Sharing my concerns that the FDA deeming regulation will decimate much of the electronic cigarette industry, Representative Robert Aderholt (R-AL) has introduced a rider to the House appropriations bill 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
Aderholt'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. Hopefully, Congress will prevent the FDA from wiping out most of the e-cigarette industry by enacting Representative Aderholt's bill.