FDA rules sacrificing smokers

E-cigarettes could lead to a 21 percent decline in deaths from smoking-related diseases for people born after 1997, according to a study published in Nicotine & Tobacco Research. Even accounting for harms people might suffer from vaping who would have otherwise not smoked at all, the researchers found a net public health gain from the presence of e-cigarettes, according to an article posted on the website InsideSources. So why is the U.S. Food and Drug Administration putting up big regulatory barriers for e-cigarettes starting Monday, Aug. 8?

The reason is simple: regulator over-caution. The FDA isn’t publicly blamed for the people who suffer and die because a drug, product or service wasn’t available due to their slow and prohibitively expensive approval process. It is, however, blamed for products that cause harm 20 or 30 years down the line. So, regulators err on the side of caution.

In the case of electronic cigarettes, they are sacrificing the millions of people who will certainly die because of their tobacco addiction for the unknown number of people who might be harmed by the long-term effects of nicotine found in vaping products.

The risks of smoking traditional cigarettes far outweigh the risks of vaping. Both contain nicotine, which is an addictive substance, but itself may be no more harmful that caffeine and might even have some benefits. But cigarettes kill 50 percent or more of its users. Vaping, though a relatively new product category, is estimated to be 95 percent less harmful than traditional tobacco products.

Equally as important, smokers seem willing to make the switch to vaping. A survey of nearly 30,000 European Union residents, published last month in the Journal Addiction, concluded that of the 7.5 million daily vapers, 35 percent had completely switched from traditional tobacco cigarettes. For simplicity’s sake, I ignored the 2 percent of vapers who, according to the study, were not tobacco smokers prior to vaping.

Applying these rates to American vapers (though there are certainly differences in culture and regulation), a conservative estimate is that of the 9 million regular vapers in the United States, 2,970,000 of them have quit smoking traditional cigarettes by using e-cigarettes.

Of course, some people don’t entirely quit smoking, but refuse their use of traditional cigarettes. According to the E.U. study, 32 percent of the current vapors fell into this category.

Yet, beginning on August 8, the FDA will treat these two very different products in functionally the same way. Manufacturers and importers will have two years to gain FDA approval for every device, component and e-liquid formula; a process that takes hundreds to thousands of man-hours and can cost up to $1 million per application. By the FDA’s own estimate, 99 percent of the current products on the market will not receive approval from the FDA and will disappear from the market.

The purpose of the Tobacco Control Act — which gave the FDA power to regulate tobacco — was to “provide new and flexible enforcement authority” and to aid the industry’s attempts to “develop, introduce and promote less harmful tobacco products.”

Yet, with this new rule the FDA is doing is exactly the opposite. As my organization’s founder Fred Smith once quipped, perhaps it’s the FDA that should come with a warning label, not e-cigarettes.

American health advocates should be raising a stink about the damage these new rules will do to public health. But instead they worry about vaping “re-normalizing” cigarette smoking, which they worked so hard to make taboo.

It’s too bad they aren’t following the lead of British health professionals, who embraced the scientific evidence that e-cigarettes are relatively safe and an effective way to quit smoking. They have even advised doctors to encourage their smoking patients to switch to vaping.

So, what can be done to stop the FDA for perpetrating this harm?

First, Congress should enact legislation that would change the “grandfather date” within the Tobacco Control Act to 2016. The grandfather or “predicate” date, which allowed tobacco products on the market before February 2007 (or similar to such products) to bypass the agency’s pre-market approval process, is set at February 2007. Because e-cigarettes didn’t really exist before this date no products would qualify for this exemption. Though TCA explicitly gives FDA “flexible enforcement authority to ensure that there is effective oversight of the tobacco industry’s efforts to develop, introduce and promote less harmful tobacco products,” the FDA indicated that it doesn’t have the authority to change the grandfather date.

To address the problem, Reps. Tom Cole, R-Okla., and Sanford Bishop, D-Ga., introduced an amendment to the Agriculture Appropriations bill that would change the predicate date to August 2016. While not a perfect solution, grandfathering in most of the products on the market now would just bring innovation to a screeching halt, rather than throwing it back nine years.

In the long term, lawmakers should enact legislation directing the FDA to issue rules that account for the relative harm of products and make it easier and cheaper for less harmful products to get approval.

FDA’s fears about vaping products are certainly not baseless. Though they’ve been around for about a decade and are safer than cigarettes, the long-term effects of vaping aren’t known. What is known, however, is that millions of people will die because of their addiction to traditional cigarettes unless they quit or switch to another product and the FDA’s new rules will make switching more expensive, less attractive and less likely.

Even if bureaucrats at the FDA don’t get the blame, their failure to enact rules that preserve the electronic cigarette market will result in deaths that could have been prevented.