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TC Online First, published on June 2, 2016 as 10.1136/tobaccocontrol-2015-052656
Research paper

Packaging colour research by tobacco companies:


the pack as a product characteristic
Lauren K Lempert,1 Stanton Glantz1,2

▸ Additional material is ABSTRACT associated them with specific package colours to


published online only. To view Background Tobacco companies use colour on make the same misleading claims about reduced
please visit the journal online
(http://dx.doi.org/10.1136/
cigarette packaging and labelling to communicate brand risks without using words.10 13 14 16–24 To address
tobaccocontrol-2015-052656). imagery, diminish health concerns, and as a replacement this practice, the WHO Framework Convention on
1 for prohibited descriptive words (‘light’ and ‘mild’) to Tobacco Control (FCTC) commits signatories to
Center for Tobacco Control
Research and Education, Philip make misleading claims about reduced risks. implement national laws that ensure that tobacco
R Lee Institute for Health Policy Methods We analysed previously secret tobacco product packaging and labelling do not promote
Studies, Helen Diller Family industry documents to identify additional ways in which tobacco products by any means that are false or
Comprehensive Cancer Center, cigarette companies tested and manipulated pack misleading25 and recommends standardised pack-
San Francisco, California, USA
2
Department of Medicine,
colours to affect consumers’ perceptions of the aging.26 Companies understand that pack struc-
University of California cigarettes’ flavour and strength. tures, shapes, openings, descriptors and colours
San Francisco, San Francisco, Results Cigarette companies’ approach to package communicate brand imagery and influence percep-
California, USA design is based on ‘sensation transference’ in which tions of product quality, strength and taste.27
consumers transfer sensations they derive from the In 1954, psychologist and marketing pioneer
Correspondence to
Professor Stanton A Glantz, packaging to the product itself. Companies manipulate Cheskin28 described using scientific testing to
Center for Tobacco Control consumers’ perceptions of the taste and strength of analyse the impact of colour on consumers’ pur-
Research and Education, Suite cigarettes by changing the colour of the packaging. For chasing choices and explained how colour could be
366 Library, 530 Parnassus, example, even without changes to the tobacco blends, used to design effective packaging. Tobacco com-
University of California
San Francisco, San Francisco, flavourings or additives, consumers perceive the taste of panies followed the work of Cheskin and his Color
CA 94143-1390, USA; cigarettes in packages with red and darker colours to be Research Institute (CRI) on consumers’ emotional
glantz@medicine.ucsf.edu fuller flavoured and stronger, and cigarettes in packs responses to packages and the impact that package
with more white and lighter colours are perceived to colour had on their perceptions of how the
Received 31 August 2015
Accepted 8 May 2016
taste lighter and be less harmful. product inside the package tasted. Cheskin revealed
Conclusions Companies use pack colours to that on an unconscious level ‘people transferred
manipulate consumers’ perceptions of the taste, strength sensations of color and design to sensations of
and health impacts of the cigarettes inside the packs, taste’, which he called ‘sensation transference’.28
thereby altering their characteristics and effectively He demonstrated that consumers transfer sensa-
creating new products. In countries that do not require tions or impressions they have about packaging to
standardised packaging, regulators should consider the product itself; indeed, consumers do not distin-
colour equivalently to other changes in cigarette guish between the package and the product.28
characteristics (eg, physical characteristics, ingredients, The existing literature focuses on how colour is
additives and flavourings) when making determinations used in package design to ‘communicate informa-
about whether or not to permit new products on the tion’ such as product identification and brand
market. imagery (eg, the red chevron shouts ‘Marlboro’),
targeted groups (eg, pastels say ‘women’s cigar-
ettes’) or reduced health risks (eg, silver whispers
INTRODUCTION ‘ultra-light’ cigarettes). Since Wakefield’s 2002
Tobacco companies have long understood that pack study,1 more than 6 million documents have been
colours influence consumers’ purchasing decisions. added to the Truth Tobacco Industry Documents
On reviewing previously secret internal industry library that match her search terms, and more than
documents available at the time, Wakefield et al 200 000 more documents have been added using
demonstrated that tobacco companies use pack narrower search terms that focus on taste. Building
design to communicate brand imagery and influ- on Wakefield’s work, we show how the industry
ence consumers’ perceptions of taste, strength and relied on Cheskin’s work to use pack designs and
harm as an important element in their overall mar- colours not only to communicate marketing infor-
keting strategies.1 Subsequent studies showed that mation, but also to influence consumers’ experi-
companies use pack colours to play an important ences of smoking the cigarettes themselves by
role in communicating brand imagery and product altering their perceptions of the cigarettes’ taste.
characteristics,2 to target specific groups3–6 and to This understanding distinguishes between using
diminish health concerns,1 7 sometimes developing pack colours to communicate information about a
To cite: Lempert LK, pack and promotional concepts before product brand or sub-brand that might be associated with a
Glantz S. Tob Control
Published Online First:
development.8 Cigarettes from packs with brand particular taste versus using pack colours to
[please include Day Month descriptors including ‘light’, ‘low’, ‘mild’, ‘smooth’, manipulate consumer perceptions of the cigarette’s
Year] doi:10.1136/ ‘silver’ and ‘gold’ are perceived as having lower taste.
tobaccocontrol-2015- health risks.9–14 Before descriptors such as ‘light’ As of March 2016, 180 countries had become
052656 and ‘mild’ were prohibited,15 the companies Parties to the WHO FCTC, which calls for tobacco

Lempert LK, Glantz S. Tob Control 2016;0:1–9. doi:10.1136/tobaccocontrol-2015-052656 1


Copyright Article author (or their employer) 2016. Produced by BMJ Publishing Group Ltd under licence.
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Research paper

product regulation (including packaging), and the USA enacted container; it … generates expectations and people generally get
the Family Smoking Prevention and Tobacco Control Act what they expect. In repeated tests, consumers will declare one
(FSPTCA). Since pack colours alter smokers’ experience of the product superior to another although only the packages or labels
cigarettes’ taste and strength, one can argue that pack colour [not the cigarettes] are different [emphasis added].”37 The
changes are tantamount to product changes, which could have manual states that designing an effective new package is import-
implications for laws regulating the introduction of new tobacco ant not only because it could be “the major factor in a new mar-
products. keting strategy by significantly improving consumer perceptions
of the total product,” but also because “a package change can
METHODS create a ‘new’ product” by giving customers the existing product
Between January 2013 and December 2014, we analysed previ- in a new form (emphasis added).37
ously secret tobacco company documents available at the
UCSF Truth Tobacco Documents Library (TTDL, https:// Company research demonstrating that altering pack colour
industrydocuments.library.ucsf.edu/tobacco/) on the industry’s changes perceptions of cigarettes’ characteristics
internal research on how cigarette package colours influence Building on Cheskin’s work and sensation transference, as early
consumers’ perceptions of the cigarettes inside the package, in as the 1950s the companies used ocular measurements (eye
particular the cigarettes’ taste. We used standard snowball search movements),30 tachistoscopic testing (consumers’ recall time
techniques,29 beginning with the search terms ‘(flavor OR after flashing a picture of the package)46 and repertory grid
flavour) AND (color OR colour)’ (106 169 documents), ‘taste techniques (colour’s influence on consumers’ assessment of the
AND (color OR colour)’ (98 460), ‘taste perception AND products’ sensory properties)41 alongside traditional market
pack*’ (3384), ‘(color OR colour) and “taste perception” and surveys to determine how cigarette pack colours not only
pack’ (1110), ‘(color OR colour) code’ (3654), ‘sensory science’ enhanced the visual prominence of their brands and supported
(181) and ‘sensation transference’ (11); additional documents brand imagery, but also influenced consumers’ experience of
were found by reviewing adjacent documents (Bates numbers). smoking the cigarettes. Table 1 compiles internal industry
We narrowed our initial searches to documents detailing the research documents focusing on the impact that cigarette pack
companies’ market research and scientific literature reviews con- colours have on particular perceptions of the taste of the cigar-
cerning the use of colour in package design to influence consu- ettes inside the pack. These documents generally show that con-
mers’ perceptions of the cigarettes’ taste and other sensory sumer perceptions of full, rich or strong flavoured cigarettes are
experiences. We reviewed ∼400 documents; this paper is based associated with red and dark colours such as brown or black,
on 54 documents showing what the tobacco companies whereas consumer perceptions of mild, smooth and mellow fla-
researched and understood about pack colours’ influence on vours are associated with light colours such as light blue or
consumers’ perceptions of cigarettes’ taste. silver. Menthol and ‘cool’ or ‘fresh’ are universally associated
with green, and low strength is associated with white or very
RESULTS light shades. Even subtle changes in colour tones, such as using
Sensation transference: the package is the product a lighter beige background, can have these effects.
Since the 1950s, tobacco companies conducted extensive social
science and psychology research to better understand how Taste and strength
package colour affects consumers’ perceptions of the cigarettes Particular pack colours led consumers to perceive the cigarettes
inside the packs.28 30–35 Companies including Philip Morris had what companies considered ‘good’ and ‘bad’ attributes,
(PM),36 RJ Reynolds (RJR),33 37 Lorillard,38 39 Brown and including full or enhanced flavour, rich tobacco taste, strong
Williamson (B&W)40 and British American Tobacco (BAT)41 taste, good aftertaste, taste like Marlboro, smooth, satisfying,
incorporated Cheskin’s theory of ‘sensation transference’28 in mild, mellow, low strength, artificial taste, cool, fresh or
their market research and package design testing and worked to menthol flavoured. Since pack colours influence consumers’ per-
design cigarette packages that would affect their customers’ sen- ceptions of the cigarettes’ taste and strength, selecting or chan-
sations and perceptions of the taste of the cigarettes inside the ging package colours was seen not only as part of brand and
packs. image development, but also as part of ‘product development’,
PM hired Cheskin and CRI to help redesign its Marlboro similar to selecting the cigarettes’ physical ingredients (table 1).
pack in the 1950s.42 43 CRI conducted psychological studies on In the 1960s, Louis Cheskin Associates conducted ‘association
how colour could inform pack design, resulting in the new tests’ with 1800 cigarette smokers to help PM determine which
Marlboro flip-top pack with its distinctive chevron design, red of three proposed pack colour combinations would most effect-
colour and brand name lettering.42 PM spent 7 years engaged in ively create ‘favourable associations’ (eg, ‘high quality tobacco’,
‘an extraordinary degree of calculation, thoughtful planning and ‘rich tobacco flavour’, ‘mild’ and ‘low-tar and nicotine’) and be
scientific testing’ on the new Marlboro packaging, refuting the less likely to create ‘unfavourable associations’ (eg, ‘low quality
industry cliché that ‘no one smokes the package’.44 By adding tobacco’, ‘little tobacco flavour’, ‘strong’ and ‘high tar and nico-
red to the mostly white package, PM converted Marlboro from tine’).31 These associations were based on the packages alone;
a ‘woman’s cigarette’ to a new brand that was ‘high quality’ and the respondents never smoked the cigarettes. Packages with
‘full flavor’,42 43 with Marlboro’s new ‘macho’ image further certain colour and label combinations (eg, brown pack with a
developed by Leo Burnett’s ‘Marlboro Man’ advertising brown label) were more effective than others (eg, brown
campaign.45 package with red-brown label) at leading consumers to believe
RJR’s ‘Brand Marketing Training Module’ emphasises how that the cigarettes inside the pack had ‘rich tobacco flavour’,
package changes are tantamount to changes in the physical ‘high quality tobacco’ and ‘low-tar and nicotine’.31
product itself: “Your primary concern is consumers’ reaction to RJR studied how package colour influences consumers’ per-
and perceptions of the product inside the package, not their judg- ceptions of cigarette taste and strength when it began research-
ment as to which is the most attractive package [emphasis ing a new package for Camel Filters in 1975. They aimed to
added].”37 Moreover, “a package is much more than a develop a contemporary package that would appeal to young
2 Lempert LK, Glantz S. Tob Control 2016;0:1–9. doi:10.1136/tobaccocontrol-2015-052656
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Research paper

