From: Susan Mayne, Director of FDA’s Center for Food Safety and Applied Nutrition

I am writing in response to the opinion piece published on March 13, 2023, titled “Be Best or Be Better,” by Bill Marler. The article references a letter sent by FDA on March 8 to the infant formula industry to share current safety information and call on the industry to take prompt action to improve processes and programs for the protection of our most vulnerable population. In the opinion piece, Mr. Marler charges the agency to do three things, which I would like to respond to.

First, Mr. Marler says FDA should “put an inspector in every plant 24/7”
Manufacturers are responsible for ensuring the safety of the formula they sell to consumers, and it’s FDA’s responsibility to verify through the use of inspections that they are taking the appropriate steps and meeting the legal requirements to keep the food they produce safe. We believe that gaining access to additional information regarding positive product samples discovered during production, as requested in the letter, would allow the agency to verify that appropriate corrective actions are taken by firms when positive samples are found. This kind of robust food safety data can allow us to make risk-informed compliance decisions while also continuing to support the much-needed growth and diversity of this market.

Importantly, the FDA has set targets to inspect facilities that produce infant formula annually, even prior to a requirement to do so established in the Food and Drug Omnibus Reform Act of 2022. This is above and beyond what is required in the FDA Food Safety Modernization Act (FSMA), which mandates high-risk facilities to be inspected at least once every 3 years and non-high-risk facilities to be inspected at least once every 5 years. We’ve taken this approach because annual routine inspections provide us with valuable insight into the operations within these facilities, but we can, and do, conduct additional follow-up or for-cause inspections as appropriate. In addition, through our prevention strategy, we are working to establish a specialized, dedicated cadre of investigators to conduct infant formula inspections. While we have been continuing to ensure that our staff who conduct or support infant formula inspections are receiving the latest and most relevant training, the dedicated cadre will allow us to have our most knowledgeable and experienced staff with the necessary expertise to focus on infant formula products.    

Second, Mr. Marler says FDA should “mandate testing of products and the facility”
FDA does not have the authority to require firms to notify us of product positives if the product has not left their facility, and we don’t have authority to mandate firms conduct Whole Genome Sequencing (WGS) or share the isolates to upload into the NCBI database. We agree, however, that requiring manufacturers to report positive product samples to us would serve the public health; that’s why the agency has explicitly sought that authority as part of the President’s FY24 budget request. As the FDA conducted our investigation at the Abbott Nutrition facility in Sturgis, Michigan, and inspected other infant formula facilities, it became increasingly apparent that having additional information about positive product samples, even if those products did not leave the facility, would help to ensure appropriate corrective actions are taken by the firms, and would help us to better understand the overall picture of infant formula safety. Therefore, the FDA included a notification requirement in the consent decree with Abbott that was entered on May 16, 2022 regarding the Sturgis facility. A month later, in a follow up to the May 25 and May 26 congressional hearings, we also made Congress aware of the gap in authority to require all manufacturers to report to us when positive product samples are found. Our current regulation in 21 CFR 106.150 requiring notification only when adulterated or misbranded product has left the facility is rooted in the authority Congress provided in section 412(e)(1)(B) of the Federal Food, Drug & Cosmetic (FD&C) Act. Therefore, only Congress can mandate that infant formula manufacturers provide the FDA with notification outside of that limited set of circumstances. 

However, food safety cannot wait for new laws to be enacted. And ultimately, under current law, it is the responsibility of infant formula manufacturers to ensure the safety of the formula they allow to enter into the market. That is why our letter – sharing the latest information we have on safety — is so important.

Third, Mr. Marler says FDA should “work to get Cronobacter a reportable bacterial infection in all states so we know what the scope of the problem is.”
The FDA supports elevating Cronobacter sakazakii infection among infants as a nationally notifiable disease and we have included this action as part of our prevention strategy. However, adding a disease to the Nationally Notifiable Disease list is something that is led by the Council of State and Territorial Epidemiologists (CSTE) with support from CDC. 

Because Cronobacter is not a reportable disease and because severe infections are rare, WGS is rarely performed on cases, so we have less genomic data to work with to help us link cases to each other, to a product, or to a food production environment. For example, the National Center for Biotechnology Information (NCBI) database has only 1,249 isolates of Cronobacter compared to more than 500,000 isolates of Salmonella enterica, a nationally notifiable disease. When we have illnesses of salmonellosis, we have compiled a lot of genomic data to work with right from the start.  This challenge surfaced earlier on during our investigation at the Abbott Sturgis facility, and we immediately began working with CSTE and CDC to explore a path forward toward making Cronobacter a nationally notifiable disease.  Therefore, we agree that increased genomic data, particularly through the uploading of sequences to the NCBI database, would be extremely helpful and we are encouraging industry to do this as we work with them on the prevention strategy. 

The FDA remains committed to strengthening the resiliency and safety of infant formula in the U.S., however there are significant gaps in data and authority that we have identified and are seeking support to address. We are tackling much of this work through the continued development of our Cronobacter prevention strategy, and an upcoming National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, as directed by Food and Drug Omnibus Reform Act of 2022. We would like to work with all our stakeholders to elevate these issues, implement new approaches, and pursue additional resources, so that together we can protect the health of our youngest, and most vulnerable populations.

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