By David B. Clissold – A bill, H.R. 2058, introduced into the House of Representatives is short in length, but potentially long on effect for many tobacco product manufacturers. The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) established February 15, 2007 as the …
By David B. Clissold – In September 2011, the Center for Tobacco Products (“CTP”) issued a draft guidance entitled “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” (“Draft Guidance”). In the Draft Guidance, the Food and Drug Administration (“FDA”) claimed …
By Jay W. Cormier & David B. Clissold — Although an apple a day idiomatically keeps the doctor away, it appears true to one federal judge that one bad apple (or in this case three) really does spoil the bunch. As we previously reported here, in 2011, Lorillard, Inc., …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By David B. Clissold – Under the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), the Food and Drug Administration (“FDA”) was given the authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Other “tobacco products” could be regulated by FDA only …
By David B. Clissold – The United States Government Accountability Office (“GAO”) recently released a report examining FDA’s Center for Tobacco Products (“CTP”) entitled, “New Tobacco Products: FDA Needs to Set Time Frames for Its Review Process” (“GAO Report”). The report focused on CTP’s review of …
By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …
By David B. Clissold – Last week, House Democrats and a consortium of public health organizations turned up the heat on FDA to issue “deeming” regulations that would bring electronic cigarettes and other types of tobacco products under the Agency’s jurisdiction. The Family Smoking Prevention and …
By Kurt R. Karst – “… — …” – That’s the international Morse code distress signal commonly shown as SOS. SOS is also in the title of the acronymized “FDA SOS Act,” or the “FDA Safety Over Sequestration Act,” which a bipartisan group of members …
By Dave B. Clissold – Earlier this week, FDA’s Center for Tobacco Products ("CTP") released its first determinations regarding the marketing of new tobacco products through the substantial equivalence (SE) pathway. CTP authorized the marketing of two new tobacco products and denied the marketing of …
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, …
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 …
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 …
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 …
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 …