men while retaining the cigarette’s flavour quality perception.


Table 1 Summary of industry research on effects of package
RJR contracted Data Development Corporation to conduct a
colour on smoker perceptions of the flavour and taste of cigarettes
package study to test consumers’ perceptions of the product’s
in the package
taste attributes (as well as brand imagery).70–72 Study respon-
Consumer perceptions Colour Company Year dents first rated how they perceived the cigarettes would taste
based only on seeing four different test packages, and next rated
Full flavour Red PM 1950s43
RJR 200147
the cigarettes’ taste ‘attributes’ after smoking cigarettes from
RJR 199148
one of the test packs.70–72 The study found no significant differ-
RJR 198749 ences in how consumers perceived the cigarettes’ characteristics
BAT 198650 after smoking them and concluded that the risk of adopting any
RJR 198451 of the proposed alternative packs would outweigh the potential
RJR 198452 gains of younger imagery: ‘“Younger” imagery seems to be
RJR 1980s37 increasing at the expense of some [ perceived] flavor quality of
Brown PM 196531 the cigarette. The current pack is seen more than the others as
Rich tobacco taste, flavourful Red PM 199953 denoting a cigarette for people who are looking for flavor
PM 198154 [emphasis added]’.70
RJR 198451 In 1979, RJR began testing revised Camel Filters packaging.
RJR 197955 RJR sought to reduce consumers’ perception that Camel Filters
Blue B&W 197856–58 were stronger than most other cigarettes while at the same time
B&W 197740 maintain desired product perceptions (taste, satisfaction, ‘tar’
PM 199959 and nicotine, smoothness) and brand attributes (masculine,
PM 199860–62 young adult, rugged).68 73 Test respondents viewed package pro-
Beige RJR 198763
totypes and measured their perceptions of the product’s
RJR 198664
strength, harshness, taste, quality, smoothness, ‘satisfaction’ and
RJR 198665
tar perception, in addition to measuring the pack’s visual prom-
RJR 198466
inence.68 The tests revealed that small pack refinements such as
B&W 199467
increasing white space, reducing the red band and lightening
Satisfying Red PM 199953
RJR 198451
brown colour tones could influence how consumers perceived
Blue B&W 197858
cigarette strength (figure 1).68
Beige RJR 198763 Although Marlboro Ultra Lights were not actually marketed
RJR 198664 until the late 1990s, in 1981 PM conducted internal consumer
RJR 198665 taste preference studies in which smokers tested identical
Strong taste Black RJR 198451 Marlboro Ultra Lights cigarettes in a blue pack versus a red
Brown RJR 197968 pack.54 Marlboro smokers generally preferred the cigarettes in
B&W 199467 the red package and perceived the cigarettes in the red pack to
Red PM 198154 have more taste than those in the blue pack. Some found cigar-
RJR 198749 ettes in the blue package ‘too mild’ or ‘not easy drawing’, while
RJR 198452 others perceived the cigarettes in the red pack as ‘too strong’ or
RJR 197968 ‘harsher’ than those in the blue pack.54
Tastes like Marlboro Red RJR 198452 In 1984, RJR launched ‘Project XG’ to create a product that
Enhances flavour Red RJR 200147 would replace Marlboro as the most relevant brand among
Green RJR 200147 younger adult smokers….74 RJR recognised that to achieve this
Good aftertaste Silver B&W 197858 goal they needed to use package colours and design and ‘non-
Smooth Blue B&W 197858
menthol taste cues’ to improve consumers’ perceptions of XG’s
Artificial taste Gray RJR 198664
product attributes, resulting in more smoothness, more strength,
Low strength White, lighter shades RJR 197968
more tobacco taste, less harshness and “a positive taste benefit
Mild Blue PM 199959
similar to Marlboro but smoother…” (table 1).51
PM 199860–62
PM 198154
Silver B&W 197858
Maintaining full flavour in reduced tar cigarettes
Gray RJR 198664
Beginning in the 1970s, tobacco companies sought to create and
Mellow Blue B&W 197858
Menthol Green RJR 200147
market products that reportedly had reduced tar to address con-
RJR 199148
sumers’ health concerns while still delivering ‘full flavour’ that
RJR 198749
met consumers’ taste preferences.40 67 68 73 75–77
RJR 198769 In 1977, responding to growing consumer health concerns
BAT 198650 and consistent with broader industry marketing practices, B&W
RJR 198451 began testing pack designs for a new Viceroy low-tar cigarette
RJR 1980s37 and examined how changes in package colours could lead con-
Cool Green RJR 200147 sumers to believe that the cigarettes inside were low-tar and full
RJR 198749 taste.40 B&W faced the problem that perceptions of tar level
Fresh Green RJR 200147 and taste are not independent; low-tar is associated with weak
Silver B&W 197858 taste and high-tar is associated with full taste. Researchers
sought a pack design that would receive the same taste ratings

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Research paper

Figure 1 Details of proposed


refinements in a 1979 new package
design for Camel Filters, consisting
mainly of increasing the amount of
white space, reducing the red band
and lightening the brown colour tones
to reduce consumers’ perceptions of
the cigarettes’ strength.68

as, but lower tar ratings than, Marlboro Lights.40 After initially designs could mitigate high tar perceptions from dark colours
finding variations in pack design produced only minor changes but maintain positive taste perceptions), effectively contributing
in the taste/tar perception,39 B&W researchers recommended to product development.55
using a royal blue pack to make a clear statement about ‘taste’ RJR’s changes in Camel pack designs from 1930 to 2005
and ‘impact’ and letting advertising pull down the perceived tar (figure 2, top) illustrate that they used pack colours to influence
level (table 1).56 consumers’ perceptions of the cigarettes’ taste. In 1930, Camel
To verify that the proposed package design for the new packs used a dark tan background above and below the camel, a
low-tar cigarette supported the desired product perceptions, dark brown camel and dark lettering.79 In 1961, the dark back-
B&W tested Viceroy Rich Lights in royal blue versus silver ground was removed above the camel and lightened below the
packs in 1978.57 After participants smoked cigarettes from royal camel, and the camel colour was lightened.80 In 1972, all of the
blue and silver packs that, unbeknownst to them, contained background was white, the lettering was lightened and the tab
identical cigarettes, they rated the cigarettes from each pack on was changed from dark blue to white for its ‘low tar Camel
different attributes.78 B&W analysed respondents’ taste percep- taste’.81 In 1990, the dark pyramid was removed, and the letter-
tions and concluded, “The blue pack outscored the silver pack ing was further lightened for ‘extra mild Camel taste’.82 In
on satisfaction, full taste, tobacco taste. The silver pack achieved 2005, the tan trees were removed, the camel was made lighter,
higher score for aftertaste, mildness, smoothness, mellowness, and the pyramid was silver for ‘extra smooth and mellow’ taste
freshness”.58 The test also showed that the silver pack was per- and ‘ultra-lights’ cigarettes.83
ceived as ‘low-tar’ cigarettes and ‘for women’, while the blue In 2010, shortly after FSPTCA’s enactment, RJR introduced the
pack was perceived as ‘average-tar’ and ‘for men’ (table 1).58 Camel ‘Break Free Adventure’ campaign84 aimed at young adults
In 1979, RJR began ‘Project BY’, an effort to enter the non- and hipsters. Since FSPTCA forbade the use of terms such as
menthol, full-flavour, low-tar (‘FFLT’) market category, and ‘light’ and ‘mild’ seen in the 1972 and 1990 packs, the 2010 pack
conducted a study to inform new BY packaging alternatives, used the identifier ‘Blue’ and a white background to connote
aiming to appeal to its target market of FFLT male smokers ‘light’, but also used colours, themes and geographic refer-
aged 25–34.55 In addition to examining the overall appeal and ences that appeal to their target young consumers. In 2014,
user imagery associated with alternative packages, the study RJR re-introduced Camel Crush, a novel tobacco product con-
assessed how changes in pack design affected consumers’ taining a capsule with menthol-flavoured liquid (subsequently
‘product perceptions’ including ‘satisfaction’, ‘taste’, ‘tar and pulled from the market by the Food and Drug Administration
nicotine’ and ‘smoothness’.55 RJR’s study based on viewing (not (FDA) in 2015). Camel Crush packs85 used the same concepts
smoking) 27 proposed packs including variations on names, that Cheskin highlighted in the 1950s, with ‘bold tasting’ pro-
colours and designs concluded that these elements work ducts using black and red packs and ‘menthol fresh’ products
together to create product perceptions (eg, wedge and diagonal using white and green packs (figure 2, bottom).
4 Lempert LK, Glantz S. Tob Control 2016;0:1–9. doi:10.1136/tobaccocontrol-2015-052656
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Research paper

Figure 2 Top: Examples of changes in Camel pack designs from 1930 through 2005, illustrating how RJR changed pack colours in ways that the
research presented in this paper indicate would affect consumers’ perceptions of the cigarettes’ taste, with progressively lighter colours and more
white conveying ‘low tar’ taste, ‘extra mild’ taste and ‘extra smooth and mellow’ taste.79–83 Bottom: Examples of Camel pack designs after
enactment of the US Family Smoking Prevention and Tobacco Control Act in 2009, including a 2010 pack84 from RJR’s ‘Break Free Adventure’ that
uses the word ‘Blue’ in lieu of the newly forbidden identifiers ‘low’, ‘light’ or ‘mild’, and Camel Crush packs85 that use black and red colours for
‘bold taste’ and green and white colours for ‘menthol fresh’ taste.

