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On Friday’s broadcast of MSNBC’s “Morning Joe,” Senate Committee on Agriculture, Nutrition, and Forestry Chairwoman Sen. Debbie Stabenow (D-MI) stated that the FDA moved too slowly to address the formula shortage and didn’t notify the U.S. Department of Agriculture (USDA) until two weeks before the Abbott plant was shut down and that it seems as though “FDA thought it was going to be a short shutdown, and then the plant itself, Abbott, has been resistant, really, in my judgment, to really quickly doing what they need to do.” Stabenow said, “USDA was given about two weeks’ heads-up before the plant...

On Thursday’s broadcast of the Fox News Channel’s “Special Report,” Senate Minority Leader Sen. Mitch McConnell (R-KY) argued that the FDA, which already has a $6 billion budget, didn’t fail to handle the formula shortage because they don’t have enough money, they failed due to “incompetence” within the bureaucracy. McConnell stated [relevant remarks begin around 5:40] that the Biden administration’s response has been “Almost total incompetence. They misjudged this from the beginning. It’s not a matter of money. The FDA has a $6 billion budget. They could certainly take care of the so-called appropriation in the House that they just...

The Food and Drug Administration (FDA) was aware early on that the COVID vaccines could spur viral reactivation of diseases like the varicella-zoster virus (shingles) in some people, but chose not to disclose it, according to renowned vaccinologist and physician Dr. Robert Malone. “They knew about the viral reactivation,” Malone declared during a recent panel discussion hosted by Del Bigtree with fellow Global COVID Summit physicians Dr. Ryan Cole, and Dr. Richard Urso. Malone, the original inventor of mRNA and DNA vaccination technology, explained that he had been “very actively engaged” with senior personnel at the FDA in the Office...

David Boulware, who submitted the EUA for fluvoxamine, argues the agency is "behind the times"The FDA rejected an emergency use authorization (EUA) application for the use of the selective serotonin reuptake inhibitor fluvoxamine to treat COVID-19 on Monday. In a brief summary of their decision, attached to their detailed analysis of the evidence for the rejection, the agency noted that "the data are insufficient to conclude that fluvoxamine may be effective in the treatment of nonhospitalized patients with COVID-19 to prevent progression to severe disease and/or hospitalization." When David Boulware, MD, MPH, an infectious disease physician and researcher at the...

Our daughters deserve to be treated authentically; they should not become fodder for political spats.As the 1987 film “The Princess Bride” nears its satisfying conclusion, a distraught Princess Buttercup, thinking her Westley is lost to her, picks up a dagger and presses it to her chest. As she contemplates life without her Westley, Westley, reclining nearby, admonishes her with, “There’s a shortage of perfect breasts in this world. It would be a pity to damage yours.” Lately, headlines have been hyper-focused on female anatomy. Due to the leak of Justice Alito’s draft addressing Dobbs, a challenge to Roe, and the...

Infant formula maker Abbott says it's reached an agreement with U.S. health officials to restart production at its largest domestic factory, a key step toward easing a nationwide shortage tied to the plant’s shutdown earlier this year. Abbott did not immediately detail the terms of the agreement reached with the Food and Drug Administration, which has been investigating safety problems at the Sturgis, Michigan, facility. The consent decree is a binding legal agreement between the company and the federal government. After production resumes, Abbott has said it will take at least eight weeks to begin shipping new product to stores.The...

The FDA “dropped the ball’’ on the country’s baby-formula crisis — shutting down a crucial plant on top of product recalls and then not warning parents of the ramifications, experts told The Post on Friday. Desperate moms and dads have been trawling stores across the country in search of baby formula ever since mega-manufacturer Abbott issued a safety recall in February for products made at its plant in Sturgis, Mich., over contamination concerns. The Food and Drug Administration later closed the plant after federal inspectors found Abbott failed to maintain sanitary conditions and procedures there — sparking a cascade of...

The biggest baby formula supplier in the U.S. has denied its Michigan plant is responsible for the deaths of two children despite the FDA closing it down. The plant was shutdown nearly three months ago after a bacterial infection caused the deaths and other serious illnesses. In mid-February Abbott Laboratories issued a nationwide baby formula recall and ceased operations at its plant in Sturgis, Michigan amid reports of babies contracting bacterial infections from its products. An Abbott spokesperson told DailyMail.com Tuesday that 'thorough investigation' by the U.S. Food and Drug Administration (FDA) and Abbott revealed 'infant formula produced at our...

A Wall Street Journal story from January had the suppliers and the shops blaming each other. "Chains like Walmart Inc. and CVS Health Corp. say the manufacturers are having supply issues; formula makers say retailers aren’t getting product to stores once it is delivered. We’ve all seen supply chain issue affect some of our favorite products. But when we couldn’t find Rice Krispies for a few weeks, my kids switched to Corn Flakes. The baby formula shortage is a much bigger problem. Which leads to a question that can be asked weekly: "Where is the president?" The Biden administration ducks...

The formula shortage is finally bringing attention to the FDA’s labeling games that have angered many moms for years.Months after distressed moms have been vocally upset and concerned about the baby formula shortage, the media is finally starting to ask, how could this happen? The short answer is lockdown supply chains and the shutdown of one of the country’s largest formula plants in Michigan over an alleged bacterial outbreak. The long answer is that, unlike the problem of sky-rocketing lumber prices or your West Elm furniture stuck on cargo ships, this crisis is intertwined with an already highly regulated industry...

