Characterization of MentholDr. William R. True

Senior Vice President, Research and DevelopmentLorillard Tobacco Company

Meeting of the Tobacco Products Scientific Advisory CommitteeJuly 15-16, 2010

Newport

• Lorillard has manufactured and sold Newport cigarettes for over 5 decades, since 1957

• Newport was reformulated in 1972 to address declining market share– In 1993, Newport became the best selling menthol brand in

the U.S.

• After the 1972 reformulation, the amount of menthol in Newport Full Flavor King Box (Lorillard’s most popular brand packing) did not change substantially for over thirty five years from 1972 to 2009

Newport Full Flavor 80mm Menthol Level (1993-2010)

Other Lorillard Menthol Brands

• Lorillard also currently manufactures menthol versions of Kent, Old Gold, Maverick and True

• Over the years, Lorillard has manufactured over 65 menthol brands

• As an example of other Lorillard menthol brands, the amount of pack menthol in Newport Lights* has also remained stable

*Lorillard no longer uses the descriptor “lights” on its cigarettes

Newport Lights 80mm Menthol Level (2000-2010)

Cigarette Design Variables• Increased filter efficiency decreases menthol in smoke

• Increased ventilation decreases menthol in smoke

• Menthol is transferred at a similar rate as “tar” and nicotine

• As a result, the pack menthol of Lorillard’s lower “tar” cigarettes, such as Newport Lights, is higher than Newport

• 20% of the menthol in Newport is transferred to smoke

• 12% of the menthol in Newport Lights is transferred to smoke

Menthol Level on Cigarette (mg/cig) & Menthol Delivery in Mainstream Smoke (mg/cig)

Compliance with Fire Standard

• New cigarette paper caused slightly higher “tar” deliveries

• In 2009, Lorillard initiated an effort to reduce “tar” levels to pre-fire standard compliant levels

• Increased filter efficiency or ventilation to lower “tar” required more menthol to maintain consistent taste

• Despite changes in pack menthol, the smoke menthol of Newport did not change

Newport Smoke Menthol Levels Pre- and Post-Fire Standard

Lorillard Menthol Application

• Menthol in Lorillard brands is applied by spraying the cut tobacco blend with menthol in an ethyl alcohol solution

Synthetic Menthol

• Lorillard uses a mixture of synthetic and natural menthol in most of its menthol cigarettes

• Synthetic menthol has different taste characteristics than natural menthol

• Sources of natural and synthetic menthol may also contribute to different taste characteristics

Menthol Levels• Lorillard does not use a specific level of menthol to

classify cigarettes as menthol cigarettes

• The menthol level in Lorillard menthol cigarettes is readily discernable by consumers

• Lorillard does identify the optimal level of menthol to complement the tobacco taste signature of each of its menthol brands

• The ultimate determination of menthol level is based on consumer preference

Menthol Levels• Individuals differ considerably (3 orders of magnitude)

in their ability to taste, smell and sense the cooling properties of pure menthol (Rosenblatt et al. (1989))

• Recent Lorillard research indicates that menthol is generally detectable by consumers at a level of 0.12% menthol in the tobacco blend

• Lorillard’s internal expert smokers and some consumers detect menthol at lower levels

• The amount of menthol used as a characterizing flavor in Lorillard’s menthol cigarettes is over 3 times this detection level

Menthol Levels• Menthol at very low levels is sometimes used in

nonmenthol brands, along with very low levels of other flavors, as a component of proprietary “top flavors” to slightly augment the key signature of Lorillard products – tobacco taste– These levels were established decades ago and have been

consistently maintained

– This use is analogous to the flavor practices employed in other consumer products

• Lorillard reports the use and amount of all of its flavoring ingredients to the FDA

Newport Menthol Levels (2000-2007)• In 2008, Kreslake et al. concluded that Lorillard

“decreased menthol concentration by 16%” in Newport between 2000 and 2007 to target “younger smokers”

Newport Menthol Levels (2000-2007)

• The study’s conclusion regarding Newport is based on a single 2007 analysis compared to a single “baseline” value from a 2000 Lorillard internal document

• Two data points are never sufficient to analyze a trend

• Therefore, the two analytical data points are entirely inadequate to support the conclusion with respect to Newport

• In fact, the actual trend line for menthol in Newport between 2000 and 2007 can only be described as unequivocally flat

Newport Menthol Levels (2000-2007)

1999 2000 2001 20032002 2004 2005 20072006 2008

Kreslake two data points

.38 .32

Newport Menthol Levels (2000-2007)

1999 2000 2001 20032002 2004 2005 20072006 2008

Kreslake two data points Lorillard data

.38 .32

Newport Menthol Levels (2000-2007)

• The two Newport menthol values used in the publication represent analyses that– Were conducted by different laboratories– Used different methods– Were presented with no statistical analysis– Are within routine production/analytical method variation

• The study design and conclusions also failed to consider the characteristics of cigarette manufacturing, statistical process control, and analytical method variability

Valid Scientific Trend Analysis• Sound scientific methodology for determining trends

in menthol levels requires– Documentation of sample identity, age and handling

• Menthol is volatile and can be impacted by shelf life and conditions

– Use of standardized, validated methods of analysis• Existing menthol analysis methods can produce widely variable results

• Even the best menthol analytical methods show inherent variability

• Without a standard, validated method, data generated by different laboratories should not be compared

– Multiple replicates• Analysis of a single sample cannot support any valid conclusion

– Valid statistical analysis of numerous data points• Statistical confidence increases with increasing data points

Characterization of Menthol – Summary

• Despite the inaccurate conclusion and deficient scientific methodology, Kreslake et al. continues to be cited as evidence that Lorillard strategically lowered the menthol levels in Newport

• Tens of thousands of data points over a ten year period demonstrate that the levels of menthol in Newport remained consistent

• The perpetuation of scientifically invalid studies to draw conclusions does an injustice to the scientific process

Characterization of Menthol – Summary

• Decisions regarding menthol must be

– data-driven

– founded on a rigorous review of all available data

– based on sound scientific methodology