Attractiveness were shown cigarette packs with design variations (including


The companies found that they could manipulate package changes in colours, lettering, dominant design shapes elements
colours to make the cigarettes inside more attractive to consu- and motifs or crests)41 and asked what associations the pack
mers by influencing perceptions that the cigarettes are higher appearance created, what type of smoking experience they
quality, more prestigious or upscale, convey trust or responsibil- would expect from the cigarettes inside those packs and the
ity, are more exciting or relaxing or are especially appealing to general personality of people they would expect to smoke those
men, women or young people (table 1). For example, in the cigarettes.86 Interviewers elicited sets of descriptive terms (‘con-
1970s BAT began using the repertory grid technique to quantify structs’) and created lists of opposite terms (‘binary grids’) to
how important brand image variables, including colour, are to describe the ‘smoke character’ (figure 3) (as well as other attri-
individuals’ assessments of cigarettes’ sensory properties.86 butes) associated with each pack,70 86 and BAT hoped that this
Based on psychologist George Kelly’s theory that individuals initial study would demonstrate how the repertory grid tech-
develop personal ‘constructs’ (basic terms expressed as contrasts nique could quantify consumers’ subjective perceptions of cigar-
between two ideas) to describe their experience, respondents ette characteristics.

Figure 3 Binary grid used by British


American Tobacco researchers in 1978
to describe consumers’ perceptions of
the ‘smoke character’ associated with
cigarette packs.86

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Research paper

DISCUSSION Packaging and labelling colour should be treated as tobacco


As early as the 1950s, tobacco companies developed a sophisti- product ingredients
cated understanding that by changing pack colours they could The FSPTCA requires companies to obtain authorisation from
not only alter brand appeal and make misleading health FDA before introducing new tobacco products into the
claims,1 9 11–13 27 87 88 but could also change consumers’ per- market, and products with different characteristics (including
ceptions of the taste, strength and other sensory attributes of changed ingredients and designs) will not be authorised unless
the cigarettes inside the packages without changing the physical it is demonstrated that the changes would be appropriate for
ingredients of the cigarettes themselves. The companies use the protection of public health.94 The industry documents
pack colours to alter the characteristics of the products, just as summarised here demonstrate that tobacco companies rou-
they use tobacco blends, flavourings and additives to change the tinely change colours in cigarette packaging and labelling not
products’ physical characteristics to manipulate consumers’ per- merely to communicate information about the product, but
ceptions of the cigarettes’ flavour and taste. They design also to change consumers’ perceptions of the product’s taste
packages that create the ideal balance between ‘low-tar’ and and strength, thereby changing the product’s ingredients and
‘full-flavour’ attributes. For example, the companies understand effectively creating a ‘new product’. Since these design changes
that by merely increasing the use of red on packs, consumers do not involve words, they allow tobacco companies to evade
perceive the cigarettes inside to have fuller, stronger, richer laws and regulations designed to prevent the companies from
tobacco taste,37 47–51 53 68 and by lightening the pack’s colour manipulating consumers. Indeed, package design experts wrote
palette or increasing the amount of white, companies can in 1995 that colour is a potent tool because it is “beyond the
reduce perceptions of the cigarette’s strength without changing law. Words can be regulated, and so can pictures, but color
the cigarette’s formula.48–51 63–66 68 Importantly, RJR’s manual cannot.”34
stated that beyond marketing, designing new packages was FDA initially stated that it would consider tobacco product
important because “a package change can create a ‘new’ labels and packaging as ‘part’ of the product in its premarket
product” by giving customers the existing product in a new reviews,95 but then retreated from this position96 97 after indus-
form (emphasis added).37 try pressure and lawsuits.98 99 FDA’s original position was
appropriate and consistent with industry understanding and
Implications for tobacco product regulation practices, and it should be followed (see online supplementary
The FCTC89 (to which USA is not a party) and FSPTCA90 text). Likewise, other countries should treat products with pack-
regulate new tobacco product introductions, ingredients disclo- aging changes as new products when implementing FCTC
sures and packaging and labelling. The Guidelines for Article 11.25 26
Implementation of FCTC Articles 9 ( product content regula-
tion) and 10 ( product disclosures regulation) recommend that
Implications for standardised packaging
Parties prohibit or restrict ingredients that may be used to
Australia became the first country to mandate standardised pack-
increase the attractiveness of tobacco products, that have
aging along with product standarisation in December 2012,100
certain colouring properties that make the products more
and in 2015 Ireland101 and the UK102 passed similar laws. In
appealing or create the impression that they have a health
December 2015, France passed a standardised packaging law,103
benefit.91 The Guidelines for Implementation of Article 11
in March 2016, Canada announced plans to adopt standardised
( packaging and labelling) seek to counter established industry
packaging104 and Finland, Norway, Sweden and New Zealand
tactics for circumventing tobacco packaging and labelling regu-
were expected to follow suit, with the European Union as a
lation and urge Parties to consider adopting standardised pack-
whole also considering the measure.105
aging measures to prevent the industry from continuing to use
Before Australia’s law was implemented, several papers sug-
packaging and labelling to mislead consumers and promote its
gested that standardised packaging may help reduce mispercep-
products.26
tions of risk communicated through pack design3 4 6 7 9 11 16 88
Our findings provide evidence of how tobacco companies
and help promote cessation, especially among youth.87 106 107
adjust pack designs and colours to manipulate consumers by
Standardised packaging may reduce smoking in current smokers
altering their perceptions of the products inside the packs and
by making the packs less appealing,108 109 by producing less
to create the impression that some cigarettes are less harmful
craving and motivation to seek tobacco110 111and by increasing
than others. This evidence can be used to support adoption of
attention to health warnings.112 113 Since the introduction of
measures to prevent companies from using packaging to deceive
standardised packaging in Australia, evidence among adult
consumers and to regulate the introduction and marketing of
smokers suggests that plain packaging has achieved its specific
new tobacco products. In particular, these findings and the
objectives and reduced the appeal of tobacco products,
accompanying legal analysis (see online supplementary text)
increased the effectiveness of health warnings, helped reduce
support mandatory reporting of package designs along with the
the extent to which smokers are misled about the harms of
mandatory reporting of physical product contents, because
smoking114 115 and reduced the ability of the pack to appeal to
package designs influence consumers’ perceptions of the cigar-
young people.116 The industry documents reviewed in this
ettes’ taste as do physical tobacco constituents (eg, additives and
paper can be used to support standardised packaging by con-
flavourings) that would be required to be disclosed under such
firming that companies use the colours on packaging to manipu-
reporting laws. For example, under Canada’s tobacco reporting
late and impact consumers’ perceptions about taste, strength
regulations, manufacturers and importers must provide Health
and relative risk of the cigarettes inside the pack.
Canada with annual reports that include tobacco product ingre-
dients, toxic constituents, toxic emissions as well as information
on product packaging.92 93 Our findings support regulations CONCLUSION
that would specifically mandate the reporting of colour changes Tobacco companies use cigarette pack colours to manipulate not
in packaging reports and would support adoption of similar only consumers’ brand choices and perceptions of harm, but
measures by other countries. also smokers’ experiences of the taste and strength of the
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Research paper

