On Monday evening, baby formula producer Abbott announced it had reached a deal with the Food and Drug Administration, laying out a path to reopen a factory in Sturgis, Michigan, that shut down amid recalls earlier this year, contributing to the current shortage.
In a statement, the company confirmed that it has entered into a consent decree with the FDA, in which the agency and company agree on the benchmarks required to resume production and ensure the facility meets safety guidelines.
FDA officials said late Monday that if a court approves the agreement, the Michigan site could restart in two weeks.
The site would initially produce specialty metabolic formulas EleCare and Alimentum, followed by Similac and eventually other formulas, food and drug officials said.
"Our number one priority is getting infants and families the high-quality formulas they need, and this is a major step toward re-opening our Sturgis facility so we can ease the nationwide formula shortage. We look forward to working with the FDA to quickly and safely re-open the facility," said chairman and CEO Robert B. Ford. "We know millions of parents and caregivers depend on us and we're deeply sorry that our voluntary recall worsened the nationwide formula shortage. We will work hard to re-earn the trust that moms, dads and caregivers have placed in our formulas for more than 50 years."
In a statement issued by the Department of Justice, Attorney General Merrick B. Garland said, “The actions we are announcing today will help to safely increase the supply of baby formula for families. The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential consumer products, and we will work alongside our partners across government to help make sure those products are available to the American people.”
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In a CNN interview earlier in the day, FDA commissioner Dr. Robert Califf had presented a somewhat rosy timeline for reopening the facility. He had predicted that once a deal was struck, the factory could reopen and resume producing formula within two weeks and be back to normal a few weeks later.
However, Abbott said things will not move quite that fast.
"From the time Abbott restarts the site, it will take six to eight weeks before product is available on shelves," the company noted in its statement.
Once it does, Abbott says it will start producing the formulas.
Can foreign formula fill the gap?
The FDA on Monday also confirmed it will allow the sale of foreign formula in the U.S.
The agency, which says it has already streamlined the process for distributing foreign formula once it arrives at U.S. ports, said it will also permit formula manufactured here but intended for export to be sold domestically.
While the U.S. produces 98% of the formula consumed here, it does currently import a small amount from Mexico, Ireland and the Netherlands.
“Today’s action paves the way for companies who don’t normally distribute their infant formula products in the U.S. to do so efficiently and safely," Califf said in a statement. "We are hopeful this call to the global market will be answered and that international businesses will rise to the occasion to assist in bolstering the supply of products that serve as the sole source of nutrition for many infants. With these flexibilities in place, we anticipate that those products that can quickly meet safety and nutrition standards could hit U.S. stores in a matter of weeks.”
Califf, along with Susan Mayne, the FDA's director of the Center for Food Safety and Applied Nutrition and FDA deputy commissioner Frank Yiannas, told reporters late Monday that companies that want to take advantage of any "flexibilities" should submit information to the FDA which will evaluate if the foreign formulas provide "adequate nutrition."
Mayne said will include labeling that "needs to be English, if possible," and other information on the formula's nutritional adequacy and their facilities' inspection history.
"These are the types of flexibilities that we are communicating in this guidance," Mayne said.
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Califf said that while an adequate supply of formula needed to feed every baby is finally in place at this point, "it's not necessarily in the right place. And so we're needing to help parents find other formula."
He added, "We'll need to be watching this every step of the way because as you know, we don't want to be sending product out which is dangerous for infants. I have every anticipation that we've got a path forward now that will work."
The baby formula shortage began in November, when about 11% of popular brands were out of stock, according to data analytics firm Datasembly. As of May 8, 43% of baby formula was sold out at retailers across the U.S. because of recalls and supply chain strains. Retailers such as CVS, Target, and Walmart have put purchase limits on formula,
In the meantime, parents are being advised to contact their pediatricians to discuss the best course of action for their child, which could entail seeking samples of new formula brands or donated pasteurized breast milk.
Pediatricians update guidance on cow's milk, plant milk and premature formula
Although the FDA's moves offer a light at the end of the tunnel, the shortage is still raging. To that end, the American Academy of Pediatrics put out new guidance Tuesday on feeding babies, taking a relaxed stance on cow's milk, plant milk and formula intended for premature babies and toddlers.
Most notably, the professional assocation now says parents can give whole cow's milk to babies who are older than six months and don't have any allergies or other special health needs, as long as they supplement it with iron-rich solid foods. The change is intended as a stopgap to tide babies over until the shortage abates, with the Academy warning, "This is not ideal and should not become routine."
AAP also said premature formula can be safely given to full-term babies for several weeks if no other option is available. As for toddler formula, it would be safe to give to babies who are close to their first birthday as long as use does not exceed a few days.
The group also said that soy milk may be an acceptable temporary substitute for babies around a year old but advised parents to seek out brands that are fortified with protein and calcium.
The financial fallout
The shortage is quickly becoming a financial crisis for many families, especially those that are low-income. Because WIC is not yet equipped to handle online shopping and many families can no longer find eligible formulas in store, some are having to use Supplemental Nutrition Assistance Program benefits or pay out of pocket, which "puts stress on the rest of the household," explains Brian Dittmeier, senior director of public policy at the National WIC Association, the nonprofit advocacy arm of WIC.
Contributing: Terry Collins, USA Today.
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This article originally appeared on USA TODAY: Baby formula shortage: FDA, Abbott agree on terms to reopen factory