Mitch Zeller, the Director of the Food and Drug Administration’s Center for Tobacco Products, has accepted an invitation to speak at the upcoming 2015 NATO Show to be held on April 22-23, 2015 at the Paris Hotel in Las Vegas, Nevada. This appearance by Mitch Zeller will provide an opportunity for NATO Show attendees to hear directly from the individual at the FDA who oversees the regulation of cigarettes, roll-your-own tobacco, and smokeless tobacco products and the extension of regulations to cigars, pipe tobacco, e-cigarettes, and hookah tobacco.
Mark your calendars now to be sure to attend the 2015 NATO Show and learn about current and proposed FDA tobacco regulations from Director Mitch Zeller.
A new report just released by the federal Substance Abuse and Mental Health Services Administration (SAMHSA) shows that retailers continue to meet SAMHSA’s federally mandated goals of preventing the sale of tobacco to youth under the age of 18.
- Minnesota and Nevada: 1% violation rate; 99% success rate.
- Maine: 2.7% violation rate; 97.3% success rate.
- Kansas: 3.1% violation rate; 96.9% success rate.
- Montana: 3.2% violation rate, 96.8% success rate.
- Arkansas: 3.3% violation rate, 96.7% success rate.
- Mississippi and South Dakota: 3.6% violation rate, 96.4% success rate.
- Hawaii: 4.2% violation rate, 95.8% success rate.
- New York: 4.8% violation rate, 95.2% success rate.
On Friday, August 8th, NATO submitted its formal comments to the U.S. Food and Drug Administration regarding the proposed tobacco deeming regulations. NATO’s comments included the following specific points:
1. NATO and its retail members support the proposed minimum age of 18 years old to purchase the deemed tobacco products, including cigars, pipe tobacco, electronic cigarettes, hookah tobacco, dissolvables, and nicotine gels.
2. NATO differs with the FDA on several characteristics in the definition of a premium cigar. Specifically, NATO disagrees with setting a minimum retail price of $10 per premium cigar as this price is unrealistic, arbitrary and capricious since not all manufacturers have a minimum suggested retail price, the retail price of a cigar will vary from state to state due to differences in state tobacco excise taxes, and a significant majority of premium cigars have a retail price below $10, with many premium cigars priced substantially less than $10 per cigar. Also, NATO explains in its comments that the variation in tobacco blends used in making premium cigars means that approximately 90% of premium cigars could be considered to have a characterizing flavor other than a having a “tobacco” flavor. The FDA proposal would only allow premium cigars to have a “tobacco” flavor. This means that banning flavors in premium cigars, other than “tobacco” flavor, would result in a ban on the sale of a majority of premium cigars since many have what could be considered by the FDA to be a characterizing flavor.
3. NATO questions whether the requirement for manufacturers to register pipe tobacco would also mandate that tobacco store retailers offering blends of two or more pipe tobaccos are required to register their pipe tobacco blends as if they were a pipe tobacco manufacturer. NATO’s position is that retailers which blend pipe tobacco would only be blending tobacco already registered by the primary manufacturer making retailer registration unnecessary or that such retailers should be granted an exemption to blend up to 5,000 pounds of pipe tobacco each year without being required to register their new blends.
4. The FDA’s proposed ban on sampling of the deemed products is questioned since sampling of cigars and pipe tobacco are a longstanding retail tradition and, like wine tastings at liquor stores, sampling of deemed tobacco products should be allowed to continue.
5. Although the FDA does not ban flavors for the deemed tobacco products, the agency is requesting comments on factors it should consider in determining whether a particular tobacco product such as a little cigar or other non-cigarette tobacco product could be characterized as a “cigarette” and thus subject to the current flavor ban. NATO argues that since Congress did not take action to extend a ban on flavors to tobacco products other than cigarettes, the FDA’s request for input on whether a tobacco product such as a little cigar or other non-cigarette tobacco product could be characterized as a “cigarette” and thus subject to the current cigarette flavor ban is overreaching. That is, a federal government agency cannot on its own essentially change the definition of non-cigarette tobacco products in order to apply a cigarette flavor restriction.
6. NATO’s comments included a serious concern that if the FDA requires manufacturers of tobacco products that were not on the market as of February 15, 2007 to file a pre-market tobacco application, then many smaller manufacturers may cease selling their products due to the time and cost involved in submitting this application. The FDA estimates that it will take a manufacturer 5,000 hours to compile information, conduct studies, and file a pre-market tobacco application to continue selling each newer tobacco product. This investment in time and studies may be too significant for some manufacturers to submit an application to keep their products on the market. In turn, this means that retail stores will be negatively affected because of the inability to sell such tobacco products.
7. NATO also explained how the FDA would have the legal authority and enforcement discretion to adopt a new grandfather cut-off date for manufacturers to file substantial equivalency applications if their tobacco products were very similar to a tobacco product already on the marketplace. The current cut-off date is February 15, 2007. NATO’s comments recommended a new cut-off date as being either the same date the deeming regulations become effective or 28 months before the date the deeming regulations take effect. This would allow manufacturers to file substantial equivalency applications instead of a pre-market tobacco application.
As of August 8th, there were 82,181 public comments submitted to the FDA through the www.regulations.gov website. The FDA must now review each of the comments and determine if any changes will be made to the deeming regulations.