ROBERT CALIFF

The FDA said the policy would shift to an individual assessment that evaluates an individual's risk regardless of gender sexual orientation.

The federal Food and Drug Administration's top food safety official resigned Wednesday, citing concerns about the agency's oversight structure and the infant formula crisis that led to a nationwide shortage. Frank Yiannas, the deputy commissioner for food policy and response since 2018, told FDA Commissioner Dr. Robert Califf in an email that he would leave Feb. 24. Yiannas said infant formula supplies have increased and necessary monitoring is in place, making it the right time to leave FDA. Currently, no single official has full oversight of FDA's sprawling food operations. Yiannas called for the appointment of a “fully empowered and experienced” deputy commissioner for foods, with direct oversight of those issues.

The Food and Drug Administration's top food safety official has resigned.

Lead exposure can impair brain development and the nervous system, resulting in learning disabilities, lower IQ and behavioral difficulties.

FDA Commissioner urges parents not to stockpile children’s flu meds amid shortages

A blistering report released Monday describes the FDA's tobacco program as “reactive and overwhelmed,” in its effort to oversee both traditional tobacco products and a sprawling market of largely unauthorized electronic cigarettes. The experts say FDA’s inconsistent approach to regulation is at least partially to blame for the spread of thousands of e-cigarette varieties that remain popular among teenagers. The review comes as the FDA’s tobacco program is besieged by criticism from all sides — including congressional lawmakers, anti-smoking advocates and tobacco companies. Created by Congress in 2009, the FDA's tobacco center was granted sweeping powers to remake the tobacco industry, including banning harmful ingredients from traditional products and authorizing new, less-harmful alternatives. One former FDA staffer said the panel should have dug deeper into the reasons for the FDA’s lack of action against traditional tobacco products.

A new report criticizes the Food and Drug Administration’s efforts to oversee the tobacco industry, including traditional cigarettes and vaping products.

The Food and Drug Administration on Thursday authorized updated COVID-19 shots aimed at protecting against the original strain of coronavirus and two subvariants that have circulated widely this year. The updated shots target the original virus and the BA.4 and BA.5 subvariants of the omicron variant. “The data to support giving an updated bivalent booster dose for these children are expected in January. Since the start of the pandemic, officials have confirmed more than 99.3 million COVID-19 infections and reported over 1 million deaths nationwide, according to numbers compiled by Johns Hopkins University. More than 647.4 million COVID-19 cases have been reported worldwide, resulting in 6.6 million deaths, according to the university.

The Food and Drug Administration is slowing its use of a pathway that expedites the approval of promising drugs.

The “lack of a single, clearly identified person” to lead the foods program has led to a culture of “constant turmoil” at the agency, the report found. “They lay out all the options,” said Bill Marler, a food safety lawyer who testified to the panel that conducted the review. In the meantime, Califf said he would closely oversee the foods program himself until changes are made. “I will be fully engaged to ensure that the program comes out of this transition," he said in a statement. Califf called for the review of the food side of FDA in July, giving the panel 60 working days to come up with recommendations for the foods program.

A panel is calling for changes at the federal agency that oversees most of the nation's food supply, saying revamped leadership, a clear mission and more urgency are needed to prevent illness outbreaks and to promote good health.

The FDA cleared Upside Foods to use animal cell culture technology to take living cells from chickens and produce cultured animal cell food.

The Food and Drug Administration’s advisory panel voted 14-1 that the injectable drug Makena should be removed from the market, despite appeals from the manufacturer to keep it available pending additional research. The experts essentially agreed with a 2020 FDA decision that deemed the drug ineffective and called for its removal. The FDA has been moving to revoke the drug's approval since then. The company's presentations included outside experts who said removing Makena would worsen racial disparities in prenatal care. The flipside of the program means removing drugs when their initial promise isn't confirmed by later studies.

A panel of federal advisers says a pregnancy drug intended to prevent premature births should be withdrawn because it doesn't work.

U.S. regulators have revealed their plan to allow foreign baby formula manufactures to stay on the market long term.

The new chief at the Food and Drug Administration's tobacco center has inherited a raft of problems.

