Under Operation Fly Formula, the FDA has authorized multinational formulations within the United States, prompting the question, Can the Formula Shortage Provide Access to Better Formula? According to experts, this could improve access in the future.
Rebecca Lancaster relocated to Boston from England for three years while raising her two young children. Although she mostly breastfed her younger child, she wanted to introduce him to formula. But, she discovered via friends and brief research that the formulas available in the United States were less clean than the HiPP Organic formula she used in England.
“Every time we returned from trips to the United Kingdom, we would bring back enough supplies to endure until our next trip,” Lancaster explains. “When we returned to England, I sold the remaining formula. There was considerable demand from interested parties.”
Yet, it is difficult for most American families to obtain these foreign-made formulas because the majority of them are not FDA-approved. Although there are more than 50 different infant formulae available in the United States, an increasing number of parents are opting for formulas created outside of the nation, which many feel provide their newborns with cleaner and higher-quality nourishment. In contrast to the United States, the European Union prohibits additional sugars such as corn syrup in baby formula and mandates that at least 30 percent of its carbs come from lactose. Even Facebook groups are devoted to assisting parents to learn about and obtain formulae that are not permitted in the United States.
With the ongoing formula scarcity problem, this could be an opportunity for change. President Joe Biden’s response to the crisis, Operation Fly Formula, facilitated at least 15 shipments of formula from other countries in a few months. During Operation Fly Formula, two European formulae, Aptamil (from parent company Danone) and Kendamil are temporarily permitted in the United States. Aussie Bubs, an Australian formula producer, is also approved.
“It is more vital than ever to diversify and improve the U.S. baby formula supply,” the FDA stated in July. The recent suspension of a major infant formula plant, which was aggravated by unanticipated natural weather occurrences, demonstrates how insecure the supply chain has become.
To combat the shortfall, the FDA declared its intention to “temporarily exercise enforcement discretion over certain requirements for infant formulae that may not comply with certain statutory and regulatory requirements…”
This could be a comfort for parents such as Liz Fogarty, who preferred European formula even before the shortage. Fogarty, a Maryland mother with a two-year-old and a baby on the way, states, “I prioritize using the purest formula for my children.” Fogarty decided to feed her first child the German formula Lebenswert Folgemilch and her second child HiPP Dutch Stage 1 since she was dissatisfied with the chemicals in some American formulas. She purchases them online and notes that they are expensive: the first costs $27.99 for a four-pack, while the second costs $46.99 per can. Not that U.S. prices are significantly lower during the scarcity. According to an analysis conducted by DataWeave, between March 2021 and May 2022, the average price of infant formula rose by 11%.
Formula for Infants and FDA Approval
The United States imports approximately 2% of its formula, primarily from Mexico, Ireland, and the Netherlands. The remaining 98% of infant formula is produced in the United States by four significant manufacturers: Abbott Nutrition, Nestle USA, Mead Johnson Nutrition, and Perrio. Although safety concerns are always cited as the rationale for restricting the import of baby formula from other countries, some claim that it is simply an attempt to dominate the market in favor of American firms.
This new discretionary enforcement has sped up FDA clearance, but in typical circumstances, FDA approval is not so straightforward.
“To be sold in the United States, companies must register their formulas with the FDA and adhere to the Infant Formula Act, which includes providing clinical data to ensure that the protein in the formula is bioavailable and that the formula promotes adequate growth in infants,” explains Dr. Anthony F. Porto, M.P.H., associate professor at Yale University School of Medicine. This time-consuming and costly process may have dissuaded businesses from pursuing it.
While there are discrepancies across formulas, such as between European and American formulas, Dr. Porto discovered that when he compared the nutrient content of European formulas to FDA criteria, nearly all formula had nutrients that met the FDA’s requirements.
“The primary distinctions between European and American infant formulae are the iron content and the fact that European formulas are available in stages, making them better suited to the needs of younger and older newborns,” explains Dr. Porto. “And European formulae stipulate not only the presence of docosahexaenoic acid (DHA) but also a minimum and maximum amount. Although the majority of U.S. formulas incorporate DHA on a voluntary basis, amounts vary and are typically below the European Union’s minimum requirement.”
Aussie Bubs’ FDA application was among the first filed with U.S. authorities after the FDA announced its rules for issuing an enforcement discretion notice for the import of specific baby formula products. According to Kristy Carr, founder and CEO of Bubs Australia and Aussie Bubs, it resulted from 18 months of planning and investment in the company’s U.S. market expansion strategy to meet the FDA’s demanding quality and safety nutrition standards.
In mid-June, Operation Fly Formula transported 1.25 million cans of infant formula from Melbourne to the United States. There have been four additional shipments since then.
Carr explains, “We had a long-term commitment to the U.S. market before the present crisis, so we always respect the local process for requiring safe and nutritious formula.” “The shortage allowed the FDA to evaluate our ability to meet those requirements, and we look forward to continuing in this market with a more inclusive list of quality producers that can prevent a future shortage.”
The Future of FDA Approval of Baby Formula
In light of the FDA’s decision to approve multinational formulas such as Aussie Bubs, Aptamil, and Kendamil, could this be the beginning of a more diverse formula variety in the coming years?
“I view it as an opportunity,” Dr. Porto explains. A chance to review the FDA Baby Formula Act regulations, which have seen little modifications since 1980, while ensuring the safety of newborns.
The FDA announced during the summer that European formulations might be sold in the United States until November. In September, it was announced that the importation policy would be extended until January 2023. Afterward, businesses might request to remain on the market longer.
Dr. Porto continues, “Hopefully, this method will allow new manufacturers to enter the market while adhering to the Baby Formula Act’s safety measures, thereby addressing the current deficit and preventing future shortages.”
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