On Tuesday October 2, at 2PM EST, Azim Chowdhury and Ben Wolf will present a webinar, “Ingredients Listing: Walk Through” sponsored by the Smoke-Free Alternatives Trade Association (SFATA). Ingredient listing reports for small-scale tobacco product manufacturers are due by November 8, 2018. This program is recommended for manufacturers of deemed tobacco products, including e-liquids, their

On September 12, 2018, in a self-described “blitz”, FDA announced a deluge of enforcement actions, including more than 1,300 warning letters and fines to retailers aimed at addressing youth use of e-cigarettes, which FDA asserts has reached “epidemic” proportions, based on new, not-yet-released survey data.[1]  FDA also requested manufacturers of five “national brands,” whose

On September 6, 2018, a coalition of vapor industry trade associations and businesses – specifically the Smoke-Free Alternatives Trade Association (SFATA), the American E-Liquid Manufacturing Standards Association (AEMSA), the American Vapor Association (AVA), and SV3, LLC (collectively, the “Vapor Coalition”) – submitted comments to the U.S. Trade Representative (USTR) arguing against the Trump Administration’s additional

In a widely anticipated move, FDA has significantly increased the frequency of inspections of vapor manufacturing and retail facilities over the past few weeks, with some inspections spanning two days. We have received reports from vapor businesses across the country that they are receiving unannounced visits from FDA investigators conducting biannual inspections pursuant to Sections

Defendant U.S. Food and Drug Administration (FDA) and the Right to Be Smoke-Free Coalition (RSF) recently submitted briefs to the federal district court of Maryland opposing a motion for summary judgment filed by various public health NGOs in American Academy of Pediatrics v. FDA.[1] The NGOs are challenging various extensions to premarket application

Today, August 10, 2018, is the compliance date for the health warnings contained in the FDA’s Deeming Rule and codified in 21 C.F.R. Part 1143.  In particular, as of today, roll-your-own (RYO) tobacco, cigarette tobacco, or covered tobacco products (except cigars and pipe tobacco) such as e-liquids that contain tobacco-derived nicotine manufactured, packaged, sold, offered

On August 2, 2018, just over one year since FDA announced its “Comprehensive Plan for Tobacco and Nicotine Regulation”[1] (hereinafter, the “Comprehensive Plan”), FDA Commissioner, Scott Gottlieb, M.D., and Center for Tobacco Products (CTP) Director, Mitch Zeller, J.D., authored a post on the Agency’s FDA Voice blog, which reviewed the progress made to date

On March 27, 2018, a coalition of public health organizations including the Campaign for Tobacco-Free Kids, the Truth Initiative, the American Cancer Society and the American Academy of Pediatrics, among others, as well as several individual physicians (collectively the “NGOs”) filed a lawsuit in the United States District Court for the District of Maryland challenging

On June 18, 2018, U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb delivered remarks on “FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science” at the Tobacco Regulatory Science Program Meeting.[1] While addressing the importance of regulatory science to inform FDA’s Center for Tobacco Products (CTP) regulatory efforts, Commissioner