The FDA will also seek new authority to compel companies to turn over key information.

WASHINGTON — (AP) — The Food and Drug Administration acknowledged Tuesday that its response to the U.S. infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation's largest formula factory. It comes nearly eight months after the FDA shuttered Abbott's Michigan plant due to safety concerns, quickly slashing domestic production within the highly concentrated formula industry. The new report stated that FDA's "inadequate processes and lack of clarity related to whistleblower complaints," may have delayed getting inspectors to the plant. “Whistleblower complaints come into the agency in many different ways, from many different sources,” said Dr. Steven Solomon, an FDA veterinary medicine official who oversaw the review. The FDA also faced challenges ramping up its testing capacity for cronobacter, a rare but potentially deadly bacteria repeatedly linked to outbreaks in baby formula.

U.S. health regulators say their response to the ongoing infant formula shortage was slowed by delays in processing a whistleblower complaint and test samples from the nation’s largest formula factory.

Republicans said in a letter to the FDA commissioner that the agency needs to explain its internal procedures for investigating food safety matters

U.S. health officials are warning doctors against overusing the lone drug available to treat monkeypox.

Pfizer and Moderna have released a new COVID booster shot that will target the highly contagious BA.4 and BA.5 omicron variant.

The U.S. on Wednesday authorized its first update for COVID-19 vaccines, clearing the way for booster doses that target the virus’ most common omicron strain. Breaking news: New omicron-targeting coronavirus booster shots are poised for rollout after being authorized Wednesday by the FDA. “These updated boosters present us with an opportunity to get ahead” of the next COVID-19 wave, FDA Commissioner Dr. Robert Califf told reporters in a telephone call. “The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” Califf added. “I think that would be unfortunate,” Topol told the Post.

WASHINGTON — (AP) — The U.S. on Wednesday authorized its first update to COVID-19 vaccines, booster doses that target today’s most common omicron strain. They contain half that original vaccine recipe and half protection against the newest omicron versions, BA.4 and BA.5, that are considered the most contagious yet. “It really provides the broadest opportunity for protection,” Pfizer vaccine chief Annaliesa Anderson told The Associated Press. That's why FDA also is no longer authorizing boosters made with the original recipe for those 12 and older. It’s the first U.S. update to the COVID-19 vaccine recipe, an important but expected next step -- like how flu vaccines get updated every year.

WASHINGTON — (AP) — The U.S. on Wednesday authorized its first update to COVID-19 vaccines, booster doses that target today’s most common omicron strain. They contain half that original vaccine recipe and half protection against the newest omicron versions, BA.4 and BA.5, that are considered the most contagious yet. “It really provides the broadest opportunity for protection,” Pfizer vaccine chief Annaliesa Anderson told The Associated Press. That's why FDA also is no longer authorizing boosters made with the original recipe for those 12 and older. It’s the first U.S. update to the COVID-19 vaccine recipe, an important but expected next step -- like how flu vaccines get updated every year.

CDC director Dr. Rochelle Walensky says new BA.5-specific Covid booster shots need to roll out quickly, even if they aren't fully tested in humans yet. Here's why.

WASHINGTON — (AP) — A long-awaited review of prescription opioid medications, including their risks and contribution to the U.S. overdose epidemic, is still underway at the Food and Drug Administration, the agency's commissioner said Tuesday. Califf promised to conduct a full review of FDA's approach to opioids, including their prescribing instructions, to clinch Senate confirmation early this year. For example, a recent FDA proposal that would require pharmacies to dispense “mail-back” envelopes with every opioid prescription has faced resistance from pharmacists, drugmakers and other groups. Elsewhere the FDA has tried for nearly a decade to require doctors and other health professionals to undergo training in safe opioid prescribing. Califf said another priority will be approving an over-the-counter version of naloxone, the medication that can reverse opioid overdose.

The head of the Food and Drug Administration says a government review of prescription opioid medications, including their risks and contribution to the U.S. overdose epidemic, is still underway.

One maker of the fruit-flavored candies halts sales after FDA issues first-of-a-kind warning of potential toxicity.

