I have a feeling I know how the FDA will respond, I just hope the committee sees through the BS.
1. The final rule notes that the FDA does “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health.” Further, the final rule states that “comments were divided on the safety and toxicity of e-liquids, e-cigarettes, and the exhaled aerosol.”
- Will the FDA issue a revised rule if there is sufficient data that finds that e-cigarettes are a safer alternative to traditional cigarettes? Please explain. Tobacco products are subject to the regulations set forth in the FSPTCA. If ecigs are a safer product, they are welcome to apply for MRTP marketing authorization.
- How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health? While the data is inconclusive, there is enough evidence to suggest a threat to overall public health, see teen usage(just don't look too closely).
2. Some stakeholders claim that the FDA’s rule on e-cigarettes will stifle innovation and result in the closure of many small businesses that create and sell e-cigarette products.
- Did the FDA determine how many e-cigarette businesses will be affected by the rule? If not, why? The FDA fully expects market attrition and consolidation, the exact numbers are impossible to determine, but we feel this is in the best interest of the regulatory procedure.
- If so, please provide that data. See above.
- Of the e-cigarette businesses that will be affected by the rule, how many of those businesses does the FDA predict will exit the market as a result of the new requirements? See above.
3. Has the FDA considered the unintended consequences if decreased access to e-cigarettes leads to increased consumption of traditional cigarette and tobacco products? Please explain.
The FDA is responsible for considering effects on Public Health as a whole, including users of tobacco products and non-users. We feel the potential effects on non-users outweigh the consequences on tobacco users, because they stink, see teen use(but again don't look too closely).