Posts by Marc Sanchez
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 edible products containing Delta-8 tetrahydrocannabinol (THC). These products are being marketed in packaging that closely resembles popular snacks and candies that children commonly consume, such as Doritos, Cheetos, and Nerds.…
Read MoreSubmission 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 proof that a tobacco product is currently pending review by the Food and Drug Administration’s Center for Tobacco Products. Tobacco products imported or offered for import into the United States…
Read MoreFDA 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 concluded that a new regulatory pathway for CBD is “needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.” The agency said…
Read MoreModernization 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 appropriators filed a 4,155-page, $1.7 trillion omnibus appropriations bill shortly after 1:30 a.m. The bill includes the Modernization of Cosmetics Regulation Act of 2022, which mirror legislation, S. 4348 (117),…
Read MoreSynthetic 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 the omnibus clarifies that FDA has the authority to regulate synthetic nicotine products by amending the definition of “tobacco product” in the Federal Food, Drug, and Cosmetic Act. It provides FDA…
Read MoreWhy 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 a routine inspection for pre-inspection prior to approval. A pre-inspection is required for some product types. For example, under 906(e)(1) of The Family Smoking Prevention and Tobacco Control Act, a…
Read MoreIs 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. The January 20th announcement from the Biden administration only concerns pending rules by federal agencies. With respect to rules that have been sent to the OFR but not published in the Federal Register, immediately…
Read MoreCongress 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 the regulation of generic drugs and biosimilar medicines by the U.S. Food and Drug Administration (FDA). Here’s everything you need to know about these new amendments: #1 Label updates. The…
Read MorePremarket 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 as Electronic Nicotine Delivery Systems (ENDS)) and e-liquids my firm has filed over 400 PMTAs. Below are a few tips on filing a PMTA, which I recently shared with Avomeen…
Read MoreFDA 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 be wrong. Typically, we talk about FDA Warning Letters, which is a precursor to formal enforcement actions by the Agency. An FDA IHCTOA Letter, however, is a private letter (i.e.,…
Read MoreMicroneedling 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) filed following the formal issuance of the Microneedling Classification Order this summer (link to Classification Order here). The FDA Atty firm worked with Esthetic Education LLC to file a microneedling 510(k) for…
Read More510(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 example, a particularly important process to follow. The FDA published a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” in December 2014 (See, Docket No. FDA-2014-D-1837). The draft…
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