Cigar Industry Loses on Substantial Equivalence Challenge
In the case of Cigar Association of America, et. Al v. U.S. Food and Drug Administration, the court declined to grant a declamatory relief....
FDA Announces the Creation of the Nicotine Steering Committee
Earlier this year, the U.S. Food and Drug Administration (FDA) announced a shift in its policy and approach toward tobacco. With a new focus...
FDA Proposed 10-Month Deadline for E-Cigarette PMTA Applications
The deadline for e-cigarette manufacturers to submit their premarket tobacco applications (PMTA) to the U.S. Food and Drug Administration (FDA) will be coming sooner...
FDA Issues Final Small Entity Compliance Guide for Certain Tobacco Products
The U.S. Food and Drug Administration (FDA) has updated its Small Entity Compliance Guide to reflect the recent court cases that impact the deeming...
Preparing for the FDA’s Tobacco Ingredient Listing Compliance Deadline
An important compliance deadline is looming for manufacturers and importers of deemed tobacco products. If your tobacco product was on the market as of...
Acing FDA Age Verification Rules
Since the FDA’s deeming regulations went into effect on August 8, 2016, anyone selling tobacco products must verify that the purchaser is over 18...
Warning Shot: Behind the Warning Label Delay
As many in the industry are aware, one of the major aspects of the FDA’s deeming regulations is the requirement that: (1) cigarmakers must...
Tobacco 21 Bill Passes in Texas Senate
Just as a bill attempting to raise the legal age to purchase tobacco products from 18 to 21 years is introduced on the federal...
McConnell and Kaine Release Tobacco-Free Youth Act
Senators Tim Kaine (D-Va.) and Senate Majority Leader Mitch McConnell (R-Ky.) introduced the Tobacco-Free Youth Act, a bipartisan legislation that if passed would raise...
Swisher Files Lawsuit Against FDA Over Deeming Rule Concerns
As first reported by Halfwheel, Swisher International, Inc. has filed a lawsuit against the U.S. Food and Drug Administration, proclaiming that the federal agency...
