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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…
Modernization of Cosmetics Regulation Act of 2022
It appears Congress will pass the first major overhaul of cosmetics regulation in 84 years, giving more authority over the market to the FDA. Congressional…
Synthetic Nicotine Loophole Getting Shut Down By Congress
Congress will close the synthetic nicotine loophole this week when it passes an omnibus spending bill. What Is in the Current Bill? Subtitle B of…
Why was created the Remote Regulatory Assessments (RRA)?
Remote Regulatory Assessments A Remote Regulatory Assessment is a necessity created by the COVID-19 pandemic. Ordinarily, FDA would conduct an on-site audit as part of…
Is the Premarket Tobacco Product Applications (PMTAs) stagnated?
Over the past few weeks, I have continued to hear and receive questions regarding whether the Biden administration has frozen the PMTA process or rule. The short answer is no….
Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars
Back in December of 2020, then-president Trump signed into law the “Consolidated Appropriations Act, 2021″. Included within this omnibus legislation are several provisions that affect…