A deeper look at the Attorneys General letter to the FDA

Earlier this week the National Association of Attorneys General submitted a letter to FDA Commissioner Margaret Hamburg pressing for immediate imposition of regulations.  Whereas there is little argument against some regulation, the authors come across as little more than Chicken Littles fearing the falling sky.  Or is it just in this age that they believe that only by overstating their position, by resorting to hyperbole, will they be able to influence events?

See here the full text of the letter (minus address, footnotes and signatures) annotated by yours truly. The bolding is mine,

The undersigned Attorneys General write to urge the Food and Drug
Administration (FDA) to take all available measures to meet the FDA’s stated deadline of October 31, 2013, to issue proposed regulations that will address the advertising, ingredients, and sale to minors of electronic cigarettes (also known as e-cigarettes).

State Attorneys General have long fought to protect their States’ citizens, particularly youth, from the dangers of tobacco products. For example, every State Attorney General sued the major cigarette companies for the harm their products caused. With the protection of our States’ citizens again in mind, the undersigned Attorneys General write to highlight the need for immediate regulatory oversight of e-cigarettes, an increasingly widespread, addictive product.

As you know, e-cigarettes are battery-operated products designed to deliver nicotine to the user by heating liquid nicotine, derived from tobacco plants, along with flavors and other chemicals, into a vapor that the user inhales. The nicotine found in e-cigarettes is highly addictive, has immediate bio-chemical effects on the brain and body at any dosage, and is toxic in high doses.

-the nicotine found in e-cigarettes is like any other nicotine. Those immediate bio-chemical effects do not seem to impair individuals or change their behavior in any easily perceptible manner. And “toxic in high doses” applies to almost any substance.  In general, “nicotine is without significant adverse health effects“.

E-Cigarette Sales are Growing Exponentially Using Marketing that Includes Television

Sales of e-cigarettes have grown rapidly in the United States, and after doubling every year since 2008, sales in 2013 are now accelerating even faster and projected to reach $1.7 billion.

The cost of e-cigarettes has fallen dramatically, as well, making them more affordable, and thus more attractive to young people. Unlike traditional tobacco products, there are no federal age restrictions that would prevent children from obtaining e-cigarettes, nor are there any advertising restrictions.

-Like the flavour argument why can’t we just say that lower prices might make a product more attractive to people of all ages? While almost all e-cigarette suppliers are in favour of age restrictions, the question of advertising restrictions should not be a case of just because they function like and resemble cigarettes that all tobacco restrictions should automatically be considered necessary.

Along with the growth of e-cigarette sales, there has also been a growth of e-cigarette advertising over the past year. For example, in this year’s Super Bowl broadcast, NJOY e-cigarettes purchased a 30-second television advertisement slot which reached at least 10 million viewers in certain markets and reportedly translated into a dramatic 30-40% increase in sales. The  advertisement depicted an attractive man smoking an e-cigarette that looked just like a real cigarette. Since then, advertisements for e-cigarettes have regularly appeared on primetime television, making it easier for those advertisements to reach children.

-The effectiveness of a satisfying safer alternative is to mimic the more harmful one as closely as possible. It is meant to attract smokers and what better way than to resemble a cigarette. As far as primetime etc., children will always be exposed to advertising not directed toward them.  Cars and coffee are not products for children but I am sure they see those ads.  We set up age restrictions because it is only use that really matters.

Moreover, e-cigarettes are not being marketed as smoking cessation devices, but rather as recreational alternatives to real cigarettes. Consumers are led to believe that e-cigarettes are a safe alternative to cigarettes, despite the fact that they are addictive, and there is no regulatory oversight ensuring the safety of the ingredients in e-cigarettes.

– It is no contradiction that e-cigarettes could be a safe alternative and yet be addictive.  Addiction is about a pattern of use and not about disease.  

E-Cigarettes Appeal to Youth

E-cigarettes contain fruit and candy flavors — such as cherry, chocolate, gummy bear, and bubble gum — that are appealing to youth. The FDA has banned such flavors from cigarettes and should take the same action regarding e-cigarettes. E-cigarettes and refills of the liquid nicotine solution used with e-cigarettes can easily be ordered online without age verification. By intentional use or mistaken ingestion from the non-child resistant containers, e-cigarettes and liquid nicotine refills can deliver dangerously high doses of liquid nicotine to youth.

– How often does this nonsense have to come up until some smart spell checker just removes it from any documents.  Yes, e-cigarettes come in many flavours, just like every other product in the world, and in order to entice smokers with a little something extra, and adults, who oddly enough enjoy flavours in everything they ingest.

There is an implication that non-child resistant containers are the norm which is certainly not true among conscientious suppliers (like ECTA members).

In addition to flavors, e-cigarette manufacturers, such as eJuiceMonkeys.com and Magic Puff City E-cigarettes, use cartoon monkeys to sell e-cigarettes, even though for many years, the major manufacturers of traditional cigarettes have been banned from using cartoons to advertise. Finally, e-cigarette manufacturers, such as White Cloud Cigarettes, offer reusable e-cigarette
“skins” — known as Vapor Jackets — that are intended to make the e-cigarette desirable or fashionable and are available in a variety of patterns that appeal to children, one of which uses images from the popular video game, Angry Birds.

– It seems that Angry Birds is most popular with the over35 group. And to carry the flavour point into design, is not possible at all that adults are attracted to a variety of skins (which seem to be associated with any tech product)?

Further, data from the 2011 and 2012 National Youth Tobacco Surveys (conducted by the Centers for Disease Control and Prevention) show that e-cigarette use among students doubled in the last year. Specifically, one in 10 high school students reported that they had tried an e-cigarette in the last year — up from one in 20 in 2011, and 1.8 million middle and high school students said they had tried e-cigarettes in 2012. The increased usage among young people echoes the growth among adult users, and researchers indicated that aggressive marketing campaigns, in part, drove the increase.

-The fear of children flocking to e-cigarettes has been discounted in many places already (in these pages, recently and nicely infographed at ashtray blog, and over at anti-thr lies) so not sure what those aggressive marketing campaigns accomplished.

 The FDA has Authority to Regulate E-cigarettes and Protect the Public

In the Tobacco Control Act, Congress recognized that nicotine is an addictive drug, and virtually all new users of tobacco products are under the age of eighteen and are therefore too young to legally purchase such products. Congress further found that tobacco advertising and marketing contributes significantly to the teenage use of nicotine-containing tobacco products. To help prevent children from using tobacco products, the Tobacco Control Act imposed restrictions on advertising and marketing to youth. These restrictions should be applied to e-cigarettes, as well, to safeguard children from nicotine addiction and other potential health effects of e-cigarettes.

The FDA has authority to regulate electronic cigarettes as “tobacco products” under the Tobacco Control Act, as they are products “made or derived from tobacco” that are not a “drug,” “device,” or combination product. Case law, such as Sottera, Inc. v. Food & Drug

Administration, 627 F.3d 891 (D.C. Cir. 2010), further supports the contention that e-cigarettes are “made or derived from tobacco” and can be regulated as “tobacco products” under the Tobacco Control Act.

We ask the FDA to move quickly to ensure that all tobacco products are tested and regulated to ensure that companies do not continue to sell or advertise to our nation’s youth.

-again, a bit of regulation of the right kind is useful but too much of the wrong kind will do little else than protect the cigarette and pharmaceutical nicotine market.

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2 thoughts on “A deeper look at the Attorneys General letter to the FDA

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  2. Pingback: A deeper look at the Attorneys General letter to the FDA | vapeforlife

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