May 16, 2014
Stanton A. Glantz, PhD
Excellent series of FDA public comments on ecig marketing, together with large collections of advertising images available
Stanford Professor Robert Jackler has submitted a series of public comments to the FDA accompanied by rich collections of advertising images for e-cigarettes to support the conclusions he draws.
His comments appear below, together with links to the collections of images from the Stanford Research into the Impact of Tobacco Advertising (SRITA) collection that Dr. Jackler and his colleagues continue to build.
The comment numbers refer to the corresponding postings on www.regulations.gov. You can locate the original comments and attachments by putting the comment numbers into the search box on that site. You can also cite these comments and the collegting images in your public comments.
Safety
While one might speculate that eCigs are a safer alternative than combustible tobacco, they are almost certainly not safe. While the effects of inhaled nicotine has been extensively studied, but little is known about the long term effects of breathing copious amounts of aerosolized propylene glycol and glycerine into alveoli. Chronic inhalation of large quantities of flavorants made of aldehydes, ketones, and other chemicals is also of concern. Eosinophilic pneumonia from eCigs has been reported and, over the long term, we may recognize a pattern of eCig caused pulmonary diseases. It would seem logical that any vapor intended to be inhaled deeply into the lungs on a daily basis ought to be carefully evaluated for safety before it could be introduced into the mass market. At present we are conducting an uncontrolled experiment on thousands of the Americans, including a large number of teens.
Robert K. Jackler, MD
Sewall Professor, Stanford University School of Medicine
Stanford Research Into the Impact of Tobacco Advertising
SRITA Link to images Comment Tracking Number: 1jy-8c3y-6bog
Teen Targeting
The e-cigarette industry professes that it only targets established adult smokers. However, examination of their promotional efforts show that they employ a multilayered approach targeting teens. Freedom-based themes such as independence, power, and rebellion are of obvious appeal to adolescents. Once adopted by their generation’s influential trendsetters, youths rebel by following the crowd. Movie actors and rockstars use of e-cigarettes, sometimes as paid endorsers, influences the young. By emphasizing the coolness and novelty of e-cigarettes, the industry attracts tech obsessed youth. The most transparent and cynical strategy used to entice teen use, is the plethora of youth-appealing flavors. Simply put, tantalizing sweet flavors such as gummy bears and snickerdoodle are highly unlikely to appeal to adult smokers. Overtly sexual themes, with scantily clad models and suggestive imagery, clearly target youth.
The CDC report of September 2013 described results of a survey of high school and middle school students from 2011 and 2012. It showed a doubling of teen experimentation with e-cigarettes from 4.5% to 10%. Such a rapid rise over such a short time span reveals a disturbing trend of increased teen use, threatening a substantial rise in the rate of nicotine addiction. Given the rapid increase is popularity of eCigs, the youth initiation rate in 2014 is likely substantially higher. Dual use was prevalent among teen vapers with only 9.3% never users of tobacco products. In another study, Korean teens’ e-cigarette use was strongly associated with current and heavy concomitant tobacco use. The CDC report also raised alarm that e-cigarettes may become a gateway to nicotine addiction for non-smoking students. Among middle schoolers, 20.3% of e-cigarette users never used tobacco. The report estimated that the US has 1.78 million students who had used e-cigarettes, of whom 160,000 had never tried tobacco. Unless the trend of growing youth adoption of e-cigarettes can be stemmed, any public health gain of decreased combustible tobacco smoking may be offset by youth initiation and dual use.
Attached is a Powerpoint collection of images of electronic cigarette advertisements, representing a number of brands, illustrating obvious youth targeting. Effective regulation of youth targeted advertisements requires more than simply taking the company’s word for it. An effective means of determining an advertisement's appeal to teens is a carefully consumer perception evaluation. Young models, youthful behavior, cartoon, endorsement by role models and heroes, etc. should not be allowed. Aligning eCig advertising regulation with those for cigarettes would be appropriate.In response to the Senate HELP committee, each major eCig company specifically denied that their advertising targeted teens. The evidence form their own advertising, and the geometrically growing rate of youth adoption, makes the truth abundantly clear.
Sutfin EL, Mccoy TP, Morrell HE, Hoeppner BB, Wolfson M. Electronic cigarette use by college students. Drug Alcohol Depend. 2013;131(3):214-21.
Corey C, Wang B, Johnson SE, et al. Electronic cigarette use among middle and high school students – United States, 2011-2012. MMWR 2013; 62: 729-730.
Lee S, Grana RA, Glantz SA Electronic Cigarette Use Among Korean Adolescents: A Cross-Sectional Study of Market Penetration, Dual Use, and Relationship to Quit Attempts and Former Smoking. J. Adolescent Health. 2013: S1054-139X(13)00748-9. doi: 10.1016/j.jadohealth.2013.11.003.
