Tuesday, May 19, 2015

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 (especially youth) will not offset the public health benefits that accrue to product users.

Most e-cigarette companies, distributors, and retailers are very small businesses that do not have the personnel, expertise, or resources required to prepare these applications and to deal successfully with the difficult scientific questions that arise. Even scientists and other experts in the tobacco control field have not yet determined how one can properly weigh the benefits and risks of electronic cigarettes, much less to do so with one particular product at a time.

This requirement makes no sense whatsoever for electronic cigarettes. When applied to regular cigarettes, it could at least make some sense because one could argue that there is no need to introduce new cigarettes to the market unless they are somehow safer than existing products. However, all e-cigarettes are safer than existing tobacco cigarettes. So there's absolutely no public health benefits to be gained from requiring e-cigarettes to go through this complicated process.

Moreover, such a process would create a nightmare of a bureaucracy at the FDA, wasting precious time and resources. The FDA already has all it can handle just trying to process the thousands of substantial equivalence applications it faces for regular cigarettes. Tying the agency down with tens of thousands of additional applications for e-cigarettes makes no sense.

As I have argued before, the FDA should simply promulgate rules that set minimum safety standards that all e-cigarettes must meet. These would address issues such as battery safety, overcharge protection, leak-proof cartridges, childproof packaging, basic quality control and assurance procedures, and some sort of regulation of temperature to minimize or prevent the formation of formaldehyde and other unwanted and unnecessary degradation products of propylene glycol and glycerin.

If the FDA deeming regulations do not change the grandfather date from 2007 to at least the effective date of regulation, then Representative Cole's bill will be absolutely necessary to protect the e-cigarette market and ensure that smokers have full access to all available options for smoking cessation.

No comments: