Tag: PMTA
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AVM: FDA Misreports PMTA Acceptance Numbers
The FDA announced Thursday it has rejected 800,000 of the approximately one million synthetic nicotine product marketing applications submitted by the May 14 filing...
New head tobacco regulator shies away from taking unauthorized e-cigs off shelves
Vapes still awaiting FDA’s marketing orders have remained in stock thanks to the agency’s enforcement discretion — even though they’re not legally on the...
FDA Criticized For Being More Lenient With Cigarettes Than Safer Alternatives
The US Food and Drug Administration (FDA) has recently authorized a tobacco company to market a reduced nicotine cigarette as a reduced risk product,...
A Curious Case
In June, long-simmering criticism of the way the U.S. Food and Drug Administration is handling premarket tobacco product applications (PMTAs) culminated in a public...
FDA’s Marketing Denial Order Issued to Bidi Vapor’s Non-Tobacco Flavored ENDS Products are Set Aside and Remanded by the 11th Circuit Court of Appeals...
Last year, Bidi Vapor LLC (Bidi or the Company), represented by Keller and Heckman LLP Partners Eric Gotting and Azim Chowdhury, petitioned the 11th Circuit Court of...
