FDA News Update
FDA Plans to Launch Updated Submission Portal for New Tobacco Product Applications in 2025
The FDA’s Center for Tobacco Products (CTP) has announced its plans to unveil the CTP Portal Next Generation (“CTP Portal NG”) in 2025, an improved…
Supreme Court Agrees to Hear Case Challenging FDA’s Vape Regulation
Supreme Court Grants FDA’s Petition for Certiorari in Wages and White Lion Investments v. Food & Drug Administration In a significant move that could reshape…
The Impact of the Supreme Court Striking Down Chevron on FDA Regulation
As has been widely reported today, the United States Supreme Court overturned a 40-year old precdent known as the Chevron Doctrine. There are excellent write-ups…
Triton Files Brief in Opposition to FDA’s Supreme Court Petition to Review PMTA Reversal
As previously posted, a federal appeals court (Fifth Circuit Court of Appeals) overturned the Marketing Denial Orders (MDOs) handed down by the U.S. Food and…
U.S. DEA to Reclassify Marijuana
The AP is reporting today that the U.S. Drug Enforcement Agency will soon begin the process to reschedule marijuana from Class I to Class III….
FDA Petitions U.S. Supreme Court Over Triton MDOs
As previously posted, a federal appeals court (Fifth Circuit Court of Appeals) overturned the Marketing Denial Orders (MDOs) handed down by the U.S. Food and…
Triton MDOs Overturned
In a much-anticipated ruling, a federal appeals court has finally overturned the Marketing Denial Orders (MDOs) handed down to Triton Distribution and Vapetasia. The court…
FDA-CBP Joint Operation Seizes $18 Million Worth of Illegal E-Cigarettes, Targets Brands Popular Among Youth
In a significant joint effort, the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) have successfully seized over $18 million…
eSTAR Medical Device Submissions
The eSTAR (Electronic Submission Template and Resource) is an interactive PDF form designed to assist applicants in preparing comprehensive medical device submissions. It offers various…
FDA Targets Delta 8 Products
The Federal Trade Commission (FTC) has partnered with the U.S. Food and Drug Administration (FDA) to send cease and desist letters to six companies selling…
Submission Tracking Number
A Submission Tracking Number or STN is becoming a critical part of successfully importing tobacco products, such as vape devices. An STN can serve as…
FDA CBD Update
The US Food and Drug Administration has announced a new regulatory pathway is needed to manage risks from a growing cannabidiol (CBD) market in the US. FDA…