FDA seizes safe baby formula and shuts down trusted suppliers during critical shortage

FDA seizes safe baby formula and shuts down trusted suppliers during critical shortage
Never got to sign the consent form. Pixabay

The FDA is seizing infant formula during a critical shortage, shutting down trusted sellers and driving parents to untested suppliers, notes an article in the Wall Street Journal:

Hundreds of thousands of parents in the U.S. are scrambling to find formula for their babies…Yet the Food and Drug Administration has been enforcing an effective ban on formula from Europe, the world’s largest producer and exporter….European baby formulas are regulated by European regulatory authorities, and research has found that most meet FDA-required nutrient levels. They don’t meet FDA labeling and other requirements, however….Major European producers such as Hipp and Holle have not spent the time and money needed to comply with FDA regulations. Nonetheless, American parents want European formulas. Some believe they are healthier…European Union food standards ban corn syrup, commonly found in U.S. formula, and require at least 30% of the carbohydrates to come from lactose, which scientists believe is preferable….

Parental demand led to American mom-and-pop vendors selling European formula because the manufacturers wouldn’t make the effort. They even provided translated instructions. But the FDA in the past year has cracked down on these sellers. Without notice, thousands of families were left scrambling to find more formula. Parents who tried to purchase directly from Europe had hundreds of dollars of formula seized by U.S. customs agents. One parent reported that she had nearly $700 of formula destroyed at the border—in the middle of a national formula shortage.

The FDA’s actions have exacerbated the problem they were trying to solve…shutting down trusted vendors who had built a reputation on importing and selling high-quality products, the FDA drove desperate parents to untested sellers, creating the storage and handling concerns that caused the FDA to distrust European products. The difficulty finding preferred baby formula brands also increased the likelihood of inauthentic products and unscrupulous sellers taking advantage of parents in need.

The FDA’s actions are not doing anything to promote food safety, according to a former FDA official:

In an interview … former FDA associate commissioner Peter Pitts confirms that the agency doesn’t view this as a safety issue, strictly speaking: U.S. health inspectors know the European products are safe. Their problem is that the products are labeled in a manner that does not meet the expectations of the U.S. government.

“The difference between European baby formula and American baby formula, more or less, is that the labeling is different,” says Pitts. “The knot in getting that product into the U.S. isn’t safety, it’s a regulatory issue. I don’t want to say it’s a nitty issue, but it’s certainly something the FDA could have jumped on a lot quicker.”

President Biden recently claimed that his administration would have to be “mind readers” to see the infant formula shortage coming. That’s wrong, says the National Review — the baby formula shortage has been discussed in the media for months, as a steadily growing problem:

President Biden and his team didn’t need to be mind-readers, they just needed to be news readers. The Wall Street Journal had a prominently-featured in-depth article on January 12, 2022:

“Baby formula has been hard to find in many parts of the U.S. for months, sending parents searching for Enfamil, Similac, Gerber and other brands….’The shelves are just bare,’ said Derval Kenny, 65, of Rye, N.Y., who has been trying to help find Similac formula for two infant grandsons who live in Connecticut and New Jersey. ‘To me, there should be an uproar.'”

The baby formula shortage “leaves desperate parents searching for food. Some parents are driving hours at a time in search of supplies. Others are watering down formula or rationing it, hoping for an end to the shortage,” reported the New York Times. The shortage is partly due to the fact that the Food and Drug Administration delays new infant formulas and obstructs the supply chain. The shortage is made worse by import restrictions that block manufacturers in Canada, Europe, and Mexico from supplying the needed formula.

The Times reported:

Maricella Marquez looked at the last can of baby formula in her kitchen on Tuesday and handed her 3-year-old daughter, who suffers from a rare allergic esophageal disorder, a smaller-than-usual portion of the special nutrition she needs to stay healthy.

Ms. Marquez has been calling suppliers all over Texas, asking about any new shipments. “Right now they are out of it, completely,” she said. “I’m desperate.”

Ms. Marquez lives outside San Antonio, a city that has seen the nation’s highest rate of formula shortages — 56 percent of normal supplies were out of stock as of Tuesday, according to the retail software company Datasembly — amid a nationwide supply crunch that has left parents scrambling to feed their children…

For parents who are having to give their babies less than the food they need, even a temporary shortage has been terrifying……For Darice Browning, the specialty formula shortage in Oceanside, Calif., has been so acute that she has considered going to the emergency room just to feed her youngest daughter, Octavia, who is 10 months old and has rare genetic conditions that currently make it impossible for her to eat solid foods. The food allergies she shares with her 21-month-old sister, Tokyo, cause both babies to vomit blood if they ingest dairy proteins.

FDA regulations are so onerous for new brands of formula than no company is likely to enter the baby formula market to fill the current shortage, according to an economist:

infant formula is subject to onerous U.S. regulatory … barriers. For example, the FDA requires specific ingredients, labeling requirements, and mandates retailers wait at least 90 days before marketing a new infant formula….Businesses also have little incentive to go through the onerous regulatory process to sell to American retailers, given … the relatively short duration of the current crisis.

LU Staff

LU Staff

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