U.S. regulators have issued a warning letter to the maker of illegal nicotine gummies.

The Jynneos vaccine can now be administered between layers of skin instead of underneath layers, allowing for a smaller dose.

A Mississippi grand jury has declined to indict the white woman whose accusation set off the lynching of the Black teenager Emmett Till nearly 70 years ago, most likely closing the case that shocked a nation and galvanized the modern civil rights movement.

Opioids FDA Promises FILE - U.S. Food and Drug Administration Commissioner Dr. Robert Califf speaks at a news conference at the Hubert H. Humphrey Building in Washington, Thursday, May 5, 2016. Califf says a comprehensive review of the opioid painkillers that triggered the nation's ongoing drug overdose epidemic is in the works. But he faces skepticism about the long-promised review from lawmakers, experts and advocates after years of delay. In response to questions about the recommendations, the FDA provided a list of actions it has taken on opioids, some which predated the report. It's been nearly 10 years since the agency required makers of long-acting opioids to conduct a dozen studies of their drugs' risks and effectiveness.

The head of the Food and Drug Administration says a comprehensive review of the opioid painkillers that triggered the nation's ongoing overdose epidemic is in the works.

The latest data shows nearly one-third of powdered formula products are still out of stock nationwide.

The FDA's tobacco center, which regulates traditional cigarettes and vaping products, is facing challenges navigating policy and enforcement issues.

FDA Commissioner FILE - U.S. Food and Drug Administration Commissioner Robert Califf testifies during a Senate Committee on Health, Education, Labor and Pensions hearing on the nationwide baby formula shortage on Capitol Hill in Washington on May 26, 2022. The announcement comes as FDA Commissioner Robert Califf attempts to push past several controversies that have dominated his second stint running the agency, including the delayed response to contamination problems at the country’s largest infant formula plant. “Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency's food program, Califf said in a statement. A cardiologist and widely respected researcher, Califf planned to focus his time at FDA on fighting medical misinformation and streamlining the agency’s data systems. But those efforts have been eclipsed by newer controversies, including political outrage over the formula shortage, which has forced the U.S. to airlift millions of containers of formula from Europe.

The head of the Food and Drug Administration is asking for a review of the agency’s food and tobacco programs.

The U.S. is getting another COVID-19 vaccine choice.

>> Read more trending newsHRA Pharma, based in Paris, will announce Monday that it has asked the FDA to authorize the pill that is now available by prescription. A second company, Cadence Health, is also expected to formally request permission to sell its birth control pill over the counter. Levonorgestrel, known by its generic name “Plan B,” an emergency contraceptive pill, was approved for over-the-counter sales in 2011. A federal judge overruled Sebelius’s decision and allowed the pill to be sold over the counter. The anti-abortion group Students for Life of America oppose contraceptive pills the group calls abortifacients.

Juul An electronic cigarette from Juul Labs is seen on on Feb. 25, 2020, in Pembroke Pines, Fla. Juul has asked a federal court, Friday, June 24, 2022, to block a government order to stop selling its electronic cigarettes. Federal health officials on Thursday, June 23, ordered Juul to pull its electronic cigarettes from the U.S. market, the latest blow to the embattled company widely blamed for sparking a national surge in teen vaping. (Brynn Anderson/AP Photo, File)A federal appeals court on Friday issued a temporary stay of a ban announced one day earlier by regulators, which would prohibit the sale of Juul electronic cigarettes nationwide, court records show. >> Read more trending newsIn an order filed in court, the U.S. Court of Appeals for the D.C. The FDA order required that Juul Labs Inc. stop selling and distributing its products in the U.S.

Before shots can be administered to kids as young as 6 months old, the CDC's vaccine advisers are scheduled to vote on updated recommendations this Saturday.

Less than two weeks after restarting formula production at its Michigan facility, Abbott has again had to halt manufacturing there amid flooding.

Abbott announced that it has put a halt on production at its Michigan plant following severe thunderstorms and heavy rains in the region Monday that resulted in power outages and flood damage.

U.S. regulators have historically inspected baby formula plants at least once a year, but they did not inspect any of the three biggest manufacturers in 2020.

