Laura Macherelli on Public Health

FDA Authorizes Marketing of Zyn Nicotine Pouches

The U.S. Food and Drug Administration (FDA) recently approved the marketing of 20 Zyn nicotine pouches, marking the first time nicotine pouches have received such authorization. This decision came through the premarket...more

1/31/2025 / Consumer Protection Laws , FDA Approval , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Marketing Authorization Application , Public Health , Tobacco

The FDA’s New Definition of ‘Healthy’: A Step Forward, or a Step Too Far?

The Food and Drug Administration (FDA) recently issued a final rule updating the definition of the term “healthy” for use on food labels. This change aims to align with modern nutrition science and the latest Dietary...more

1/28/2025 / Consumer Protection Laws , Dietary Guidelines , Final Rules , Food and Drug Administration (FDA) , Food Manufacturers , Product Labels , Public Health , Regulatory Requirements

FDA Advances Proposal To Lower Nicotine in Cigarettes

In the final days of the Biden administration, the Food and Drug Administration (FDA) has taken a significant step toward reducing nicotine levels in cigarettes by submitting a proposed rule to the Office of Management and...more

1/28/2025 / Biden Administration , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Proposed Rules , Public Health , Tobacco Regulations

Federal Court Blocks FDA’s Graphic Cigarette Warning Rule: The Limits of Regulatory Authority

On Monday, a federal judge from the Eastern District of Texas, Judge J. Campbell Barker, ruled that the U.S. Food and Drug Administration (FDA) exceeded its authority under the Tobacco Control Act by requiring cigarette...more

1/27/2025 / Administrative Procedure Act , Advertising , Appeals , Constitutional Challenges , Final Rules , First Amendment , Food and Drug Administration (FDA) , Preliminary Injunctions , Public Health , Regulatory Authority , Statutory Interpretation , Tobacco , Tobacco Regulations , Warning Labels

Navigating FDA’s Guidance on Validation and Verification of Analytical Testing Methods for Tobacco Products

The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides tobacco product...more

1/14/2025 / Analytics , Compliance , Data Collection , Final Guidance , Food and Drug Administration (FDA) , Manufacturers , Public Health , Regulatory Requirements , Risk Management , Tobacco Regulations

Supreme Court Hears FDA’s Flavored Vape Case

On Monday, the Supreme Court heard oral arguments in a pivotal case that examines the Food and Drug Administration’s (FDA) authority to regulate flavored e-cigarettes. At the heart of the debate are the agency’s denials of...more

12/6/2024 / E-Cigarettes , Food and Drug Administration (FDA) , Minors , Oral Argument , Popular , Public Health , Regulatory Authority , SCOTUS , Vaping

What a Second Trump Administration Could Mean for Tobacco Industry Regulations

As the tobacco industry anticipates a second Trump administration, it’s banking on what some public health experts describe as his unpredictable approach to regulation. Trump’s history of abrupt policy shifts makes tobacco...more

11/27/2024 / Department of Health and Human Services (HHS) , Deregulation , Food and Drug Administration (FDA) , Popular , Public Health , Tobacco , Tobacco Regulations , Trump Administration , Vaping

FDA's Center for Tobacco Products Announces Next Steps to Strengthen Tobacco Program

FDA Commissioner Robert M. Califf, MD, MACC, released a statement on Feb. 24, 2023, announcing next steps the FDA’s CTP plans to take in response to an external evaluation conducted by the Reagan-Udall Foundation. Califf...more

3/6/2023 / Food and Drug Administration (FDA) , Public Health , Tobacco , Tobacco Regulations

Laura Macherelli

BakerHostetler

Popular Topics by This Author

Latest Posts › Public Health