Category — FDA
On April 7, 2014, legislators from California, Connecticut, Illinois, Iowa and Massachusetts wrote joint letters to the head of the Federal Trade Commission (the “FTC”) and the Food and Drug Administration (the “FDA”). The legislators’ letters urged the FTC and FDA to take action against manufacturers of electronic cigarettes that purportedly make false or unsubstantiated claims in their advertising and marketing. [Read more →]
April 8, 2014 Comments Off
Since the start of 2014, the FDA Center for Tobacco Products (CTP) has issued four Not Substantially Equivalent (NSE) Orders, 13 Refusals to Accept Exemptions from Substantial Equivalence (SE), four Refusals to File (RTF) submissions for Premarket Tobacco Applications (PMTAs), and 43 Withdrawals of SE Reports. [Read more →]
March 20, 2014 Comments Off
Troutman Sanders tobacco practice partner Bryan Haynes was quoted in a February 27th Reason article titled “FDA Cigarette Regulations Protect Big Tobacco, Not Public Health.” [Read more →]
March 1, 2014 Comments Off
On February 21, 2014, the FDA issued it’s first orders to stop the sale & distribution of tobacco products that are currently on the market, as they were found not substantially equivalent (NSE). FDA’s press release on the subject can be found here. [Read more →]
February 21, 2014 Comments Off
Troutman Sanders Tobacco Practice Comments on Applicability of FDA New Product Requirements to E-Cigarettes
Troutman Sanders tobacco team partner Bryan Haynes was quoted in a February 20th article titled “E-cig industry on tenterhooks ahead of U.S. regulation.”
The article discusses the heavy cloud of speculation hanging over the rapidly expanding e-cigarette industry as it awaits the release of deeming regulations by the FDA. In addition to concerns over potential advertising restrictions, flavoring bans, and the regulation of internet sales, the article also discusses how regulations could affect this relatively new segment of the tobacco industry when it comes to its rapidly changing product dynamic. [Read more →]
February 20, 2014 Comments Off
Another shameless plug for a Troutman Sanders tobacco team publication — we recently published an article in the Food and Drug Law Journal entitled “Compelled Commercial Speech: the Food and Drug Administrationi’s Effort to Smoke Out the Tobacco Industry through Graphic Warning Labels.” The article discusses the court decisions addressing the FDA’s mandate for cigarette packages to bear graphics depicting the health consequences of smoking, as well as possible approaches to future litigation involving the warning labels.
December 17, 2013 Comments Off
Bryan Haynes of the Troutman Sanders tobacco team recently authored the chapter “Understanding the Tobacco Control Act and FDA Investigative Process,” which discusses the FDA’s enforcement of the Family Smoking Prevention and Tobacco Control Act, in the recent book, Inside the Minds –Recent Developments in Food and Drug Law.
December 17, 2013 Comments Off
Troutman Sanders’ Tobacco team practice partner Bryan Haynes was quoted in a July 30 Washington Post article titled “FDA backs low-nicotine cigarette research as it weighs new regulatory power” about a new study regarding the effect of cigarettes with lower levels of nicotine, and how the FDA may choose to respond to the findings. To read the article, click here.
July 30, 2013 Comments Off
The Troutman Sanders Tobacco practice will be presenting at the Tobacco Merchants Association Annual Meeting and All-Industry Conference in Williamsburg, Virginia on May 16th.
Ashley Taylor will present on “Promotions in Rhode Island & New York.” Bryan Haynes will participate in a panel entitled “Deeming Regulations — A Conversation,” which pertains to the Food and Drug Administration’s anticipated regulation that would deem additional tobacco products (such as cigars, e-cigarettes and pipe tobacco) subject to FDA’s authority under the Tobacco Control Act.
We look forward to seeing our friends at the conference.
May 16, 2013 Comments Off
On April 22, 2013, the United States Supreme Court denied a petition for writ of certiorari in a First Amendment challenge to the 2009 Family Smoking Prevention and Tobacco Control Act’s graphic warning label requirement. The law requires that cigarette packages display graphic warning labels covering 20 to 50 percent of the product packaging. [Read more →]
May 5, 2013 Comments Off