FDA warns Target, Walmart over failure to pull recalled baby formula from shelves
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The Food and Drug Administration sent Walmart, Target, Kroger and Albertsons warning letters last week for continuing to sell recalled baby formula after being instructed to remove it from their shelves.
Why it matters: The multi-state botulism outbreak has not only infected at least 51 infants, but it has also exposed the clear pitfalls of the FDA not requiring formula companies to test products for the bacteria that cause the illness.
What they're saying: "Food safety is a shared responsibility," FDA Commissioner Marty Makary said in a Monday news release.
- "It is of utmost importance that all parties in the supply chain act swiftly and vigilantly to protect our nation's children from unsafe food."
The intrigue: The FDA is "particularly concerned with these retailers' capability to quickly remove unsafe products from their store shelves and ensure it remains off shelves as required during a public health emergency."
Catch up quick: ByHeart Inc. initiated a voluntary recall of its Whole Nutrition Infant Formula on Nov. 8, which it then expanded to all of its formula products a few days later.
- The retailers were informed of the recall in writing, but the products continued to be sold in over 175 locations across 36 states, per the FDA's letter.
- In one case, the formula remained on shelves over three weeks after the recall was issued, the letter said.
The big picture: Infant botulism occurs when a baby swallows Clostridium botulinum spores, which release a toxin in the baby's gut.
- It can be fatal if left untreated, but in milder cases, it can cause difficulty feeding, constipation, and lack of head control.
Zoom in: ByHeart told Axios' Carly Mallenbaum that "until now, this bacterium was not among the pathogens routinely tested for across the industry, despite thousands of safety tests conducted by all manufacturers."
- The company said they would use the current outbreak as an opportunity to make its "processes and the industry at-large safer for families."
- After learning that ByHeart wasn't previously testing for the bacteria, Frank Yiannas, a former deputy commissioner for food policy at the FDA reacted by asking, "Why weren't you already doing that test?'"
- "The leading edge science-based organizations that have been producing powdered infant formulas for years, they're aware of this, and they already screened for this."
What we're watching: The FDA gave the retailers 15 days to respond to the warning letters with specific steps they've taken to remove the contaminated products.
Go deeper: Infant formula safety: FDA doesn't require botulism test
