Latest news with #SaraBrenner
Medscape
21-05-2025
- Health
- Medscape
Is the FDA Poised to Ban Talc?
The FDA may be poised to ban talc as an ingredient in the products it regulates, including foods, pharmaceuticals, and cosmetics. The agency convened what it called an expert panel on talc on May 20, led by FDA Commissioner Martin Makary, MD, MPH, and Principal Deputy Commissioner Sara Brenner, MD, MPH. The 2-hour meeting was livestreamed. But, unlike a traditional FDA advisory committee meeting, there were no lengthy, data-driven presentations from panelists or manufacturers that might be impacted by any agency decision. There were no votes on any questions, and none of the panelists disclosed any potential conflicts. Makary said the meeting was being held to listen to what 'the experts think we should be doing about it, if anything at all.' Talc is carcinogenic and likely pro-inflammatory, said Makary. 'I'm not suggesting that talc is the driver of our chronic disease epidemic, but if we generally believe it's pro inflammatory, and kids are ingesting it, aside from the potential cancer-causing effects, shouldn't there be reason for concern?' 'I think we need to take a serious look, not just at talc, but at all chemicals,' around which the 'scientific community has been waving a flag for decades, saying, stop and take a look around,' said Makary. Use of talc around the genital area has been linked to ovarian cancer, and in 2024, the World Health Organization's International Agency for Research on Cancer classified talc as 'probably carcinogenic to humans.' A mineral, talc is usually mined from open pits and crushed into a fine powder that is used in a variety of products. It is most commonly found in gums and candy, said panelist George Tidmarsh, MD, an adjunct professor of pediatrics and neonatology at Stanford University, California. It is also in many over-the-counter vitamins and medications and is used to coat cheeses or to prevent flour and rice from caking. On a talc information webpage, the FDA said that talc is used in cosmetics to absorb moisture, to prevent caking, and to make facial makeup opaque. In December 2024, the agency proposed to require manufacturers to begin testing and assessing talc-containing cosmetics for potential contamination with the cancer-causing mineral asbestos. The two minerals are often found together in mines. The FDA experts mostly said there was no reason to allow talc in any product. Panelist Nicolas Wentzensen, MD, PhD, a cancer epidemiologist at the National Cancer Institute, said that the data on whether talc led to cancer in other body parts besides the ovaries was not a 'slam dunk' in part because of asbestos contamination. Studies with cosmetic products are also difficult because they are often based on self-reports, he said. 'There is a lot more that we do not know about talc, than what we know,' he said. But conducting studies to evaluate exposures could take many years, said Wentzensen. 'If there's a safe, functionally equal alternative that avoids the potential harms, then that should be really considered,' he said. Panelist Nicole Kleinstreuer, PhD, acting deputy director of the National Institutes of Health, who was recently director of the National Toxicology Center's interagency center for the evaluation of alternative toxicological methods, said that a preliminary assessment had shown that magnesium stearate 'has a much more favorable safety profile, particularly in terms of inhalation risk, carcinogenicity, and biological clearance.' Another panelist, Joellen M. Schildkraut, PhD, MPH, an epidemiologist at the Rollins School of Public Health at Emory University, Atlanta — who has demonstrated an increased risk of ovarian cancer with body powder use — cautioned that her work could not show causality. Still, 'if you don't need to use it, why use it, why take a chance,' said Schildkraut. She said she 'would be in favor of eliminating' talc from the FDA's regulated products. Makary told panelists that the FDA 'will take a close look at this literature and get back with you as we have questions.'
Gulf Insider
20-05-2025
- Health
- Gulf Insider
Top FDA Official Discloses She Never Received COVID-19 Vaccine
A top Food and Drug Administration (FDA) official said on May 15 that she never took a COVID-19 vaccine due to concerns about biodistribution. Dr. Sara Brenner, the FDA's principal deputy commissioner, said during an event in Washington that she did not receive any of the COVID-19 vaccines. Brenner said that she was pregnant during the COVID-19 pandemic. 'It was unknown at the time what the biodistribution patterns of those products were, and in my case, in particular, what the excretion would be in breast milk,' Brenner said. 'That was my primary concern, and that exposure I was very concerned about.' When asked whether the information that has emerged since then validates her choice, Brenner, who said she was not speaking on behalf of the FDA, said she thinks it does. Researchers reported in a 2022 paper that messenger ribonucleic acid, which is in the Pfizer and Moderna COVID-19 shots, was detected in human breast milk. Another paper, in 2023, detailed similar findings. Pfizer and Moderna did not return requests for comment. Dr. Marty Makary, the FDA's commissioner, has been critical of COVID-19 vaccine boosters. He has indicated that he received a primary series of one of the vaccines. Click here to read more…
Epoch Times
16-05-2025
- Health
- Epoch Times
Top FDA Official Says She Never Received a COVID-19 Vaccine
A top Food and Drug Administration (FDA) official said on May 15 that she never took a COVID-19 vaccine due to concerns about biodistribution. Dr. Sara Brenner, the FDA's principal deputy commissioner, said during an event in Washington that she did not receive any of the COVID-19 vaccines.
