Posts by Marc Sanchez
Nicotine Pouches and FDA Regulations
Nicotine pouches have gained popularity as an alternative to smoking. Here, we will guide you through the FDA regulations surrounding nicotine pouches.
Read MoreRegulatory Attorneys vs Consultants: The Right Choice for You
Understanding the roles of regulatory consultants and attorneys is crucial when bringing a product into the market. Here, we will showcase their differences.
Read MoreConfidently Responding to a 510(k) FDA Deficiency Letter
Not sure how to handle an FDA deficiency letter? This guide outlines steps to confidently respond and get your product cleared for market.
Read MoreImporting 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 are additional layers of compliance to navigate. This guide will help you prepare for the 2024 holiday season and ensure that your imports meet all necessary requirements. This includes complying…
Read MoreListeria 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 other deli meat products due to concerns about potential listeria contamination. The latest update is reporting on facility inspection findings by the U.S. Department of Agriculture (USDA). USDA records show,…
Read MoreFDA 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) products, the Food and Drug Administration (FDA) and the Department of the Treasury have announced a proposed rule that could significantly impact how these products enter the United States. This…
Read MoreFDA 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 web portal for submitting applications for new tobacco products. Two notices issued in the Federal Register highlight the upcoming changes aimed at enhancing the application process. Key Improvements Transition Details…
Read MoreSupreme 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 regulatory landscape for the tobacco and vaping industries, the Supreme Court has agreed to hear the case Wages and White Lion Investments v. Food & Drug Administration. This decision…
Read MoreThe 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 of the Court’s opinion here and here. At it’s simpliest the Chevron Doctrine required courts to give deference to federal agencies, like the U.S. Food and Drug Administration, when creating…
Read MoreTriton 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 Drug Administration to Triton Distribution and Vapetasia. In March the FDA filed a petition for writ of certiorari requesting the Supreme Court review the Fifth Circuit opinion and reverse it.…
Read MoreU.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. The DEA is proposing to reclassify marijuana as a less dangerous drug, acknowledging its medical uses and lower potential for abuse compared to other substances. This shift follows President Joe…
Read MoreFDA 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 Drug Administration to Triton Distribution and Vapetasia. This week the FDA filed a petition for writ of certiorari requesting the Supreme Court review the Fifth Circuit opinion and reverse it.…
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