Tag Archives: FDA regulations

Attack of the Vapers, Part duh… The Empire Strikes Back

My apologies for the long delay in what I thought would be a quick follow up to the first Attack of the Vapers (AOTV). However, if you have been reading along with the program, you have seen that there has been a big dust up recently with the proposed regulations and legal ramifications of using alternative nicotine delivery systems. However, given the timeline of the Federal Food and Drug Administration decisions, I decided to stop procrastinating and get this out there to maybe provide some information and encourage individuals in the vaping community to use their voices to impact the future of the phenomenon while there is still time to do so.

First, I will start by saying that there are a lot… let me repeat that… a LOT of rumors and speculations flying about the internet and the various vaping shops. Everyone has a perspective and a perception. I am going to give you my best, objective summary, and I am going to give you a bit of my opinion (as well as some I have gotten speaking with shop owners and enthusiasts in my local area). However, I am also going to provide you with a list of my references with links. Read what is available, and not from only one source. Educate yourself, and be knowledgeable about what is being proposed. Then, get involved. And now, I’m getting ahead of myself.

What Is Going On?

Since the first patent on the electronic nicotine delivery system in 1963, there has been resurgence in the evolution of the electronic cigarette. Since 2008, the number of electronic nicotine delivery system users has increase exponentially. In part, this is due to the indoor clean air regulations and non-smoker rights activists. There are fewer and fewer places for smokers to light up. People turned to alternative methods of acquiring nicotine. In 2009, the FDA was allowed by law to regulate tobacco products. However, that did not apply to electronic cigarettes. Additionally, the regulations imposed by the FDA were targeted to prevent smoking in the youth population of the country. Tobacco companies were restricted from using pretty colors, cartoon characters, and “candy” flavors that were seen as marketing to a younger user (Whitcomb & Gorman, 2014).

Tobacco companies complied. However, with the change to the cigarette prices, flavors, and restrictions, adults sought other ways of meeting their nicotine and behavioral desires. The original e-cigarettes were cartomizers with primarily propylene glycol and polyethylene glycol and tobacco flavoring in a system looking much like a cigarette. Many former smokers tried these, but in truth, they were found by and large to be a poor substitute to the smoking ritual and flavor. However, innovation is fed by deficits in the system, and smokers can be very innovative about getting their nicotine. While some chose to use the smoking cessation alternatives, the gum, patch, and medication routes were successful in approximately 6% of the population. Additionally, not every smoker actually wants to quit. That generally comes as a shock to the anti-smokers of the world, but some people enjoy their smoke. That being said, the removal of some of the flavors allegedly used to market to children was essentially punishing adults who may also enjoy flavored cigarettes, cigars, pipes, and now, vapors. In response, nicotine vapor alternatives became more and more prevalent, and they grew in popularity.

Several things occurred. Cigarette sales decreased as more smokers switched over to electronic nicotine delivery. Vaping does not carry the same taxes as the tobacco products, and there was a decrease in tax revenue as smokers switched to the less expensive vaping options. Anti-smoking activists were alarmed by the increased number of people mimicking smoking behavior regardless that it merely produced water vapor. Public health concerns about the long term effects were raised. Because there were no regulations, there were significant concerns about sales to minors. Lawmakers claim that e-cigarettes are a gateway drug to draw children and teens into smoking (Hunt, 2014; Moskowitz, 2014). Complaints are that marketing uses celebrity status to make e-cigarettes attractive. Additionally, free trial offers and samples concern critics. Critics also claim that e-cigarettes keep people from “quitting altogether,” neglecting to acknowledge the fact that people may not want to quit (Moskowitz, 2014).

What Does the Law Say?

Initially, the regulation and ban of vaping indoors was left to individual businesses, but more broad legislation has been proposed and ratified to restrict vaping indoors (Opfer, 2013). Currently, there are precious few clearly stated laws about vaping, but that is changing with each passing cloud of fragrant water vapor. In March of this year, Los Angeles joined New York, Boston, and Chicago in banning vaping from public venues such as restaurants, bars, and nightclubs (Whitcomb & Corman, 2014). The map of legislation is currently in flux. More and more states are scrambling to understand the phenomenon and regulate use in a meaningful way. There are varying laws in the U.S. restricting sales and use of e-cigarettes and their vaporizing counterparts, but there are still surprisingly few that forbid sale to minors (License to Vape, 2014). There are no regulations on the chemicals used or the disclosure of ingredients that could be potentially dangerous to vapers. However, beware vapers! A man in New York received a citation for vaping while driving. New York has a law that prohibits the use of electronic devices. Though electronic cigarettes are not specifically named in the law defining the devices, the judge ruled he had violated the law (Sherwood, 2014). We won’t actually discuss how distracting dropping a lit cigarette in the crotch is while driving, but apparently that is still legal.

