Upcoming FDA Public Workshop on E-Cigarette Battery Risks and Hazards, Final Rule on Regulating Toba
Thursday, January 12, 2017
Posted by: Natalia Gromov
The FDA plans to host a two-day public workshop April 19-20, 2017, in Silver Spring, MD, to gather information and stimulate discussion on battery safety concerns (e.g., overheating, fire, explosion, other modes of failure), reducing the risk of incidents, and design parameters related to electronic nicotine delivery systems (ENDS), including e-cigarettes. Presentations and panelists will discuss substantive scientific information relating to hazards and risks associated with the use of batteries in ENDS. The FDA also plans to collect information on how these safety hazards and risks are communicated to consumers. A public comment session will be held on April 20, 2017, during which the FDA will accept oral comments. FDA has made a new downloadable infographic available which outlines how cigarettes are engineered.
The workshop will also be webcast live, with transcripts posted on the FDA website after the event. Seating and webcast viewing slots are limited, so early registration is recommended. Register here.
FDA Issues Final Rule to Clarify Regulation of Tobacco Products
On January 6th, the FDA issued a final rule entitled “Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses’”. This rule describes circumstances in which a product made or derived from tobacco is subject to regulation by the FDA’s Center for Drug Evaluation and Research, Center for Devices and Radiological Health, or Center for Tobacco Products. This rule is intended to help manufacturers and researchers better understand which regulatory standards apply to their products or studies, respectively. The agency also anticipates that the rule will help consumers clearly distinguish products made or derived from tobacco that are intended for tobacco cessation from those intended for other uses.
FDA Issues Industry Guidance on Plans for Cigar Warnings
FDA released a guidance document to help those involved in the manufacturing, distribution, or sale of cigars to understand new cigar warning requirements being implemented as part of FDA’s final deeming rule. This guidance reiterates that starting on May 10, 2018, cigars will be required to display one of six different warning statements on their packaging and in their advertisements. Learn more here.
FDA Issues Warning Letters for Selling Flavored Cigarettes
Four tobacco manufacturers received warning from FDA for selling flavored cigarettes that are labeled as little cigars or cigars, a violation of the Family Smoking Prevention and Tobacco Control Act. The products in violation include the Swisher Sweets, Cheyenne, Prime Time, and Criss-Cross brands. Manufacturers have 15 working days to respond after receiving the warning letters. Learn more here.
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