FDA provides update on efforts to increase supply and availability of safe and nutritious infant formula
SILVER SPRING, MD., June 22, 2022 /PRNewswire/ — Today, the U.S. Food and Drug Administration provided an update on the steps it has taken and will continue to take to ensure U.S. consumers have access to preparations for safe and nutritious infants in the weeks and months to come.
“The FDA is working day and night to ensure that parents and caregivers can easily find safe and nutritious formula products for any child who needs them,” the FDA commissioner said. Robert M. CaliffMD “I have personally spoken with infant formula manufacturers over the past few weeks and all have significantly increased their production efforts, translating into an increased supply that will be available on store shelves in the future. ‘coming.”
FDA flexibilities resulted in approximately 365 million bottles of infant formula
In the past month, the FDA has issued discretionary enforcement letters for the importation of infant formula from six countries, with an estimated total quantity of 17 million cans, or approximately 365 million full-size bottles of 8 oz. These products have already started hitting the US market and more will appear on store shelves in the weeks and months to come.
Consumers should be confident that infant formula imported into the United States through this process involves careful consideration of information provided by companies, including details of the product’s nutritional adequacy and safety, results of microbiological testing, labeling information and, most importantly, details of the manufacturing plant’s food safety production practices and inspection history.
Agency continues regular inspections of infant formula preparation facilities
The FDA takes seriously its responsibility to ensure that the foods we eat are safe and meet our rigorous quality and safety standards – this is especially true for infant formula. While the FDA Food Safety Modernization Act (FSMA) requires the agency to inspect domestic food facilities at least once every 3-5 years, the FDA has a policy of annually inspecting infant formula manufacturers because products are the only source of nutrition for some of our most vulnerable consumers.
This goal of annual surveillance inspections of these facilities has consistently been met over the years, with the exception of 2020 during the COVID-19 pandemic. However, even throughout the COVID-19 pandemic, the FDA has continued to inspect facilities, including infant formula preparation facilities. In fact, we inspected six companies in fiscal year 2020 (October 1, 2019 – September 30, 2020), including several during the height of the pandemic in the summer and fall of 2020. In order to establish a priority list of companies to inspect throughout 2021, the FDA assessed companies that we did not not inspected in 2020 to focus on companies that met certain risk criteria, including a company’s inspection history, danger signals such as consumer complaints, and other factors.
While the agency postponed some food surveillance inspections during the pandemic, the FDA resumed its annual surveillance inspection schedule for infant formula facilities starting in July 2021. In fiscal year 2021 (October 1, 2020 – September 30, 2021), we prioritized inspections of infant formula companies, carrying out 16 nationwide inspections throughout the year; including Abbott, Mead Johnson, Gerber and Nestlé. Since the beginning of fiscal year 2022 (October 1, 2021), we have completed 10 domestic infant formula inspections and one foreign inspection, including Abbott, Mead Johnson and Gerber.
It is important to note that it is the responsibility of a company to ensure the consistent quality and safety of the products it manufactures. In addition to our oversight work, the FDA emphasizes the importance of a company’s quality systems and culture. Ultimately, when issues are detected, the onus is on the company to correct them to keep consumers safe.
Last update on Some specialized metabolic infant formulas are marketed by Abbott on a case-by-case basis
The FDA continues to work to ensure that infants and people with medical conditions who depend on certain specialty, amino acid-based, and metabolic infant formulas have access to these vital products. Some of these products have been available on a case-by-case basis from Abbott Nutrition for the past few months, as the risk of not having access to them could significantly worsen underlying medical conditions and, in some cases, pose life-threatening risks. .
To date, this case-by-case distribution has provided life-saving products to more than 2,411 infants and people in need, and more than 280,000 containers of additional products remain accessible to those in need. Products are available on a case-by-case basis to patients, hospitals and institutions by calling Abbott Nutrition at 1-800-881-0876.
Abbott Nutrition has tested certain product lots stocked by Abbott since FDA approval. February 17 warning and the company’s voluntary recall due to concerns that they were manufactured in unsanitary conditions. These products have now undergone enhanced batch testing and the company reports that none of the batches tested positive for Cronobacter, a bacterium that can cause serious foodborne illness, primarily in infants. Enhanced testing provides additional security guarantees for those who wish to access these products.
It is important to note that even with the completion of enhanced batch product testing, the agency continues to recommend that parents and caregivers who wish to access these products first work with their health care provider. child to determine if comparable products or other changes in feeding practices may be an appropriate substitute.
If comparable alternative products are not available or appropriate, parents and caregivers using these products should consider following the most recent FDA and CDC guidance on how to reduce the possibility of a Cronobacter infection. As powdered formulas are not sterile and can also be contaminated in homes, it is advisable to wash your hands with soap and water, especially before preparing bottles and feeding. Ensuring that all surfaces and feeding items are clean when preparing infant formula will also reduce the risk of possible contamination.
Abbott Sturgis Facility Update and Pre-Installation Inspections
Abbott recently announced that recent severe weather and rainfall has resulted in flooding in areas of the Sturgis facility on Monday, June 13. While this is an unfortunate setback and a reminder that natural weather events can also cause unforeseen supply chain disruptions, Abbott is working quickly to assess the damage and will report its progress to the agency in the coming days. We will return to the plant and work closely with Abbott so that the Sturgis plant can restart production of safe, quality formula products as quickly as possible.
Ensuring parents and caregivers have access to safe and available infant formula remains a top priority for the FDA, and our teams are working day and night to make it happen.
Additionally, given the overwhelming public interest in the FDA’s prior inspections of the Sturgis facility, the FDA is also releasing facility inspection reports for several previous Abbott inspections.
As previously reported, during our 2019 and 2021 inspections, the agency collected and tested samples of finished products. These samples tested negative for the pathogens. During these inspections, it was determined that the company had found lots of Cronobacter contaminated finished product and had taken the appropriate measures to destroy three batches, two in 2019 and one in 2020, before distribution.
Our last inspection in January 2022 was an inspection prompted by consumer complaints of childhood illnesses resulting from the consumption of infant formula produced at Abbott’s facilities in Sturgis.
Agency review of consumer complaints about Abbott infant formula
The work the FDA does to make sure the food we eat is safe is ongoing. This work includes ongoing monitoring of every consumer complaint she receives regarding products regulated by the agency. To date, the FDA has reviewed and investigated a total of 129 complaints associated with Abbott Nutrition formula products. Of these, 119 complaints were reported after Abbott voluntarily recalled the product on February 17.
The FDA previously reported on its review of complaints related to nine infant deaths. Only two have been associated with the investigation into the Abbott Nutrition Sturgis factory, and despite a thorough investigation, the evidence does not establish or rule out a definitive link between these infant deaths and the product made at the factory. Abbott Nutrition factory in Sturgis.
The agency was notified of another consumer complaint on June 10, 2022which resulted in the death of an infant in January 2022. The agency opened an investigation, as the complaint mentioned that the infant had consumed an Abbott product. However, the investigation into this most recent consumer complaint is in its preliminary stages and the agency will provide an update as it learns more.
Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer requests: 888-INFO-FDA
The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.
SOURCE US Food and Drug Administration