By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
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- Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75!June 25th, 2013
- House Appropriations Committee Report Expresses Concerns About FDA; Would Require a Slew of New Action DeadlinesJune 13th, 2013
By Kurt R. Karst – A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …
- Caronia Webinar – Slides and Audio Available for DownloadFebruary 8th, 2013
On January 31, 2013, Hyman, Phelps & McNamara, P.C. presented a webinar addressing the real-world implications from the Second Circuit decision in United States v. Caronia. Panelists addressed the potential impacts to the pharmaceutical, devices, dietary supplements, and tobacco industries. HP&M was quite pleased that …
- Real-World Implications of United States v. Caronia – A Hyman, Phelps & McNamara, P.C. WebinarJanuary 10th, 2013
Hyman, Phelps & McNamara, P.C. will hold a complimentary webinar on Thursday, January 31, 2013, from 12:00 – 2:00 PM (Eastern) on the Second Circuit's recent and long-awaited decision in United States v. Caronia. This webinar is not just another summary of the Second Circuit's decision. Nor …
- FDA Petitions D.C. Circuit for Rehearing on Cigarette Graphic WarningsOctober 12th, 2012
By Ricardo Carvajal – A few weeks ago, we posted on a decision by a divided three-judge panel of the D.C. Circuit Court of Appeals vacating FDA’s regulations that require graphic warnings on cigarette packages (see here). FDA has now petitioned the D.C. Circuit Court of …
- D.C. Circuit Affirms District Court Decision Striking Down FDA Regulation Requiring Graphic Warnings on Cigarette PackagesAugust 28th, 2012
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). …
- Where There’s Smoke, There’s Guidance: FDA Issues Two Draft Guidance Documents for Tobacco ProductsApril 2nd, 2012
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 …
- 6th Circuit Largely Affirms District Court Ruling on Constitutionality of the Tobacco ActMarch 22nd, 2012
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 …
- D.C. District Court Strikes Down FDA Regulation Requiring Graphic Warnings on Cigarette PackagesMarch 2nd, 2012
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. …
- FDA Highlights Compliance Efforts Against Tobacco Product RetailersNovember 13th, 2011
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 …
- Judge Leon Grants Preliminary Injunction- FDA’s Final Rule Requiring Graphic Warnings on Cigarette Packages Appears in JeopardyNovember 8th, 2011
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 …
- Pathways to Market for New Tobacco Products Begin to Take ShapeOctober 5th, 2011
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 …
- FDA Requests Nominations for TPSAC Voting MembersSeptember 2nd, 2011
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 …
- Tobacco Companies Sue FDA Over Graphic Warnings RuleAugust 17th, 2011
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 …
- FTC: Sales, Advertising, and Promotion Decline for Cigarettes, Increase for Smokeless TobaccoAugust 2nd, 2011
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 …