FDA flexibilities to produce millions more boxes of infant formula in coming months to increase supply available to US consumers

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SILVER SPRING, MD., May 24, 2022 /PRNewswire/ — Today, the U.S. Food and Drug Administration provides an update on steps it has taken that will make millions of additional boxes of infant formula and specialties available. for American consumers.

“We continue to do everything in our power as part of government-wide efforts to ensure that adequate infant formula is available where and when parents and caregivers need it,” the FDA commissioner said. Robert M. CaliffMD “Our recent measures will help to further strengthen the supply of infant formula, in particular through the importation of safe and nutritious products from abroad based on our increased flexibilities announced last week. Importantly, we expect additional infant formula to be able to be imported quickly and safely into the United States in the near term based on ongoing discussions with manufacturers and suppliers around the world. »

Key activities

Britain’s Kendal Nutricare will ship around 2 million cans to the US

The FDA has informed Kendal Nutricare that the agency is exercising its discretion to import certain infant formulas under the Kendamil brand. Under the agency’s recent increased flexibilities regarding the importation of certain infant formula, the company initially estimates that about 2 million boxes of infant formula are expected to land on U.S. store shelves starting in June. Kendal Nutricare currently has more than 40,000 boxes in stock for immediate shipment, and the US Department of Health and Human Services has begun conversations to assess options for getting the products to the United States as quickly as possible. Kendamil has set up a website for consumers to receive updates and locate the product once it arrives in the United States.

The agency has reviewed the applicable information relating to certain Kendamil products and, based on the information provided, is confident that the products are safe to use and provide adequate nutrition. To reach this decision, the FDA evaluated information related to nutritional adequacy and safety, including microbiological testing, labeling, and additional information about the facility’s production and inspection history.

Today’s announcement follows guidance issued last week that outlined a process by which the FDA would not object to the importation of certain infant formula intended for a foreign market or for distribution in the United States. States of products produced here to be exported to foreign countries. This guidance may also provide flexibilities to those manufacturing infant formula domestically and may be able to further increase the amount of domestically produced product for the US market.

The agency is continuing discussions with manufacturers and suppliers regarding additional sourcing and intends to prioritize submissions for products that can demonstrate safety and nutritional adequacy and have the greatest product volume. available and/or those who can put the products on US shelves the fastest. The FDA has published a webpage that will be updated with information on additional products destined for the United States.

Abbott will release approximately 300,000 cans of EleCare specialty formula on a case-by-case basis

FDA Announces No Objection to Release of Approximately 300,000 Boxes of EleCare Amino Acid Infant Formula Previously Produced at Abbott Nutrition Sturgis, Mich., facilitated to those in need of an urgent and vital supply of this specialty formula on a case-by-case basis. These products will be subjected to reinforced microbiological tests before they are placed on the market. Although some EleCare products were included in Abbott Nutrition’s infant formula recall, these EleCare products that will be marketed belonged to different lots, were never marketed and were kept under control by Abbott Nutrition.

These batches of EleCare products were not part of the recall but were suspended due to concerns they were produced under unsanitary conditions observed at Abbott Nutrition. Sturgis, Mich., facility. As indicated above, these products will be subjected to reinforced microbiological tests before being placed on the market.

Given the critical need for this product for some people, the FDA encourages parents and caregivers to consult with their health care providers to weigh the potential risk of bacterial infection with this product. The FDA will continue to work closely with healthcare provider organizations and stakeholders to understand the potential risks and benefits of using this product. Parents and caregivers wishing to access these products should contact Abbott directly to request that a product be made available to them by calling 1-800-881-0876. Parents and caregivers should continue to work with their healthcare provider to determine if comparable alternative products may be appropriate.

The FDA also announces that in response to the agency’s concerns, Abbott has confirmed to the agency that EleCare will be the first formula produced in Sturgis installation when production restarts, and other specialized metabolic formulas will follow closely. In addition, under the consent decree with the FDA, Abbott is required to retain the services of an independent expert to review the Sturgis facility operations to ensure compliance with the law.

Additional efforts underway to increase the supply of infant formula

On Friday, the agency hosted a webinar with more than 700 attendees to review recent guidance for the infant formula industry, particularly manufacturers and processors who do not currently manufacture infant formula for the US market.

The FDA’s round-the-clock work as part of government-wide efforts has already begun to improve supply and availability. The agency expects the steps and actions it takes, and the potential for Abbott Nutrition Sturgis, Mich.facility to resume production safely in the near term, will mean more and more supplies are on the way or on store shelves in the future.

As more infant formulas become available for the general infant population, the agency understands that the availability of specialty products – such as specialty amino acid formulas and metabolic products – continues to be of concern. The FDA has already taken steps with Abbott Nutrition to make the product available to people with life-threatening conditions on a case-by-case basis and will continue efforts to make these products even more readily available as the agency works with the company to implement provisions of a consent decree. In addition, these products have been discussed with other manufacturers who manufacture comparable products. As a result of the recall and working with the FDA, other manufacturers increased production of comparable product lines and, in some cases, expedited importation of these products when available.

The FDA continues to advise against making infant formula at home or diluting formula. Caregivers are encouraged to work with their child’s health care provider for recommendations on modifying feeding practices, if needed. The US Department of Health and Human Services also released a fact sheet with information to help families find infant formula.

The agency also monitors online marketplaces for fraudulent products and works with major online retailers to remove non-compliant and harmful products offered for sale on their sites. Additionally, since many of these fraudulent products originate overseas, the agency targets and examines these products at ports of entry. The FDA also monitors and tracks various external signals such as consumer complaints about potentially counterfeit and fraudulent products.

The FDA will continue to dedicate all available resources to help ensure infant formula remains available in the United States and will keep the public informed of progress updates.

Further information:

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer requests: 888-723-3366

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

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