By David B. Clissold – Last week, FDA released Agency's first guidance for tobacco product manufacturers concerning the introduction of “new” tobacco products. The guidance was issued in final form since some manufacturers will need it to help them submit reports to FDA over the next few months. A “new …
By Susan J. Matthees – Last Tuesday, FDA announced the availability of final results from its experimental study of graphic cigarette warning labels. As we previously reported, FDA proposed 36 graphic warning images to accompany the health warning statement required under section 201 of the Family …
By Ricardo Carvajal – The D.C. Circuit Court of Appeals upheld the D.C. District Court’s grant of an injunction that bars FDA's regulation of e-cigarettes as drug/device products absent claims of intended use to that effect (for our prior posting on the district court decision, see …
By Ricardo Carvajal – The graphic artists working on behalf of FDA have been busy, busy, busy! The agency posted 36 proposed graphic health warnings that would accompany the new health warning statements required under section 201 of the Family Smoking Prevention and Tobacco Control Act. …
By Nisha P Shah – In a letter to the Electronic Cigarette Association, FDA stated its intention to regulate electronic cigarettes (also referred to as e-cigarettes or e-cigs) as drug products. Specifically, FDA maintained that e-cigarettes “meet the definitions of both a drug and device …
By Ricardo Carvajal – June 22 looms large on the calendar for firms subject to the requirements of the Family Smoking Prevention and Tobacco Control Act (“FSPTCA”) and FDA’s final rule curbing promotion and sale of cigarettes and smokeless tobacco to underage consumers. In anticipation …
By Ricardo Carvajal – Some smaller cigarette manufacturers have sued FDA to invalidate a provision in FDA’s recently issued final rule that would restrict a manufacturer from using certain product names on the ground that the restriction violates the First and Fifth Amendments, among other …
By Peter M. Jaensch – On March 23, 2010, Judge McMahon of the U.S. District Court for the Eastern District of New York issued a memorandum decision in U.S. Smokeless Tobacco Manufacturing Company, LLC, and U.S. Smokeless Tobacco Brands, Inc. v. City of New York denying …
By Jamie K. Wolszon & David B. Clissold – FDA published two Federal Register notices Friday, March 19th related to its oversight and regulation of cigarettes and smokeless tobacco, including a much heralded final rule to restrict the sale of cigarettes and smokeless tobacco to …
By Peter M. Jaensch – On January 14, 2010, the United States District Court for the District of Columbia issued a decision in Smoking Everywhere, Inc. and Sottera, Inc. d/b/a NJOY v. United States Food and Drug Administration, et al., in which the court granted …
By David B. Clissold – Acting on cross motions for summary judgment, a Federal District Court in Kentucky has struck down some provisions of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) as unconstitutional, and upheld others. As we had reported earlier, the …
By Ricardo Carvajal & David B. Clissold – The most recent issue of the Food and Drug Law Journal contains an article on the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) authored by Hyman, Phelps & McNamara’s (“HPM’s”) Ricardo Carvajal, David B. Clissold, and …
By Ricardo Carvajal – FDA has prevailed on summary judgment in a lawsuit brought by BBK Tobacco & Foods, LLP ("BBK") which sought a declaration that separately sold flavored rolling papers are not tobacco products subject to regulation under the FDCA. Previously, FDA issued a draft …
By Ricardo Carvajal – FDA has issued a draft guidance that proposes a “preliminary” timetable for the agency’s review of applications for approval of modified risk tobacco products (MRTP’s). FDCA section 911(a) prohibits the introduction of an MRTP into interstate commerce unless FDA has issued …
By David B. Clissold and Ricardo Carvajal The Center for Tobacco Products has scheduled a web-based training session on use of the eSubmitter program to electronically submit establishment registration and product listing information (see here). Submission of that information by December 31 is required under …
