FDA Enforcement
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.
FDA 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)…
FDA-CBP Joint Operation Seizes $18 Million Worth of Illegal E-Cigarettes, Targets Brands Popular Among Youth
In a significant joint effort, the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) have successfully seized over $18 million…
FDA Targets Delta 8 Products
The Federal Trade Commission (FTC) has partnered with the U.S. Food and Drug Administration (FDA) to send cease and desist letters to six companies selling…
Submission Tracking Number
A Submission Tracking Number or STN is becoming a critical part of successfully importing tobacco products, such as vape devices. An STN can serve as…
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…
Redacting a FOIA Request
Redacting a FOIA Request – Tips & Insights The Freedom of Information Act Amendments of 1996 (FOIA). FOIA allows members of the public to request…
FDA Warning Letters 2017
FDA Warning Letters 2017 is a post summarizing last year’s Warning Letters. Each year the FDA releases an enforcement report along with a summary of…
Regulatory Mediator
Mediation is an increasingly used tool both by courts and parties to avoid litigation. When a dispute involves regulatory issues, such as FDA compliance questions,…
FSMA Inspections
FSMA inspections are well underway. The Food Safety Modernization Act (FSMA) is slowly beginning to roll out. The implementation is a learning curve both for…
What represents an FDA Consent Decree?
An FDA Consent Decree represents a serious step in FDA enforcement. To obtain a consent decree the FDA must work with the Department of Justice…