SRITA Link to images Comment Tracking Number: 1jy-8c40-pjud
Escaping FDA regulation by use of non-tobacco sourced nicotine – an evasion pathway the FDA needs to recognize and inhibit.
Some companies in the eCig industry would clearly prefer to escape coming FDA tobacco regulations. eCigs contain a variable amount of nicotine (from 0 to 36 mg per ml). Nicotine is the only tobacco derived constituent in most eCigs and some would argue is the only aspect of the product which enables the FDA tobacco regulations to apply. The argument goes that with use of non-tobacco sourced nicotine that the FDA Tobacco regulations would not apply. Brands have begun to advertise that they are not tobacco derived products (see attached GreenSmartLiving advertisement asserting use of non-tobacco nicotine sources).
It seems clear that the intent of Congress, when it gave the FDA authority over tobacco products in 2009, was to encompass all uses of nicotine intended for recreational (as opposed to therapeutic) use. Although use of non-tobacco nicotine is not economically feasible today, given the potential for unregulated profits, the industry could invest in a more cost effective synthesis. Common vegetables have nicotine, a chemical the plant produces as an insecticide. Tomatoes and Eggplant, for example, produce nicotine, albeit in microgram quantities rather than milligrams in tobacco leaf. As a gene exists in these plants to synthesize nicotine. With genetic manipulation it is entirely feasible that an alterative non-tobacco plant could be engineered to produce copious amounts of nicotine.
The FDA has a clear path forward to closing this potential 8 lane highway of escape from regulation. Nicotine products should have two choices: FDA tobacco or FDA drug regulation. There is no justification for a third, unregulated pathway.
Nicotine content of common vegetables. NEJM 1993; 329: 437
Robert K. Jackler, MD
Sewall Professor, Stanford University School of Medicine
Stanford Research Into the Impact of Tobacco Advertising
Comment Tracking Number: 1jy-8c40-if0z
Tobacco cessation claims:
Electronic cigarette companies are aware that the desire to cut down or quit tobacco smoking motivates a large fraction of their customers. As a cessation tool, e-cigarettes may be at most marginally better than other methods, but still has limited effectiveness of well less than 10%. In a recent Lancet study, 7.3% of tobacco users quit smoking on e-cigarettes compared with 5.8% with nicotine patches. A recent UCSF study shows no cessation effectiveness.
The FDA will not permit e-cigarette brands to be marketed as smoking cessation devices under threat of being subject to stringent pharmaceutical restrictions. Nevertheless, cessation effectiveness claims permeate e-cigarette advertising. (see accompanying Powerpoint) Companies skirt the edges of these limits with slogans that are proxies for quitting such as “smoking alternative,” “switch,” “change,” “it works!”, “kiss tobacco goodbye,” and “kick some ash.” SouthBeach Smoke asks consumers to “Make the Switch Today and Change Your Life.” The brand name Fin is French for “the end” and the brand name Instead makes a clear suggestion. The Smokeless brand has obvious implications beyond its device making less smoke as do the brands Smoke Relief, Smokepass, Smoke Assist, and Nicocure. The ambiguous meaning of the brand name Quitesmoke, which can be read as either quite-smoke or quit-esmoke, makes one wish they would cease trying to be so slick. Even stores get into the act with one in Canada named “The End.”
Clever use of reverse psychology in V2’s “don’t quit” and Blu’s “why quit” is used as a means of technically respecting FDA boundaries while the prominence of the word “quit” conveys the marketers intended message. Some explicit claims of cessation efficacy appear in the form of testimonials on blogs and forums of e-cigarette companies. Other supposedly independent and unbiased claims appear in online vaping vendor websites, e-cigarette review sites, and are undoubtedly offered by sales people in brick and mortar vapor stores.
Bullen C, Howe C, Laugesen M, et al. Electronic cigarettes for smoking cessation: a randomised controlled trial. Lancet. 2013;382(9905):1629-37.
Cobb NK, Brookover J, Cobb CO . Forensic analysis of online marketing for electronic nicotine delivery systems. Tob Control. 2013 Sep 13. doi: 10.1136/tobaccocontrol-2013-051185.
Grana RA, Popova L, Ling PM.A longitudinal analysis of electronic cigarette use and smoking cessation. JAMA Intern Med. 2014; 174: 812-3.
