Tuesday, May 3, 2011

So e-cigarettes are a “tobacco product.” Now what?

Be sure to tune in to the CASAA discussion on this topic Thursday, May 5th at 7:00PM EST/8:00pm CST on VP-Live's BlogTalk radio show:http://www.blogtalkradio.com/vapersplace/2011/05/06/special-edition-so-were-a-tobacco-product-now-what

On April 25, 2011 the FDA announced its decision to forego petitioning for Supreme Court review of the legal victory won last December by a major electronic cigarette distributor. (See, http://www.casaa.org/files/ct%20app%...injunction.pdf )

"The FDA's decision to regulate electronic cigarettes under the Tobacco Act is a great victory for public health," stated Dr. Theresa Whitt, M.D., CASAA Medical Director.

While it is obvious that CASAA* sees this as a victory for vapers everywhere, it is understandable that many folks not as closely associated with the legal case view the announcement with some reservation and concern.

“Concerns for taxation and specific restrictions are my cautions. I guess by putting e-fluid under the Tobacco Act, it gives FDA power it previously didn't have and unless another source of nicotine comes cost effectively available, we are under the FDA thumb, which is horrifying,” wrote one CASAA member. “I'm not letting my guard down even if CASAA claims a success.”

It is a common theme on e-cigarette discussion boards. Yet many of the concerns are based on misunderstandings of the PACT Act, the FSPATC Act, the Tobacco Act, Chapter IX and the FDA’s existing regulatory power over nicotine products. Members mainly worry about the future of e-cigarettes regarding increased taxes and costs, the ability to purchase over the internet, excessive regulatory standards imposed on vendors, indoor use bans and reduction in effectiveness through reduced nicotine strengths and flavor restrictions.

The first thing to remember is that CASAA views this success as winning a major battle, but is well aware that there are many more battles ahead before we can claim to have won the war. All of the issues mentioned previously are concerns, but they are not as imminent nor as black and white as it may seem at first blush. In order to have a clear view of these issues, one must read the aforementioned legislation to understand how they currently relate to e-cigarettes. CASAA’s Legal Director Yolanda Villa and CASAA Advisor Bill Godshall of Smokefree Pennsylvania have reviewed this legislation extensively as related to e-cigarettes.

As Director Villa recently wrote, “First the FDA has to propose its new regulations over e-cigarettes, then there is a public comment period and only after the whole administrative process is undertaken do the regulations become officially in effect. This can take up to two years, during which time we must all be vigilant and active in the battle to ensure that any actually official regulations are reasonable and science-based. And we must start to prepare, now, whatever evidence will be needed in that battle, starting with a very careful reading of the full [FDA] announcement and then paying equally close attention to other "guidance" documents the FDA issues as it proceeds."

"Yes, we have a lot of other battles to wage, but this concession to the court ruling in favor of Njoy is still a huge win for now!"

"And this does not mean automatic PACT Act inclusion [excluding internet/mail sales.] That would only happen with an amendment of the PACT Act itself. Nor does it mean an automatic flavor ban as that specifically only applies to cigarettes. All future regulation of e-cigs remains to be proposed, warred over - and that can include further litigation, even, if the proposals are unnecessarily harsh or rigid - and then ultimately enacted,“ said Villa.

“If e-cigarette sales/consumption continues to double, triple, quadruple in the next year, as I suspect it will, we'll have even more folks to advocate against unwarranted regulations, against state/local sales ban proposals and against state/local usage restrictions,” wrote Bill Godshall.

On the subject of tobacco taxes, CASAA Vice President Elaine Keller reminded members that tobacco taxes are set not by FDA classification but by the individual states. Tobacco tax rates, specifically “sin taxes” applied to combustible tobacco products to discourage smoking, should be directly related to perceived harm.

“One of the ways that we as consumers can help to keep the taxes down is to learn all we can about the concept of Tobacco Harm Reduction -- how switching to less harmful alternative sources of nicotine reduces health risks -- and then educate our legislators on these concepts. Whenever a state starts making noises about taxing smokeless products as highly as cigarettes, we need to be ready to make a lot of phone calls and send a lot of letters,” wrote Keller.

Regarding indoor use bans Keller reminded, “The issue regarding clean indoor air laws is not how a product is categorized. Snuff and chaw are tobacco products but are not covered in smoking bans. The issue is smoke and if someone tries to turn the issue into "The FDA says they're tobacco products" it will be our job to jump all over their case about it.”

As far as this being a "new" power for the FDA, the FDA actually has had the power to regulate tobacco products since the FSPTCA was passed and it has always regulated non-tobacco nicotine and smoking cessation treatment products. There was never a question about the FDA having power to regulate e-cigarettes in the U.S. So, it wasn't a "win" in any way on Monday for the FDA to be able to regulate e-cigarettes, because they always had that ability. That "win" occurred a long time ago in a completely different battle. This fight was about how they would be allowed to regulate e-cigarettes - as a drug or as tobacco. They wanted to regulate as a drug, we wanted to be a tobacco. The courts ruled in "our" favor; the FDA finally admitted defeat on Monday and that is 100% a win for e-cigs.

The point is that the PACT Act, flavor bans (per the FSPTCA), indoor use bans and tobacco taxation are specific laws which name and affect specific tobacco products – specifically combustible tobacco products. So not even all existing tobacco products are included in those laws, especially not e-cigarettes and it can take years to get them included. In the meantime, the vaping community will continue to grow in both numbers and influence, CASAA, harm reduction advocates and other vapers will have the opportunity to testify on behalf of e-cigarette regulation and safety and harm reduction studies can be completed. E-cigarettes will have science, truth and fact on their side.

Mr. Godshall summed it up quite succinctly. “If everyone who has negatively speculated about the future of e-cigarettes joined forces with CASAA, NVC, Smokefree Pennsylvania and tobacco harm reduction advocates, to hold the FDA accountable for promulgating sound regulations; to oppose e-cigarette taxes; to oppose e-cigarette sales and usage bans and to educate the public, we'll continue winning most - and maybe all - battles and e-cigarette sales will continue to skyrocket, which will give us even more clout in the public policy process,” he said.

*The opinions expressed here are the views of the writer and those quoted and do not necessarily reflect the views and opinions of CASAA.
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