Representative Cole Introduces Legislation to Force FDA to Grandfather In All Electronic Cigarettes on the Market as of Effective Date of Its Deeming Regulations

Sharing my concerns that the FDA deeming regulation will decimate much of the electronic cigarette industry, Representative Tom Cole of Oklahoma has introduced legislation that would essentially overrule the FDA and statutorily set the "grandfather" date for electronic cigarettes as the effective date of the FDA deeming regulation.The significance of this legislation is that it would allow all electronic cigarettes currently on the market (and all those on the market as of the effective date of FDA regulation) to remain on the market without having to submit complex and resource-intensive new product or substantial equivalence applications.If the final FDA regulations look anything like the proposed deeming regulation, then every electronic cigarette product on the market will have to submit a new product application (because no product on the market today is "substantially equivalent" to products on the market as of February 2007). To do this successfully, a company would have to demonstrate that its product is beneficial to the public's health, taking into account not only product users but those who do not currently use e-cigarettes but who might start vaping because of the availability of the product.This is an incredibly complex and difficult showing because a manufacturer or distributor would have to demonstrate that:1. Every one of their products is safer than smoking.2. Every one of their products will help smokers quit.3. The uptake of their products by non-users (es...
Source: The Rest of the Story: Tobacco News Analysis and Commentary - Category: Addiction Source Type: blogs