Robert K. Jackler, MD
Sewall Professor, Stanford University School of Medicine
Stanford Research Into the Impact of Tobacco Advertising
SRITA Link to Images Comment Tracking Number: 1jy-8c4r-6ro4
Teen Targeted Flavors
The most transparent and cynical strategy used to entice teen use, is the plethora of youth-appealing flavors. Simply put, tantalizing sweet flavors such as gummy bears and snickerdoodle are highly unlikely to appeal to adult smokers. (see accompanying Powerpoint) In 2009, the FDA prohibited use of characterizing flavors in cigarettes. In its flavored product lines, eCig makers have greatly exceeded anything that the tobacco industry was willing to do. It appears as though they went through flavorant company catalogs and created ejuice varieties in every conceivable flavor which might appeal to young people. Use of flavored tobacco is well recognized as a gateway to nicotine addiction. Flavored ejuice types include: Candy (eg. bubble gum, gummy bear, cotton candy, chocolate); Ice Cream (eg. mint chocolate chip, banana split); Pastry (eg. cinnamon bun, maple pancake), Fruit (eg. peach, pineapple); Alcoholic beverage (eg. beer, mojito); Pepperoni pizza, and many others. Poison centers report a rash of poisoning among toddlers who imbibe sweetened ejuice, including a number of fatal cases. The policy adopted for ciagettes should be extended to eCigs. The combination of nicotine and flavoring in vapor products targets young people and should not be permitted.
A sample of the innumerable E-cigarette vapor flavors on the market
Candy
Cotton candy
Bubble gum
Sweet Tarts
Gummy bears
Honey
Chocolate
Maple syrup
Candy cane
Peanut butter cup
Truffle
Peppermint patty
Mint
Peppermint
Menthol
Ice Cream
Mint chocolate chip
Caramel Frappeé
Boom boom pop
Sultrysickle
Pastry
Cinnamon bun
Apple pie
Chocolate chip cookie
Sugar cookie
Grahm cracker
Blueberry muffin
Snickerdoodle
Blueberry waffle
Vanilla cupcake
Maple pancake
Peach cobbler
Strawberry cheesecake
Coconut macaroon
Beverages
Cola
Cherry cola
Root beer
Dr. Pepper
Hawaiian punch
Ice lemonade
Alcoholic Drinks
Whiskey
Beer
Pina colada
Mojito
Brandy
Margarita
Gin and tonic
Peach Schnapps
Amaretto
Absinthe
Champagne
Coffee and Tea
Kona coffee
Mocha
Cappuccino
Coffee jolt
Black tea
Spiced tea
Fruits
Bananna
Peach
Apple
Orange
Watermelon
Melon
Kiwi
Lime
Berries
Strawberry
Rasberry
Blueberry
Coconut
Honey fig
Grape
Spices
Cinnamon
Vanilla
Clove
Pumpkin spice
Tobacco
Classic tobacco
Bold tobacco
Turkish tobacco
Mild tobacco
Exotic tobacco
Full flavor
Pipe
Havana
Camel
Kool
Marlboro
Virginia Slim
King BA, Tynan MA, Dube SR, Arrozola R. Flavored-little-cigar and flavored-cigarette use among US middle and high school students. J Adolescent Health 2014: 54(1); 40-46.
Villanti AC, Richardson A, Vallone DM, Rath JM. Flavored tobacco product use among US young adults. Am J Prev Med. 2013; 44: 388 –391.
Robert K. Jackler, MD
Sewall Professor, Stanford University School of Medicine
Stanford Research Into the Impact of Tobacco Advertising
SRITA Link to images Comment Tracking Number: 1jy-8c4r-ank1
Prohibited Health Claims in Backdoor Online Channels
Most eCig advertising involves new media channels such as web sites, online video, blogs, wikis, and a heavy presence on social media (Facebook, Tumblr, Twitter, etc.). Brand web sites may avoid obvious therapeutic claims, but commentary within the site in the form of customer testimonials, forums, blogs, and wikis often make overt health claims. (see accompanying Powerpoint) Industry sponsored blogs and forums are rife with testimonials touting the wonderful attributes of e-cigarettes. Other supposedly independent and unbiased claims appear in online vaping vendor websites, e-cigarette review sites, and are undoubtedly offered by sales people in brick and mortar vapor stores. Brands should be held accountable for unfounded health claims embedded in their website in any form. In addition, forensic investigation may reveal linkage of other, supposedly independent website claims with the brand’s marketing department.
