Small Business Administration Raises Concerns with FDA About Deeming Document’s Financial Impact

The Small Business Administration’s Office of Advocacy is the latest group to contact the Food and Drug Administration with concerns over the proposed regulations that will effect the premium cigar industry as well as e-cigarette and other tobacco product manufacturers.

In a letter dated June 11, Winslow Sargeant, Ph.D., the Chief Counsel for Advocacy, and Dillon Taylor, Assistant Chief Counsel Advocacy, express concerns that “the Initial Regulatory Flexibility Analysis (IRFA) does not discuss the quantitative or qualitative costs of the proposed rule on many potentially affected small entities,” and more specifically, that “the IRFA does not adequately consider or explain significant alternatives which accomplish the stated FDA objectives while minimizing the significant economic impact of the proposal on small entities.”

Advocacy has called FDA’s IRFA deficient, and as such has called on the FDA to republish for public comment a Supplemental IRFA before proceeding with this rulemaking.

Throughout its letter, Advocacy reminds FDA that the estimates on costs to small businesses provided in the deeming document have uncertainty, so much so that “the FDA concedes that it has not accurately quantified all of the costs and burdens associated with extending its authority to regulate previously uncovered products.” Between the significant costs of coming into compliance with FDA’s proposed regulations and the uncertainty surrounding those costs, Advocacy says that several businesses have confided that it will force them to exit the market and cease operating.

The full text of the letter can be found on the SBA website.

Patrick Lagreid

I strive to capture the essence of a cigar and the people behind them in my work – every cigar you light up is the culmination of the work of countless people and often represents generations of struggle and stories. For me, it’s about so much more than the cigar – it’s about the story behind it, the experience of enjoying the work of artisans and the way that a good cigar can bring people together. In addition to my work with halfwheel, I’m the public address announcer for the Colorado Rockies and Arizona Diamondbacks during spring training, as well as for the Salt River Rafters of the Arizona Fall League, the WNBA's Phoenix Mercury and previously the Arizona Rattlers of the Indoor Football League. I also work in a number of roles for Major League Baseball, plus I'm a voice over artist. Prior to joining halfwheel, I covered the Phoenix and national cigar scene for Examiner.com, and was an editor for Cigar Snob magazine.