Latest news with #FoodAndDrugAdministration
The Independent
3 days ago
- Business
- The Independent
Juul will be allowed to sell e-cigarettes ending long fight over flavored tobacco on store shelves
Vaping brand Juul Labs can continue to sell its e-cigarettes and refill cartridges, the Food and Drug Administration announced Thursday. The decision comes after the company struggled for years against heightened regulatory scrutiny and intense backlash as the brand's flavored pods became popular amongst young people, contributing to the rise in teen vaping. Despite this, the FDA ruled that Juul's studies show its e-cigarettes are less harmful for adult smokers, who can benefit from switching from cigarettes to vaping. The decision applies to both tobacco and menthol-flavored versions of the e-cigarettes, which are used with nicotine-filled cartridges sold in two different strengths. 'This is an important milestone for the company and I think we made a scientifically sound case for the role that menthol can play in e-vapor,' Juul CEO K.C. Crosthwaite told The Associated Press. Ahead of the decision, Juul attempted to drive away some of its teen consumers by discontinuing several fruit and candy flavors that were favored by that demographic. The FDA had ordered the company to remove its products from the market in June 2022, but quickly changed course after Juul pushed back in court. The announcement is also not an approval or endorsement of Juul's products, and the FDA reiterated that people who do not smoke should not use Juul or any other e-cigarettes.
France 24
3 days ago
- Health
- France 24
US health experts reassess hormone replacement therapy risks
HRT is taken to replace estrogen the body stops producing after menopause -- when periods end permanently -- and helps relieve symptoms such as hot flashes, vaginal discomfort, and pain during sex. But its use has plummeted in recent years amid concerns including a potential link to invasive breast cancer. Food and Drug Administration (FDA) chief Marty Makary, who convened Thursday's meeting of outside experts, has long advocated for HRT, saying its risks have been overstated. "For decades, hormone replacement therapy for women -- that is estrogen or estrogen plus progesterone -- has helped women alleviate the symptoms of menopause, including hot flashes, dryness, mood swings, weight gain and poor sleep quality, to name a few," he said in a video ahead of the meeting. He added that when initiated within a decade of the onset of the transitional period before menopause, HRT may even reduce cognitive decline, the risk of Alzheimer's, and prevent osteoporosis and cardiovascular disease. Makary blamed the drop in HRT use on a landmark clinical trial, the Women's Health Initiative, which was halted in the early 2000s after it flagged increased risks of breast cancer and stroke. But he said subsequent studies had not replicated the findings on breast cancer. "The many benefits of hormone therapy were ignored as it was seen as a carcinogen. Prescriptions for hormone replacement therapy plummeted in the United States, women flushed their pills down the toilet," he said Thursday. "Fifty million plus women have not been offered the incredible potential health benefits of hormone replacement therapy because of medical dogma," he added, including his own mother, who suffered multiple bone fractures in her older life. Critics of the trial argue it was flawed because the participants were too far from menopause, when risks are elevated and benefits limited, and that the formulations used are now outdated. Label changes Still, the issue remains divisive within the medical community. The FDA's own warning label for HRT -- which can be administered through various means including orally, through skin patches, or vaginally -- cites risks including endometrial cancer, breast cancer, and life-threatening blood clots. This week, the American Family Physician journal published an editorial that found limited benefits and significant harms associated with HRT. "Menopause is a positive life experience for many women and should not be medicalized," the authors concluded. The nature of the FDA expert meeting is also unusual. Unlike standard practice before the Trump administration, no agenda was publicly posted. Several of the named panelists have ties to companies offering menopause treatments or who belong to the advocacy group "Let's Talk Menopause," which receives funding from pharmaceutical companies and campaigns to revise the FDA warning label.
CBS News
3 days ago
- Health
- CBS News
Power Stick deodorant recalled from retailers because of manufacturing defects
Some Power Stick deodorants manufactured by A.P. Deauville are under recall for manufacturing defects, according to the Food and Drug Administration. The recall impacts more than 67,000 cases of roll-on deodorants that were sold nationally, a notice posted by the agency shows. The issue is related to deviations with "current good manufacturing practices," a set of guidelines for for pharmaceutical manufacturing, although the recall notice didn't specify the issues with the deodorants. Easton, Pennsylvania-based A.P. Deauville didn't immediately respond to a request for comment. The recalled deodorants are: The recall involves 21,265 cases of Power Stick for Her Roll-on Antiperspirant Deodorant Powder Fresh; 22,482 cases of Power Stick Invisible Protection Roll-On Antiperspirant Deodorant Spring Fresh; and 23,467 cases of Power Stick Original Nourishing Invisible Protection Roll-On Antiperspirant Deodorant.
Wall Street Journal
3 days ago
- Business
- Wall Street Journal
FDA Authorizes Juul E-Cigarettes
Juul Labs has won authorization from federal regulars for its e-cigarettes to remain on the U.S. market, according to people familiar with the matter. The decision breathes new life into the vaping company after a federal ban in 2022 pushed it to the brink of bankruptcy. The Food and Drug Administration has authorized Juul's original vaporizer, along with refill cartridges in tobacco and menthol flavors, the people familiar with the matter said.
Washington Post
11-07-2025
- Health
- Washington Post
When accepting or rejecting new drugs, the FDA will be transparent
Marty Makary is commissioner of the Food and Drug Administration. The letters the Food and Drug Administration sends to pharmaceutical companies explaining its decisions on drugs are a treasure trove of valuable information. They detail how the agency thinks and reveal patterns of where companies fall short in trying to bring new drugs to the market. For too long, the contents of these letters have been seen, for the most part, only by the individual applicants. The result: Companies stumble — making common mistakes because of the lack of a road map — and cures and meaningful treatments are delayed for the American people.