cigarettes inside the pack to effectively create new products, just 10 Hammond D, Parkinson C. The impact of cigarette package design on perceptions
as they would by making changes to the cigarette’s ingredients of risk. J Public Health (Oxf ) 2009;31:345–53.
11 Bansal-Travers M, Hammond D, Smith P, et al. The impact of cigarette pack
or physical properties. Since changes in packaging colours influ- design, descriptors, and warning labels on risk perception in the US. Am J Prev
ence consumers’ perceptions and experiences of smoking the Med 2011;40:674–82.
cigarettes, including leading consumers to believe that the pro- 12 Mutti S, Hammond D, Borland R, et al. Beyond light and mild: cigarette brand
ducts taste better, these package changes effectively create new descriptors and perceptions of risk in the International Tobacco Control (ITC) Four
Country Survey. Addiction 2011;106:1166–75.
tobacco products. In countries that do not require standardised
13 Yong HH, Borland R, Cummings KM, et al. Impact of the removal of misleading
packaging, regulators should recognise this reality and consider terms on cigarette pack on smokers’ beliefs about ‘light/mild’ cigarettes:
colour equivalently to other changes in cigarette characteristics cross-country comparisons. Addiction 2011;106:2204–13.
(eg, ingredients, additives and flavourings) when determining 14 Bansal-Travers M, O’Connor R, Fix BV, et al. What do cigarette pack colors
whether to permit new products on the market. communicate to smokers in the U.S.? Am J Prev Med 2011;40:683–9.
15 Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, Section
911 (2009).
16 Peace J, Wilson N, Hoek J, et al. Survey of descriptors on cigarette packs: still
What this paper adds misleading consumers? N Z Med J 2009;122:90–6.
17 King B, Borland R, Abdul-Salaam S, et al. Divergence between strength indicators
in packaging and cigarette engineering a case study of Marlboro varieties in
▸ Cigarette pack colours are used not only to manipulate Australia and the USA. Tob Control 2010;19:398–402.
18 Altria Sales & Distribution. Retailer brochure: introducing new packaging on many
consumers’ brand choices and perceptions of harm, but also Philip Morris USA (PM USA) brands. 2010. Philip Morris. https://
to change smokers’ perceptions of the taste and strength of industrydocuments.library.ucsf.edu/tobacco/docs/fgmf0217 (accessed 20 Apr
the cigarettes inside the pack without changing the 2015).
cigarettes themselves. 19 Connolly GN, Alpert HR. Has the tobacco industry evaded the FDA’s ban on
‘Light’ cigarette descriptors? Tob Control 2014;23:140–5.
▸ When tobacco companies change pack colours, they 20 [Author unknown]. New packaging guide. 2010. Philip Morris. http://legacy.library.
effectively create new tobacco products, just as when they ucsf.edu/tid/xjn30i00 (accessed 11 Jan 2013).
make changes to the cigarettes’ ingredients, additives or 21 Sarmento J. FW: Packaging changes. 17 Jun 2010. Philip Morris. http://legacy.
flavourings; all new tobacco products should be subject to library.ucsf.edu/tid/xwr30i00 (accessed 22 Jan 2013).
equivalently rigorous new tobacco product review. 22 Pugh K. FDA pack identifiers. 28 Jan 2010. Philip Morris. http://legacy.library.ucsf.
edu/tid/cjl30i00 (accessed 22 Jan 2013).
23 Wilson D. Coded to obey law, Lights become Marlboro Gold. 2010. http://www.
nytimes.com/2010/02/19/business/19smoke.html?_r=0 (accessed 10 Apr 2015).
24 Wilson D. FDA seeks explanation of Marlboro Marketing. 2010. http://www.
Acknowledgements The authors thank Janet Hoek and Lucy Popova for providing nytimes.com/2010/06/18/health/18tobacco.html?_r=0 (accessed 10 Apr 2015).
valuable feedback on the manuscript. 25 World Health Organization. WHO Framework Convention on Tobacco Control,
Contributors LKL collected the data and prepared the first draft of the paper. LKL Article 11. 2005. http://www.who.int/fctc/text_download/en/ (accessed 01 Apr
and SG collaborated to prepare the final manuscript. 2015).
26 World Health Organization. Guidelines for implementation of Article 11 of the
Funding This work was funded by National Cancer Institute grants CA-087472 and WHO Framework Convention on Tobacco Control ( packaging and labelling of
1P50CA180890 from the National Cancer Institute and Food and Drug tobacco products). 2008. http://www.who.int/fctc/guidelines/adopted/article_11/en/
Administration Center for Tobacco Products. The content is solely the responsibility (accessed 8 Apr 2015).
of the authors and does not necessarily represent the official views of the National 27 Kotnowski K, Hammond D. The impact of cigarette pack shape, size and opening:
Institutes of Health or the US FDA. The funding agencies played no role in the evidence from tobacco company documents. Addiction 2013;108:1658–68.
conduct of the research or preparation of the manuscript. 28 Cheskin L. Color guide for marketing media. 1954. Brown & Williamson. http://
Competing interests None declared. legacy.library.ucsf.edu/tid/yjb14f00 (accessed 20 Dec 2012).
29 Anderson SJ, McCandless PM, Klausner K, et al. Tobacco documents research
Provenance and peer review Not commissioned; externally peer reviewed. methodology. Tob Control 2011;20(Suppl 2):ii8–11.
Data sharing statement All source materials for this paper are publicly available. 30 Dupuis RN. Challenges in tobacco research. 1955. Philip Morris. http://legacy.
The tobacco documents are all available at the UCSF Legacy Tobacco Documents library.ucsf.edu/tid/gde58e00 (accessed 15 Jan 2014).
Library, http://legacy.library.ucsf.edu. 31 Cheskin L. File No. 1965 A-1 Confidential Report Association Tests: Philip Morris
Filter Packages. 26 Mar 1965. Philip Morris. http://legacy.library.ucsf.edu/tid/
tid05e00 (accessed 19 Dec 2012).
REFERENCES 32 Cheskin L. Code No. A-3 660000 Confidential Report Association Test: Philip
1 Wakefield M, Morley C, Horan JK, et al. The cigarette pack as image: new Morris Filter (Brown) Packages. 30 Sep. 1966. Philip Morris. http://legacy.library.
evidence from tobacco industry documents. Tob Control 2002;11(Suppl 1):I73–80. ucsf.edu/tid/xid05e00 (accessed 19 Dec 2012).
2 National Cancer Institute. The role of the media in promoting and reducing 33 Sherrill J. Trip Report to Chicago September 2, 1970 (700902). 09 Sep 1970. RJ
tobacco use. Tobacco control monograph No. 19. Bethesda, MD: US Dept. of Reynolds. http://legacy.library.ucsf.edu/tid/rbg69d00 (accessed 19 Dec 2012).
Health and Human Services, National Institutes of Health, National Cancer 34 Hine T. The total package seeing and believing. 1995. Lorillard. http://legacy.
Institute, 2008. http://cancercontrol.cancer.gov/brp/tcrb/monographs/19/m19_ library.ucsf.edu/tid/uxh54a00 (accessed 21 Dec 2012).
complete.pdf 35 [Author unknown]. Sensory Science 101. 08 Oct 2004. Philip Morris. http://legacy.
3 Moodie C, Ford A. Young adult smokers’ perceptions of cigarette pack innovation, library.ucsf.edu/tid/eza90g00 (accessed 10 Jan 2013).
pack colour and plain packaging. Aust Mark J 2011;19:174–80. 36 Cheskin L. How to predict what people will buy. New York: Liveright Publishing
4 Moodie C, Ford A, Mackintosh AM, et al. Young people’s perceptions of cigarette Corporation, 1957. https://archive.org/stream/howtopredictwhat00ches—page/n5/
packaging and plain packaging: an online survey. Nicotine Tob Res mode/2up
2012;14:98–105. 37 [Author and date unknown]. Brand marketing training module. RJ Reynolds. http://
5 Balbach ED, Gasior RJ, Barbeau EM. R.J. Reynolds’ targeting of African legacy.library.ucsf.edu/tid/gqy09d00 (accessed 21 Dec 2012).
Americans: 1988–2000. Am J Public Health 2003;93:822–7. 38 Cooper KR. Package testing. 29 Nov 1978. Lorillard. http://legacy.library.ucsf.edu/
6 Doxey J, Hammond D. Deadly in pink: the impact of cigarette packaging among tid/quw41e00 (accessed 14 Jan 2014).
young women. Tob Control 2011;20:353–60. 39 Greene J. Old Gold Filter package test. 14 Dec 1978. Lorillard. http://legacy.library.
7 Wakefield MA, Germain D, Durkin SJ. How does increasingly plainer cigarette ucsf.edu/tid/vxn10e00 (accessed 14 Jan 2014).
packaging influence adult smokers’ perceptions about brand image? An 40 [Author unknown]. Viceroy low tar pack design test. 12 Dec 1977. Brown &
experimental study. Tob Control 2008;17:416–21. Williamson. http://legacy.library.ucsf.edu/tid/bxs00f00 (accessed 14 May 2013).
8 Pollay RW, Dewhirst T. A Premiere example of the illusion of harm reduction 41 [Author unknown]. Marketing news. 1973. British American Tobacco. http://legacy.
cigarettes in the 1990s. Tob Control 2003;12:322–32. library.ucsf.edu/tid/itg64a99 (accessed 11 Jan 2013).
9 Hammond D, Dockrell M, Arnott D, et al. Cigarette pack design and perceptions 42 [Author unknown]. Marlboro—the pack the people picked. 1970. RJ Reynolds.
of risk among UK adults and youth. Eur J Public Health 2009;19:631–7. http://legacy.library.ucsf.edu/tid/joz51c00 (accessed 19 Dec 2012).

