Posts by Marc Sanchez
Understanding the FDA’s Proposed Rule on Food Labeling
The FDA’s proposed Front-of-Package Nutrition Labeling Rule marks a key step in improving transparency for consumers. Learn more about it in this blog!
Read MoreWhy FDA Staff Losses Are a Public Health Concern
The recent wave of staff reductions at the U.S. Food and Drug Administration (FDA) has raised urgent questions about the Agency’s ability to fulfill its critical mission. The FDA is more than just another government entity—it is the backbone of the nation’s public health infrastructure, responsible for ensuring the safety of $2.6 trillion in consumption…
Read MoreThe Ultimate Guide to FDA Registration: Types, Renewals, and Guidelines
Navigating the complexities of FDA registrations is essential for companies. Here, we will showcase the ultimate guide to the types of FDA registration.
Read MoreThe Role and Importance of a US Agent for FDA Registration
Need a US agent for FDA registration? Get expert legal support for FDA compliance, food facility registration, and more. Contact us today for assistance!
Read MoreCan 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 Nicotine Pouches: A Milestone for Harm Reduction and PMTA Pathway Insights
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 MoreEnd-of-Year Recap: 2023 Recall Trends and Projections for 2024/2025
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 MoreUS Supreme Court Hears Flavored Vape Case: Key Takeaways for Industry Stakeholders
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.
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