On May 24, FDA issued guidance for industry and investigators, Meetings with Industry and Investigators on the Research and Development of Tobacco Products, which aims to assist tobacco manufacturers, importers, researchers and investigators who would like to meet with the staff of FDA’s Center for Tobacco Products (“CTP”) to discuss their research and development plans related to tobacco products.
Public Health Advocates Use New Tobacco Product Launch as Opportunity to Lobby FDA
Posted in FDA
Altria has announced it will test a new smokeless nicotine product in convenience stores throughout Virginia starting in early June.
FDA to Issue “Deeming Regulations” Covering Additional Tobacco Products This Summer
Posted in FDA
In a notice stating that FDA intends to issue a solicitation for proposals to identify tobacco advertisements, FDA recently stated that it intends to issue this summer so-called “deeming regulations” covering additional tobacco products under the Tobacco Control Act.
FDA Issues Draft Guidance on Submitting Applications for Modified Risk Tobacco Products
Posted in FDA
Earlier this month, FDA offered draft guidance for requests for approval of modified risk tobacco products under the Tobacco Control Act. Comments on FDA’s draft guidance may be submitted by June 4, 2012.
Testing Tobacco Products to be Required
Posted in FDA
The Food and Drug Administration (“FDA”) issued on March 30, 2012 a Draft Guidance (attached) which contains requirements for Reporting Harmful and Potentially Harmful Constituents (“HPHC”) in Tobacco Products and Tobacco Smoke.
FDA Gathering Information From E-Cigarette Manufacturers
Posted in FDA
The FDA Center for Tobacco Products has issued letters to e-cigarette manufacturers requesting information regarding the safety of electronic cigarettes.
The Institute of Medicine Issues Recommendations for the FDA’s Regulation of MRTPs Under the Tobacco Control Act
Posted in FDA
Acting under the Tobacco Control Act’s mandate and its engagement by the FDA Center for Tobacco Products, the Institute of Medicine (“IOM”) recently released its recommended minimum standards for the regulation of modified risk tobacco products (“MRTPs”).
Obama Administration Punts on Petition to Recognize E-Cigarettes as an Alternative to Smoking
Posted in FDA
The Obama Administration, through FDA’s Center for Tobacco Products, recently responded to a 5,700 signature petition to support the “emerging technology” of electronic cigarettes.
FDA Regulation of Electronic Cigarettes Could Lead to Restrictions on Online Sales
Posted in FDA
Although the PACT Act imposes a functional ban on online sales of cigarettes, roll-your-own tobacco and smokeless tobacco, the PACT Act’s remote sales restrictions are inapplicable to e-cigarettes. The Internet is perhaps the most popular venue for consumers to purchase e-cigarettes.
Food and Drug Administration Solicits Comments on Brand Name Restriction
Posted in FDA
On November 10, FDA solicited comments on proposed amended regulations addressing the use of tobacco brand names that are also nontobacco brand names.