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Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco: Guidance for Industry (PDF)

This guidance document is intended to assist any person who manufactures, packages, sells, offers to sell, distributes, or imports cigars or pipe tobacco with respect to the labeling requirements in sections 903(a)(2) and 920(a) of the Federal Food, Dr
FDA - Food and Drug Administration
added Aug 9, 2018 23:08
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Guidance: Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies
FDA - Food and Drug Administration
added Aug 9, 2018 23:05
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Labeling and Warning Statements for Tobacco Products

FDA has provided a compliance date of August 10, 2018, for the required health warning statements on packages and advertisements for "covered" tobacco products (except cigars and pipe tobacco1) and roll-your-own / cigarette tobacco products.2
FDA - Food and Drug Administration
added Aug 9, 2018 23:03
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Comment from Andrey Khlystov, Desert Research Institute / Comment from Andrey Khlystov, Desert Research Institute The is a Comment on the Food and Drug Administration (FDA) Proposed Rule: Regulation of Flavors in Tobacco Products

The current evidence from several independent research groups strongly suggests that flavoring compounds influence production of aldehydes, carbon monoxide, total particulate matter, and free radicals in e-cigarettes. Evidence to the contrary is limited
Regulations.gov
added Aug 10, 2018 17:27
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FDA's Comprehensive Plan for Tobacco and Nicotine Regulation

FDA's comprehensive plan places nicotine, and the issue of addiction, at the center of the agency's tobacco regulation efforts. This plan serves as a multi-year roadmap to better protect youth and help addicted adult smokers quit, significantly reducing t
FDA - Food and Drug Administration
added Aug 8, 2018 20:12
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Tobacco Product Application Review - A Public Meeting / October 22-23, 2018

This meeting is intended to improve public understanding and seek feedback on the policies and processes for the submission and review of tobacco product marketing applications, including the general scientific principles relevant to various application
FDA - Food and Drug Administration
added Sep 10, 2018 23:41
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Tobacco Product Application Review - A Public Meeting

8:30 a.m. to 4:30 p.m. on October 22, and 8:30 to 3 p.m. on October 23 / Substantial Equivalence Reports (SE Reports) – Section 905(j) Exemption Requests (Ex Reqs) – Section 905(j) Premarket Tobacco Product Applications (PMTAs) – Section 910 Modified Ri
FDA - Food and Drug Administration
added Aug 3, 2018 22:42
12 Views

FDA's Comprehensive Plan for Tobacco and Nicotine Regulation

FDA's comprehensive plan places nicotine, and the issue of addiction, at the center of the agency's tobacco regulation efforts. This plan serves as a multi-year roadmap to better protect youth and help addicted adult smokers quit, significantly reducing t
FDA - Food and Drug Administration
added Aug 2, 2018 20:22
3 Views

Tobacco Product Application Review - A Public Meeting October 22-23, 2018

This meeting is intended to improve public understanding and seek feedback on the policies and processes for the submission and review of tobacco product marketing applications, including the general scientific principles relevant to various application
FDA - Food and Drug Administration
added Aug 2, 2018 20:21
7 Views

GOTTLIEB/ZELLER: Advancing Tobacco Regulation to Protect Children and Families: Updates and New Initiatives from the FDA on the Anniversary of the Tobacco Control Act and FDA’s Comprehensive Plan for Nicotine

The public comment periods for all three ANPRMs, which were extended by 30 additional days to allow more time for submissions, have now closed. We are beginning the process of reviewing those comments. At the same time, the FDA is also pursuing additional
FDA Blogs
added Aug 2, 2018 20:19
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