Listeria outbreak tied to soft cheese kills 1, sickens others across several states, FDA says
The Maryland Department of Health has suspended Clover Hill Dairy’s operating license. Source link
All posts tagged: FDA
FDA Grants Emergency Approval for Over-The-Counter Drug to Treat Screwworm in Pets
June 11 (Reuters) – The U.S. Food and Drug Administration on Thursday authorized the emergency use of a generic over-the-counter tablet to treat infestations caused by the New World screwworm in dogs and cats, as the government steps up efforts to contain the parasite. U.S. officials this month confirmed the first domestic cases of the parasite in more than six decades in cattle, a goat and a dog in Texas and New Mexico. New World screwworm is a fly whose larvae feed on living tissue, entering animals through open wounds and burrowing into the flesh. The agency said nitenpyram tablets, a fast-acting treatment, can be used in pets weighing at least two pounds and at least four weeks old, adding that the drug is expected to help kill most larvae within hours of the first dose. A second dose should be given six hours after the first, the agency said, but added that the drug may not protect against reinfestation and veterinarians may still need to remove remaining larvae and treat wounds. U.S. officials have warned …
FDA OKs First New Sunscreen Ingredient in More Than 25 Years
WASHINGTON (AP) — Federal health regulators on Tuesday signed off on the first new sunscreen ingredient for the U.S. market in more than 25 years, giving Americans access to a skin-protecting chemical long used in Europe and other parts of the world. The Food and Drug Administration says the ingredient, bemotrizinol, met the agency’s standards for protecting from dangerous ultraviolet rays while causing little irritation or absorption into the skin. The ingredient is safe for adults and children 6 months and older, the agency stated in a release. Bemotrizinol will initially be sold in the U.S. by the Dutch manufacturer DSM Nutritional Products under the brand name Parsol Shield, which is expected to launch later in the year. After an 18-month exclusivity period, the ingredient will be available for use by other manufacturers. Experts say bemotrizinol will fill an important niche in the U.S. market: protecting against both ultraviolet A and B rays while not leaving white streaks associated with mineral-based sunscreens. “For decades, Americans have used outdated sunscreen tech while the rest of the …
FDA allows bemotrizinol, a popular sunscreen ingredient long used in Europe and Asia
The Food and Drug Administration on Tuesday expanded its list of allowed sunscreen ingredients to include the chemical compound bemotrizinol. Subscribe to read this story ad-free Get unlimited access to ad-free articles and exclusive content. The change has been eagerly anticipated for years: Bemotrizinol has long been popular in Europe, Australia and some Asian countries. It also marks the first time in more than 20 years the FDA has permitted a new compound onto its sunscreen ingredient list. Why the excitement? Bemotrizinol is a UV light filter, meaning it blocks out harmful ultraviolet rays from the sun. To be most effective, these filters need to be broad-spectrum, meaning they block UVA and UVB rays. UVA rays cause aging and wrinkles, while UVB rays cause sunburn, according to the American Academy of Dermatology. Both contribute to skin cancer, according to the Skin Cancer Foundation. UV filters come in two formats: mineral or chemical. The mineral sunscreens — which contain zinc oxide or titanium dioxide — block both UVA and UVB rays but often leave a white …
‘Sexual Chocolate’ Faces Recalls After FDA Tests Reveal Undisclosed Viagra
The US Food and Drug Administration regularly announces recalls. But it has recently issued a surprising series of alerts: Several brands of chocolate marketed for “sexual enhancement” contain undisclosed drugs prescribed for erectile dysfunction, according to lab analyses conducted by the agency. The flagged products—some of which are being voluntarily recalled—are sold online under names like Boner Bears Chocolate, DTF Sexual Chocolate, Lovion Chocolate With Ginseng for Men, and Rhino Choco VIP. Some are labeled “all natural” or claim to contain herbal ingredients such as pau de cabinda powder, which is used as a libido enhancer. The FDA is advising consumers not to purchase the chocolates, because they contain sildenafil and tadalafil, the active ingredients in Viagra and Cialis, respectively. They work by relaxing blood vessels and boosting blood flow to the penis. One of the products, Pink Pussycat Aphrodisiac Chocolate, is marketed to women. (The FDA hasn’t approved Viagra or Cialis for women.) “FDA approval of Viagra and Cialis is restricted to use under the supervision of a licensed health care professional,” according to …
