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Read the blog for important updates to FDA and USDA rules and regulations that could affect your business.
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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 CBD Update
The US Food and Drug Administration has announced a new regulatory pathway is needed to manage risks from a growing cannabidiol (CBD) market in the US. FDA…
Modernization of Cosmetics Regulation Act of 2022
It appears Congress will pass the first major overhaul of cosmetics regulation in 84 years, giving more authority over the market to the FDA. Congressional…
Synthetic Nicotine Loophole Getting Shut Down By Congress
Congress will close the synthetic nicotine loophole this week when it passes an omnibus spending bill. What Is in the Current Bill? Subtitle B of…
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….
Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars
Back in December of 2020, then-president Trump signed into law the “Consolidated Appropriations Act, 2021″. Included within this omnibus legislation are several provisions that affect…
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…
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…
Microneedling FDA Clearance
Microneedling FDA Clearance has been granted to Esthetic Education LLC for its SkinStylus SteriLock MicroSystem (K200044). Esthetic Education is among the very first microneedling 510(k)…
510(k) Transfer of Ownership
A 510(k) for a medical device can be thought of as like a patent making a 510(k) transfer of ownership, say following a sale, for…