What Is Proposed By the FDA?

The FDA proposed regulation April 24th, 2014, that while not as restrictive as feared (Craver, 2014; Sullum, 2014), still concerns many in the vaping community. The released proposal expands the definition of tobacco products to include electronic cigarettes, pipe tobacco, hookah tobacco, dissolvables, gels, and some cigars. It also covers products that could be considered paraphernalia, such as papers, tubes, charcoals, and hookah flavor enhancers (Langley, 2014). The FDA is proposing required health warnings on products (including addictive properties of nicotine), ban on sale to minors, prohibition of free samples, and disclosure of chemicals used in e-cigarettes (Burton & Esterl, 2014). Additionally, the FDA proposed that manufacturers of e-cigarettes will have to substantiate claims that they are safer than traditional cigarettes. Manufacturers may be required to register with the FDA for products and submit to premarket ingredient review, inspection, and approval (Devaney, 2014; Langley, 2014). Though Senate Health Committee Chair Tom Harkin is pushing to ban “candy” flavors, claiming it is marketing to children, the FDA stopped short of banning sweet flavors (Moskowitz, 2014). The primary focus of the language in the proposed regulations appears to be the e-cigarette devices of the cartomizer variety, such as Blu, NJOY, Logic, CB, and Nicotek (Burton & Esterl, 2014; Craver, 2014).

What Is Tennessee Proposing?

According to CASAA (2014), Tennessee is proposing a bill that would identify vapor products (e-cigarettes, vape pens, etc.) as non-tobacco, and therefore not taxed as such. They would also not be subject to the Tennessee Clean Indoor Air Act. This means that while smoking in certain indoor venues is banned, vapers would still be free to puff away. While the vaping community would be pleased with this outcome, the non-vapers and anti-smoking activists in Knoxville have expressed displeasure. Some people are still very sensitive to the residual PG or nicotine in some of the high nicotine vapor expressed by those using devices, and some are merely fearful believing that the water vapor is “just like smoke.” The bill proposed in Tennessee legislature mirrors one proposed in Oklahoma on April 16th, 2014. The law would also prevent proposed “sin” taxes such as that attempted by Vermont on April 7th, 2014 for 92% (honestvape, 2013). The proposed Tennessee law has met with some opposition from tobacco lobbyists for revenue and tax concerns, according to local vape vendors in Knoxville and e-cigarette enthusiasts.

Arguments Get Heated

Electronic cigarette companies such as NJOY expressed concern that a push to ban vaping is a deterrent to individuals switching from combustible tobacco. Instead of changing over to electronic cigarettes or their vape counterparts, people may choose to continue smoking rather than quit (Whitcomb & Gorman, 2014). The claims that strict regulations will encourage people to quit nicotine entirely ignores the fact that some people still enjoy their vaping after tapering down to zero nicotine. Critics feel that the FDA is not aggressive enough (Burton & Esterl, 2014). Many critics still feel that the flavors, ads and internet sales are a targeted marketing towards children and teens, again neglecting to recognize that adults favor flavors in their e-liquids much like they do flavored beverages.

Vendors, manufacturers, and enthusiasts are concerned that innovation and industry growth will be stifled in the newly regulated market (Craver, 2014). Individual manufacturers, such as small to mid-sized companies will be unable to afford staying in business and “Big Tobacco” and pharmaceutical companies will be the only entities capable of paying for required approvals (Craver, 2014; Moskowitz, 2014; Opfer, 2013). Without the ability to expand and the creativity of the community with the ability to experiment, devices proposed by medical and technology professionals inspired by the new vaper devices for smoking cessation and abuse resistant medication delivery devices may never come to light (Clark, 2014).

