By Ricardo Carvajal & JP Ellison – A divided three-judge panel of the D.C. Circuit affirmed U.S. District Judge Richard Leon’s grant of summary judgment to plaintiffs in R.J. Reynolds et al v. FDA et al. (for our previous summary of that decision, see here). …
By David B. Clissold & Ricardo Carvajal – Last Friday, the FDA Center for Tobacco Products announced two new draft guidance documents for tobacco products. The first guidance, entitled “Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the …
By Ricardo Carvajal – A divided 6th Circuit panel affirmed a lower court’s ruling that some provisions of the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”) are unconstitutional, but others are not. As we noted in a prior posting, a federal district court ruled …
By Ricardo Carvajal - Last November, we noted that FDA’s regulation requiring the display on cigarette packages of graphic warnings intended to dissuade would-be smokers appeared in jeopardy at the hands of U.S. District Judge Richard Leon in R.J. Reynolds et al v. FDA et al. …
By Ricardo Carvajal – FDA issued a press release announcing the issuance of more than 1,200 warning letters to tobacco retailers alleged to have violated the agency’s Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents. Common alleged violations …
By David B. Clissold – As we previously reported, a group of five tobacco companies (R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc.) filed a complaint against FDA in the U.S. District Court for the District …
By David B. Clissold & Ricardo Carvajal - FDA issued two draft guidance documents that set out the agency’s thinking with respect to new tobacco products and the requirement to either demonstrate substantial equivalence under FDC Act § 905(j) or secure premarket approval under § 910. The draft …
By Ricardo Carvajal – FDA published a Federal Register notice asking for nominations of individuals to serve as voting members on the Tobacco Products Scientific Advisory Committee ("TPSAC"). The TPSAC has been ensnared in controversy due to allegations of bias and conflicts of interest among current …
By Kurt R. Karst – Earlier this week, a group of five tobacco companies (R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, Commonwealth Brands, Inc., Liggett Group LLC, and Santa Fe Natural Tobacco Company, Inc.) filed a four-count Complaint against FDA in the U.S. District Court for …
By Ricardo Carvajal – The Federal Trade Commission ("FTC") issued the latest in a series of reports on sales, advertising, and promotion of cigarettes and smokeless tobacco. The reports are based on data submitted to FTC by industry. The cigarette report states that the “total number …
By Jennifer D. Newberger – On April 25, 2011, FDA announced the availability of two guidance documents issued by the Center for Tobacco Products ("CTP"). The first, a final guidance document issued in March 2011, is titled “Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.” …
By Ricardo Carvajal – Rep. Henry Waxman, Ranking Member of the Committee on Energy and Commerce, sent FDA Commissioner Margaret Hamburg a letter urging the agency to investigate Kretek International’s (Kretek) marketing of clove-flavored cigars, and to ban flavored cigars that are “marketed for the purpose …
By David B. Clissold – In a federal lawsuit filed on Friday, February 25, 2011 in the District of Columbia, Lorillard, Inc., Lorillard Tobacco Company, and R.J. Reynolds Tobacco Company sued the FDA, DHHS, Kathleen Sebelius, Margaret Hamburg, and Lawrence Deyton for declaratory and injunctive relief …
By Ricardo Carvajal – Totally Wicked-E.Liquid (“TWI”), an importer and distributor of electronic cigarettes, filed suit to prevent FDA from regulating TWI’s electronic cigarettes as drugs, devices, or combination products, and from barring their importation into the U.S. TWI claims that the nicotine in its product …
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 …
