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Biden must demand cowardly FDA action as baby formula shortage worsens

It's been half a year, the baby formula shortage continues to worsen, and there is no end in sight. Unlike the global semiconductor and grain shortages, formula shortages are an American phenomenon. This means that the solution can be found at home.

But by focusing on importing limited quantities of foreign-made formula approved by the Food and Drug Administration, President Joe Biden is only addressing the symptoms of the problem, not the root cause. Yes. He needs to cut through the ridiculous bureaucracy that bares store shelves.

Formula out-of-stock rate is 30%. This is higher than when parents started panicking a few months ago, and stratospheric compared to his typical pre-pandemic 5% to his 7%.

Abbott Nutrition recalled her in February after five infants contracted severe infections after consuming formula made at the company's plant in Sturgis, Michigan. And the shortage worsened. Abbott recalled the formulation and halted production after an FDA inspection found unsanitary conditions and other violations. However, no infection-causing bacteria were found in Abbott's formula.

Baby formula
Getty Images/Brandon Bell

However, the U.S. infant formula market is so concentrated that 80% of all infant formula is supplied by just two companies, one being Abbott, which is now undergoing a recall. The company also has a monopoly on formula purchased for the U.S. Department of Agriculture's Women, Infants and Children program, and has partnerships with governments in 34 states and the District of Columbia.

When Abbott recalled formula milk and halted production at one of its largest factories, its market power meant it would inevitably cause a backlash. Action was needed to prevent shortages, especially for babies who needed special formulas for survival, but no immediate action was taken.

FDA  reported that "the United States produces 98% of the infant formulas we typically consume." This is partly due to the imposition of up to 17.5% tariffs on imported infant formula, putting foreign competitors at a distinct competitive disadvantage. Few people bother to go through the FDA approval process. However, mass shortages in such a large market prompted many foreign companies to begin wanting to sell to the United States, but they needed FDA approval to do so.

Despite the urgency, the FDA took three months to issue relaxation guidance on restrictions on foreign milk powder. And even after that May guidance, approval still requires extensive documentation and analysis. So the FDA is still causing delays.

In fact, Reuters reported that foreign formula companies Nature's One and Holle were ready to ship large quantities of formula, but "They may be waiting a while." FDA "slow to respond."

Parents desperate for formula don't have time.

These delays are unacceptable and Americans deserve to know why the FDA has been so slow and unresponsive. The advocacy group Americans for Prosperity recently filed a document regarding the FDA's mishandling of the issue under the  Freedom of Information Act. Perhaps AFP's revelation sheds light on why the FDA has not responded more quickly.

taking action. In May, lawmakers passed the Access to Prescriptions Act to allow WIC programs to purchase alternative prescriptions. Last month, they passed a bill that temporarily exempts all tariffs on baby formula. But if the FDA doesn't speed up approval, it's all for nothing.

The FDA's primary concern, of course, is safety. However, foreign formulas may not go through the agency's approval process, but are regulated by the European Commission.Brigitte Young, a professor of pediatrics , said that the European Commission's infant formula regulations They point to stricter regulations than ours, including bans on certain added sugars.

Baby formula
Reuters/Bing Guan

2019 survey found Among popular European brands, “all but one formula was] met FDA nutritional requirements”. "None met all FDA labeling requirements." Although these foreign formulas are healthier than many domestic brands and meet nutritional requirements, the FDA labeling

to keep them out of the US market. Granting Emergency Use Authorization to foreign-approved formulations in a crisis situation could have been done easily without another cumbersome and time-consuming process.In May, FDA Commissioner Robert “In retrospect, some decisions were not optimal,” Caliph told lawmakers. I am not joking.

And now it's Augustand the FDA is still unfazed.

Given the FDA's track record in COVID testing, infant formula,and monkeypox vaccines poorly, the American wonders whether his FDA can get the job done. It's understandable to be skeptical. We can't wait to reform our government agencies to expedite approvals while maintaining security. It's a matter of life and death.

Marion Mass is a Philadelphia-area pediatrician, trained at Duke University School of Medicine and Northwestern University, and co-founder of Practicing Physicians of America.