FDA
US Supreme Court Hears Flavored Vape Case
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…
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.
Regulatory 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.
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…
FDA IHCTOA Letter
What does IHCTOA mean? FDA IHCTOA Letter is an acronym for It Has Come to Our Attention Letter, which is an early alert something may…
Tobacco Health Certificate (NCTTP)
The tobacco health certificate will be one of two submissions for newly regulated tobacco companies (vape, e-cig, e-liquid, cigar, hookah, etc.). These certificates must be…
Amazon FDA Registration Proof
Amazon FDA registration proof can be a moving target. Is it a certificate, a screenshot, or something else!? The answer varies from week to week…
FDA New Tobacco Deadlines
As is well known by now the FDA Deeming Regulation is effective as of August 8, 2016. What is less well understood are the various…