On Monday, U.S. District Judge Richard Leon issued a preliminary injunction blocking implementation of FDA’s new graphic warnings requirements, which would have required, beginning September 22, 2012, all cigarette packages to display one of nine new textual warnings showing the dangers of smoking, graphic images on the top fifty percent of both the front and rear panels.
FDA on the Verge of Asserting Jurisdiction Over Additional Tobacco Products?
Posted in FDA
On October 14th, 2011, Senators Lautenberg (NJ), Blumenthal (CT) and Brown (IL) wrote to FDA Commissioner Hamburg to request FDA’s action to regulate additional tobacco products under the Tobacco Control Act.
The Tobacco Control Act requires FDA to regulate certain tobacco products, including cigarettes, roll-your-own and smokeless, and permits FDA to regulate others, such as pipe tobacco, cigars and electronic cigarettes. FDA must promulgate regulations in order to assert authority over these tobacco products.
FDA Issues Guidance for Small Businesses Regarding Compliance with New Required Warnings for Cigarette Packages and Advertisements
Posted in FDA, Significant Cases
Earlier this week, FDA published guidance to help small businesses understand and comply with FDA’s regulations regarding the new required cigarette warnings. These regulations take effect on September 22, 2012 and, as previously reported, require all cigarette packages and advertisements to contain one of nine new textual warning statements, a corresponding graphic image, and a specified toll free smoking cessation assistance resource phone number. Roll-your-own and cigarette tobacco are not covered by the regulations. Further, small advertisements of less than 12 square inches need not comply with the smoking cessation assistance resource requirement.
FDA Issues Draft Guidance on Applications for Premarket Review of New Tobacco Products
Posted in FDA
As previously reported here, the Tobacco Control Act requires that, when you create a “new tobacco product,” you must submit a premarket tobacco product application (PMTA) and receive a marketing authorization order prior to marketing the product.
FDA Issues Draft Guidance on Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products
Posted in FDA
Last month, FDA issued draft guidance addressing the submission of warning plans for cigarettes and smokeless tobacco products. As we previously reported, beginning on September 22, 2012, all cigarette packages and advertisements must bear one of the nine new federally mandated textual warnings with an accompanying color graphic (subject to certain manufacturers’ constitutional challenge to this requirement).
FDA Inspections and Product Liability Audits
Posted in FDA
In August, we reported that the FDA will begin in October inspecting the facilities of all U.S.-based tobacco product manufacturers subject to the FDA’s authority.
FDA Issues Advance Notice of Proposed Rulemaking Regarding Non-Face-to-Face Sale of Tobacco Products
Posted in FDA
Earlier this month, FDA issued advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of non-face-to-face sale and distribution of tobacco products and the advertising, promotion, and marketing of tobacco products.
FDA Issues Draft Guidance on Demonstrating Substantial Equivalence
Posted in FDA
Earlier this month, FDA issued draft guidance addressing substantial equivalence of new tobacco products. In doing so, FDA provided tobacco manufacturers with much needed guidance on FDA’s “current thinking” on this subject. Comments on the draft guidance are due by November 8, 2011.
Second Warnings Suit Filed Against FDA by Big Tobacco
Posted in FDA, Significant Cases
In early July, we reported that the four leading tobacco companies were threatening legal action against the Food and Drug Administration (FDA) over the nine new graphic cigarette health warnings that must appear on each cigarette package beginning in September 2012.
What is an Unacceptable Tobacco Brand Name Sponsorship Under FDA’s Regulations?
Posted in FDA
Effective June 2010, FDA issued advertising and marketing restrictions under the Tobacco Control Act. Among those requirements is a provision prohibiting tobacco manufacturers, distributors and retailers from “sponsoring” any “athletic, musical, artistic, or other social or cultural event, or any entry or team in any event” in the brand name, logo or selling message of any cigarette or smokeless tobacco brand.”