Tag Archives: FDA

Courthouse News reports: A federal judge sided with health advocacy groups in ruling that the Food and Drug Administration must stop electronic cigarette companies from selling their products until they win approval from the agency. In a lawsuit filed in March of last year, the American Academy of Pediatrics, American Heart Association, American Lung Association and other groups and physicians …

The Wall Street Journal reports: The Food and Drug Administration approved a controversial drug for depression that could be the first of a long-awaited wave of new treatments, but that has also raised concerns about abuse. The drug, a nasal spray that manufacturer Johnson & Johnson JNJ 0.21% has branded Spravato, is a close chemical relation to ketamine. Ketamine is …

The Washington Post reports: Food and Drug Commissioner Scott Gottlieb, who used his post to tackle difficult public health issues from youth vaping to opioid addiction – surprising early skeptics worried about his drug industry ties – resigned Tuesday, effective in about a month, according to an administration official. Gottlieb, who has been commuting weekly to Washington from his home …

CNBC reports: The Food and Drug Administration called out 15 retailers on Monday for allegedly selling tobacco products to minors and requested information from more than 40 e-cigarette companies the agency thinks may have illegally introduced new products onto the market. The agency named corporate-owned and franchise retailers who were allegedly found selling tobacco products to minors more than 15 …

CBS News reports: More than 86 tons of frozen Boston Market dinners are being recalled from retailers across the U.S., as well as from a Defense Department facility, after consumers reported that some items contained pieces of glass or plastic. Produced by Bellisio Foods in Jackson, Ohio, between Dec. 7, 2018, to Feb. 15, 2019, the boneless pork rib patties …

CNBC reports: The Food and Drug Administration said Monday it sent warning letters to more than a dozen companies the agency said are “illegally selling” products that claim to prevent or cure Alzheimer’s disease. Many of these products, which are often sold on websites and social media platforms, “have not been reviewed by the FDA and are not proven safe …

NBC News reports: Food and Drug Administration Commissioner Dr. Scott Gottlieb made his most direct threat yet against e-cigarette companies Friday, saying they face an “existential threat” if they don’t stop marketing to youth. Gottlieb said he was horrified at the recent rapid rise in teen vaping. He called out the most popular product — Juul— by name and said …

NBC News reports: The ongoing federal government shutdown has stopped most food safety inspections, but the Food and Drug Administration is planning to resume at least some of them. To do it, the agency will have to force furloughed workers to come back without pay. FDA Commissioner Dr. Scott Gottlieb said he is trying to pinpoint the most essential inspections, …

CBS News reports: Jennie-O Turkey Store Sales, Inc., is recalling more than 164,000 pounds of raw ground turkey products over possible salmonella, the U.S. Department of Agriculture’s Food Safety and Inspection Service said Friday. The items that might be contaminated were shipped across the U.S. and produced on two days: October 22 and 23. “The products subject to recall bear …

Via press release from the FDA: FDA wants you to be aware that some decorative glitters and dusts promoted for use on foods may, in fact, contain materials that should not be eaten. Many decorative glitters and dusts are sold over the Internet and in craft and bakery supply stores under names such as luster dust, disco dust, twinkle dust, …

The New York Times reports: Facing mounting government pressure and a public backlash over the epidemic of teenage vaping, Juul Labs announced on Tuesday that it would stop selling most of its flavored e-cigarette pods in retail stores and would discontinue its social media promotions. The decision by the San Francisco-based company, which has more than 70 percent of the …

The Washington Post reports: The Food and Drug Administration, alarmed by a huge increase in vaping among minors, is expected to impose severe restrictions on the sale of most e-cigarettes products throughout the United States — actions that will likely have a significant impact on an industry that has grown exponentially in recent years with little government oversight. As soon …

CNBC reports: The Food and Drug Administration is threatening to pull new e-cigarette products from shelves if the companies don’t prove they’re selling the items legally. The FDA sent letters on Friday to 21 e-cigarette manufacturers requesting information to investigate whether they illegally introduced more than 40 new devices and nicotine liquids to the market without receiving agency approval. Business …

Gizmodo reports: In its ongoing crusade against rad teens, the Food and Drug Administration announced Tuesday that it raided the headquarters of Juul Labs, which is under investigation for potentially marketing e-cigarettes to children. The “unannounced on-site inspection,” executed on Friday, resulted in the seizure of “thousands of pages of documents,” according to the FDA. The surprise inspection of Juul …

USA Today reports: According to a notice issued Wednesday by the United States Department of Agriculture Food Safety and Inspection Service, Cargill Meat Solutions is recalling approximately 132,000 pounds of ground beef products made from the chuck portion of the cow. Officials said the ground beef was produced and packaged on June 21, 2018, and affects 12 different Cargill products. …

The Associated Press reports: U.S. regulators have approved the first drug with a sensor that can track whether patients have taken their medicine. The Abilify pill was first approved by the Food and Drug Administration in 2002 to treat schizophrenia, and the sensor technology was approved for marketing in 2012. The FDA said in a statement Monday that the digitally-enhanced …

The New York Post reports: Snortable chocolate is so dangerous that its health effects must be investigated by the feds, Sen. Charles Schumer is urging. Coco Loko — a raw cacao powder infused with a “special energy blend” — is marketed like a drug and should be closely regulated, Schumer demanded in a letter to the Food and Drug Administration …

This will be a lifesaver for many people: The Food and Drug Administration on Friday announced its approval of Teva’s abbreviated new drug application the first generic of Gilead’s Truvada (emtricitabine and tenofovir disoproxil). The drug is indicated both as a treatment for HIV-1 in combination with other antiretroviral drugs and for pre-exposure prophylaxis to prevent sexually acquired HIV infection …

The Washington Post reports: President Trump is expected to pick Scott Gottlieb, a conservative physician and businessman with deep ties to the pharmaceutical industry, to be commissioner of the Food and Drug Administration, a person familiar with the nomination said Friday. If confirmed, Gottlieb would bring a strong pro-industry, deregulatory approach to an agency that Trump has criticized as being …

Activist Matt Baume takes a look at the FDA’s recently amended ban on blood donations from gay men and what may come once notoriously anti-gay Tom Price takes over the agency. From the clip description: “Back in the 80s, when the ban was created, it was a best-guess effort to keep blood donations safe since there hadn’t been much research …