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.