Synthetic Nicotine and FDA Regulatory Power
On March 10, 2022, the U.S. Senate passed a $1.5 trillion federal funding bill that included an amendment that gives the U.S. Food and Drug [...]
Final Guidance Issued by FDA Related to Tobacco Product User Fees
The U.S. Food and Drug Administration has issued final guidance relating to tobacco product user fees. The recently released document, “Tobacco Product User Fees: [...]
FDA Graphic Cigarette Warnings Further Postponed by Court Order
The following update was contributed by the National Association of Tobacco Outlets (NATO): On Nov. 12, 2021, the U.S. District Court for the Eastern [...]
Marketing Denial Order Issued to Humble Juice Co. Rescinded by FDA
E-liquid maker Humble Juice Co. has revealed that the U.S. Food and Drug Administration (FDA) has rescinded the Marketing Denial Order (MDO) it issued [...]
Four Verve Oral Tobacco Products Authorized by The FDA
The U.S. Food and Drug Administration has authorized the marketing of four new oral tobacco products manufactured by U.S. Smokeless Tobacco Company under the [...]
First E-Cigarette Authorization Granted by FDA
The U.S. Food and Drug Administration (FDA) has authorized the marketing of three new electronic nicotine delivery system (ENDS) products. These products are the [...]
ENDS Manufacturers Hit With MDOs by FDA
The list of companies that have received Marketing Denial Orders (MDOs) for their flavored electronic nicotine delivery system (ENDS) products continues to grow. In [...]
FDA Decision and The Fate of More than 6.5 Deemed Tobacco Products
On Sept. 9, 2021, the U.S. Food and Drug Administration (FDA) announced that it had made what it calls “significant progress” in reviewing the [...]
Potential FDA Regulatory Loophole for Vapor Manufactures
The vapor industry, regulated as tobacco products by the U.S. Food and Drug Administration (FDA), is facing increasing challenges in getting its products approved [...]
Latest FDA Lawsuit Ruling For Cigar Industry
In an appeal from the the United States District Court for the District of Columbia, a panel of judges ruled against the cigar industry [...]
Big Time Vapes v. FDA Declined by U.S. Supreme Court
The vapor industry has been dealt another blow as the U.S. Supreme Court has declined to hear Big Time Vapes v. FDA, a case [...]
FDA: Two Key Rules for Premarket Tobacco Product Applications
On the final full day of the Trump Administration, the U.S. Food and Drug Administration (FDA) finalized two foundational rules for the premarket review [...]
FDA Calls for E-Liquid Removal Due to Lack of PMTAs
The U.S. Food and Drug Administration (FDA) has issued warning letters to 10 firms that manufacture and run websites that sell electronic nicotine delivery [...]
Sale of IQOS 3 Tobacco Heating System Device in U.S. Authorized by FDA
Altria Group, Inc. has announced that the U.S. Food and Drug Administration (FDA) has given it the authorization to begin selling the IQOS 3 [...]