Cobb NK, Brookover J, Cobb CO . Forensic analysis of online marketing for electronic nicotine delivery systems. Tob Control. 2013 Sep 13. doi: 10.1136/tobaccocontrol-2013-051185
Robert K. Jackler, MD
Sewall Professor, Stanford University School of Medicine
Stanford Research Into the Impact of Tobacco Advertising
Comment Tracking Number: 1jy-8c4r-9kgs
Sponsorships
Resuming a practice banned for tobacco products by the 1998 Master Settlement Agreement, e-cigarette brands have become sponsors for music festivals (Blu, Veppo), auto and motorcycle racing (Blu, Green Smoke, Mistic, E-Lites), football (Fin Go Daddy Bowl), poker tournaments (e-Swisher World Series of Poker), basketball (V4L) and soccer (Kimree, Totally Wicked). (See accompanying Powerpoint) For the past four years, e-cigarettes have even been given out at the Oscars in their “swag bags” (Krave-2010, Blu-2011, Vapor Trim 2012, V2 and Vapor Couture -2012, and NJOY -2013). Electronic cigarettes should be held to the same standard as combustible cigarettes with sponsorships not allowed.
SRITA Link to images Comment Tracking Number: 1jy-8c4r-8yqz
Sampling
The 1998 Master Settlement agreement prohibited sampling of cigarettes except in places with only adults could be present. Distribution of free sample of nicotine containing electronic cigarettes is common at fairs, race tracks, on college campuses, and even on street corners. Samples are given out by attractive young men and women, sometimes offering cookies and other inducements. (see accompanying powerpoint) According to Bloomberg, Victory Electronic Cigarettes Corp. planned to hand out 1 million e-cigarettes in late 2013 at events in 50 U.S. cities. As adopted for cigarettes in 1998, public sampling in locations where underage youths may be present should not be allowed.
Edney A. E-Cigarette Marketing Seen Threatened by FDA Scrutiny. Bloomberg. Oct 15, 2013. http://www.bloomberg.com/news/2013-10-16/e-cigarette-marketing-seen-threatened-by-fda-scrutiny.html. Accessed January 4,2014.
Robert K. Jackler, MD
Sewall Professor, Stanford University School of Medicine
Stanford Research Into the Impact of Tobacco Advertising
SRITA Link to images Comment Tracking Number: 1jy-8c4s-729u
Unsupported health claims in electronic cigarette advertising
Assertions of healthfulness have been prohibited for cigarette advertisements by a series of regulatory actions over the last 80+ years. Current electronic cigarette advertisements routinely make health claims (see attached Powerpoint).
Medicinal effects (banned early 1930s through1940s)
Weight loss
Energy booster
Sleep aid
Nourishing
Aphrodisiac
Overt Health Claims (banned 1955 by the FTC)
Reduced harm, safer
Images of doctors & nurses
Images of medical symbols (stethoscopes, chest x-rays, etc)
Improves longevity, Long life
Improves breathing
No cancer
No toxins
Proxy Health Claims (banned 2009)
More intelligent, smarter, wiser.
Mild, low, low, ultralight, superlight, super, ultra
Pure, fresh
Robert K. Jackler, MD
Sewall Professor, Stanford University School of Medicine
Stanford Research Into the Impact of Tobacco Advertising
SRITA Link to images Comment Tracking Number: 1jy-8c4s-k9w3
Celebrity Endorsements
Endorsement of cigarettes by movie stars, musicians, and sports heroes was banned in 1964 by the Cigarette Advertising code. (see accompanying Powerpoint) Many electronic cigarette brands use celebrity endorsers including Blu’s use of rock star Courtney Love and action movie star Steven Dorff. For the past four years, e-cigarettes have even been given out at the Oscars in their “swag bags” (Krave-2010, Blu-2011, Vapor Trim 2012, V2 and Vapor Couture -2012, and NJOY -2013). Even the image of dead celebrities have been exploited for eCig marketing purposes including Marilyn Monroe, John Lennon, James Dean, and even Benjamin Franklin. The FDA celebrity endorsement policy should align with that held for cigarettes for a half a century.
Robert K. Jackler, MD
Sewall Professor, Stanford University School of Medicine
Stanford Research Into the Impact of Tobacco Advertising
SRITA Link to images Comment Tracking Number: 1jy-8c4s-k9w3
Electronic cigarettes advertisements which imply lack of second hand effect.
Electronic cigarette brands include images of children accompanied by parents exhaling vapor near them or even at them. (see attached powerpoint) The most outrageous show a mother exhaling a plume of vapor over a baby carriage. In another, a father toast’s his son’s juice cup with a beer while holding a eci in his other hand. Other ads recommend eCigs as a Mother’s or Father’s Day gift. As eCigs put nicotine and other chemical in the air, clearly advertisements which imply lack of a second hand effect should d not be allowed.
Robert K. Jackler, MD
Sewall Professor, Stanford University School of Medicine
Stanford Research Into the Impact of Tobacco Advertising
SRITA Link to images Comment Tracking Number: 1jy-8c4s-szat
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