Royce DuBiner

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Retailers at Risk: FDA Issues Advisory on Recreational Nitrous Oxide Products

On June 4, 2025, the U.S. Food and Drug Administration issued a public advisory urging consumers not to inhale nitrous oxide (N2O) from commercial dispensers, including canisters, tanks and portable chargers. The advisory...more

6/17/2025 / Class Action , Consumer Protection Laws , Enforcement Actions , Food and Drug Administration (FDA) , Hazardous Substances , Manufacturers , Product Labels , Regulatory Oversight , Retailers , Risk Management

FDA’s Emergency Use Authorization Process for COVID-19 Tests May Alleviate Shortage

As the nation battles shortages of novel coronavirus (COVID-19) testing kits, the U.S. Food and Drug Administration (FDA) has engaged its emergency use authorizations (EUA) process for unapproved products and uses to...more

3/27/2020 / Clinical Laboratory Testing , Coronavirus/COVID-19 , Diagnostic Tests , Employer Group Health Plans , Enforcement Actions , FDA Approval , Food and Drug Administration (FDA) , Health Insurance , Infectious Diseases , New Guidance

FDA to Prioritize Enforcement Actions Against Unapproved Homeopathic Drugs

On Oct. 24, 2019, in a joint statement from U.S. Food and Drug Administration (FDA) acting Commissioner Norman E. Sharpless, and the Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, FDA announced that...more

11/27/2019 / Center for Drug Evaluation and Research (CDER) , Enforcement Actions , Food and Drug Administration (FDA) , Pharmaceutical Industry , Warning Letters

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