FDA

Subscribe to FDA via RSS

The Food and Drug Administration’s (“FDA”) proposed deeming regulations raise concerns for cigar manufacturers with product labels that include descriptors such as “light,” “mild,” “medium” or “low.”  In 2009, the Tobacco Control Act banned these descriptors for cigarettes.  The stated rationale for the ban was the assertion that many consumers believed that descriptors such as “light” or “mild” meant that certain cigarettes were less harmful than other cigarettes.

On August 4, 2014, thirteen Members of Congress signed a letter calling on the Food and Drug Administration (“FDA”) to expand the regulations on e-cigarettes to include more stringent rules regarding alleged youth exposure to the products.  The signatories state: “While FDA’s proposed rule sets the stage for future regulations, strong regulatory actions on marketing to children, e-cigarette flavors, and online sales cannot wait. FDA has an existing mechanism to protect children now—without waiting years to implement new regulations to accomplish these goals.”

Earlier this week, the Tobacco Merchants Association hosted a conference on the FDA’s proposed tobacco product deeming regulations, which would subject a host of new products — including e-cigarettes, cigars and pipe tobacco — to the FDA’s regulatory authority.  The Troutman Sanders tobacco team participated in the discussion regarding how the industry can best contribute to the ongoing debate as to how these products should be regulated, if at all.

Under the Patient Protection and Affordable Care Act (the “Affordable Care Act”) (also known as “ObamaCare”), which became law in 2010, health insurance companies may charge smokers and tobacco users more than those who do not smoke or use tobacco.  Specifically, smokers and tobacco users may be charged up to 50 percent more.

The FDA’s proposed deeming regulations call for testing of harmful and potentially harmful constituents in electronic cigarettes.  Those requirements would not be triggered until three years after the regulations become effective, and in the meantime the FDA presumably would need to establish protocols for e-cigarette testing and a list of constituents to be reported.

FDA’s proposed deeming regulation issued earlier today would cover a variety of products that meet the statutory definition of a “tobacco product,” including electronic cigarettes, cigars and pipe tobacco.  This blog entry discusses three provisions that would apply to the tobacco products “deemed” to be subject to FDA regulation. 

The FDA’s proposed deeming regulations issued earlier today purport to contain a number of relatively modest proposals for regulation of the newly “deemed” products — generally e-cigarettes, cigars and pipe tobacco.  However, lost in the shuffle of the media commentary thus far is the proposal’s impact on tobacco companies’ ability to market new products, or even to continue to market products that are currently being sold.