Wednesday, December 09, 2015

Changing Grandfather Date Does Not Mean FDA Cannot Review E-Cigarette Products; Instead, It Will Force Agency to Regulate E-Cigarettes Properly

Groups that are against tobacco-free cigarettes, and which want to make sure that all cigarettes continue to contain tobacco, continue to mislead the public into thinking that changing the grandfather date in the FDA deeming regulations will prevent the FDA from reviewing electronic cigarette products.

According to an article in the Washington Examiner, Gregg Haifley, director of federal relations for the American Cancer Society's Cancer Action Network, stated that the idea behind the grandfather date was to "not let the market be completely flooded with new products without any consideration of the impact of public health. Obviously, the industry is maneuvering to escape that kind of review by the FDA."

And according to Erika Sward, assistant vice president for national advocacy for the American Lung Association, the rationale for the law in the first place was to prevent tobacco companies from putting new products on the market that fraudulently claimed to be safer, but really were not, and in some cases were more addictive: "The 2009 law recognized that the tobacco industry is constantly trying to find new products to entice kids and made it harder for smokers to quit."

The Rest of the Story

It is simply not true that changing the grandfather date precludes the FDA from reviewing electronic cigarette products. The FDA is free to set any rules it wishes for the review of electronic cigarettes, including setting uniform safety standards that all products must meet. In fact, moving the grandfather date to the effective date of the deeming regulations has the great advantage of forcing the FDA to regulate electronic cigarettes properly: that is, by directly setting uniform safety standards.

So the truth is that the industry is not trying to escape review by the FDA. The industry is trying to escape from prohibition of virtually all of its products. The industry would still be subject to stringent product review based on any specific features that the FDA set as standards.

It is also important to point out that the only reason for the new product approvals in the first place was that cigarette companies had a history of introducing products that they claimed were safer, but were actually just as dangerous. In some cases, new products contained additives that made them more addictive. Congress decided in 2009 that it wanted to prevent any of this from continuing. That's why it required FDA approval for new cigarette products.

However, the electronic cigarette industry is a total different story. It is not coming out with new products with an intent to deceive consumers into thinking they are safer. It is trying to come out with new products that actually are safer and more effective. Thus, the need for new product approval is not relevant with these products. The FDA should simply not make e-cigarettes subject to the new product approval provisions of the Tobacco Act.

The rest of the story is that anti-vaping groups continue to mislead the public and policy makers into thinking that changing the grandfather date will remove the FDA's ability to regulate and review electronic cigarettes, giving them a free pass. This is untrue. The FDA can regulate electronic cigarettes as stringently as it wishes. And in fact, that is exactly what it should be doing, rather than creating a huge bureaucracy to deal with tens of thousands of cumbersome new product applications.

The real effect of failing to change the grandfather date is the decimation of most of the electronic cigarette market. What the anti-vaping groups are really doing is helping to ensure that all cigarettes on the market remain full of tobacco, rather than working to transform the market so that a huge proportion of cigarettes are tobacco-free.

The Campaign for Tobacco-Free Kids may want kids to be tobacco-free, but it certainly does not appear to want smokers to be tobacco-free.

1 comment:

Blogger said...

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