FDA issued the long-awaited deeming regulation this morning. With respect to cigars, FDA proposed two options for the scope of the rule. FDA is requesting comments on the two options, and comments must be submitted within 75 days of the issuance of the proposed rule.
Potential Testing Requirements for Little Cigars
Posted in FDA
Many observers assume the FDA will deem little cigars to be within its jurisdictional purview once the so-called “deeming regulations” are issued. Given the physical similarity to cigarettes, one would also assume that the FDA will require reporting of harmful and potentially harmful constituents (HPHCs) on the products.
Legislators Pressure the FTC and FDA to Regulate E-Cigarette Advertising and Marketing
Posted in FDA, Legislation
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.
FDA Reports Action on Tobacco Product Premarket Approval Applications
Posted in FDA
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.
The FDA’s Regulatory Quagmire – and What it Could Mean for E-Cigarettes and Cigars
Posted in FDA
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.”
Pending FDA Regulation, Lobbyists Push for E-Cigarette Clarity in Washington
Troutman Sanders tobacco team partner Bryan Haynes was quoted in a February 26th NPR article titled “Lobbyists Amp Up Efforts To Sell Washington On E-Cigarettes.”
FDA’s First Order of Not-Substantially-Equivalent for Four Currently Marketed Tobacco Products.
Posted in FDA
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.
Troutman Sanders Tobacco Practice Comments on Applicability of FDA New Product Requirements to E-Cigarettes
Posted in Articles and Publications, FDA
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.
Graphic Warning Labels are Unconstitutional
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 Administration’s Effort to Smoke Out the Tobacco Industry through Graphic Warning Labels.” The article discusses the court decisions addressing…
Understanding the Tobacco Control Act and FDA Investigative Process
Posted in Articles and Publications, FDA
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.…