Chicago Tribune
23-04-2025
- Health
- Chicago Tribune
Novavax says its COVID-19 shot is on track for full FDA approval after delay
WASHINGTON — Novavax's closely watched COVID-19 vaccine is on track for full approval after additional discussions with the Food and Drug Administration, the company said Wednesday. The news sent company shares soaring more than 21% in morning trading and appeared to resolve concerns that Trump administration officials might be holding up a decision on the shot. Novavax makes the nation's only traditional protein-based COVID-19 vaccine. It is still being sold under emergency use authorization — unlike mRNA vaccines made by Pfizer and Moderna that have earned full FDA approval for certain age groups. The FDA recently asked Novavax to develop a plan for collecting additional clinical data from those who have gotten the shot, the company said in a statement. It said it is 'engaging with the FDA expeditiously' in hopes of receiving approval 'as soon as possible.' At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax's license by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss confidential agency matters. But FDA's acting commissioner, Dr. Sara Brenner, directed the agency's lead official overseeing the vaccine to pause the decision, according to one of the people. The delay, first reported by The Wall Street Journal, sparked concerns of political interference under Robert F. Kennedy Jr., who spent decades leading antivaccine groups before joining the federal government as health secretary. Last month, FDA's longtime vaccine chief, Dr. Peter Marks, was forced out over disagreements with Kennedy about vaccine safety. With full FDA approval, Novavax would have permission to keep its shot on the market indefinitely. Products that receive emergency authorization can be removed by FDA after there is no longer a health emergency. All the COVID-19 vaccines used in the U.S. train the body to fight the coronavirus by recognizing its outer coating, the spike protein. The Pfizer and Moderna options deliver genetic instructions for the body to temporarily make copies of the protein. In contrast, the Novavax vaccine uses lab-grown copies of the spike protein packaged into nanoparticles and combined with an immune-revving ingredient. Protein-based vaccines have been used for years to prevent other diseases including hepatitis B and shingles.
San Francisco Chronicle
23-04-2025
- Health
- San Francisco Chronicle
Novavax says its COVID-19 shot is on track for full FDA approval after delay
WASHINGTON (AP) — Novavax's closely watched COVID-19 vaccine is on track for full approval after additional discussions with the Food and Drug Administration, the company said Wednesday. The news sent company shares soaring more than 21% in morning trading and appeared to resolve concerns that Trump administration officials might be holding up a decision on the shot. Novavax makes the nation's only traditional protein-based COVID-19 vaccine. It is still being sold under emergency use authorization — unlike mRNA vaccines made by Pfizer and Moderna that have earned full FDA approval for certain age groups. The FDA recently asked Novavax to develop a plan for collecting additional clinical data from those who have gotten the shot, the company said in a statement. It said it is 'engaging with the FDA expeditiously' in hopes of receiving approval 'as soon as possible.' At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax's license by its April 1 target date, according to two people with direct knowledge of the situation who spoke on condition of anonymity to discuss confidential agency matters. But FDA's acting commissioner, Dr. Sara Brenner, directed the agency's lead official overseeing the vaccine to pause the decision, according to one of the people. The delay, first reported by The Wall Street Journal, sparked concerns of political interference under Robert F. Kennedy Jr., who spent decades leading antivaccine groups before joining the federal government as health secretary. Last month, FDA's longtime vaccine chief, Dr. Peter Marks, was forced out over disagreements with Kennedy about vaccine safety. With full FDA approval, Novavax would have permission to keep its shot on the market indefinitely. Products that receive emergency authorization can be removed by FDA after there is no longer a health emergency. All the COVID-19 vaccines used in the U.S. train the body to fight the coronavirus by recognizing its outer coating, the spike protein. The Pfizer and Moderna options deliver genetic instructions for the body to temporarily make copies of the protein. In contrast, the Novavax vaccine uses lab-grown copies of the spike protein packaged into nanoparticles and combined with an immune-revving ingredient. Protein-based vaccines have been used for years to prevent other diseases including hepatitis B and shingles. Each year, the three manufacturers update their vaccine recipes to better match the latest COVID-19 variants that are circulating, just like flu shots are updated yearly.
