In a letter sent last Wednesday to the Office on Management and Budget (OMB), 11 Democratic senators, led by Jeff Merkley (OR) and Richard Blumenthal (CT), urged the agency to expedite its review of the FDA's electronic cigarette deeming regulations and not to change the proposed grandfather date of February 15, 2007.
In the letter, Senators Markley, Blumenthal, and colleagues wrote: "We urge OMB to work quickly to finalize review of the final deeming
rule, ensuring that the rule gives FDA authority over all tobacco
products including e-cigarettes and cigars, explicitly bans the use of
flavorings and marketing that appeals to children, and mandates
child-proof packaging of e-liquids (liquid nicotine). We also implore
that the final rule not move the “grandfather date” for new products
(set at February 15, 2007). Altering this grandfather date would exempt a
wide range of e-cigarettes and related products from any premarket
review to determine whether they constitute threats to public health."
Other senators co-signing the letter were: Charles E. Schumer (D-NY), Patty Murray (D-WA), Barbara Boxer (D-CA),
Edward J. Markey (D-MA), Sherrod Brown (D-OH), Dick Durbin (D-IL), Jack
Reed (D-RI), Dianne Feinstein (D-CA), and Elizabeth Warren (D-MA).
The Rest of the Story
Far from protecting the public's health, establishing a grandfather date of February 15, 2007 would lead to the decimation of the electronic cigarette industry, forcing thousands of vapers back to tobacco cigarettes and preventing successful cessation among thousands of others, thus wreaking a terrible toll on the public in terms of disease and death.
Why? Because with a grandfather date in 2007, every electronic cigarette on the market will have to file a new tobacco product application with the FDA. New product applications require that the company demonstrate that the
product is appropriate for the public's health. This means not only that
the product must be shown to be safer than cigarettes for smokers who
switch to the product, but also that the product benefits the public's
health, taking into account nonusers of the product. Thus, in order to
meet FDA approval, you would have to prove that the product
improves health, both on an individual and a population level.
While I believe it would be quite straightforward to demonstrate the
individual health benefits of electronic cigarettes over real ones, it
is not so trivial to have to demonstrate the overall population-level
benefits. To do this, one would have to estimate the proportion of
smokers who would switch to electronic cigarettes and the proportion of
nonsmokers who would start using the product. One would also have to
know the percentage of nonsmokers who would progress to smoking. And finally, one would need to know the natural course of changes in smoking behavior over time when a cohort of smokers tries electronic cigarettes.
The studies required to obtain this information are substantial, and it
is doubtful that most smaller companies have the resources to conduct
these studies. It is not initially clear to me that any company would be
able to meet this regulatory burden. However, if any companies are
equipped to do so, it is the tobacco companies and perhaps the largest
of the electronic cigarette companies.
The end result of this provision would likely be to contract the market, making fewer choices available to consumers.
But taking a step back, what sense does it make to require new product applications in the first place?
With cigarettes, I can see how new product applications make sense. The
tobacco companies had a history of introducing products to the market
that appeared safer, but were not. They also had a history of making
product changes in order to make cigarettes more addictive. Therefore,
it might make some sense to require new product applications for
However, for electronic cigarettes, it makes absolutely no sense. To be
sure, the newer products are the safest and the most effective. It is
the older products - the antiquated ones - that were much less effective
and generally not as safe. With time, product quality has improved,
more manufacturing standards have been put in place, better methods have
been developed, and safer products have been produced.
requiring new product applications for electronic cigarettes would greatly inhibit
innovation and constrict the e-cigarette market, reducing the beneficial
impact of electronic cigarettes in reducing combustible cigarette
The rest of the story is that this group of senators has it all wrong. They are doing
the exact opposite of what they should be doing. Instead of urging that there be a requirement for new product applications for all the new and improved electronic
cigarettes to stay on the market or to enter the market, these senators should be urging OMB to make sure that the FDA sets uniform safety standards for all electronic cigarettes. This would protect the public's health while allowing consumers to continue quitting smoking or cutting down substantially with a host of electronic cigarette brands and vaping products.
The truth is that what these senators are demanding will harm the public's health
rather than protect it. Or stated another way, their demands will result in more deaths than lives saved.