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Research paper
43 Somasundaram M, Wall Street Journal. Red Packages Lure Shoppers Like Capes 73 Monahan EN. Consumer research proposal: Camel Filter Alternate Package
Flourished at Bulls: Marlboro, Coca-Cola, Colgate Wear Most Popular Color on Research (MRD #79-). 1979. RJ Reynolds. http://legacy.library.ucsf.edu/tid/
Global Market Shelves. 1995. http://legacy.library.ucsf.edu/tid/kpn39h00 (accessed pxb79d00 (accessed 11 Dec 2012).
19 Dec 2012). 74 DSN. TSB Technology Optimization Program. 16 Oct 1984. Research. http://legacy.
44 [Author unknown]. Never say die: history of Red Roof Pack. 1993. Philip Morris. library.ucsf.edu/tid/ylk76b00 (accessed 19 Sep 2014).
https://industrydocuments.library.ucsf.edu/tobacco/docs/mgdx0122 (accessed 10 75 Rawson DE. Salem King and Salem Lights Package Testing. 12 Apr 1978. RJ
Apr 2015). Reynolds. http://legacy.library.ucsf.edu/tid/ows13a00 (accessed 19 Dec 2012).
45 Cullman JF. Cigarette marketing today. An address by Joseph F. Cullman, 3rd 76 RJR. RJR News. Vol. 9, No. 75. R.J. Reynolds Tobacco Co. Developing New
Executive Vice President of Philip Morris Inc before the Chicago Federated Cigarette. 14 Sep 1987. RJ Reynolds. http://legacy.library.ucsf.edu/tid/wre05d00
Advertising Club, Chicago, Illinois, on Thursday, 551020. 20 Oct 1955. Philip (accessed 13 Mar 2013).
Morris. http://legacy.library.ucsf.edu/tid/cms34e00 (accessed 1 Aug 2013). 77 [Author unknown]. SHF cigarette market place opportunities search and situation
46 [Author unknown]. GR&DC Research Programme 1984—1986 psychology analysis volume ii management report. 1976. Lorillard. http://legacy.library.ucsf.
research. British American Tobacco. http://legacy.library.ucsf.edu/tid/qgn36a99 edu/tid/dxy41e00 (accessed 23 Jan 2013).
(accessed 7 Jan 2013). 78 Kightlinger SA. Viceroy Rich Lights pseudo-product/pack test (Project #197829).
47 Bockweg T, Chapple N, Cornell C, et al. Color documentation for Doral packaging 14 Feb 1978. Brown & Williamson. http://legacy.library.ucsf.edu/tid/uws00f00
colors. 16 Jan 2001. RJ Reynolds. http://legacy.library.ucsf.edu/tid/hsu14j00 (accessed 14 May 2013).
(accessed 12 Jun 2013). 79 Stanford Research into the Impact of Tobacco Advertising. Camel pack design,
48 Cato Gobe & Associates. Savings segment project for R.J. Reynolds Tobacco 1930. http://tobacco.stanford.edu/tobacco_main/images.php?token2=fm_st151.
Company a Visual Category Investigation First Presentation. 1991. RJ Reynolds. php&token1=fm_img4657.php&theme_file=fm_mt018.php&theme_name=
http://legacy.library.ucsf.edu/tid/rup03d00 (accessed 19 Dec 2012). Smoking in Sports&subtheme_name=Football (accessed 8 Mar 2016).
49 [Author unknown]. Packaging. 1987. RJ Reynolds. http://legacy.library.ucsf.edu/tid/ 80 Stanford Research into the Impact of Tobacco Advertising. Camel pack design,
yre05d00 (accessed 2 Jan 2013). 1961. http://tobacco.stanford.edu/tobacco_main/images.php?token2=fm_st151.
50 Miller L. Principles of measurement of visual standout in pack design: report no. php&token1=fm_img4618.php&theme_file=fm_mt018.php&theme_name=
RD 2039. 23 May 1986. British American Tobacco. http://legacy.library.ucsf.edu/ Smoking in Sports&subtheme_name=Football (accessed 8 Mar 2016).
tid/ihb34a99 (accessed 7 Jan 2013). 81 Stanford Research into the Impact of Tobacco Advertising. Camel pack design,
51 [Author unknown]. Project XG packaging briefing document. 1984. RJ Reynolds. 1972. http://tobacco.stanford.edu/tobacco_main/images.php?token2=fm_st100.
http://legacy.library.ucsf.edu/tid/lkc85d00 (accessed 8 Jan 2013). php&token1=fm_img9572.php&theme_file=fm_mt007.php&theme_name=Light,
52 [Author unknown]. Project XG packaging development. 1984. RJ Reynolds. http:// Super & Ultra Light&subtheme_name=Light (accessed 8 Mar 2016).
legacy.library.ucsf.edu/tid/mkc85d00 (accessed 8 Jan 2013). 82 Stanford Research into the Impact of Tobacco Advertising. Camel pack design,
53 [Author unknown]. Marlboro Milds Menthol test market image study—topline 1990. http://tobacco.stanford.edu/tobacco_main/images.php?token2=fm_st105.
report. 1999. Philip Morris. http://legacy.library.ucsf.edu/tid/zkv39h00 (accessed 23 php&token1=fm_img3270.php&theme_file=fm_mt007.php&theme_name=Light,
Jan 2013). Super & Ultra Light&subtheme_name=Mild as Ma (accessed 8 Mar 2016).
54 Isaacs J. Identified HTI test of Marlboro Ultra Lights in a Blue Pack Versus 83 Stanford Research into the Impact of Tobacco Advertising. Camel pack design,
Marlboro Ultra Lights in a Red Pack (Project No. 1256/1257). 1981. Philip Morris. 2005. http://tobacco.stanford.edu/tobacco_main/images.php?token2=fm_st203.
http://legacy.library.ucsf.edu/tid/geb36e00 (accessed 25 Jan 2013). php&token1=fm_img6073.php&theme_file=fm_.php&theme_name=&subtheme_
55 [Author unknown]. Project BY package exploratory study (MDD #79-1985) name= (accessed 8 Mar 2016).
executive summary. 1979. RJ Reynolds. http://legacy.library.ucsf.edu/tid/emf49d00 84 Campaign for Tobacco Free Kids. Camel’s Break Free Adventure Contest 2010.
(accessed 23 Sep 2014). http://www.tobaccofreekids.org/pressoffice/camelpromotion/camelbreakfreeadventure.
56 [Author unknown]. Viceroy low tar pack design test, phase II. 05 Jan 1978. Brown pdf (accessed 8 Mar 2016).
& Williamson. http://legacy.library.ucsf.edu/tid/dxs00f00 (accessed 14 May 2013). 85 Bella’s Blog. Play Camel Crush’s instant win game. 2014. http://bellasblog.info/
57 McCafferty B. Viceroy Rich Lights pseudo product test. 08 Feb 1978. Brown & 2014/01/15/play-camel-crushs-instant-win-game/ (accessed 8 Mar 2016).
Williamson. http://legacy.library.ucsf.edu/tid/dys00f00 (accessed 14 May 2013). 86 Ferris RP, Oldman M. Application of repertory grid technique: I. an investigation of
58 [Author unknown]. Viceroy Rich Lights product, pack, and advertising testing of brand images report no. RD.1617. 27 Sep 1978. Brown & Williamson. http://
blue and silver packs. 1978. Brown & Williamson. http://legacy.library.ucsf.edu/tid/ legacy.library.ucsf.edu/tid/ebm00f00: (accessed 10 Jan 2013).
ews00f00 (accessed 23 Jan 2013). 87 Gallopel-Morvan K, Moodie C, Hammond D, et al. Consumer perceptions of
59 [Author unknown]. Marlboro test market launch of Marlboro Milds Menthol. cigarette pack design in France: a comparison of regular, limited edition and plain
1999. Philip Morris. http://legacy.library.ucsf.edu/tid/fkp00i00 (accessed 12 Sep packaging. Tob Control 2012;21:502–6.
2014). 88 Hammond D. “Plain packaging” regulations for tobacco products: the impact of
60 Sun Research Corporation. Executive summary—a qualitative focus on new standardizing the color and design of cigarette packs among UK adults and youth.
product development for Marlboro: Marlboro Milds. May 1998. Philip Morris. Salud Publica Mex 2010;52:S226–32.
http://legacy.library.ucsf.edu/tid/wdy89h00 (accessed 12 Sep 2014). 89 World Health Organization. WHO framework convention on tobacco control.
61 Bennette A, Ellis N. Marlboro Milds research—final report. 28 May 1998. Philip Geneva, Switzerland, 2005. http://www.who.int/fctc/text_download/en/ (accessed
Morris. http://legacy.library.ucsf.edu/tid/feb99h00 (accessed 12 Sep 2014). 1 Apr 2015).
62 Monieson M. Milds research findings. 17 Jun 1998 Philip Morris. http://legacy. 90 Family Smoking Prevention and Tobacco Control Act, Pub. L. 111-31 (2009).
library.ucsf.edu/tid/xdy89h00 (accessed 12 Sep 2014). 91 World Health Organization. Partial guidelines for implementation of Articles 9 and
63 [Author unknown]. Packaging graphics. 1987. RJ Reynolds. http://legacy.library. 10 of the WHO Framework Convention on Tobacco Control (Regulation of the
ucsf.edu/tid/cse05d00 (accessed 2 Jan 2013). contents of tobacco products and regulation of tobacco product disclosures).
64 [Author unknown]. Project Spa Quantitative Package test. 1986. RJ Reynolds. 2012. http://www.who.int/fctc/guidelines/adopted/article_9and10/en/ (accessed 1
http://legacy.library.ucsf.edu/tid/tvo35d00 (accessed 8 Jan 2013). Apr 2015).
65 Toben TP. New business research and development report: Project Spa Package 92 Health Canada. Tobacco reporting regulations. 2005. http://www.hc-sc.gc.ca/
Test. 18 Apr 1986. RJ Reynolds. http://legacy.library.ucsf.edu/tid/lko64d00 hc-ps/tobac-tabac/legislation/reg/indust/index-eng.php (accessed 1 Apr 2015).
(accessed 8 Jan 2013). 93 World Health Organization. Best practices in tobacco control: regulation of tobacco
66 [Author unknown]. Packaging status. 1984. RJ Reynolds. http://legacy.library.ucsf. products: Canada Report. 2005. http://www.who.int/tobacco/global_interaction/
edu/tid/xls35d00 (accessed 8 Jan 2013). tobreg/Canada Best Practice Final_For Printing.pdf?ua=1 (accessed 1 Apr 2015).
67 Vasudevan B. Barclay Pack Color Change. 07 Sep 1994. Brown & Williamson. 94 Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, Section
http://legacy.library.ucsf.edu/tid/aoq30f00 (accessed 19 Dec 2012). 910 (2009).
68 Etzel EC. Camel Filter revised packaging test. consumer research proposal. 1979. 95 FDA Center for Tobacco Products. Draft Guidance for Industry and Food and Drug
RJ Reynolds. http://legacy.library.ucsf.edu/tid/qxb79d00 (accessed 11 Dec 2012). Administration Staff. Demonstrating the substantial equivalence of a new tobacco
69 Pasterczyk RC. Appendix II—new business research and development report: product: responses to frequently asked questions. September, 2011.
Project CMB Package test. 27 May 1987. RJ Reynolds. http://legacy.library.ucsf. 96 FDA Center for Tobacco Products. Guidance for industry, demonstrating the
edu/tid/lgm83d00 (accessed 15 Mar 2013). substantial equivalence of a new tobacco product: responses to frequently asked
70 Data Development Corp. Recommendations. 1975. RJ Reynolds. http://legacy. questions. March 4, 2015 and reissued on September 8, 2015. Available at:
library.ucsf.edu/tid/sxb79d00 (accessed 11 Dec 2012). http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/
71 Data Development Corp. Appendix Table 1. Anticipated usage of Camel Filters— ucm436462.htm (accessed 25 May 2016).
pre-trial among total respondents. 1975. RJ Reynolds. http://legacy.library.ucsf.edu/ 97 FDA Center for Tobacco Products. This week in CTP: FDA announces interim
tid/txb79d00 (accessed 11 Dec 2012). enforcement policy related to substantial equivalence FAQ guidance. 2015. http://
72 Data Development Corp. Camel Filter Package study. 1975. RJ Reynolds. http:// www.fda.gov/TobaccoProducts/NewsEvents/ucm448854.htm (accessed 29 May
legacy.library.ucsf.edu/tid/rxb79d00 (accessed 11 Dec 2012). 2015).

