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TheThe “Family Smoking “Family Smoking Prevention and Tobacco Prevention and Tobacco
Control Act”Control Act”
Darryl JaysonVice President
Tobacco Merchants Association
2010 U.S. Tobacco ForumJune 10, 2010
Raleigh, North Carolina
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act(HR 1256)(HR 1256)
HR HR 12561256 was signed by President was signed by President Obama on Obama on June 22, 2009June 22, 2009..
HR HR 12561256 grants the US Food & Drug grants the US Food & Drug Administration (FDA) the authorization Administration (FDA) the authorization to regulate the manufacture, sale and to regulate the manufacture, sale and distribution of tobacco products.distribution of tobacco products.
SectionSection DescriptionDescription 4b4b Agricultural ActivitiesAgricultural Activities
““The provisions of this division (or anThe provisions of this division (or anamendment made by this division) amendment made by this division)
whichwhichauthorize the Secretary to take authorize the Secretary to take
certaincertainactions with regard to tobacco and actions with regard to tobacco and
tobaccotobaccoproducts shall not be construed to products shall not be construed to
affectaffectany authority of the Secretary ofany authority of the Secretary ofAgriculture under existing law Agriculture under existing law
regardingregardingthe growing, cultivation, or curing of the growing, cultivation, or curing of
rawrawtobacco.”tobacco.”
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 901901 FDA Authority Over Tobacco ProductsFDA Authority Over Tobacco Products
While the FDA does have the While the FDA does have the authority toauthority to
regulate all tobacco products, regulate all tobacco products, this Act this Act doesdoes
not apply to tobacco leaf:not apply to tobacco leaf:(1) that is not in the possession of a(1) that is not in the possession of amanufacturer of tobacco products; or manufacturer of tobacco products; or (2) of the producers of tobacco leaf, (2) of the producers of tobacco leaf, including tobacco growers, tobaccoincluding tobacco growers, tobaccowarehouses, and tobacco growerwarehouses, and tobacco growercooperatives.cooperatives.
Nor shall any FDA employee have anyNor shall any FDA employee have anyauthority to enter onto a farm owned authority to enter onto a farm owned
by aby aproducer of tobacco leaf without theproducer of tobacco leaf without thewritten consent of such producer.written consent of such producer.
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
FSPTCA – Implication for FSPTCA – Implication for Tobacco GrowersTobacco Growers
The FDA cannot The FDA cannot directlydirectly affect tobacco affect tobacco growing or its practices.growing or its practices.
IndirectlyIndirectly, it is not as clear as , it is not as clear as manufacturer leaf requirements could manufacturer leaf requirements could change over time.change over time.
SectionSection DescriptionDescription 901901 FDA Authority Over Tobacco ProductsFDA Authority Over Tobacco Products
By September 22, 2009, the FDA mustBy September 22, 2009, the FDA must create the “Center for Tobacco create the “Center for Tobacco Products”Products”
By an as-of-yet undetermined date, By an as-of-yet undetermined date, createcreate
an office to assist small an office to assist small manufacturersmanufacturers
(those that employ less than 350 (those that employ less than 350 employeesemployees
in total for all entities)in total for all entities) 902902 Adulterated Tobacco ProductsAdulterated Tobacco Products
Defined as a tobacco product that Defined as a tobacco product that consistsconsists
of “of “any filthy, putrid or decomposedany filthy, putrid or decomposedsubstancesubstance” or a “” or a “contaminatedcontaminated” ”
product orproduct orone “one “prepared, packed or held underprepared, packed or held underinsanitary [sic] conditionsinsanitary [sic] conditions””
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 903903 Misbranded Tobacco ProductsMisbranded Tobacco Products
Defines as those tobacco products Defines as those tobacco products withwith
labeling that is “labeling that is “false or misleading false or misleading in anyin any
particularparticular;” those failing to provide ;” those failing to provide anan
““accurate statement of the quantityaccurate statement of the quantity”.”.
904904 Submission of Health InformationSubmission of Health InformationCigarette manufacturers are required Cigarette manufacturers are required
totoprovide to the FDA:provide to the FDA:
Ingredient DisclosureIngredient DisclosureSmoke ConstituentsSmoke ConstituentsAll health-related and marketing-All health-related and marketing-related internal studiesrelated internal studiesInformation concerning additivesInformation concerning additives
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 905905 Annual RegistrationAnnual Registration
On or before December 31st each On or before December 31st each year,year,
tobacco products manufacturers tobacco products manufacturers mustmust
register their facilities & tobacco register their facilities & tobacco products.products.
906906 General ProvisionsGeneral ProvisionsSets out general requirements with Sets out general requirements with
regard regard to notices of proposed rulemakings,to notices of proposed rulemakings,public comment, and other aspects public comment, and other aspects
ofofrulemakings.rulemakings.
Requires that all aspects of Requires that all aspects of manufacturing, manufacturing, including “including “preproduction preproduction designdesign
validationvalidation” meet “” meet “good good manufacturingmanufacturing
practicespractices”. ”.
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 907907 Tobacco Product StandardsTobacco Product Standards
Tobacco products will need to meet aTobacco products will need to meet astandard based on (1) standard based on (1) nicotine nicotine
yieldsyields; (2); (2)““construction, components , construction, components ,
ingredients,ingredients,additives, constituents, including additives, constituents, including
smokesmokeconstituents, and propertiesconstituents, and properties”; and ”; and
(3) as(3) asdetermined by regulations related todetermined by regulations related toas-of-yet undefined testing as-of-yet undefined testing on a on a
sample.sample.
