Triton MDOs Overturned

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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 has directed the FDA to conduct fresh evaluations of the companies’ marketing applications. The en banc panel of judges decisively voted 10-6 in favor of granting Triton and Vapetasia the…

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FDA-CBP Joint Operation Seizes $18 Million Worth of Illegal E-Cigarettes, Targets Brands Popular Among Youth

Seized Elf Bar BC5000

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 worth of unauthorized e-cigarette products, marking a crucial step in the ongoing battle against the illegal tobacco trade. The operation, conducted over three days, resulted in the examination of 41…

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eSTAR Medical Device Submissions

Alt-text: FDA Sign outside their headquarters in Washington DC.

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 features such as automation, content and structure complementing FDA internal review templates, integration of multiple resources, guided construction for each submission section, and automatic verification. The eSTAR will begin to…

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FDA Targets Delta 8 Products

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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 edible products containing Delta-8 tetrahydrocannabinol (THC). These products are being marketed in packaging that closely resembles popular snacks and candies that children commonly consume, such as Doritos, Cheetos, and Nerds.…

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Submission Tracking Number

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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 proof that a tobacco product is currently pending review by the Food and Drug Administration’s Center for Tobacco Products. Tobacco products imported or offered for import into the United States…

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FDA CBD Update

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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 concluded that a new regulatory pathway for CBD is “needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.” The agency said…

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Modernization of Cosmetics Regulation Act of 2022

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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 appropriators filed a 4,155-page, $1.7 trillion omnibus appropriations bill shortly after 1:30 a.m. The bill includes the Modernization of Cosmetics Regulation Act of 2022, which mirror legislation, S. 4348 (117),…

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Synthetic Nicotine Loophole Getting Shut Down By Congress

Vape Loophole

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 the omnibus clarifies that FDA has the authority to regulate synthetic nicotine products by amending the definition of “tobacco product” in the Federal Food, Drug, and Cosmetic Act. It provides FDA…

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Why was created the Remote Regulatory Assessments (RRA)?

PMTA 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 a routine inspection for pre-inspection prior to approval. A pre-inspection is required for some product types. For example, under 906(e)(1) of The Family Smoking Prevention and Tobacco Control Act, a…

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Is the Premarket Tobacco Product Applications (PMTAs) stagnated?

Vape PMTA Frozen

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. The January 20th announcement from the Biden administration only concerns pending rules by federal agencies. With respect to rules that have been sent to the OFR but not published in the Federal Register, immediately…

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Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

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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 the regulation of generic drugs and biosimilar medicines by the U.S. Food and Drug Administration (FDA). Here’s everything you…

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Premarket Tobacco Product Applications (PMTAs) Tips

PMTA Tips

PMTA Tips There are a few tips in preparing a Pre-Market Tobacco Application (PMTA). Since September 9, 2020, the PMTAs deadline for e-cigarettes (also known as Electronic Nicotine Delivery Systems (ENDS)) and e-liquids my firm has filed over 40 PMTAs. Below are a few tips on filing a PMTA, which I recently shared with Avomeen…

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