it had ample time prior to the shut down to prevent and prepare for the shortage. Rating his statement: flippant, misleading, and false.