Two weeks ago the FDA released its proposed regulation attempting to exert regulatory authority over e-cigarettes as tobacco products. To better understand the import of these regulations, please see our summary of the what and why of the deeming regulation and CASAA’s preliminary analysis of proposed regulations.
Early on, we asked CASAA members to be patient and to refrain from making formal comments about the proposed regulations until CASAA leadership had sufficient time to review the regulations and offer guidance. The membership has been patient at a time when every instinct we have is to react, do something -- do anything! -- because we know that these regulations, if enacted in anything remotely resembling their current form, will decimate the industry and destroy the diversity in the marketplace. And, of course, it's the diversity in the marketplace, the ability of customers to customize the experience, that makes this product such an extraordinarily effective alternative to smoking. There is a very real possibility that such regulations would eliminate the entire legal market for e-cigarettes.
The last two weeks, we have spent our days (and nights) analyzing the proposed regulations (241 pages), the FDA's regulatory impact analysis (81 pages), the Tobacco Control Act itself, and data about the FDA's operations to assess the real-world implications of the proposed regulations. We have thus far found no reason to believe that these proposed regulations will provide any benefit to consumers, especially in light of the crippling and insurmountable restrictions it will impose on industry, and, by extension, consumers. They appear to be all cost and no benefit.
This is not a battle that is going to be won based solely on comments to the proposed regulations. Accordingly, we are going to attack this on several different fronts. Before the draft regulations were published, we had envisioned a single Call to Action with several suggested actions. However, upon seeing the details, we decided the best strategy to effect positive change is to prepare a comprehensive Action Plan which consists of several Calls to Action issued at staggered dates to maximize effectiveness.