Posts by Marc Sanchez
Can Elon Musk Use DOGE to Dismantle the FDA?
As the new Presidential administration takes shape, much of the attention has been on Elon Musk. Using an Executive Order, the President established the Department of Government Efficiency to implement the President’s DOGE Agenda. It appears Mr. Musk’s appointment wasn’t subject to confirmation by the U.S. Senate. As discussed below, this may limit the actions…
Read MoreFDA Greenlights ZYN: Harm Reduction & PMTA Pathway
On January 16, 2025, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway. This marks the first instance of the FDA authorizing nicotine pouches, which are smokeless, tobacco-free products designed to deliver nicotine when placed between the gum and lip.…
Read More2023 Recall Trends & Projections: Year-End Recap | FDA Atty
As 2024 concludes, it’s time to reflect on the key trends that defined the year in product recalls and consider how 2024 is shaping up. In particular, how it compared to 2023. Businesses and consumers alike have faced a rapidly evolving regulatory landscape, and staying informed about recall patterns is crucial for compliance and risk…
Read MoreFDA Influencer Marketing Guide for Compliance
Navigating the complex landscape of FDA advertising guidelines is crucial for food and drug companies looking to leverage the power of influencer marketing while staying within legal boundaries. This comprehensive guide outlines essential regulations and best practices to help you maintain compliance and build effective marketing strategies. FDA Regulations for Influencer Marketing in the Food…
Read MoreSupreme Court Flavored Vape Case: Key Takeaways
The U.S. Supreme Court heard oral arguments on Monday in Wages and White Lion Investments. The Court heard arguments regarding the FDA’s defense of refusing to let two e-cigarette companies sell nicotine-containing flavored vape products deemed risky to youths. The FDA appealed a lower court’s decision, claiming it failed to follow proper legal procedures under…
Read MoreNicotine 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…
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