One of the proposed regulations is that the FDA would require proof of claims that there are health benefits to switching to e-cigarettes from traditional combustible tobacco (Burton & Esterl, 2014). Currently, the FDA claims there is no substantiation for claims that vaping is healthier than smoking. However, the FDA arguments appear to be primarily founded on first generation devices, and enthusiasts and vendors feel that there is more current research that shows the positive impact of vaporizing devices over combustible tobacco with regards carcinogen production and combustible toxicants (Toole, 2014). Anecdotal evidence from those who have switched indicates improved taste and smell, becoming less winded after activity, and overall feeling better (Moskowitz, 2014). These narrative reports from vapers are supported by positive evaluations from medical professionals that indicated not only are those who switch over feeling better, they have measurably increased lung capacity (Toole, 2014). Contrary to arguments to the contrary, e-vapor appears to be less addictive than the smoke of traditional cigarettes, as vapers tend to decrease their nicotine levels over time, often continuing to vape at zero nicotine levels (Craver, 2014). Oliver Kershaw of the E-Cigarette Forum worries about the selection and availability of products for vapers in future as he believes most of the current products will not qualify with the FDA approval requirements (Sullum, 2014). Public health professionals indicated that the FDA proposals are a victory for “Big Tobacco” as smaller players in the market could be driven out of business due to cost of earning approval for any new or existing products, and individuals losing their flavor options and expense benefits may return to combustible tobacco products (Craver, 2014; Moskowitz; 2014, Sullum, 2014). Still, the proposed regulations seem to be of little concern to the “Big Three” tobacco companies who have their own foot in the door of the electronic cigarette market (Mangan, 2014). The new federal regulations are not expected to make any impact on the expanding e-cigarette phenomenon. Industry giants acquiring existing lines may be the only way for certain juices and devices to stay on the market (Moskowitz, 2014). Bill Godshall of Smokefree Pennsylvania says, “What it will do is effectively give the entire industry to big tobacco,” (Opfer, 2013).

Safety is the biggest consideration in the argument for regulation. Spot tests conducted by the FDA claim to have found that nicotine levels and labels were vastly inconsistent with zero nicotine liquids still showing evidence of nicotine content (FDA, 2014). Many distributors refuse to disclose their ingredients claiming proprietary recipes. For people with allergies, this is a red flag and possibly a deterrent to purchase from said vendor. Strangely enough, the FDA is not trying to ban traditional cigarettes which have been shown to be far more dangerous (Sullum, 2014). The FDA and public health officials claim that “we just don’t know the long term effects of electronic cigarettes.” Well, we didn’t know about cigarettes for 20 years either, but they haven’t banned them yet. By the same logic, nicotine gum, dissolvables, patches, and inhalers are still on the market, despite somewhat poor outcomes for smoking cessation, and they are already approved and regulated by the FDA as pharmaceuticals (Sullum, 2014).

There are hopes that FDA regulations with “spike the guns” of various states imposing much stricter regulations (Craver, 2014). With broader federal guidelines, it would normalize the laws across the board and give less opportunity for wide variance of infraction from state to state.

Word On the Street

Local vendors and customers alike are worried about what the proposed regulations will do to their ability to vape inexpensively and have access to the same quality of products to which they have become accustomed.

One patron of Knoxville Vapors stated that government involvement will reduce options and access to quality e-juices and increase the cost. He agreed that regulation is needed to prevent sale to minors, but he is concerned that regulation won’t prevent unscrupulous vendors from selling to whomever they please. “It will only be the good folks who wouldn’t sell to kids in the first place who will be hit, and we will all be hit in the wallet.”

Vintage Vapors Knoxville owner echoes the concern, elaborating that producers of their most popular juices cannot compete with the big companies with an added cost of FDA approval which can cost between $5000-$10,000 per flavor per nicotine level. “The only ones who can afford it will be Big Tobacco or Big Pharmacy.”

Where Does This Leave Us?

People are still woefully ignorant of the science and the proposed regulatory legislation. It is time to read up, people. There are 75 days from the time the FDA proposal was released during which arguments and public comments will be heard.

Regulation is needed to prevent poor quality, sale to people less than 18 years old, and preserve safety to end users. From my own perspective, I want to know what is in the e-juice. That doesn’t mean I want a detailed list of their “secret special recipes,” but knowing the percentages of VG or PG (which can aggravate respiratory conditions or other allergies) is important. I believe knowing what ingredients have contributed to the flavors is reasonable. Again, people have allergies! Health warning labels are always a good idea, and child-proof caps, PLEASE! Nicotine is still a poison, and no one wants a child accidentally exposed.

So, my suggestion? Get involved in your local vape community, organizations, online groups, etc. Get educated. Voice your opinions to the FDA and your government representatives. If you do not want the government or large corporate entities controlling your vape, you need to heed the call to action and speak up to the people making the decisions.

