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Headlines Tagged with FDA 8,356 headlines found

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Q&A: Modified Risk Tobacco Products

Modified risk tobacco products (MRTPs) are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
FDA - Food and Drug Administration
added May 24, 2017 22:16
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Perspective: Lessons Learned from the First Review of Modified Risk Tobacco Product (MRTP) Applications

On December 14, 2016, we denied Swedish Match North America Inc.’s request to remove one of the required warning statements for eight General snus products....Below, we explain the scientific review process and what was considered in taking these actions
FDA - Food and Drug Administration
added May 24, 2017 22:16
4 Views

Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding "Intended Uses"

The U.S. Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco, that is intended for human consumption, will be subject to regulation as a tobacco product, drug, device,
FDA - Food and Drug Administration
added May 24, 2017 22:16
7 Views

Less Risky Tobacco Product? Only if the Science Says So

"We are forging new territory to ensure that tobacco companies provide accurate information and do not mislead American consumers," said FDA Commissioner Margaret Hamburg, M.D. "We are committed to stopping practices that may cause people to start or con
FDA - Food and Drug Administration
added May 24, 2017 17:47
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Section 911 of the Federal Food, Drug, and Cosmetic Act - Modified Risk Tobacco Products

In General. No person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product.
FDA - Food and Drug Administration
added May 24, 2017 17:43
7 Views

Modified Risk Tobacco Products

Section 911 of the Federal Food, Drug and Cosmetic (FD&C) Act, as amended by the Tobacco Control Act, gives FDA responsibility to establish rigorous criteria that must be met before the agency can issue an order authorizing the marketing of a modified ris
FDA - Food and Drug Administration
added May 24, 2017 17:41
10 Views

PMP S.A. [PHILIP MORRIS PRODUCTS] Executive Summary (PDF - 5.74 MB) (PDF)

PMI has developed the THS system, to be marketed as “iQOS”. The THS system consists of a device that heats, but does not burn, a proprietary Tobacco Stick (“HeatSticks”), creating an inhalable nicotine-containing aerosol that provides a range of consum
FDA - Food and Drug Administration
added May 24, 2017 17:36
10 Views

Philip Morris Products S.A. Modified Risk Tobacco Product (MRTP) Applications

The FDA has filed for scientific review three Modified Risk Tobacco Product (MRTP) applications from Philip Morris Products S.A. (PMP S.A.) for its IQOS system and three types of Heatstick products.
FDA - Food and Drug Administration
added May 24, 2017 17:33
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Cigarette Filter Ventilation and its Relationship to Increasing Rates of Lung Adenocarcinoma

Thus, the FDA should consider regulating its use, up to and including a ban. Herein, we propose a research agenda to support such an effort.
Journal of the National Cancer Institute
added May 24, 2017 03:11
2 Views

CEI Joins Coalition Letter Opposing E-Cigarette Rules

Despite the success of educational campaigns on the harms of tobacco use, cessation efforts have hit a plateau, with a portion of the population unable to kick their deadly habit. We recognize that quitting tobacco use is a complex and personal challenge
Competitive Enterprise Institute (CEI)
added May 24, 2017 03:09
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