FDA Issues Deeming Regulation on Tobacco Products
On April 24, 2014, the U.S. Food and Drug Administration (FDA) released proposed regulations to extend the authority of the FDA’s Center for Tobacco Products (CTP), under the Family Smoking Prevention and Tobacco Control Act, to additional tobacco products. Currently, the agency oversees cigarettes, roll-your-own tobacco, and smokeless tobacco.
The FDA released two options for consideration during the 75 day public comment period, effective today. Option 1 would extend the agency’s regulatory authority to all categories of tobacco products including cigars, pipe tobacco, electronic cigarettes, nicotine gels, hookah tobacco and dissolvables. Related accessories, such as lighters, cutters, and carriers, are not included in the regulation. Option 2 would extend the FDA’s regulatory authority to all of these categories of tobacco products, excluding premium cigars and related accessories.
Under Option 2, premium cigars are defined as wrapped in whole tobacco leaf; contains a 100 percent leaf tobacco binder; contains primarily long filler tobacco; is made by combining manually the wrapper, filler, and binder; has no filter, tip, or non-tobacco mouthpiece and is capped by hand; has a retail price (after any discounts or coupons) of no less than $10 per cigar; does not have a characterizing flavor other than tobacco; and weighs more than 6 pounds per 1000 units.
The deeming rule has numerous potential negative implications for the premium cigar industry. Specifically, the regulations could make the following changes:
- Impose a ban on sampling
- Require product registration and ingredient disclosure
- Impose labeling requirements for manufacturers
- Establish an arbitrary price point of $10, excluding all other products from the premium category
- Prohibit characterizing flavors other than natural tobacco
A 75 day public comment period begins today, April 25, 2014, and concludes on July 9, 2014. Public comments, data, and research submitted during this time will be reviewed, and will determine which provisions are enacted. It is critical that you remain engaged throughout the duration of the public comment period to further clarify why premium cigars should not be subject to the same regulatory framework as other products. IPCPR will provide you with instructions on how you can submit public comment.
Upon conclusion of the public comment period, the FDA will review all of the comments submitted. Any revisions to the initially proposed regulations will be sent to White House Office of Management and Budget (OMB) for economic review before the final regulations become effective.
“The proposed regulations released by the FDA Center for Tobacco Products demonstrate a misguided attempt to regulate the premium cigar and pipe tobacco industries,” said IPCPR President Finnie Helmuth. “While IPCPR is encouraged to see progress in defining the unique tobacco products our retailers carry, this regulation remains flawed. The facts are clear: premium handmade cigars are not desirable to, marketed to, or affordable to America’s youth. The products our retailers sell are a celebratory luxury enjoyed by adults, and do not have the same habitual use patterns as other tobacco categories. We do not believe it was the intent of the United States Congress to regulate premium cigars under the Family Smoking Prevention and Tobacco Control Act of 2009. IPCPR looks forward to working with FDA moving forward, and encourages all interested parties to submit comments on how this rule will affect their small businesses.”
The proposed rule can be read in full at http://www.fda.gov/TobaccoProducts/Labeling/ucm388395.htm