FDA News Update

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…

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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….

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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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…

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