FDA advisers to weigh updated COVID vaccine targeting XFG subvariant
The Food and Drug Administration’s (FDA) advisory committee on vaccines this week will consider whether to change the COVID-19 vaccine to target the XFG subvariant for the upcoming 2026-2027 respiratory viral season. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Thursday to discuss whether COVID-19 vaccines should target the NB.1.8.1… Source link
.jpg?ssl=1 "Trump Wants to Be the Hero Vapers Don’t Really Need")
Trump Wants to Be the Hero Vapers Don’t Really Need
In December of 2019, Mitch Zeller, who at the time ran the FDA’s Center for Tobacco Products, got an urgent phone call from a fellow staffer at the agency. A few months earlier, President Donald Trump and his administration had vowed to take e-cigarettes in every flavor except tobacco off the market to quash a youth vaping epidemic that, at the time, saw almost 30 percent of American teens using nicotine. By the time Zeller received that December call, he says, the White House had different instructions for the FDA: Limit the ban to pod-based vapes, like Juuls, and leave menthol flavors alone. Zeller says this softer touch “absolutely” came about because Trump, heading into the 2020 election year, got spooked by pushback to his original plans. “The White House,” Zeller says, “went into political retreat.” Almost seven years later and well into his second term, Trump is vice-signaling even more aggressively to the pro-vape crowd and the industry that supplies it. The payoff is unclear, given that vapers make up a relatively small chunk …
FDA drops guardrails on vaping industry in major Trump pivot
The Trump administration is pivoting hard on vaping, taking down guardrails that have limited the industry’s growth in recent years and making clear the tobacco industry’s enduring influence over Washington. In the span of two weeks, the Trump administration granted marketing authorization to four flavored vaping products and issued new guidance allowing unauthorized vapes to stay on… Source link
FDA exit could threaten abortion access nationwide
Food and Drug Commissioner Marty Makary’s planned resignation creates a new opening for anti-abortion activists to push for national restrictions on the procedure — and in particular, limit the availability of a key abortion drug. The move comes as anti-abortion groups became angry over what they viewed as his agency’s failure to curb access to the drug. Makary’s planned resignation, which multiple outlets reported Tuesday, followed reports of Trump’s growing dissatisfaction with the commissioner. According to The Wall Street Journal, Trump was frustrated by an FDA decision not to approve multiple flavored vape products, which Makary worried might particularly appeal to children. Trump pressed Makary to approve the products, calling flavored vape availability a key issue for younger supporters. After Trump’s intervention, those products received federal approval. But Makary had drawn ire from other corners of the conservative movement. Abortion opponents have been pressing the FDA for months to rescind a decision approving the drug mifepristone, which is used in most abortions, to be dispensed without an in-person visit. The Supreme Court is now reviewing a …
FDA Commissioner Makary resigns after tumultuous tenure : NPR
As Food and Drug Administration commissioner, Dr. Marty Makary was often at the center of controversies. Anna Moneymaker/Getty Images hide caption toggle caption Anna Moneymaker/Getty Images Dr. Marty Makary resigned as commissioner of the Food and Drug Administration Tuesday, ending a 13-month tenure marked by turmoil. President Trump spoke at the White House about the FDA leadership change as he was preparing to leave on a trip to meet China’s President Xi Jinping. “Marty is a great guy. He’s a friend of mine. He’s a wonderful man, and he’s going to be off and the assistant, the deputy, is taking over temporarily,” Trump said. “He was having some difficulty, you know, he’s a great doctor, and he was having some difficulty. But he’s going to go on and he’s going to do well.” Later in the afternoon, Trump posted on Truth Social: “I want to thank Dr. Marty Makary for having done a great job at the FDA. So much was accomplished under his leadership. He was a hard worker, who was respected by all, …