8 Lempert LK, Glantz S. Tob Control 2016;0:1–9. doi:10.1136/tobaccocontrol-2015-052656


Downloaded from http://tobaccocontrol.bmj.com/ on June 3, 2016 - Published by group.bmj.com

Research paper
98 Philip Morris USA Inc. et al. v. U.S. Food and Drug Administration et al., Case No. 108 Hoek J, Gendall P, Gifford H, et al. Tobacco branding, plain packaging,
1:15-cv-00544, U.S. District Court for the District of Columbia. 2015. http://www. pictorial warnings, and symbolic consumption. Qual Health Res
plainsite.org/dockets/2l1grm3pb/district-of-columbia-district-court/philip-morris-usa- 2012;22:630–9.
inc-et-al-v-united-states-food-and-drug-administration-et-al/ (accessed 25 May 109 Stead M, Moodie C, Angus K, et al. Is consumer response to plain/standardised
2016). tobacco packaging consistent with framework convention on tobacco control
99 Field E. Big tobacco sues FDA over label guidance. 2015. https://www.law360. guidelines? A systematic review of quantitative studies. PLoS One 2013;8:
com/articles/642999/big-tobacco-sues-fda-over-label-guidance-?article_related_ e75919.
content=1 (accessed 5 Jun 2015). 110 Hogarth L, Maynard O, Munafò M. Plain cigarette packs do not exert Pavlovian to
100 Tobacco Plain Packaging Act 2011. No. 148, 2011 as amended. 2011. http:// instrumental transfer of control over tobacco-seeking. Addiction
www.comlaw.gov.au/Details/C2013C00190 (accessed 1 Apr 2015). 2015;110:174–82.
101 BBC. Republic of Ireland passes cigarette plain package law. 2015. http://www. 111 Brose LS, Chong CB, Aspinall E, et al. Effects of standardised cigarette packaging
bbc.com/news/world-europe-31722210 (accessed 10 Feb 2016). on craving, motivation to stop and perceptions of cigarettes and packs. Psychol
102 Perraudin F. MPs pass legislation to introduce standardised cigarette packaging. Health 2014;29:849–60.
2015. http://www.theguardian.com/politics/2015/mar/11/mps-pass-legislation- 112 Munafò M, Roberts N, Bauld L, et al. Plain packaging increases visual attention to
introduce-standardised-cigarette-packaging (accessed 10 Feb 2016). health warnings on cigarette packs in non-smokers and weekly smokers but not
103 The Guardian. France votes for plain cigarette packaging from 2016. 2015. http:// daily smokers. Addiction 2011;106:1505–10.
www.theguardian.com/society/2015/dec/18/france-votes-for-plain-cigarette- 113 Maynard OM, Munafo MR, Leonards U. Visual attention to health warnings on
packaging-from-2016 (accessed 10 Feb 2015). plain tobacco packaging in adolescent smokers and non-smokers. Addiction
104 Pfeffer A, CBC News. Federal government moves ahead on plain packaging for 2013;108:413–19.
cigarettes. 2016. http://www.cbc.ca/news/canada/ottawa/plain-package-cigarette- 114 Hastings G, Moodie C. Death of a salesman. Tob Control 2015;24:ii1–2.
plan-1.3492992 (accessed 20 Mar 2016). 115 Wakefield M, Coomber K, Zacher M, et al. Australian adult smokers’ responses to
105 Action on Smoking & Health (ASH). Plain packaging for tobacco will become the plain packaging with larger graphic health warnings 1 year after implementation:
global norm. 2015. http://ash.org/plain-packs-pr/ (accessed 1 Oct 2015). results from a national cross-sectional tracking survey. Tob Control 2015;24:
106 Hoek J, Wong C, Gendall P, et al. Effects of dissuasive packaging on young adult ii17–25.
smokers. Tob Control 2011;20:183–8. 116 White VM, Williams T, Wakefield M. Has the introduction of plain packaging with
107 Scheffels J, Sæbø G. Perceptions of plain and branded cigarette packaging among larger graphic health warnings changed adolescents’ perceptions of cigarette packs
Norwegian youth and adults: a focus group study. Nicotine Tob Res 2013;15:450–6. and brands? Tob Control 2015;24:ii42–9.

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Packaging colour research by tobacco


companies: the pack as a product
characteristic
Lauren K Lempert and Stanton Glantz

Tob Control published online June 2, 2016

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Packaging colour research by tobacco companies:

The pack as a product characteristic

Lauren K. Lempert and Stanton Glantz

Supplemental File:

Implications for FDA Review of New Tobacco Products

The 2009 Family Smoking Prevention and Tobacco Control Act1 (FSPTCA)

requires tobacco companies to obtain premarket authorization from the U.S. Food and

Drug Administration (FDA) before they can legally market a “new tobacco product” in

the United States. A “new tobacco product” is defined as a tobacco product that was not

commercially marketed in the U.S. on February 15, 2007, or that has been modified,

including but not limited to changing any part or any other additive or ingredient.2 The

companies can obtain this authorization using one of three pathways, described more

fully below and spelled out in FSPTCA sections 905(j) and 910:

(1) Submit a premarket tobacco product application (PMTA); 3

(2) Submit a “substantial equivalence” (SE) report;4or

(3) Demonstrate that the product is exempt from new product or SE requirements. 5

As of September 2015 (the most recent data posted by FDA as of April 2016), FDA

had received a total of 5,333 product submissions, including 1,721 regular SE

submissions (including 662 streamlined applications), 3,517 provisional SE submissions,

and 68 SE exemption submissions, as well as 12 premarket applications for new tobacco

products and 15 modified risk tobacco product applications.6 7Of the 5,306 SE

submissions it had received,6 as of April 2016 the agency had issued 555 SE orders, 176

1
Not Substantially Equivalent (NSE) orders, and 37 “Refuse to Accept” orders (for

incomplete SE reports), 23 SE order rescissions, and 982 manufacturers had withdrawn

their applications. Of the 3,517 provisional SE applications, as of April 2016 FDA has

issued 48 provisional NSE orders (4 in February 2014, 7 in August 2014, 10 in May

2015, 1 in August 2015, 5 in September 2015, 10 in October 2015, and 11 in February

2016, leaving 3,469 new tobacco products that were introduced between February 2007

and March 2011 and had not been evaluated by FDA remaining on the market while

awaiting SE review.8

Products that do not have pre-market authorization as required by FSPTCA

section 910 are deemed “adulterated” under FSPTCA section 902. 9 Products with

labeling that is false or misleading in any particular are deemed “misbranded” under

FSPTCA section 903. 10 Products that FDA determines are “not substantially equivalent”

(NSE) and for which it issues NSE orders are considered both adulterated and

misbranded. 11 When a tobacco product is deemed adulterated or misbranded, it is illegal

to sell or distribute the product in interstate commerce or import the product into the

United States. 11, 12

Premarket Tobacco Product Application

Under the premarket tobacco product application (PMTA) pathway,

manufacturers must present data and information sufficient to enable FDA to make a

finding that the marketing of a new tobacco product is "appropriate for the protection of

the public health," and the product and its manufacture and labeling conform to

requirements in the Act and related rules. 3 The public health standard requires FDA to

2
consider the risks and benefits to the population as a whole, including users and nonusers

of the tobacco product, and taking into account:

(A) the increased or decreased likelihood that existing users of tobacco products
will stop using such products; and
(B) the increased or decreased likelihood that those who do not use tobacco
products will start using such products.13

Importantly, FSPTCA 910(b)(1)(F) requires new tobacco product applications to

contain “specimens of the labeling proposed to be used for such tobacco product” 14 in

addition to reports of health risks; statements of components, ingredients, additives,

properties, and principles of operation; descriptions of manufacturing methods; and other

relevant information and product samples.15 This statutory requirement establishes that

Congress intended product labeling, like other tobacco product characteristics, to be an

important factor in FDA’s determination of whether the marketing of a tobacco product

for which an application has been submitted is appropriate for the protection of the public

health. FDA highlighted this statutory requirement in its September 2011 Guidance for

Industry, Applications for Premarket Review of New Tobacco Products 16 (“PMTA

Guidance”), further specifying that the requirement includes “labels, inserts/onserts,

instructions, and other accompanying information or materials.”

In addition to implementing the public health standard, FDA is required to deny

any PMTA if the product’s package labeling is “false or misleading in any particular.” 17

Therefore, in its September 2011 PMTA Guidance, FDA recommends that manufacturers

submit adult human subject studies that provide evaluations of “consumer perceptions

including risk perceptions based on the product itself, as well as on the packaging and

labeling of the new tobacco product [emphasis added]” to enable FDA to determine

whether the product’s packaging or labeling is false or misleading in any particular and

3
whether allowing the product on the market would be appropriate for the protection of the

public health.16

As of April 2016, FDA had received just 12 PMTA applications6 for which it

issued four “Refuse-to-File” (RTF; i.e., refuse to undertake an extensive new product

review) final actions and eight PMTA marketing orders in October 2015 (for Swedish

Match snus products).8 FDA may refuse to file an application if it is missing one or more

items required by FSPTCA section 910(b) (e.g., a full statement of the components

ingredients, additives, and properties of the product; samples of the product; or specimens

of the labeling). 7, 15 In its “Brief Summary of Refusal-to-File Determinations,” 7FDA

cited a failure to provide an adequate example (“specimen”) of the proposed labeling as a

deficiency in one or more of the PMTA applications it reviewed. Notably, FDA stated

that one or more of the submitted labeling specimens were deficient and triggered a RTF

action because the specimen was not reproduced in color.7 These RTFs are significant

because they show that FDA has not been willing to authorize the marketing of a new

tobacco product under the PMTA route if it is unable to properly evaluate the package,

including the color of the package.

