Food and Drug Administration News

FDA’s Juul Inquiry Found Consumers Had 2,600 Health Complaints

Juul Labs Inc. received roughly 2,600 complaints about adverse health effects related to its e-cigarette during its first three years in operation, with customers citing issues such as burning sensations in the lungs, blistered lips and vomiting, according to an …

Government Experts Urge New Talc Testing Standards Amid Asbestos Worries

An expert panel formed by the U.S. Food and Drug Administration has endorsed asbestos testing standards for cosmetics that reject long-held industry positions and reflect those of public health authorities and experts for thousands of plaintiffs who allege contaminated talc …

FDA Under Fire for Years of Delays on E-Cigarette Regulation

As the FDA pressures e-cigarette firms to stamp out youth vaping, the agency faces criticism itself for failing to rein in the fast-growing industry after years of bureaucratic delays dating back to the Obama administration. Despite recent tough talk, the …

Drug-Plant Inspections Ebbed as Tainted Pills Flowed to U.S.

Inspections of foreign drug manufacturers by the U.S. Food and Drug Administration have fallen in recent years despite increasing worry about the safety and quality of generic medications, congressional investigators said. FDA inspections of overseas pharmaceutical manufacturers declined 10% from …

J&J CEO Spurns U.S. Congressional Hearing on Carcinogens in Talc Products

Johnson & Johnson Chief Executive Officer Alex Gorsky has declined to appear at a U.S. congressional hearing set for Tuesday on the safety of the company’s Baby Powder and other talc-based cosmetics. In an announcement, the House of Representatives Subcommittee …

FDA is Green-Lighting Drugs at Breakneck Speed and Raising Alarm

The U.S. is approving new drugs so fast that companies are now preparing for a green light months in advance of the scheduled decision date, a pace that’s helping patients with rare or untreatable diseases but raising alarm among consumer …

Powder Keg: FDA Bowed to Industry for Decades as Alarms Were Sounded Over Talc

At an invitation-only gathering late last year, U.S. regulators and their guests huddled at a hotel near Washington, D.C., to discuss the best way to detect cancer-causing asbestos in talc powders and cosmetics. The “Asbestos in Talc Symposium,” sponsored by …

Dollar Tree Gets FDA Warning for Potentially Dangerous Drugs

Dollar Tree received a warning letter from U.S. regulators for buying over-the-counter drugs from foreign manufacturers that were made in such substandard conditions that they had been barred from entry to the U.S. The letter sent to Greenbrier International Inc., …

Bausch Yanked Talc From Its Body Powder Months Before J&J Recall

As retailers pull Johnson & Johnson’s recalled talc-based baby powder from their shelves over reports of asbestos contamination, one competitor has yanked the mineral from its product altogether. Bausch Health Cos. Inc., maker of Shower to Shower powder, said it …

Georgia Plant Agrees to Close in Fight Over Gas Emissions

ATLANTA — Georgia officials reached an agreement Monday to temporarily shut down a medical sterilization facility that uses a gas that studies have linked to an increased risk of cancer. A Newton County judge signed off on a deal between …