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By Ricardo Carvajal – FDA has issued a draft guidance that proposes a “preliminary” timetable for the agency’s review of applications for approval of modified risk tobacco products (MRTP’s).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 …
By Kurt R. Karst – The U.S. District Court for the Western District of Kentucky (Bowling Green Division) denied a Motion for Preliminary Injunction in a case concerning the Constitutionality of the recently enacted Family Smoking Prevention and Tobacco Control Act (“FSPTCA”). As we previously reported, five …
By Ricardo Carvajal, David B. Clissold & Jeffrey K. Shapiro – FDA has published a draft guidance for industry on the listing of ingredients in tobacco products that manufacturers and importers are required to submit to the agency under FDCA section 904(a)(1). The FDCA does …
By Ricardo Carvajal – FDA has issued a draft guidance document that addresses FDCA section 201(rr)(4), which prohibits a tobacco product from being “marketed” in combination with any other FDA-regulated product. The guidance provides the following as an example of prohibited conduct: "Nicotine that is derived …
By David B. Clissold & Ricardo Carvajal – An importer and distributor of cigars has sued FDA to enjoin the agency from taking any adverse action with respect to Djarum brand cigars under Chapter IX of the FDCA until such time as the agency lawfully asserts …
By David B. Clissold & Ricardo Carvajal – As we discussed in a prior post, the FDC Act’s ban on "characterizing flavors" in cigarettes took effect on September 22, 2009. FDA marked the occasion by issuing a press release that highlights the effects of those cigarettes …
By Ricardo Carvajal – FDA has issued a letter to the tobacco industry offering a reminder that, under the standard for cigarettes in FDCA section 907(a)(1)(A), a cigarette or any of its component parts may not contain “an artificial or natural flavor (other than tobacco or …
