The 2009 law which gave the FDA oversight over tobacco products the Family Smoking Prevention and Tobacco Control Act (FSPTCA, the TCA) is one of the worst laws ever enacted. In the guise of reining in the health risks of tobacco products, promulgated to a great extent by the fraudulent, deceptive manipulations of the Big Tobacco companies last century, the law instead does close to nothing of the sort while erecting substantial obstacle for any new product which might actually do that job.
The products that have burst upon the market over the past decade providing smokers with an effective means of quitting deadly, addictive cigarettes e-cigarettes and vapor products, harm reduction products are novel, innovative devices supply smokers with nicotine in a vapor of low health risk. Millions of smokers have switched to vaping, while the FDA-approved methods (patches, gum and drugs) have proven largely ineffective.
A provision of the TCA echoed in the FDA s draft deeming regulations would require any product deemed by the agency to be a tobacco product to go through a lengthy, expensive premarket tobacco application process to remain on the market unless it s marketers can prove (to the FDA s satisfaction) that it s substantially equivalent (SE) to a similar product already on the market as of Feb. 15th, 2007 (Why that date? It was essentially a random, arbitrary decision by those who wrote the law among whom were representatives of the world s biggest cigarette maker, Philip Morris). This proviso is just one of several whose effect would be to keep competitive, novel products off the market and protect cigarette sales.
Two separate measures have recently been proposed by House Republicans: Rep. Tom Cole of OK authored a bill to move the grandfather date for SE to the date at which the FDA s final rule is published (ie., from 2/15/07 to, in all likelihood, sometime this year). And Rep. Aderholt (AL) wrote an amendment to an Agriculture subcommittee appropriations bill which would, in essence, defund the FDA in any enforcement action of the SE provision of the TCA, making it null and void, in effect.
Both of these measures would have the beneficial effect, for America s public health and for the diverse small businesses called by some the e-cigarette industry, of obviating the imminent enforcement of the SE section of the TCA. If that SE requirement goes into effect, 99 percent or more of the current e-cigs on the market would be forced off, permanently in all likelihood: most e-cig makers cannot tolerate the burden of paperwork the FDA would require, and would be forced into bankruptcy or takeover by the cigarette companies. The Cole bill would attack the law directly with an amendment, while the Aderholt proviso would do the same indirectly by cutting off funding for enforcement. Of course, the public health nonprofits who have carried on a crusade against e-cigs, possibly because of their multi-million-dollar support from the pharmaceutical companies who make ineffective but expensive cessation products, accuse the Congressmen of giving a gift to Big Tobacco. They know this is a lie, of course, since Big Tobacco would love to see the small e-cig companies go under, and e-cigs have no tobacco. Anyone actually hoping to reduce the toll of smoking should encourage Congress to enact these measures.
