White House Responds to FDA Exemption Petition

After more than 40,000 signatures and 750 days, the White House has formally responded to a petition to exempt premium cigars from the Food & Drug Administration’s (FDA) control. Earlier today, Mitch Zeller, the director of the FDA’s Center for Tobacco, responded with a letter regarding the petition.

In short, the petition to the White House was rejected.

Zeller responded by stating that the recently-proposed deeming regulations, which would signal the first step in the FDA’s formal regulation of cigars, allows for premium cigars to be exempted.

Zeller indicated that the regulatory body is seeking comment on the exemption to deal with some of the issues mentioned by the premium cigar industry.

The full response reads:

Thank you for your petition on premium cigars.
First, it’s important to remember that regulating a tobacco product isn’t the same as banning it. FDA is not proposing a ban on all cigars or on any type of cigar.
Second, although all tobacco products are harmful and potentially addictive, FDA has heard the input from stakeholders about the possible differences in the public health impact of premium cigars compared to other cigars. We are taking this into account as we consider potential regulatory options around the categories of cigars.
In the proposed rule, the FDA has suggested two different ways the agency could regulate cigars. One option is to regulate all kinds of cigars. The other option is to exclude premium cigars, as described in the rule, from the scope of the regulation.
Here’s where you come in: We’re seeking formal comments on the proposed rule as to how cigars should be regulated. You have a chance to tell us what you think of FDA’s proposed rule, and comments are due on July 9, 2014. We encourage you, as well as manufacturers, retailers, and other stakeholders, to provide comments and to include any data and information you may have to support your comments.
Although tobacco products including cigars do vary, we know that cigars are not safe. All cigars, including premium cigars, contain the same chemicals and toxicants that are known to cause cancer and heart disease. FDA has several public health concerns regarding cigar use.
One major public health concern is youth cigar usage. We know that kids smoke cigars, and more research is needed about how this affects public health. Research also suggests that youth see cigars in a more positive light than cigarettes and believe cigars are more natural and less harmful; and some do not realize that cigars contain nicotine.1 Such false beliefs about product risks can be a significant predictor of subsequent use behavior.2
Here are some other health concerns about cigars, including premium cigars:
—Cigar smoking causes cancers of the lung, larynx, and esophagus, and also cardiovascular disease. Even cigar smokers who reported that they did not inhale were about three times more likely to die from lung cancer than those who have never smoked.
—The amount of nicotine in a cigar can range from the equivalent of a single cigarette to the equivalent of an entire package of cigarettes, depending on cigar size and the amount of tobacco incorporated into its components. In addition, the concentrations of some toxic and cancer-causing compounds are higher in cigar smoke than in cigarette smoke, and tobacco smoke is a major source of fine-particle and carbon monoxide indoor air pollution.
—Cigars can and do deliver nicotine at a level that can produce dependence. Factors — such as the degree of inhalation, the rate of oral nicotine absorption, the development of tolerance to nicotine, the age of initiation, and the duration of exposure — can contribute to the development of dependence.
Here’s some background on FDA’s authority, which you may already know: The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) amended the Federal Food, Drug, and Cosmetic (FD&C) Act to give FDA immediate authority to regulate certain tobacco products — cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. And while it didn’t apply right away to other tobacco products, such as cigars, the law gave FDA authority to cover those products through regulation.
We understand that cigar manufacturers and retailers are concerned about being subject to this type of regulation for the first time. That’s why the FDA has met several times with representatives of different cigar manufacturers and their trade associations to better understand how premium cigars are made, marketed, distributed, and used. We are always open to meeting with these and other stakeholders to hear from all points of view on issues related to product regulation.
We’ve issued a proposed rule in the April 25, 2014 issue of the Federal Register containing two options for regulating additional products that meet the legal definition of a tobacco product. Because cigars meet this statutory definition, their potential regulation by FDA is discussed in this proposed rule.
It’s important to remember that this is only a proposed rule and is not final. That’s why we’re seeking comments, and encouraging you, as well as manufacturers, retailers, and other stakeholders to formally provide comments through the FDA and to include any data and information you may have to support your comments. Thank you for participating in this We the People petition.

The deeming document was introduced last year. It outlines two potential options for the regulation of cigars. One option would include the regulation of all types of cigars. Another would specifically exempt “premium cigars.” The FDA is seeking comment both on the potential for an exemption and what the definition of premium cigar might be.

As of now, the public comment period to the FDA will close on July 9, 2014, but multiple organizations have requested an extension to the original 75-day period.

The petition was a joint effort by the International Premium Cigar and Pipe Retailers Association (IPCPR) and Cigar Rights of America (CRA).

To read the document in its entirety, click here. To submit public comment, click here.

Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.