Abbott says it's restarted production at the Michigan factory that's tied to the ongoing baby formula shortage.

FDA Commissioner Dr. Robert Califf said it will take about two months for shelves to be full with formula again.

Commissioner Robert Califf admitted the agency's reaction was "too slow," while a formula maker exec apologized to parents.

Sluggish response and questionable decisions by the Food and Drug Administration exacerbated the nation's infant formula shortage, officials say.

Baby Formula Congress Food and Drug Administration Commissioner Robert Califf testifies via video during a House Commerce Oversight and Investigations subcommittee hybrid hearing on the nationwide baby formula shortage on Wednesday, May 25, 2022, in Washington. The shortage mostly stems from Abbott’s Michigan plant, which the FDA shut down in February due to contamination issues. The FDA's response was: “Too slow and there were decisions that were suboptimal along the way,” Califf told lawmakers. Several lawmakers raised longstanding concerns that the FDA’s food program — which oversees most U.S. foods except meat, poultry and eggs — is underfunded and needs restructuring. When Rep. Nanette Diaz-Barragan, D-Calif., asked who is in charge of food safety, Califf and food center director Susan Mayne gave extended answers, describing different roles and responsibilities.

Abbott Nutrition and U.K.-based Kendal Nutricare plan to ship more than 2 million cans of formula.

Abbott Nutrition and U.K.-based Kendal Nutricare plan to ship more than 2 million cans of formula.

Baby Formula Congress Food and Drug Administration Commissioner Robert Califf testifies via video during a House Commerce Oversight and Investigations subcommittee hybrid hearing on the nationwide baby formula shortage on Wednesday, May 25, 2022, in Washington. The shortage mostly stems from Abbott's Michigan plant, which the FDA shut down in February due to contamination issues. FDA staff began honing in on Abbott's plant last fall while tracking several bacterial infections in infants who had consumed formula from the facility. As a result, the FDA didn't begin its inspection until Jan. 31. Califf also faced questions about why his agency didn't anticipate the shortage, given that Abbott's plant supplies roughly one-sixth of the U.S. formula supply.

The FDA and President Joe Biden face mounting political pressure to explain why they didn't intervene earlier to try and address the supply problems.

The FDA and President Joe Biden face mounting political pressure to explain why they didn't intervene earlier to try and address the supply problems.

ADDITION Baby Formula Shortage Michelle Saenz of Santee, Calif. buys baby formula at a grocery story across the border, Tuesday, May 24, 2022, in Tijuana, Mexico. As the baby formula shortage continues in the United States, some parents are opting to cross the border into Mexico, where the shelves are still stocked with options to feed their babies. FDA staff began honing in on Abbott's plant last fall while tracking several bacterial infections in infants who had consumed formula from the facility. As a result, the FDA didn't begin its inspection until Jan. 31. FDA regulators did not contact the U.S. Department of Agriculture about impacts to the formula supply until Feb. 11.

Members of Congress began a House subcommittee hearing Tuesday by accusing north suburban-based Abbott Laboratories of negligence

FDA Commissioner Robert Califf will answer questions from House lawmakers about what's caused the formula shortage.

ADDITION Baby Formula Shortage Michelle Saenz of Santee, Calif. buys baby formula at a grocery story across the border, Tuesday, May 24, 2022, in Tijuana, Mexico. FDA staff began honing in on Abbott's plant last fall while tracking several bacterial infections in infants who had consumed formula from the facility. As a result, the FDA didn't begin its inspection until Jan. 31. The FDA has also faced questions over delays in reviewing an October whistleblower complaint alleging numerous safety violations at Abbott’s plant, including employees falsifying records. FDA regulators did not contact the U.S. Department of Agriculture about impacts to the formula supply until Feb. 11.

The House Oversight and Investigations subcommittee hearing will begin at 11 a.m.

