Week 52 is often more laid back than any of the other 51 weeks in the calendar year. It offers us a chance to sift through and clean out the office in preparation for yet another busy year. But it’s also a chance for this …
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Tobacco
- Need Some Holiday Reading? Recent FDA Scholarship Worth a SpinDecember 29th, 2016
- Will Any of FDA’s Recent Rules Wind Up On the Congressional Chopping Block?December 8th, 2016
There has been a spate of recent news articles about the potential use of the Congressional Review Act (CRA) to overturn final rules issued toward the end of the Obama Administration. That prompted us to see which of FDA’s recently issued final rules might be …
- FDA’s Final Deeming Regulations Covers all “Tobacco Products”May 10th, 2016
By David B. Clissold – On May 10, 2016, FDA published in the Federal Register the final “deeming regulation” asserting control over all tobacco products, even products that do not yet exist, meeting the broad statutory definition of a “tobacco product.” Under the Family Smoking Prevention …
- DC Circuit Vacates District Court Regarding TPSAC; Is the Menthol Report Back or in Limbo?January 18th, 2016
By Jay W. Cormier & David B. Clissold – As we reported 18 months ago here, in July of 2014 the District Court for the District of Columbia granted summary judgment for what is now R.J. Reynolds Tobacco Holdings, Inc. in a lawsuit that alleged that the FDA …
- Swedish Match North America, Inc. First to Cross FDA’s PMTA Finish LineNovember 12th, 2015
By David B. Clissold – On November 10, 2015, FDA announced that for the first time it has authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. The FDA press release describes marketing orders for eight Swedish Match North America, Inc. …
- A Long Overdue Revision to the Intended Use RegulationOctober 18th, 2015
By Jeffrey K. Shapiro – A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. The intended use of …
- Senate and House Lawmakers Add to FDA’s To-Do List in Fiscal Year 2016 Appropriations BillsJuly 24th, 2015
By Kurt R. Karst – Earlier this month, legislation was introduced in both the U.S. Senate and U.S. House of Representatives to fund FDA for the next fiscal year: Fiscal Year 2016. Both the Senate bill and the House bill, titled “Agriculture, Rural Development, Food and …
- Proposed Legislation Would Link the “Grandfather” Date in the Tobacco Control Act to FDA’s Deeming RegulationsApril 30th, 2015
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 …
- Tobacco Companies Challenge CTP Guidance on Substantial EquivalenceApril 16th, 2015
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 …
- Court Finds Three Appointments Tainted the FDA’s Tobacco Products Scientific Advisory Committee, Including its Menthol ReportJuly 23rd, 2014
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., …
- As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List GrowsMay 29th, 2014
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 …
- Deem the e-Cigarettes! Full Speed Ahead!April 28th, 2014
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 …
- When is a Very, Very Long Delay the Same Thing as a Ban? FDA’s Review of Tobacco Product Submissions Under the MicroscopeOctober 23rd, 2013
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 …
- As Partial Government Shutdown Kicks In, FDA’s Foods Program Is Hardest HitOctober 1st, 2013
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 …
- Up in Smoke (or Vapor, as the Case May Be)September 22nd, 2013
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 …