‘Lessons have not been learned’: FDA knew of positive test months before latest infant formula recall
A recent recall of infant formula was announced nearly three months after Food and Drug Administration officials first learned that some products at a major plant had tested positive for bacteria — a delay that mirrors the agency’s slow response to reports of food safety problems and infant deaths ahead of last year’s massive recall over the same type of bacteria. In late February, formula giant Reckitt issued a press release recalling 145,000 cans of Enfamil ProSobee Simply Plant-Based Infant Formula over the “possibility of cross-contamination with Cronobacter sakazakii” — the deadly pathogen that sparked the infant formula crisis last year. Dozens of news outlets covered this as breaking news, recommending parents and caregivers toss the products or return them for a refund. FDA inspectors, however, had become aware of the positive test that ultimately sparked this recall in November, an FDA spokesperson confirmed to POLITICO. Reckitt had found Cronobacter sakazakii in a batch of formula made at its Zeeland, Mich., plant, during internal testing conducted in early September. The batch that tested positive was destroyed, but the FDA later determined that not enough cleaning had been done following the positive test. Two batches of formula made right after the contaminated batch would ultimately be recalled on February 20 — more than five months after the products had been distributed nationally, including in Guam and Puerto Rico. The revelation that this recall took months to announce comes more than a year after a massive infant formula recall from Abbott Nutrition, renewing questions about FDA’s oversight of formula and whether enough has changed in the wake of this crisis to prevent another one. There have been four formula recalls over Cronobacter contamination in the past year — more formula recalls than there have been in the last decade combined. The Reckitt recall in February was relatively small compared to the Abbott recall — which was likely the largest in history — and both FDA and the company maintain there have been no reports of illness related to this incident. For food safety advocates, however, it feels like a test that the agency didn’t pass. “It’s stunning that it’s almost identical to what happened in 2021,” said Mitzi Baum, CEO of STOP Foodborne Illness, a group that advocates on behalf of victims of outbreaks, referring to the lengthy timeline from positive test to recall. “Lessons have not been learned.” “FDA continues to be reactive,” Baum added. “It’s the internal processes that have not been fixed, if this is happening again.” A House oversight subcommittee has scheduled a hearing on the agency’s handling of the infant formula crisis on Tuesday. Food safety advocates are eager for Congress to look into the problems, though they are wary of the issue becoming partisan. The committee also last week sent a letter to top agency officials seeking a trove of documents and communications. Reckitt did not respond to multiple requests for comment. The FDA, for its part, has over the last year been taking a closer look at formula makers’ own records during food-safety inspections as a response to last year’s incident, which was initially set in motion by reports of four infant illnesses, including two deaths, from Cronobacter infections. FDA officials later found serious food safety violations at Abbott’s Sturgis, Mich., plant, which was shuttered for months for cleaning and upgrades, fueling a national shortage and a major disruption to the market because the plant had once made roughly a fifth of the U.S. supply. The FDA also found Cronobacter in 20 places in the plant, though none of the strains matched the illnesses. One of the biggest unanswered questions remaining from the formula crisis of last year is why FDA inspectors had missed major food safety problems at Sturgis, including things like roof leaks — conditions that FDA Commissioner Robert Califf later characterized as “egregious.” The agency has not provided a full explanation for why these issues were not found during a routine inspection five months prior to the recall. The FDA also did not heed a detailed warning from a whistleblower about the plant, a