PCA Submission to FDA

[TommyBB]

Not an interview question, but a pronouncement from the newly-christened PCA and its president.

The IPCPR appreciates the opportunity to provide comments and data to the agency regarding whether and how the substantial equivalence process should apply to premium cigars. In this regard, IPCPR wholly endorses and incorporates as their own the comments submitted today by Cigar Rights of America (attached hereto as Exhibit A2) and Davidoff of Geneva USA, Inc., General Cigar Company, Nick’s Cigar Company d/b/a Tabacalera Perdomo, SWI-DE, LLC d/b/a Drew Estate, Tabacalera Unidas, Inc. d/b/a C.L.E. Cigar Company, and Tabacalera USA Inc. (attached hereto as Exhibit . Both comments demonstrate that the substantial equivalence system reflected in the Proposed Rule is wholly inappropriate for premium cigars.Indeed, applying that system to premium cigars will be detrimental to the agency’s public health mission. That is because premium cigars are so varied—they are made by hand, from natural tobacco that depends on weather and growing conditions. As a result, there are nearly 51,000 separate types of premium cigars, as measured by so-called stock keeping units or “SKUs.” At the same time, these products are used infrequently, with fewer than 0.5 percent of U.S. adults using premium cigars and those who do, use the product only 1.4 days per month. Naturally, the agency will be inundated with premium cigar applications for substantial equivalence and will need to evaluate tens of thousands of submissions for products used by only one-half a percent of the U.S. population. And because premium cigars are made by hand from natural tobacco, as they have been for centuries, the agency will be diverting scarce resources to evaluate premium cigar products that do not present unique or novel questions of public health distinct from the premium cigars that have been on the market for centuries.

We have some big guns in the industry working together, I like it.
LONG document.