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Read the blog for important updates to FDA and USDA rules and regulations that could affect your business.

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Importing FDA Regulated Products for the Holidays in 2024

The holiday season is a peak time for businesses importing goods into the United States. However, when these goods are regulated by the FDA, there…

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Listeria Outbreak Difference Between Deli Meat and Cantaloupes

As has been widely reported, Boar’s Head issued a recall in late July for more than 7.2 million pounds of its ready-to-eat liverwurst and some…

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FDA Tobacco Submission Tracking Number Import Requirement

New FDA and Treasury Rule Proposes Streamlined Import Process for E-Cigarettes In an important step toward regulating the import of Electronic Nicotine Delivery System (ENDS)…

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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…

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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…

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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…

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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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