Substantial Equivalence

Manufacturers may avoid the PMTA process if they use the SE pathway. To

obtain an SE order, the manufacturer must submit an SE report to FDA and demonstrate

that the product has the “same characteristics” as a tobacco product commercially

marketed in the U.S. on February 15, 2007, or its different characteristics do not raise

“different questions of public health” compared to the 2007 product, and the product is

otherwise in compliance with the Act. 18 If the new product raises different questions of

4
public health, the product is not SE. The FSPTCA defines “substantial equivalence” in

terms of “characteristics,” and defines “characteristics” as the “materials, ingredients,

design, composition, heating source, or other features of a tobacco product [emphasis

added].” 19, 20 The statute does not further define each of the terms used in the definition

of “characteristics.” However, the fact that the definition is not limited to “materials” and

“ingredients,” and also includes “design” and “other features,” suggests that packaging

and labeling, and their coloring, are included, especially given that labeling is included in

PMTA reviews along with ingredients and other features, 15and given the provision’s

goal of protecting against any product changes or differences of any kind that could cause

new or increased public health harms.

Exemption from Substantial Equivalence

Under the exemption from SE pathway, a manufacturer that modifies a legally

sold product by adding or deleting a tobacco additive, or increasing or decreasing the

quantity of an existing tobacco additive, may be exempt from submitting a SE report if

the modified version of the product is “minor,” the product’s marketing “would be

appropriate for protection of the public health,” and an exemption is “otherwise

appropriate.” 5 As of April 2016, FDA received 73 SE exemption submissions,6 issued

one exemption from SE action, 50 “refuse to accept” (RTA) letters for exemption

requests, and received two withdrawals. 8 In its decision summary for the exemption from

SE request, 21 FDA does not discuss whether there were any packaging or color changes

or public health impacts of the new tobacco product.

FDA Guidances on Substantial Equivalence

FDA’s Center for Tobacco Products issues guidance documents for industry and

5
FDA staff that, while not legally binding requirements, represent FDA’s current thinking

on a particular topic and provide information to assist those who must understand and

comply with the law.22, 23 Before issuing a final guidance, FDA often publishes a draft

guidance to solicit comments from industry, other stakeholders, and the general public.

Both draft and final guidances are only guidelines and are not binding on FDA or the

companies. In particular, FDA can later adopt and use “an alternative approach [even if

it contradicts a published guidance] if the approach satisfies the requirements of the

applicable statutes and regulations.” 24

FDA stated in its September 2011 Draft Guidance for Industry and Food and

Drug Administration Staff. Demonstrating the Substantial Equivalence of a New Tobacco

Product: Responses to Frequently Asked Questions 25that FDA considered the label and

packaging of a tobacco product to be a “part” of that product, and that a change to any

part of a tobacco product after February 15, 2007 makes that product a "new tobacco

product." Thus, FDA indicated that a cigarette would be considered a “new tobacco

product” subject to enforcement under requirements for SE reports and PMTA

applications (FSPTCA sections 905(j) and 910) if a modification to the font size, ink

color, or background color of a tobacco product’s packaging raised different questions of

public health. 25The standard FDA described in its September 2011 draft guidance was

consistent with the industry practices described in our paper. 26

Perhaps anticipating the tobacco industry’s First Amendment commercial speech

claims and imminent lawsuits, FDA softened this policy in its March 2015 Guidance for

Industry, Demonstrating the Substantial Equivalence of a New Tobacco Product:

Responses to Frequently Asked Questions 24by stating that a label is not a “part” of the

6
tobacco product, unless the label is modified in a way that renders the product “distinct”

from the predicate product. The language of the March 2015 guidance is confusing

because it says that a product can both have the “same characteristics” as a predicate

product and also be “distinct” from that product.24 FDA explained that a product with a

label change might be considered a “distinct product” depending on the circumstances,

for example, if changes were made to a product’s logo, “identifiable patterns of color,”

product descriptors, or any combination thereof.24 Importantly, when a company

changes the tobacco product’s label, FDA believes it is a “new product” subject to the SE

provisions if the label change would “lead consumers to believe that the product is

different from the predicate” or if consumers are “likely to perceive it as ‘new’ by virtue

of the different label.” 24 In this regard, we have documented that actual industry

practices treat color changes in packaging and labels as “distinct” changes to the

product.26

FDA’s March 2015 guidance offers a muddled description of its current

thinking on how color changes in packaging may make a tobacco product “distinct” and

therefore a “new product.” FDA indicates that if a product is new because it is “distinct”

but otherwise has the “same characteristics” as the predicate product, FDA thinks the

manufacturer may comply with the law by submitting a streamlined “Same

Characteristics SE Report” in lieu of submitting a full SE report or premarket application

under section 910(b).24 (The “Same Characteristics” report, unanticipated in the

FSPTCA, is an invention of FDA and intended to be easier for the manufacturer to

prepare and for FDA to review.) In contrast, if a change to a logo, colors, product

descriptors or other aspects of the label is unlikely to lead consumers to believe that the

7
product is different from the predicate, then the guidance indicates that FDA would not

consider the product a “new tobacco product” subject to the related statutory

requirements. 24 As an example, FDA suggests in the guidance that a change in

background color from green to red may result in a “distinct product,” but a change from

white to cream likely would not.

If a company changes the label on a product that is being legally marketed

because a “provisional SE report” was previously filed, the guidance indicates that FDA

will allow the changed product to remain on the market so long as a new Same

Characteristics SE Report was filed by April 3, 2015. For products that are not already on

the market, the guidance indicates that a manufacturer may legally market a product that

is otherwise “identical” except for a change in the label 90 days after it submits a Same

Characteristics SE Report. According to the process suggested by the guidance, the

product may then remain on the market unless and until FDA issues a not substantially

equivalent (NSE) order. 24

Industry Lawsuit and Subsequent Submissions

Even though FDA’s guidance indicated that FDA would be taking a considerably

more permissive approach to label changes than a plain reading of the statute might

suggest and was not legally binding, Philip Morris, R.J. Reynolds, Lorillard, and three

other tobacco companies sued FDA in April 2015, claiming that FDA’s more permissive

approach to label changes in its March 2015 guidance was still an abuse of discretion that

infringed the companies’ free speech rights under the First Amendment to the United

States Constitution.27 In May 2015, FDA issued an interim enforcement policy on new

tobacco products,28 added as a footnote to the agency’s March 2015 guidance,24 stating

8
that for tobacco products in which the only modification or difference is “a label change

that creates a distinct product with identical characteristics to the predicate product,”

FDA would not take any actions against the manufacturers for not first obtaining a

premarket authorization and would not issue any “not substantially equivalent” orders.28

In June 2015, after FDA weakened its enforcement policy, the companies dropped their

lawsuit.29

Shortly after FDA announced its new enforcement policy, the companies submitted

and FDA accepted and issued orders on, the new streamlined shorter, easier Same

Characteristics SE reports. On July 17, 2015, FDA announced30 it had issued 125 SE

orders in June 2015, which included final actions on streamlined Same Characteristics SE

reports for 105 products.31

Legal Implications of Using Color to Change Consumers’ Perceptions of the Taste,

Strength, and Texture of Tobacco Products

FDA’s original September 2011 thinking was correct and supported by the

tobacco companies’ own research and marketing activities,26as well as by the legal

framework for new product and SE reviews established in FSPTCA sections 910 and

905(j).32 Because consumers perceive tobacco products in packages with changed label

colors (including labels with slightly lightened colors or more white space) to taste and

feel different from products in their original packages, 26 FDA should treat products in

packages with changes in label colors as “new products” subject to the SE provisions

requiring regular SE reports, and should conduct social science evaluations of the

packaging changes. In contrast, FDA’s March 2015 policy24 is inconsistent with the

tobacco companies’ actual product characteristic decisions26 in which the companies

9
sometimes change pack colors to alter consumers’ perceptions and experiences about the

taste, strength, and texture of the cigarettes inside the pack just as when they make

changes in the rod length, tobacco blend, or additives. Cigarette packaging and labels

modified in this way operate as cigarette “characteristics” or ingredients and are “part” of

the tobacco products. When tobacco companies change these product characteristics, they

create distinct and “new tobacco products.” Indeed, the companies explicitly

acknowledge this fact in some of their internal discussions of product changes.33-36 Under

the FSPTCA such new products require premarket authorization.32

A change to the tobacco blend, rod length, or additives would not be subject to

First Amendment protection. Likewise, a change to package colors is not subject to First

Amendment protections if it is regulated not to restrict commercial speech, but as a

product change that changes how consumers experience the taste or texture of the

cigarettes when smoked.

Ingredient and product changes, including changes to packaging and labeling, that

influence consumers’ experiences of smoking the cigarettes contrast with packaging and

labeling changes that include new communicative text or images that are used to

communicate accurate product information to legal consumers, which may trigger First

Amendment protections if regulated to restrict commercial speech. However, even if

FDA’s treatment of color changes to packaging or labeling were seen as regulating

commercial speech that might be subject to First Amendment protections, it could not

qualify for such constitutional protections because such color changes are false and

misleading. The common industry practices documented in our paper26 demonstrate that

pack and labeling colors, by changing the way consumers experience the cigarettes’ taste

10
and texture, can mislead consumers into thinking inaccurately that some cigarette brands

or sub-brands are significantly less or more harmful than others. This conclusion is

further supported by other research finding that smokers think cigarettes are less harmful

than other cigarettes if they perceive them to taste and feel “lighter,” “smoother,” less

“harsh,” or less “full-flavored,”37.

Moreover, if color changes that alter consumers’ harm or risk perceptions are

considered commercial speech, products making such changes would also likely violate

FSPTCA section 91138 if the manufacturer did not first obtain a “modified risk tobacco

product” (MRTP) order from FDA. FSPTCA section 911 prohibits tobacco companies

from marketing tobacco products with labeling that represents explicitly or implicitly that

the product presents a lower risk of disease or is less harmful than other tobacco products

unless FDA issues an MRTP order stating that the product actually would reduce harm

and benefit the public health.38 Products that violate FSPTCA section 911 are deemed

“adulterated” under FSPTCA section 902,9 and products with labeling that is false or

misleading in any particular are deemed “misbranded” under FSPTCA section 903.10

Summaries of FDA Final Actions on New Tobacco Product Submissions

While FDA has the authority and capacity to do “Social Science” reviews,39 which

would include consideration of color in packaging and its impact on the population using

the “public health standard,” it is not clear if FDA is regularly doing any such reviews or

how FDA is considering any information it might be receiving from any such reviews.

