New analysis has identified 25 chemicals linked to cancer that the Food and Drug Administration ( FDA) still allows in American food production. The findings come from scientists at the Environmental Defense Fund (EDF), a nonprofit environmental advocacy group, who determined that eight of the chemicals are classified as known human carcinogens and 17 are reasonably anticipated to be human carcinogens.
The Food and Drug Administration is holding a public meeting Thursday to consider whether Philip Morris International can advertise its pouches as a less-harmful alternative for adults who currently smoke cigarettes. Government documents posted before the meeting suggest FDA regulators are leaning toward approving the company's request. But the meeting will give an outside panel of health experts a chance to weigh in and ask questions of both the company and the agency.
The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries that the plan may run afoul of legal, ethical, and scientific standards long used to vet the safety and effectiveness of new medicines. Marty Makary's program is causing new anxiety and confusion among staff already rocked by layoffs, buyouts, and leadership upheavals, according to seven current or recently departed staffers.
On Friday, Vinay Prasad-the Food and Drug Administration's chief medical and scientific officer and its top vaccine regulator-emailed a stunning memo to staff that quickly leaked to the press. Without evidence, Prasad claimed COVID-19 vaccines have killed 10 children in the US, and, as such, he announced unilateral, sweeping changes to the way the agency regulates and approves vaccines, including seasonal flu shots.
As of Wednesday, the Food and Drug Administration (FDA) said, 31 cases of suspected or confirmed infant botulism have been reported in babies who consumed ByHeart Whole Nutrition formula and got sick between August and mid-November. No deaths have been reported. But all 31 babies were hospitalized with the illness, which can cause a potentially life-threatening form of gradual paralysis in infants less than a year old.
In September, Tidmarsh went after Tang's Aurinia and its drug voclosporin that treats lupus nephritis, a disease in which the immune system attacks the kidneys. In a startling post on his LinkedIn account, Tidmarsh claimed that the FDA-approved drug had not been shown to provide "hard" clinical benefit and that the drugmaker had not performed necessary trials. Such a post from the FDA's top drugmaker turned heads.
Oura Health Oy, the Finnish smart ring maker, is the latest wearable company seeking to move into blood pressure monitoring. On Monday, the startup said it plans to launch a Blood Pressure Profile study later this year, designed to detect early signs of hypertension or elevated blood pressure without displaying actual systolic or diastolic readings, as part of efforts to develop a future consumer feature. The study will track users' data without a traditional cuff and provide information to help users better understand their potential risk levels.
The FDA has issued another recall notice, expanding the list of products that could be contaminated with Cs-137. This recall is being carried out by Aqua Star (USA) Corp. of Seattle. As with previous recalls, these shrimp were processed by an Indonesian company whose containers tested positive for Cs-137. Cs-137 is a radioactive isotope that is widely found in trace amounts throughout the environment, due to widespread testing of nuclear weapons in the 1950s and 1960s.
"Patients may self-attest to their qualifying condition-no proof or additional documentation is required," Walgreens spokesperson Brigid Sweeny told SFGATE in an email. "We encourage anyone with questions about their eligibility or personal risk factors to speak directly with our pharmacists, who are available to provide guidance and support."
The U.S. Food and Drug Administration (FDA) has published a recall notice on its website warning of potential Listeria monocytogenes in several cheese products. The FDA's warning was published on September 8, three days after the Ohio-based company behind the cheese announced the recall. That company is Middlefield Original Cheese Co-op, which produces multiple cheese products. Middlefield initiated the recall after detecting Listeria monocytogenes in some of its finished products as well as on cutting equipment surfaces.
The Fourth Circuit Court of Appeals upheld West Virginia's law banning FDA-approved medication abortion, marking the first federal court to sanction such a ban and undermining the FDA's regulatory authority.