ADDITION Baby Formula Shortage Michelle Saenz of Santee, Calif. buys baby formula at a grocery story across the border, Tuesday, May 24, 2022, in Tijuana, Mexico. As the baby formula shortage continues in the United States, some parents are opting to cross the border into Mexico, where the shelves are still stocked with options to feed their babies. Members of an Energy and Commerce subcommittee will also hear from three infant formula manufacturers, including a top Abbott executive. FDA staff began honing in on problems at Abbott's plant after tracking four bacterial infections in infants who had consumed formula from the facility. The FDA has also faced questions about its timeline for reviewing an October whistleblower complaint alleging numerous safety violations at Abbott’s plant, including employees falsifying records and failing to test formula.

The head of the Food and Drug Administration testified about a series of setbacks that led to a months-long delay in inspecting the plant at the center of a nationwide baby formula shortage.

But Abbott has said that, after production resumes, it could take about two months before new formula begins arriving in stores. The company's factory has been closed due to contamination problems.

Doctors: Don’t make baby formula at home The American Academy of Pediatrics said DIY formulas lack the “critical components babies need.” (NCD)The head of the Food and Drug Administration said parents who have been met with empty shelves when they are seeking baby formula for their children “should begin to see improvement” shortly. >>Related: House panel to examine baby formula shortage; when will it be available? He also said that Abbott Nutrition’s plant in Sturgis, Michigan, should resume production by next week the following week at the latest. Previous coverage:• Baby formula shortage: Biden announces steps to help lessen supply chain issues• Baby formula maker Abbott reaches agreement to restart largest production plant• Why is there a baby formula shortage; what can parents do? • Baby formula shortage: What parents need to know• Baby formula shortage: FDA approves plan to release some Abbott-produced formula• Baby formula shortage worsens, nearly 30% of popular brands sold out• Recall alert: More Similac baby formula added to recall list• American Academy of Pediatrics offer new guidance for parents who can’t get formula• FDA closes investigation into contaminated powdered infant formula produced by Abbott Nutrition©2022 Cox Media Group

The FDA closed the plant in February — after four infants who drank formula produced there contracted bacterial infections, two of whom died.

Baby Formula Shortage FILE - Infant formula is stacked on a table during a baby formula drive to help with the shortage May 14, 2022, in Houston. FDA Commissioner Dr. Robert Califf faced a bipartisan grilling from House lawmakers over the baby formula issue that has angered American parents and become a political liability for President Joe Biden. The problems are largely tied to Abbott Nutrition's Michigan formula plant, the largest in the U.S., which has been closed since February due to contamination problems. The FDA announced a preliminary agreement with Abbott earlier this week to restart production, pending safety upgrades and certifications. The baby formula shortage is the first major crisis for Califf since returning to the FDA in February.

Republicans argued that the plan didn't force federal agencies to look for formula that could be redirected to U.S. homes immediately.

Baby Formula Shortage FILE - Infant formula is stacked on a table during a baby formula drive to help with the shortage May 14, 2022, in Houston. President Joe Biden has invoked the Defense Production Act to speed production of infant formula and has authorized flights to import supply from overseas. The company shut its Michigan plant in February after FDA inspectors began investigating four bacterial infections in infants who had consumed formula from the plant. The baby formula shortage is the first major crisis for Califf since returning to the FDA in February. On Wednesday evening, House Democrats passed a $28 million spending bill that would boost FDA funding to inspect domestic and international formula producers.

The Food and Drug Administration's commissioner says a shuttered baby formula factory could be up and running by next week.

President Joe Biden's administration has announced new steps to ease the national shortage of baby formula, including allowing more imports from overseas.

The U.S. government has released its long-awaited plan to ban menthol cigarettes and flavored cigars.

Vacant high-ranking positions across the executive branch could be taking a toll on the Biden administration.

The Senate has narrowly confirmed President Joe Biden’s pick to lead the Food and Drug Administration, filling a position that had been open for more than a year.

President Joe Biden’s pick to lead the powerful Food and Drug Administration has stalled in the narrowly divided Senate.

President Joe Biden’s pick to lead the Food and Drug Administration deftly parried questions on crises ranging from the COVID pandemic to the opioid epidemic.

President Joe Biden is nominating former Food and Drug Administration Commissioner Dr. Robert Califf to again lead the powerful regulatory agency.