References

Burton, T., & Esterl, M. (April, 2014). E-cigarettes face first regulations. The Wall Street Journal. Retrieved from http://online.wsj.com/news/articles/SB10001424052702304788404579520131790105314?mg=reno64-wsj&url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB10001424052702304788404579520131790105314.html

CASAA.org. (February, 2014). Call to Action! (UPDATED) SUPPORT Tennessee Bill that Excludes E-Cigarettes from Smoking Bans and Tobacco Taxes. Retrieved from http://blog.casaa.org/2014/02/call-to-action-support-tennessee-bill.html

Clark, T. (May, 2014). E-cigarettes become an unlikely inspiration for new medical devices. Huffington Post Business. Retrieved from http://www.huffingtonpost.com/2014/05/04/e-cigarette_n_5262520.html

Craver, R. (May, 2014). Reaction mixed to FDA e-cig regulations. Winston-Salem Journal. Retrieved from http://www.journalnow.com/business/business_news/local/reaction-mixed-to-fda-e-cig-regulations/article_e2e40682-36d6-5a8d-9ba5-73a4d7663904.html

Devaney, T. (April, 2014). FDA proposes regulations for e-cigarettes. The Hill. Retrieved from http://thehill.com/regulation/healthcare/204258-fda-proposes-e-cig-regs

FDA. (April, 2014). E-cigarettes: Questions and answers. Retrived from http://www.fda.gov/forconsumers/consumerupdates/ucm225210.htm

honestvape. (August, 2013). E-cig state laws: Current and pending. License to Vape. Retrieved from http://www.licensetovape.com/e-cigarette-state-laws-guide/

Hunt, A. (April, 2014) Marketing rules too lax on e-cigarettes critics say. USA Today. Retrieved from http://www.usatoday.com/story/news/politics/2014/04/27/federal-regulation-e-cigarettes/8231849/

Langley, A. (April, 2014). New FDA regulations affect vape pens, e-cigarettes and other smoking products. Summit Daily. Retrieved from http://www.summitdaily.com/news/11188069-113/tobacco-cigarettes-products-fda

Mangan, D. (April, 2014). E-cig makers say proposed FDA regs should keep sales smoking. NBC News. Retrieved from http://www.nbcnews.com/business/consumer/e-cig-makers-say-proposed-fda-regs-should-keep-sales-n88936

Moskowitz, E. (April, 2014). FDA e-cigarette plan brings complaints from both sides. The Boston Globe. Retrieved from http://www.bostonglobe.com/metro/2014/04/25/fda-cigarette-plan-brings-complaints-from-both-sides/1BuuMakxoOrn7XNdUW3LbM/story.html

Noll-Marsh, K. (April, 2014). FDA regulation of e-cigarettes: huge costs, little or no benefit, says CASAA. Retrieved from http://blog.casaa.org/2014/04/fda-regulation-of-e-cigarettes-huge.html

Opfer, C. (November, 2013). Coming Soon to the E-Cigarette Regulation Debate: A Sliver of Clarity. The Atlantic Cities. Retrieved from http://www.theatlanticcities.com/politics/2013/11/coming-soon-e-cigarette-regulation-debate-sliver-clarity/7517/

Sherwood, J. (March, 2014). Electronics cigarette lands a man a traffic ticket in Upstate New York. The Examiner. Retrived from http://www.examiner.com/article/electronics-cigarette-lands-man-a-traffic-ticket-upstate-new-york

Sullum, J. (May, 2014). Will FDA regulation preserve or destroy the e-cigarette industry? Forbes. Retrieved from http://www.forbes.com/sites/jacobsullum/2014/05/01/will-fda-regulation-preserve-or-destroy-the-e-cigarette-industry/

Toole, J. (April, 2014). N.H. health officials pleased by U.S. regulation of e-cigarettes: E-cigarette regulation praised by health officials, questioned by retailers. Eagle-Tribune. Retrieved from http://www.eagletribune.com/latestnews/x2117353741/N-H-health-officials-pleased-by-U-S-regulation-of-e-cigarettes

Whitcomb, D., & Gorman, S. (March, 2014). Los Angeles moves to ban e-cigarettes, joining NY, others. Reuters U.S. edition. Retrieved from http://www.reuters.com/article/2014/03/05/us-usa-ecigarettes-california-idUSBREA2324920140305

Honorable Mentions

Knoxville Vapors. http://knoxvapors.com/

Vintage Vapors Knoxville. http://www.vintagevapors.com/Knoxville-Location-s/1673.htm

Smokey Mountain Vapers. http://www.smokymountainvapers.com/

Vapor Boss. http://vapor-boss-inc.com/