July 1, 2022
The U.S. Food and Drug Administration is providing information to health care professionals to help their patients obtain access to medically necessary specialty, amino acid-based and metabolic infant formula products.
The FDA is continuing to work to ensure infants and individuals with medical conditions who rely on certain specialty, amino acid-based and metabolic infant formula products have access to these life-sustaining products since Abbott Nutrition voluntarily recalled certain infant formula products on Feb. 17. Some of these products have been available on a case-by-case basis from Abbott Nutrition over the last several months because 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 release has provided life-sustaining products to 2,958 infants and individuals in need, and approximately 500,000 containers of additional product remain accessible to those in need. These products have not been impacted by a June 13 storm that flooded parts of Abbott’s Sturgis, MI facility. Products are available on a case-by-case basis to patients, hospitals, and institutions by calling Abbott Nutrition.
Contact information for Abbott and other manufacturers who produce specialty and metabolic formulas is below. Health care professionals may contact manufacturers for information or assistance to obtain products.
Abbott Nutrition: 1-800-881-0876 (Alimentum, EleCare, and metabolic products)
Mead Johnson/Reckitt: 1-812-429-6399 (Nutramigen, Puramino, and metabolic products)
Nutricia: 1-800-365-7354 (Neocate and metabolic products)
Gerber Products Company: 1-800-284-9488 (Gerber Good Start Extensive HA Infant Formula)
Nestlé Health Science: 1-800-422-2752 (Alfamino products)
Contacting the FDA
If you are not able to find formula from the manufacturers, email email@example.com to report the problem. Please identify yourself as a health care provider.
In addition, the FDA is asking that health care providers report any adverse event related to a shortage of medically necessary infant formula products. To report such adverse events related to the shortage, use the MedWatch Online Voluntary Reporting Form and click on the Health Professional button.
The FDA is continuing to work to ensure infants and individuals with medical conditions who rely on certain specialty, amino acid-based, and metabolic infant formula products have access to these life-sustaining products. On February 17, the FDA warned consumers not to use certain powdered infant formula products from Abbott Nutrition’s Sturgis, Michigan, facility, and Abbott initiated a voluntary recall of certain products. Before the voluntary recall of several infant formula products produced at the Abbott Nutrition facility, the FDA was working to address supply chain issues associated with the pandemic, including those impacting the infant formula industry. Closure of the Abbott facility, combined with supply chain issues, has led the FDA to take action to increase infant formula supplies. Medically necessary infant formulas have been of special concern because of the limited number of manufacturers that produce them and the fact that product batches are typically produced less often and in lower volumes.
To increase the supply of infant formula, the FDA is:
- Working with current infant formula producers that service the U.S. market to increase production. This includes ensuring ingredients are available to sustain the continued production of infant formula.
- Helping manufacturers bring safe product to the market by exercising enforcement discretion on a case-by-case basis for both domestic and imported products to help increase volume of product available. This is being carried out only following the review of information provided by the manufacturer pertaining to nutritional adequacy and safety, including microbiological and nutrient testing, labeling and additional information about facility production and inspection history. Both regular infant formula and specialty formulas for infants with special medical needs have been given enforcement discretion.
- Working closely with U.S. partners and domestic and international manufacturers to immediately increase the availability of specialized medical infant formula available in the U.S.
- Working with Abbott Nutrition under a consent decree to ensure Abbott Nutrition’s Sturgis, Michigan, facility will operate in a safe and sanitary manner and prioritizing production of amino acid and medical and specialty formulas.
If you have questions about this notice or for general information about infant formula, contact FDA’s Center for Food Safety and Applied Nutrition’s Food & Cosmetic Information Center.