The U.S. Food and Drug Administration’s (FDA) has issued its deeming rule. Deeming Rule for regulation of other tobacco products including e-cigarettes, pipe tobacco, and premium cigars.  This regulation proposes sweeping changes that will have a significant impact on the cigar industry.  As a part of the proposals, the FDA is seeking public comment – specifically in the area of premium cigars.  Specifically this public comment deals with the issue if premium hand-rolled cigars should be in a separate category, thus not subject to FDA authority.

In regards to premium cigars, the press release from the FDA says as follows:

The FDA recognizes that different tobacco products may have the potential for varying effects on public health and is proposing two options for the categories of cigars that would be covered by this rule. The FDA specifically seeks comment on whether all cigars should be subject to deeming, and which other provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars.”

The public comment period would last for 75 days.  At that point the FDA will review the responses and make a ruling.  After the ruling is made, the new regulations could go into effect 30 days later.

In 2009, Congress and the Obama Administration passed into law the Family Smoking Prevention and Tobacco Act  giving the FDA power over premium cigars and other tobacco products.

The exemption is something the premium cigar industry has been seeking for several years.  The industry has been lobbying Congress through H.R. 792 and S 772 for such an exemption. A petition to the White House has been open for nearly two years with over 40,000 signatures asking for such an exemption.

The press release mentions four points around regulation that impact cigars:

  • Register with the FDA and report product and ingredient listings
  • Only market new tobacco products after FDA review
  • Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole;
  • Not distribute free samples.

The text of the proposed regulations mention a ten dollar price point for premium cigars.

.These proposed regulations have been a major fear of the premium tobacco industry – and the business impacts it can have to many companies, particularly the boutique cigar industry.  A potential exemption to separate premium cigars would be vital to many companies in the cigar industry.

In an outline of the proposal issued to several media sources, it has been mentioned that at this time the FDA will not seek a ban on flavored tobacco products or other tobacco marketing efforts. The reports also say FDA described all proposed regulations as “foundational” and said this could be the first step in what could be more regulations.

The full text of the proposed regulations can be read here.

The IPCPR, CAA, and CRA have not yet issued a formal comment to these reports.