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DeLauro Requests HHS Office of Inspector General Review FDA’s Enforcement Discretion Approval of Imported Infant Formula

June 3, 2022

Congresswoman Rosa DeLauro (CT-03) today sent a letter to the Department of Health and Human Services (HHS) Office of Inspector General (OIG) requesting an investigation into the enforcement discretion process and decisions being made by the Food and Drug Administration (FDA) regarding the importation of infant formula from non-FDA approved facilities abroad. She issued the following statement after making the request:

"When the Food and Drug Administration announced they would take action to restore the domestic supply of infant formula, I welcomed the action to get safe infant formula back on the shelves. However, I made clear that any imported formula must be safe – period. I am concerned that the FDA's announced guidance does not do enough to guarantee the safety of imported formula. Instead of importing infant formula from only FDA-regulated facilities, they have opened the door to companies that self-identify their formula as ‘safe'. That is unacceptable and not nearly enough – particularly when several babies have been hospitalized and at least two have died.

"As I have said before, the food we give our babies should be the safest product on the market. But this guidance allows for the importation of infant formulas that may not comply with certain statutory and regulatory requirements. While I am not opposed to formula being imported from manufacturers abroad, it is vital that we thoughtfully determine that the product is safe and do our due diligence to ensure that it is. These decisions must be made with adequate data and in a standardized way.

"I hope the HHS Office of Inspector General will accept my request and review how the FDA has applied this enforcement discretion regarding the importation of infant formula."

The full text for the letter sent today can be found here and below.

On March 3, 2022, House Appropriations Committee Chair Rosa DeLauro (CT-03) sent a letter to the Inspector General of the Department of Health and Human Services (HHS), Office of Inspector General (OIG), Christi A. Grimm calling for an investigation into whether the Food and Drug Administration (FDA) took prompt, appropriate, and effective action leading to the recall involving infant formula produced by Abbott Nutrition.

On June 2, 2022 the Department of Health and Human Services Office of Inspector General announced they would determine whether FDA followed the inspections and recall requirements in accordable with Federal law.

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June 3, 2022

The Honorable Christi A. Grimm
Inspector General
Office of the Inspector General
Department of Health and Human Services
330 Independence Avenue, SW
Washington, DC 20201

Dear Ms. Grimm:

I write to seek your assistance in investigating the enforcement discretion process and decisions made by the Food and Drug Administration (FDA) regarding the importation of infant formula. Abbott Nutrition announced a recall of several of its powdered infant formulas on February 17, 2022 after multiple consumer complaints of infant illnesses related to Cronobacter sakazakii and Salmonella Newport infections, which ultimately led to closing their Sturgis, Michigan facility.

Due to issues of market consolidation, and Abbott owning 43% of the infant formula market in the United States, the closing of the bacteria-filled Sturgis, Michigan facility without Abbott having a contingency plan led to an infant formula shortage.

In May, the Biden Administration invoked the Defense Production Act (DPA) to increase infant formula supply in the United States and launched Operation Fly Formula to quickly import infant formula from FDA-approved facilities abroad. It is crucial that this product be coming from FDA-approved facilities abroad, as we have a safety standard process that facilities must undergo for an extensive amount of time to be given approval from the FDA.

However, on May 16, 2022, the FDA issued guidance to temporarily exercise enforcement discretion with respect to certain requirements for infant formulas that may not comply with certain statutory and regulatory requirements and is seeking information from manufacturers regarding the safety and nutritional adequacy of their products. This guidance allows manufacturers to apply for consideration for the importation of their products.

The following week, on May 24, 2022, the FDA announced exercising enforcement discretion for a Kendal Nutricare product, under their Kendamil brand. Three days later, on May 27, 2022, the FDA announced exercising enforcement discretion for the importation of certain infant formula products manufactured by Bubs Australia.

The FDA has only nine full-time staff members working on the review of these applications. Additionally, the guidance does not make it mandatory for manufacturers to submit all information outlined in the guidance. Instead, manufacturers can pick and choose what to submit from the guidance list. My concern here is that the approval process for enforcement discretion is moving quickly for having only nine full-time staff members, while the standard process for approval is more extensive and takes longer. An additional concern I have is that there is no standardized application that the FDA is making their decisions from; if manufacturers are able to pick and choose what they submit from the guidance list, then there is no uniform application being submitted.

As such, I request that you investigate whether the FDA applied this enforcement discretion to the importation of infant formula in a safe manner with established plans in place. As part of this review, I encourage your office to focus on the following central questions:

  • How much formula was needed to adequately restock infant formula in the United States, and what gap was importing from non-FDA facilities filling?
  • What data did they base their answer above numbers from?
  • What was the FDA's justification to release enforcement discretion guidance if we were already planning to import infant formula from FDA-approved facilities?
  • How many applications were submitted?
  • How many applications were approved?
  • How many applications were denied?
  • What was the FDA's established internal review process of these applications?
  • While reviewing applications, what specific guidance measures did they internally require, if any, having been submitted to inform their decision making?
  • Given that manufacturers do not have to submit all information outlined in the guidance, how did they compare applications? What made one facility viewed as safer than another?
  • What inspections of the facilities were completed to ensure these manufacturing facilities abroad were safe and clean?
  • How did they ultimately come to the decision that these facilities were safe?
  • What justification did they have on each approved facility through enforcement discretion as to how they came to their decision?
  • What plan did the FDA establish to test these products for safety once imported to the United States?
  • What plan did the FDA establish to monitor and trace these products once imported to the United States?
  • What plan did the FDA establish to respond if an enforcement discretion infant formula product leads to sickness, hospitalizations, deaths, and outbreak?
  • Once the enforcement discretion expires, what plan did the FDA establish to deal with enforcement discretion manufacturers that seek full approval to the United States market to continue importing to the United States?