The Food and Drug Administration recently issued a solicitation for proposals for a 10 port cigar smoking machine that will simulate human cigar smoking under a variety of conditions and collect smoke residue for chemical analysis. The stated purpose of the solicitation is to increase the FDA's capability to analyze cigar smoke products and support regulatory work for the Center for Tobacco Products. The machine must analyze smoke under a variety of testing regimes, including ISO, CORESTA, Canadian Intense and Massachusetts Intense.
It is no secret that the FDA has for some time been preparing to regulate cigars under the so-called "deeming regulations." The draft regulations were issued in April 2014, went through an extensive notice and comment period, and are now at the White House Office of Management and Budget, Office of Information and Regulatory Affairs ("OIRA"), for the final stage of review. The regulations could be issued any day now, although there have been indications that the regulations could be delayed by ongoing questions regarding the economic impact of a February 15, 2007 grandfather date for purposes of premarket review.
Based on the FDA's solicitation, however, it is clear that the FDA's goal is to regulate cigars as soon as possible. Whether OIRA allows the regulations to go forward is a different question. We will report back on developments as this issue unfolds.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
