Category Archives: Cronobacter sakazakii

FDA

The U.S. Food and Drug Administration is announcing important updates on its ongoing work to increase the supply and availability of infant formula in the U.S. On Feb. 17, the agency warned consumers not to use certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan infant formula production facility, and Abbott voluntarily ceased production at this facility as well as initiated a voluntary recall of certain products.

Today, a proposed consent decree of permanent injunction between the FDA and Abbott Nutrition, as well as three Abbott principals, was filed in the U.S. District Court for the Western District of Michigan. Under the proposed consent decree, which is subject to court approval and entry, Abbott has agreed to take corrective actions following an FDA inspection of its Sturgis, Michigan facility. The proposed consent decree obliges Abbott to take actions that are expected to ultimately result in an increase of infant formula products, while ensuring that the company undertakes certain actions that would ensure safe powdered infant formula is produced at the facility. When the company decides to restart production at this facility, it must conform with the provisions of the proposed consent decree and meet FDA food safety standards. If contamination is identified, the company must notify the FDA, identify the source of the problem and conduct a root-cause investigation before resuming production.

“Today’s action means that Abbott Nutrition has agreed to address certain issues that the agency identified at their infant formula production facility in Michigan. The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which American consumers have come to expect and deserve,” said FDA Commissioner Robert M. Califf, M.D. “We recognize the hardships that parents and caregivers have faced in obtaining infant formula and the FDA is focused on boosting the availability of the country’s supply of these products, including new steps regarding importation. We are also taking a look at the supply of infant formulas developed by manufacturers across the country and around the world to determine if a reallocation of their distribution can be made to help get the right product to the right place, at the right time.” 

In the complaint, filed by the U.S. Department of Justice on behalf of the FDA, the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility were adulterated because they were made under insanitary conditions and in violation of current good manufacturing practice requirements. On Jan. 31, the FDA commenced a for-cause inspection and identified Cronobacter sakazakii, a bacterium that can potentially cause severe foodborne illness primarily in infants, in the facility and observed significant operational deficiencies. While the agency’s inspection was ongoing, Abbott Nutrition voluntarily recalled certain powdered infant formula products and voluntarily shut down its facility to implement corrective actions that address issues raised by the FDA.

Under the proposed consent decree, Abbott Nutrition will be required to retain an independent expert to review the Sturgis facility’s operations to ensure compliance with the law. It also includes requirements for testing products, as well as ceasing production, and promptly notifying the FDA should contamination be detected. The proposed consent decree also requires the implementation of a sanitation plan, environmental monitoring plan and employee training programs.

In the meantime, the FDA is also continuing to implement several important steps to improve the supply of infant and specialty formula products in the U.S. The agency has been in ongoing discussions with all infant formula manufacturers who are reporting that they are all producing at an expanded capacity. In fact, Gerber has reported that it increased the amount of their infant formula available to consumers by approximately 50% in March and April and Reckitt is supplying more than 30% more product year to date.

This increased production is now evident in increased infant formula sales. According to data from Information Resources Inc. (IRI), national infant formula sales by volume for the month of April were up more than 13% compared to the month prior to the recall and national infant formula sales by unit for the month of April are also up by more than 5% compared to the month prior to the recall.

While some data suppliers have reported lower in-stock rates, the most complete data sets available from IRI are showing nearly 80% in-stock rates at the week ending May 8. This means that if a local supermarket normally carries 50 different infant formula products, an 80% in-stock rate would translate to 40 of those 50 product types being available.

What the sales volume data and in-stock rates tell us is that while there is more product being sold, it may be of less variety than prior to the recall. With increased production by other manufacturers, forthcoming import actions and the potential for Abbott Nutrition’s Sturgis facility to resume production in the near-term, the FDA expects supply to continue to improve over the next couple of months. The FDA recognizes that there is variation in availability throughout the country and is working with federal partners to better understand where shortages of certain formulas exist at a more local level, as well as explore further ways to alleviate more immediate and geographical supply challenges through better distribution of products.

Increased sales are a good indicator of formula available to the general population of infants, but the agency understands that availability of specialty products such as amino acid-based specialty formulas and metabolic products continues to be of concern. The FDA has already taken steps with Abbott Nutrition to make product available to those with life-threatening conditions on a case-by-case basis and will continue its efforts to make these products even more readily available as the agency works with the company to implement provisions of the proposed consent decree. In addition, these products have been an area of focus for discussions with other manufacturers that make comparable products. As a result of the recall and work with the FDA, other manufacturers have increased production of comparable product lines and in some cases expedited the importation of these products where they exist.

The agency is also looking at ways to mitigate future, potential supply issues including building on work to date with its 21 Forward supply chain continuity system. It has made requests for new authorities from Congress to allow the FDA to regularly collect important supply data from the broader infant formula industry and is continuing to implement several important steps to improve supply.

The FDA is committed to transparently communicating updates on this dynamic situation. The agency will continue to dedicate all available resources to help ensure that infant formula products remain safe and available for use in the U.S. and will keep the public informed of progress updates.

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