Infant Formula Crisis Update
FDA provided an update on steps it has taken that will lead to millions of cans of additional infant and specialty formula being available to U.S. consumers.
Among the latest developments, the United Kingdom’s Kendal Nutricare will send approximately 2 million cans to the United States after FDA informed Kendal Nutricare that the agency is exercising enforcement discretion for the importation of certain infant formula under the Kendamil brand. These products are expected to land on U.S. store shelves beginning in June.
FDA says it remains in further discussions with manufacturers and suppliers regarding additional supply and intends to prioritize submissions for products that can demonstrate safety and nutritional adequacy and have the largest volume of product available and/or those who can get product onto U.S. shelves the quickest.
Additionally FDA announced it is not objecting to the release of about 300,000 cans of EleCare amino acid-based infant formula previously produced at Abbott Nutrition’s Sturgis, Michigan, facility to individuals needing urgent, life-sustaining supplies of this specialty formula on a case-by-case basis. These products will undergo enhanced microbiological testing before release. Although some EleCare product was included in Abbott Nutrition’s infant formula recall that led to the shutdown of its Sturgis plant, these EleCare products that will be released were in different lots, have never been released and have been maintained in storage under control by Abbott Nutrition. Abbott also has confirmed that EleCare will be the first formula produced at the Sturgis facility when it restarts production, and other specially metabolic formulas will closely follow.
Late last week, President Biden signed the bipartisan Access to Baby Formula Act into law, helping to ensure those who rely on the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) have the formula they need amid the ongoing shortage. The bill from Sens. Debbie Stabenow, D-Mich., chairwoman of the Senate Agriculture Committee, and John Boozman, R-Ark., the committee’s ranking member, unanimously passed the Senate on May 19 after a 414-9 vote in the House of Representatives.
This law gives USDA the authority it needs to be more flexible during a crisis such as a natural disaster, public health emergency or recall and shortage currently facing the country. This flexibility ensures that the brand or type of formula families can buy isn’t restricted by program rules, allowing families to purchase whatever is available in the store. In addition, the law requires formula manufacturers that provide formula for WIC babies to have a plan in place to respond to a shortage so that families will be able to purchase the formula they need.
USDA also is encouraging state agencies and their infant formula manufacturers to consider seeking temporary flexibility in their infant formula contracts to allow WIC participants to purchase alternate sizes, forms or brands of infant formula during the current shortage. To maximize access for WIC participants, USDA is recommending state agencies work together with Rickett Mead Johnson (RMJ) and Gerber to consider temporarily allowing alternate brand formulas. The newly signed Access to Baby Formula Act will cover additional costs of alternate brand formulas in states that have contracts with RMJ or Gerber if the contracted size, form or brand of formula is unavailable. In states with Abbott contracts, Abbott currently is covering that cost difference.
Meanwhile, yesterday Wisconsin Gov. Tony Evers signed Emergency Order No. 164 prohibiting infant formula price gouging. The order declares that a period of abnormal economic disruption exists and prohibits price gouging of infant formula for the next 90 days.
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