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
Azim Chowdhury and Manon Ombredane will attend the Next Generation Nicotine Delivery Conference in London. Azim will present “Determining the Impact of the FDA’s Stance on Nicotine Containing Products.” Manon will participate on the panel “Roundtable Discussing The Variance of TPD Implementation in Different EU Member States.” The conference will take place November 14-15. 2017.