The baby formula shortage continues to get worse Abbott Nutrition has finally provided a timeline for when new stock from its shuttered Sturgis, Michigan, baby formula manufacturing facility could hit store shelves in the U.S.: At least two months. "We understand the situation is urgent – getting Sturgis up and running will help alleviate this shortage," the company said in a statement on Wednesday. "Subject to [U.S. Food and Drug Administration] approval, we could restart the site within two weeks," the statement continues. "We would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac...

Washington, D.C. (May 9, 2022) – Today, Rep. James E. Clyburn, Chairman of the Select Subcommittee on the Coronavirus Crisis, issued the following statement after a staff briefing by Dr. Peter Marks, Director for the Center of Biologics Evaluation and Research at the Food and Drug Administration (FDA), on the status of coronavirus vaccine candidates for young children that took place on the afternoon of May 6. The briefing followed Chairman Clyburn’s April 25 letter to FDA Commissioner Dr. Robert M. Califf after reports emerged that the agency was considering delaying its review of the first coronavirus vaccine for children...

Several top Food and Drug Administration (FDA) officials, including Commissioner Robert Califf, admitted that Americans will now have to accept COVID-19 as another respiratory virus, comparing it to influenza.Califf, Principal Deputy Commissioner Janet Woodcock, and top vaccine official Dr. Peter Marks wrote for the Journal of the American Medical Association that COVID-19 will be around for the foreseeable future while suggesting that it will require yearly vaccines targeting the most threatening variations of the virus.“Widespread vaccine- and infection-induced immunity, combined with the availability of effective therapeutics, could blunt the effects of future outbreaks,” the officials said, referring to another name...

The U.S. Food and Drug Administration (FDA) is investigating reports of relapses among people who took Pfizer’s COVID-19 pill. The FDA “is evaluating the reports of viral load rebound after completing paxlovid treatment and will share recommendations if appropriate,” an agency spokesperson told The Epoch Times in an email. In a recent preprint case report, Veterans Affairs researchers reported that a 71-year-old male who took the pill, also known as nirmatrelvir, experienced a “rapid and progressive reduction” in the viral load of SARS-CoV-2, the virus that causes COVID-19. But four days after completing the treatment course, there was a “surprising...

The Food and Drug Administration (FDA) announced on May 5 that it will restrict the use of the Johnson & Johnson COVID-19 vaccine to adults who can’t receive mRNA vaccines because of the risk of potentially life-threatening side effects.The agency said the COVID-19 vaccine can now only be administered to people aged 18 years of age and older who can’t receive either the Moderna or Pfizer vaccines, both of which are two-dose vaccines and use mRNA technology. J&J’s single-shot vaccine uses adenovirus technology.People 18 and older who want to receive the J&J vaccine “because they would otherwise not receive a...

The Food and Drug Administration said the shot should only be given to adults who cannot receive a different vaccine or specifically request J&J's vaccine. U.S. authorities for months have recommended that Americans starting their COVID-19 vaccinations use the Pfizer or Moderna shots instead. FDA officials said in a statement that they decided to restrict J&J's vaccine after taking another look at data on the risk of life-threatening blood clots within two weeks of vaccination. J&J's vaccine was initially considered an important tool in fighting the pandemic because it required only one shot. But the single-dose option proved less effective...

The Food and Drug Administration (FDA) is planning to ban the use of menthol cigarettes in America, a move that had been called on by anti-tobacco groups, anti-teen smoking groups, racial justice groups in America. The move had been expected since the beginning of the Biden administration last year, when the President made it a priority to tackle upward trends in teen smoking. Menthol cigarettes - often colloquially referred to as just 'menthols' - are known for their mint-like flavor, and have been associated with the higher rates of smoking, and smoking-related illnesses, in black Americans over recent decades. Flavored...

"Long-awaited action" should reduce youth smoking, health disparitiesAfter more than a decade of discussing a ban on menthol in tobacco products, on Thursday the FDA finally proposed rules to eliminate menthol additives in cigarettes and all flavors other than tobacco in cigars. The rules would apply to heated tobacco products, although FDA Commissioner Robert M. Califf, MD, said in a press briefing that decisions about menthol electronic nicotine delivery system (ENDS) products are pending. Those decisions will be based on data presented by each manufacturer that wants to keep their ENDS products on the market, he added. The actions against...

[…]I’m posting this to establish a public record that they were informed and offered the evidence and took no action.This is extremely important evidence that has been in the public domain for a while that they have been willfully ignoring.I don’t expect a reply anytime soon because every time they have indicated that they aren’t interested in evidence showing they are killing people. They don’t want to see it.I don’t expect a reply because the videos and tissue samples would be impossible to explain. All of this information has been known for months (since at least Feb. 4 when Hirschman...

FDA on Thursday announced the availability of a draft guidance that, if finalized, would state the agency’s “intent to exercise enforcement discretion” regarding the distribution and sale of products labeled as dietary supplements and containing NAC (N-acetyl-L-cysteine). The draft guidance, which is scheduled to be published April 22 in the Federal Register, was released three weeks after FDA reaffirmed its position in responses to two citizen petitions that NAC is excluded from the definition of a dietary supplement because the ingredient was first approved as a drug in 1963. FDA, however, is still considering commencing a rulemaking to permit the...