revelation that was first reported by POLITICO. In the case of Reckitt’s Zeeland plant, FDA inspectors initially “made note” of the positive Cronoacter test in November while they were in the facility for a “limited inspection” that was sparked by a “non-illness” complaint FDA had received related to the plant, the agency said. The formula recall didn’t happen, however, until FDA inspectors went back to this plant for a follow up inspection in February — a visit that was scheduled because agency inspectors found food-safety problems when they were in the plant for a routine inspection in July, the agency said. It was during this February follow-up visit that inspectors “obtained additional information which, when combined with the positive sample, led to the agency’s concerns about the adequacy of cleaning in relation to the production of these two product lots that are the subject of the recall,” a spokesperson said. https://open.firstory.me/story/clfmwdmuo020d01x09xeu5zr1 https://open.firstory.me/story/clfmx2b5f020h01x0eozg1zu4 https://open.firstory.me/story/clfmxlmnw020j01x0bhrzgsqj https://open.firstory.me/story/clfmy1bsy020m01x0fwpo8e45 https://open.firstory.me/story/clfmyg38j027m01tl4aszc7wj https://open.firstory.me/story/clfmyzbox020q01x073zzcr9m https://open.firstory.me/story/clfnv89kz0064010wbaipcx24 https://open.firstory.me/story/clfnvnx3q0068010w3i3p1ee7 https://open.firstory.me/story/clfnx30cd006v010w6assgvbn https://open.firstory.me/story/clfnxgt10005u010dgzrl2sjx https://open.firstory.me/story/clfnyhpzq0079010wduo27f41 https://open.firstory.me/story/clfnyx3j0006m010d725efywo https://open.firstory.me/story/clfo13fqq0009010df06cczqv https://open.firstory.me/story/clfo1fu7u000o010d3fz2c9op https://open.firstory.me/story/clfo1xbn80011010d3goa8v05 https://open.firstory.me/story/clfo2dtlw0019010d0ruw7n0b https://open.firstory.me/story/clfo2thyo009u010w6ckc8wjm https://open.firstory.me/story/clfo39fhn001q010dey62edd5 https://open.firstory.me/story/clfo3lm9x001x010debxrgtti https://open.firstory.me/story/clfo42nhb00ap010w8my57idh https://open.firstory.me/story/clfoeuevp00eb010wc8zv7dud https://open.firstory.me/story/clfofbnzl006d010d6qhkbn24 https://open.firstory.me/story/clfoftc3u006h010d2ou93xdm https://open.firstory.me/story/clfogcoy9006j010depbm5mfa https://open.firstory.me/story/clfogx92h006m010dbsn51fsk https://open.firstory.me/story/clfqnm3tf003901v39rimb22j https://open.firstory.me/story/clfqo78yn009d01uq1fe8cfe6 https://open.firstory.me/story/clfqonryp009j01uqdu1q7nxb https://open.firstory.me/story/clfqpay4w009t01uq3snkaij9 https://open.firstory.me/story/clfqpt9e7004501v34r2ngw7x https://open.firstory.me/story/clfqqf36z004e01v3772eeovn https://open.firstory.me/story/clfqr1luf004r01v30ruofiki https://open.firstory.me/story/clfqre4fi00ab01uqfdkq9bty https://open.firstory.me/story/clfqrvvt100ao01uq4i27hynf https://open.firstory.me/story/clfqs87ub006701v3774n0wls https://replit.com/@A-House-With-Good-Bones https://replit.com/@Community-Board https://replit.com/@Facets-of-Revolution https://replit.com/@Forever-JR-Ward https://replit.com/@Four-Charming-Spells https://replit.com/@Hang-the-Moon https://replit.com/@Her-Lost-Words https://replit.com/@Hiss-and-Tell https://replit.com/@Humanly-Possible https://replit.com/@Intrigue-in-Istanbul https://replit.com/@Lone-Women https://replit.com/@Love-Honor-Betray https://replit.com/@Love-Stories-of-Bible-Speak https://replit.com/@Loyalty-Lisa-Scottoline https://replit.com/@Max-Wildes-Cowboy-Heart https://replit.com/@Mostly-True-Story-of-Tanner https://replit.com/@On-the-Line https://replit.com/@Ringmaster-Riesman https://replit.com/@Rubicon-JS-Dewes https://replit.com/@Safe-All-Along https://replit.com/@Save-It-for-Sunday https://replit.com/@Seen-Loved-and-Heard https://replit.com/@Seventy-Times-Seven https://replit.com/@Spinsters-Guide-to-Danger https://replit.com/@Stars-and-Smoke https://replit.com/@The-Ball-in-the-Air https://replit.com/@The-Last-Carolina-Girl https://replit.com/@The-Perfumist-of-Paris https://replit.com/@Those-Empty-Eyes https://replit.com/@Trust-Henry-Cloud https://replit.com/@What-Happens-in-Ballroom https://replit.com/@Whats-Your-Heaven https://replit.com/@White-Cat-Black-Dog https://replit.com/@Youre-Going-to-Make-It https://replit.com/@outlive-peter-attia
