FDA Approval
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!
FDA 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…
FDA 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…
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.
Confidently 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.
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…
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…
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…
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…
Why was created the Remote Regulatory Assessments (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…
Is the Premarket Tobacco Product Applications (PMTAs) stagnated?
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….
Premarket Tobacco Product Applications (PMTAs) 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…