The new European Union (EU) General Data Protection Regulation (GDPR) replaces the Data Protection Directive on May 25, 2018 and will directly impact all companies, including vapor product retailers and businesses, that market and sell products to consumers in the EU and/or employ residents of the EU. The reforms will give European consumers new rights
The 2nd Annual Keller and Heckman E-Vapor and Tobacco Law Symposium held on February 6-7, 2018 in Irvine, California was a huge success with over 100 attendees from all over the country and world. Check out the highlight video below. We are in the process of securing a location for next year’s symposium and
In FDA’s latest effort to implement its comprehensive plan for tobacco and nicotine regulation, the Agency published two additional advanced notice of proposed rulemakings (ANPRMs) concerning regulation of premium cigars and tobacco product flavors. Specifically, on March 21, 2018, the FDA published an ANPRM, “Regulation of Flavors in Tobacco Products,” which solicited comments on, among
In the U.S. Food and Drug Administration’s (FDA’s) latest effort to implement its comprehensive regulatory plan[1] to shift the trajectory of tobacco-related disease and death, the Agency issued, on March 15, 2018, an advanced notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set a
February 26, 2018 – Keller and Heckman LLP is pleased to announce the introduction of its Audit and Inspection Program (AIP) for Tobacco and Vapor Product Manufacturing Establishments.
The AIP was developed in response to the Food and Drug Administration’s (FDA) inspection authority under the Food, Drug, and Cosmetic Act (FDCA or the Act), as
On February 20, 2018 several organizations filed amicus (“friend of the court”) briefs in support of Plaintiff-Appellants Nicopure Labs’ and the Right to be Smoke-Free Coalition’s appeal in the Deeming Rule challenge now pending in the U.S. Court of Appeals for the D.C. Circuit.
The Washington Legal Foundation (WLF) is a nonprofit, public-interest law firm
On February 12, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition[i] (the Appellants) filed their opening brief in the appeal of last year’s decision from the U.S. District Court for the District of Columbia, which ruled in favor of FDA in the first lawsuit challenging aspects of the Tobacco Control Act
Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems Releases Report Documenting Massive Review of Existing Scientific Literature
On January 23, 2018, the National Academies of Sciences, Engineering and Medicine (hereinafter referred to as the “National Academies”) Committee on the Review of the Health Effects of Electronic Nicotine Delivery Systems (ENDS)
Beyond the Food and Drug Administration (FDA) and Tobacco Control Act requirements that now apply to deemed tobacco products, manufacturers and retailers of vapor products, and particularly e-liquids, also face stringent environmental and waste management regulations and compliance issues that are significantly more complex than those faced by cigarette and traditional tobacco product companies. This
Electronic cigarette and e-liquid (collectively “e-vapor”) manufacturers are increasingly the targets of California Proposition 65 enforcement actions brought by private plaintiffs. Of the 168 private enforcement actions brought against e-vapor manufacturers, 150 of these have been filed since 2016. We provide background on Proposition 65 below, followed by specifics regarding how the e-vapor industry has