FDA posts summaries of selected SE, NSE, and other marketing orders on its Tobacco

Product Marketing Orders website, but these postings suggest that FDA has not regularly

been doing social science reviews of color or labeling changes, and they provide little

11
insight into the agency’s current thinking on how it treats changes in packaging and label

colors in PMTA and SE reviews.8 Large sections of the reports are redacted to prevent

disclosure of unsubstantiated trade secrets claimed by the industry (“(b)(4)” redactions).40

In many cases, so much of the report is redacted that it is difficult to understand the basis

for FDA’s SE determination. (See, for example, the April 2015 Technical Project Lead

(TPL) Review for SE0010167-SE0010171,41 the March 2015 TPL Review for

SE0010365-SE0010369 and SE0010422,42 and the June 2014 Technical Project Lead

(TPL) Memorandum: SE Reports SE0003503-SE0003524 & SE0010338-SE0010359.43)

Most SE reports include Chemistry, Engineering, and Toxicology reviews, with

only a few including Social Science reviews. One example of a SE evaluation that did

include a Social Science review is the SE report on eight SE applications for Swedish

Match loose moist snuff products sold in plastic cans,44 which appears to consider whether

the darker color of the new tobacco products compared to the corresponding predicate

tobacco products increases the appeal of the new products. However, while the report

states that the SE reports submitted by the manufacturer included information about

consumer perception testing, the submitted information did not actually address the

specific color differences between the new and corresponding predicate products.44 The

report stated that at the time the social science reviews were conducted (July 2012,

January 2013, August 2013, and September 2013), “the available scientific evidence is not

sufficient to establish that the product color differences in this case are significant enough

to cause the new tobacco products to raise different questions of public health,”44 and

therefore concluded that the differences in product appeal between the predicate and

corresponding new tobacco products did not raise different questions of public health.44

12
FDA’s conclusion ignores and contradicts the fact that tobacco companies use

color differences to influence consumers’ perceptions of the taste, strength, and general

appeal of their tobacco products.26 At the very least, the darker color of the product in the

Swedish Match SE application44 raises different questions of public health in regard to

how consumers will perceive its taste compared to the predicate and how that might

affect existing and potential new consumers’ purchase and use decisions.

Conclusion

The routine industry practices documented in our paper26 -- using color changes

and differences in packaging and labels as ingredients that alter consumers’ perceptions

of the cigarettes’ taste, texture, and strength -- support the position originally taken by

FDA in its September 2011 guidance on SE,25 in which FDA considered cigarette

packaging and labeling as a “part” (i.e., a “characteristic”) of the new tobacco product in

the same way it considers other tobacco product ingredients when it evaluates SE reports.

Analogous to changes in rod length, tobacco blend, or additives, color changes in

packaging and labels that operate as ingredients changes are not entitled to First

Amendment protections. While FDA is not legally bound by its guidances, the agency

should follow the guidelines it articulated in its original September 2011 guidance, rather

than the convoluted recommendations in its March 2015 guidance.24 Moreover, even if

FDA relied on its March 2015 interpretation, color changes in tobacco product packaging

and labels render tobacco products “distinct” by FDA’s definition24 since they lead

consumers to believe that the products in one pack are different from identical products in

another pack with different colored labeling.26 Therefore, FDA should consider any

tobacco product with color changes in its packaging and labels as a “new product”

13
subject to rigorous SE review. FDA should require full-length SE reports, rather than

streamlined “Same Characteristics” reports, for all SE submissions with any color

changes to the product’s packaging and labeling, and should conduct Social Science

reviews that consider the public health impacts of new tobacco products as actually used

by consumers for all SE submissions.

14
REFERENCES

1. Family Smoking Prevention and Tobacco Control Act, Pub. L. 111-31 (2009).

2. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 910 (a)(1) (2009).

3. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 910 (2009).

4. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 910 (a)(2)(A)(i) and 905(j) (2009).

5. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 910 (a)(2)(A)(ii) and 905(j)(3) (2009).

6. FDA. Total number of product submissions received or filed in the month.

http://www.accessdata.fda.gov/FDATrack/track?program=ctp&id=CTP-OS-total-

product-submissions-received&fy=all - related_links (accessed 01 Apr 2016)

7. FDA Center for Tobacco Products. Brief Summary of "Refusal-to-File"

Determinations. 2014.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UC

M389515.pdf (accessed 19 Jul 2015)

8. FDA. Tobacco Product Marketing Orders.

http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.ht

m (accessed 01 Apr 2016)

9. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 902 (2009).

10. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 903 (2009).

15
11. FDA Center for Tobacco Products, Office of Compliance and Enforcement.

Letter to Industry on Certain Tobacco Products Found to be Not Substantially Equivalent,

Feb. 21, 2014.

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInform

ation/UCM386534.pdf (accessed 15 Jun 2015)

12. FDA Center for Tobacco Products. Misbranded and Adulterated NSE Tobacco

Products.

http://www.fda.gov/TobaccoProducts/Labeling/TobaccoProductReviewEvaluation/NewT

obaccoProductReviewandEvaluation/ucm371765.htm (accessed 15 Jun 2015)

13. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 910 (c)(4) (2009).

14. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 910(b)(1)(F) (2009).

15. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 910(b)(1)(A)-(G) (2009).

16. FDA Center for Tobacco Products. Guidance for Industry, Applications for

Premarket Review of New Tobacco Products (Draft Guidance). 2011.

17. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 910 (c)(2)(C) (2009).

18. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Sections 910 (a)(3)(A)(i) and (ii) and 905(j) (2009).

19. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 910 (a)(3)(A) (2009).

16
20. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 910 (a)(3)(B) (2009).

21. FDA Center for Tobacco Products, Office of Science,. Technical Project Lead

(TPL) Review: Exemption Request EX0000026. 2015.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UC

M443552.pdf (accessed 09 Apr 2015)

22. 21 CFR 10.115 - Good Guidance Practices.

http://www.gpo.gov:80/fdsys/pkg/CFR-2012-title21-vol1/pdf/CFR-2012-title21-vol1-

sec10-115.pdf (accessed 15 Apr 2015)

23. FDA Center for Tobacco Products. Implementing the Tobacco Control Act

through Policy, Rulemaking, and Guidance.

http://www.fda.gov/TobaccoProducts/AboutCTP/ucm383160.htm (accessed June 15,

2015)

24. FDA Center for Tobacco Products. Guidance for Industry, Demonstrating the

Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked

Questions. 2015.

25. FDA Center for Tobacco Products. Draft Guidance for Industry and Food and

Drug Administration Staff. Demonstrating the Substantial Equivalence of a New Tobacco

Product: Responses to Frequently Asked Questions. September, 2011.

26. Lempert L, Glantz S. Packaging colour research by tobacco companies: The pack

as a product characteristic. 2016

27. Philip Morris USA Inc. et al. v. U.S. Food and Drug Administration et al., case

no. 1:15-cv-00544, U.S. District Court for the District of Columbia (2015).

17
28. FDA Center for Tobacco Products. This Week in CTP: FDA Announces Interim

Enforcement Policy Related to Substantial Equivalence FAQ Guidance. 2015.

http://www.fda.gov/TobaccoProducts/NewsEvents/ucm448854.htm (accessed 29 May

2015)

29. Godoy J. Tobacco Cos. Drop Suit After FDA Holds Labeling Enforcement. 2015.

https://www.law360.com/articles/662834/tobacco-cos-drop-suit-after-fda-holds-labeling-

enforcement?article_related_content=1 (accessed 5 Jun 2015)

30. FDA Center for Tobacco Products. This Week in CTP: Roundup of Recent

Tobacco Product Review Actions. 2015.

31. FDA Center for Tobacco Products. Technical Project Lead (TPL) Review: SE

Reports Submitted by Atlas Pacific Manufacturing 2015.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UC

M486212.pdf

32. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Sections 910 and 905(j) (2009)

33. [Author and date unknown]. Brand Marketing Training Module. RJ Reynolds.

http://legacy.library.ucsf.edu/tid/gqy09d00 (accessed 21 Dec 2012)

34. Etzel EC. Camel Filter Revised Packaging Test. Consumer Research Proposal.

1979. RJ Reynolds. http://legacy.library.ucsf.edu/tid/qxb79d00 (accessed 11 Dec 2012)

35. Isaacs J. Identified HTI Test of Marlboro Ultra Lights in a Blue Pack Versus

Marlboro Ultra Lights in a Red Pack (Project No. 1256/1257). 1981. Philip Morris.

http://legacy.library.ucsf.edu/tid/geb36e00 (accessed 25 Jan 2013)

18
36. [Author unknown]. Viceroy Rich Lights Product, Pack, and Advertising Testing

of Blue and Silver Packs. 1978. Brown & Williamson.

http://legacy.library.ucsf.edu/tid/ews00f00 (accessed 23 Jan 2013)

37. Shiffman S, Pillitteri JL, Burton SL, Rohay JM, Gitchell JG. Smokers' beliefs

about "Light" and "Ultra Light" cigarettes. Tob Control 2001;10 Suppl 1:i17-23

38. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31,

Section 911 (2009).

39. U.S. Government Accountability Office. New Tobacco Products: FDA Needs to

Set Time Frames for Its Review Process (GAO-13-723) 2013.

http://www.gao.gov/products/GAO-13-723

40. Velicer C, Lempert L, Glantz S. Cigarette company trade secrets are not secret: an

analysis of reverse engineering reports in internal tobacco industry documents released as

a result of litigation. Tob Control. 2014 Jun 11. pii: tobaccocontrol-2014-051571. doi:

10.1136/tobaccocontrol-2014-051571 2014;

41. FDA Center for Tobacco Products OoS. Technical Project Lead (TPL) Review:

SE0010167-SE00101712015.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UC

M444778.pdf

42. FDA Center for Tobacco Products OoS. Technical Project Lead (TPL) Review:

SE0010365-SE0010369 and SE00104222015.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UC

M440366.pdf

19
43. FDA Center for Tobacco Products OoS. Technical Project Lead (TPL)

Memorandum: SE Reports SE0003503-SE0003524 & SE0010338-SE00103592014.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UC

M403987.pdf

44. FDA Center for Tobacco Products OoS. Technical Project Lead (TPL)

Memorandum: SE Reports SE0001762, SE0003525, SE0003526, SE0003528,

SE0003529, SE0004386, SE0004387, SE00043882013.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UC

M375196.pdf

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