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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

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Tobacco product manufacturing establishments in the United States must register with the Food and Drug Administration (FDA) immediately upon beginning manufacturing operations (e.g., the manufacture, preparation, compounding, or processing of a tobacco product).  As part of the registration process, establishment operators must submit a detailed list of products manufactured at the establishment, along

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At yesterday’s meeting with the U.S. House Subcommittee on Agriculture and Rural Development to discuss FDA’s Fiscal Year 2019 budget, Food and Drug Administration (FDA) Commissioner Scott Gottlieb discussed the Agency’s regulation of the tobacco industry and noted, among other things, that when all the requirements for the newly deemed products, including vapor products, went

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The vapor device industry has been requesting FDA for years to exempt devices from the Tobacco Control Act Section 904(a)(1) ingredient listing requirement, respectfully arguing, among other things, that the information required for non-consumable hardware products and components provides no meaningful information to FDA that would help it protect the public health.[1]  On April

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Per Section 904(a)(1) of the Tobacco Control Act (TCA), one of the core requirements for manufacturers, including manufacturers of deemed tobacco products such as e-liquid, vapor devices, cigars and hookah, is the requirement to submit to the Food and Drug Administration (FDA) a list of all ingredients that are “added by the manufacturer to the

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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

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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

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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

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Azim Chowdhury and Adam Susser will participate in the FDLI Tobacco Products and Regulation and Policy Conference, which will take place October 26-27, 2017 in Washington, DC.

This KH sponsored event will bring together public health advocates, researchers, manufacturers, lawyers, consumer interests, entrepreneurs, governmental agencies and others to effectively regulate the broad spectrum of tobacco

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On August 30, 2017, the Right to be Smoke-Free (RSF) Coalition, a non-profit, industry-led trade association of vapor businesses dedicated to advocating for reasonable and responsible laws and regulations, joined Nicopure Labs LLC in appealing the recent decision in Nicopure Labs, LLC and Right to be Smoke-Free Coalition et al. v. Food and Drug