The U.S. Food and Drug Administration (FDA) is doing "everything in [its] power" to increase the nation's supply of baby formula, which has severely dwindled in recent months after some formula was recalled due to contamination with deadly bacteria, the agency announced (opens in new tab) Tuesday (May 10).
The baby formula shortage not only impacts the health of infants, but also that of older kids and adults with severe food allergies, The Washington Post reported (opens in new tab).
Tuesday's update from the FDA follows a warning (opens in new tab) that the agency issued in mid-February, notifying consumers that they should avoid specific powdered infant formula products made at Abbott Nutrition’s facility in Sturgis, Michigan. At that time, Abbott had issued a voluntary recall (opens in new tab) of these powdered formulas, which included brands called Similac PM 60/40, Similac, Alimentum and EleCare, according to the Centers for Disease Control and Prevention (opens in new tab) (CDC).
The FDA issued the warning after being notified of four cases of infant illness tied to Abbott formulas. These incidents were reported in Minnesota, Ohio and Texas, and the FDA teamed up with the CDC and state and local partners to investigate the reports further. In all four incidents, reported between September 2021 and January 2022, the infants had to be hospitalized, and two of the babies died.
To find out if the product you have is included in this recall, visit similacrecall.com (opens in new tab) and type in the code on the bottom of the package, or call +1-800-986-8540 (U.S.) and follow the instructions provided.
At Abbott's Michigan facility, FDA investigators detected Cronobacter sakazakii bacteria, which can cause deadly infections in newborns, according to the CDC (opens in new tab). The germ can trigger sepsis, a life-threatening inflammatory response to an infection, and meningitis, which causes the tissues surrounding the brain and spinal cord to swell. In regards to the two reported fatalities, "Cronobacter infection may have contributed to the cause of death for both patients," the FDA stated in its Feb. 17 warning.
The Abbott recall worsened an existing baby formula shortage in the U.S.
This shortage resulted from a combination of factors, including staffing shortages related to the COVID-19 pandemic and supply chain disruptions at the national and international level, Time reported (opens in new tab). According to Datasembly, a company that tracks grocery and retail pricing and supply, the national out-of-stock rate for baby formula shot up to 43% last week, up about 10% from last month's average, The New York Times reported (opens in new tab).
Six states, including Iowa, South Dakota, North Dakota, Missouri, Texas and Tennessee, have been hit particularly hard by the shortages, CNN reported (opens in new tab). In these states, more than 50% of baby formula products were out of stock in the last week of April, Datasembly data suggests. The shortage "has been compounded by supply chain challenges, product recalls and historic inflation," Ben Reich, chief executive and cofounder of Datasembly, told The Washington Post.
The FDA is leading a federal initiative to increase the nation's supply of formula. "Ensuring the availability of safe, sole-source nutrition products like infant formula is of the utmost importance to the FDA," FDA Commissioner Dr. Robert M. Califf said in the May 10 statement. "Our teams have been working tirelessly to address and alleviate supply issues and will continue doing everything within our authority to ensure the production of safe infant formula products."
To increase supply, the FDA is working with major infant formula manufacturers to maximize production and prioritize the "product lines that are of greatest need, particularly the specialty formulas," such as those made for infants with allergies, for instance, the FDA statement reads. The agency is also monitoring in-stock data from different jurisdictions, to determine where formula is most desperately needed, and streamlining the importation process for certain foreign formula brands.
The FDA is also allowing Abbott to release specific specialty and metabolic formulas that have been on hold at its Sturgis facility; such products may be released "on a case-by-case basis" to caregivers in need of "urgent, life-sustaining supplies." (Anyone needing specialized formulas can call Abbott at 1-800-881-0876 to request a product.)
Doctors' offices sometimes stock samples of specialty formulas, and thus might offer another way for caregivers to get hold of the brand they need, according to The New York Times; in general, caregivers should consult a pediatrician before switching their child to a new specialty formula.
If your infant doesn't require specialty formulas, there may be other suitable options available. For example, if you typically buy brand-name formulas, you might consider looking for the generic version in stores or other formulas that contain the same ingredients. If switching your infant from one formula to another, it's best to introduce the new product by first mixing it with your old formula, 1 part new to 3 parts old. After that, you can gradually increase the ratio of new formula to old. If it's not possible to gradually transition between formula brands, the infant may experience some gassiness after the initial switch, but they should otherwise be okay, the Times reported.
Amidst the shortages, the FDA strongly advises against making homemade infant formula. "Homemade infant formula recipes have not been evaluated by the FDA and may lack nutrients vital to an infant’s growth," the agency website states (opens in new tab). In the past, some infants required hospitalization for severely low calcium levels (known as hypocalcemia) after being fed homemade formula.
Homemade formulas can also expose infants to foodborne illnesses, the agency states. For example, C. sakazakii, the bacterium found at the Abbott facility, can also live on surfaces in the home, including on kitchen counters and sinks, and in water, according to the CDC.
Some caregivers have reportedly taken to rationing or watering down their infants' formula to stretch their supply, the Times reported. "We also recommend not watering down the formula because it can lead to poor nutritional balance and create serious problems," Kelly Bocanegra, program manager for the federal Women, Infants and Children (WIC) program in the San Antonio metro area, told The New York Times.
Caregivers who have tried to buy formula online during the shortage have been faced with price gouging by private sellers, as well as outright scams, the Times reported.
"Do not buy formula online that comes from outside the United States. This formula could be counterfeit — for example, it may have fake labels to misrepresent the quality or identity of a formula, the product may not have the proper nutrients or ingredients to feed your baby, or it might have a fake label with a wrong use-by date," the CDC website warns (opens in new tab).
Originally published on Live Science.