“We have made tremendous progress, including notable steps in just the past week, which will allow us to immediately begin bringing specialty and infant formula products into the US as quickly as possible,” said FDA Commissioner Robert Califf. “We continue to work closely with our US government partners and domestic and international manufacturers to identify additional formula product that will be available to parents and caregivers in the weeks and months ahead. It is our goal to ensure that hospitals, specialty pharmacies, and retail store shelves will begin seeing adequate supplies again in the coming weeks.”
The FDA has been working with Danone’s Nutricia business over the ‘past several months’ to boost production of these products at its facilities and to identify additional supply of other infant formula products moving forward.
About 500,000 additional cans of specialized medical formula manufactured by Danone’s Nutricia business will be headed to the US. These Neocate amino acid-based formula products are made at facilities in Europe and will amount to more than 5 million full-size, 8-ounce bottles, FDA revealed.
The specialized medical formula will be distributed through direct ordering, hospitals, health care professionals, pharmacies, healthcare product distributors and Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) local access points.
FDA leveraging ‘flexibilities’
FDA is leveraging a number of ‘flexibilities’ to bolster the supply of products that serve as the sole source of nutrition for many infants while ensuring the infant formula can be used safely and provides adequate nutrition.
Last week, the FDA issued guidance that outlined a process by which the FDA would not object to the importation of certain infant formula products intended for a foreign market or distribution in the US of products manufactured here for export to foreign countries.
The enforcement body is in further discussions with manufacturers and suppliers regarding additional supply to ensure there’s adequate infant formula supplies.
Last week, Kendal Nutricare revealed it will begin shipping formula from the UK after FDA revealed it is ‘exercising enforcement discretion’. The company estimates that about 2 million cans of infant formula are expected to land on US store shelves beginning in June. Kendal Nutricare currently has over 40,000 cans in stock for immediate dispatch.
The FDA also announced that 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. This will target individuals needing ‘urgent, life-sustaining supplies’ of this specialty formula on a ‘case-by-case basis’. Abbott’s Sturgis site was shut down and a massive product recall was initiated after products manufactured there were linked to illnesses in infants, including two deaths. The EleCare products that are now being released will undergo enhanced microbiological testing.
FDA said the measures and steps it is taking, and the potential for Abbott Nutrition’s Sturgis, Michigan, facility to safely resume production in the near-term, will mean more and more supply is on the way or on store shelves moving forward.
Nestlé increases deliveries from Europe
As part of President Joe Biden’s Operation Fly Formula, Swiss group Nestlé is also increasing shipments of infant formula produced in Europe. Last week, the company delivered 114 pallets of Nestlé’s Gerber Good Start Extensive HA. This was Nestlé’s second delivery from Europe in three days as part of Operation Fly Formula, previously the group shipped 132 pallets of Nestlé Health Science Alfamino Infant and Alfamino Junior. In total, Nestlé has brought approximately 1.5 million 8-ounce bottles of formula into the US market, while the Nestlé US infant formula manufacturing facility in Eau Claire, WI, is operating at full capacity.
These products were prioritized because they serve a critical medical purpose as they are for children with cow’s milk protein allergies, the company noted.
“While it will take complete collaboration between the full industry and our partners at all levels of government to solve this crisis, people from across Nestlé have worked around the clock to be part of the solution - ramping up production, partnering with retailers to accelerate getting product onto shelves and providing guidance to caregivers through our 24/7 helplines and other resources. Our hope is that this progress gives concerned parents a little more comfort during this challenging time,” CEO of Nestlé Zone North Amierca Steve Presley commented.