The sale of flavored cigarettes isThe sale of flavored cigarettes is prohibited (except for prohibited (except for mentholmenthol), ), effectiveeffective
September 22, 2009.September 22, 2009.
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
FSPTCA – Implication for FSPTCA – Implication for Tobacco GrowersTobacco Growers
Over time, tobacco growers may be asked Over time, tobacco growers may be asked by manufacturers to:by manufacturers to:
Further restrict nitrosaminesFurther restrict nitrosaminesRemove other, as of-yet-unknown,Remove other, as of-yet-unknown,constituents in tobacco leafconstituents in tobacco leaf(possibly created during the curing(possibly created during the curingprocess)process)
Use, restrict or limit certain Use, restrict or limit certain pesticides,pesticides,
herbicides or other chemicals herbicides or other chemicals currentlycurrently
used in tobacco growingused in tobacco growing
SectionSection DescriptionDescription 907907 Tobacco Product StandardsTobacco Product Standards
Not later than one year after theNot later than one year after theestablishment of the TPSAC, thisestablishment of the TPSAC, thiscommittee will submit a report andcommittee will submit a report andrecommendations on “recommendations on “the impact on the impact on
thetheuse of menthol in cigarettes on the use of menthol in cigarettes on the
publicpublichealth… among children, Africanhealth… among children, AfricanAmericans, Hispanics and other Americans, Hispanics and other
racial andracial andethnic minoritiesethnic minorities.” .”
The Secretary is The Secretary is notnot, however, , however, limited inlimited in
his/her “authority to take action.”his/her “authority to take action.”
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 907907 Tobacco Product StandardsTobacco Product Standards
Not later than 2 years after itsNot later than 2 years after itsestablishment, the TPSAC will issue establishment, the TPSAC will issue
aareport and recommendations on thereport and recommendations on theimpact on the public health of impact on the public health of
dissolvabledissolvabletobacco productstobacco products. Again, the . Again, the
Secretary’sSecretary’sauthority is not limited. authority is not limited.
Beginning June 22, 2011, Beginning June 22, 2011, manufacturersmanufacturers
are prohibited from using either are prohibited from using either domesticdomestic
or foreign tobacco with or foreign tobacco with pesticide pesticide residueresidue
levels above a given tolerance. levels above a given tolerance.
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 907907 Tobacco Product StandardsTobacco Product Standards
Section 3: LIMITATION ON POWERSection 3: LIMITATION ON POWERGRANTED TO THE FDAGRANTED TO THE FDA
““Because of the importance of a decision of the Because of the importance of a decision of the Secretary to issue a regulation -- Secretary to issue a regulation --
(A) banning all cigarettes, all smokeless tobacco (A) banning all cigarettes, all smokeless tobacco products, all little cigars, all [large] cigars, all products, all little cigars, all [large] cigars, all pipe tobacco, or all roll-your-own tobacco pipe tobacco, or all roll-your-own tobacco productsproducts; or ; or
(B) requiring the reduction of nicotine yields of (B) requiring the reduction of nicotine yields of a tobacco product to zeroa tobacco product to zero, ,
the Secretary is prohibited from taking such the Secretary is prohibited from taking such actions under this Actactions under this Act.” .”
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 908908 Notification & Other RemediesNotification & Other Remedies
Grants the FDA the authority to first Grants the FDA the authority to first issueissue
a notification order, if the Secretarya notification order, if the Secretarydetermines that a tobacco productdetermines that a tobacco product“presents an unreasonable risk of“presents an unreasonable risk ofsubstantial harm,” and second to substantial harm,” and second to
issue aissue arecall notice.recall notice.
909909 Records & Reports on Tobacco Records & Reports on Tobacco ProductsProducts
All manufacturers and importers areAll manufacturers and importers arerequired to maintain records and required to maintain records and
makemakewhatever reports are mandated whatever reports are mandated
underunderregulation to ensure that the regulation to ensure that the
products areproducts areneither misbranded nor adulterated.neither misbranded nor adulterated.
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 910910 Application for Review of Tobacco Application for Review of Tobacco ProductsProducts
All tobacco products (including those All tobacco products (including those in testin test
markets) that were not commerciallymarkets) that were not commerciallymarketed in the U.S. as of February marketed in the U.S. as of February
15, 200715, 2007or those that have undergone anyor those that have undergone anymodification after February 15, 2007 modification after February 15, 2007
areareconsidered “new tobacco products,” considered “new tobacco products,”
and areand aresubject to premarket reviews.subject to premarket reviews.
911911 Modified Risk Tobacco ProductsModified Risk Tobacco ProductsPre-market approval is required Pre-market approval is required
though forthough forclaims to be made with regard to claims to be made with regard to
relativerelativerisk additional barriers need to be risk additional barriers need to be
clearedclearedusing as its basis the scientific using as its basis the scientific
evidenceevidencepresented by the applicant.presented by the applicant.
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 912912 Judicial ReviewJudicial Review
Any person adversely affected by theAny person adversely affected by theregulation implementing the regulation implementing the
“tobacco“tobaccostandard” or has his/her application standard” or has his/her application
forforreview denied has 30 days to file a review denied has 30 days to file a
petitionpetitionfor judicial review with the U.S. for judicial review with the U.S.
Court ofCourt ofAppeals District of Columbia.Appeals District of Columbia.
913913 Equal Treatment of Retail OutletsEqual Treatment of Retail Outlets
The FDA is required to issue The FDA is required to issue regulationsregulations
bearing on advertising restrictions bearing on advertising restrictions forfor
““retail establishments for which theretail establishments for which thepredominant business is the sale ofpredominant business is the sale oftobacco productstobacco products” “” “accessible toaccessible toindividuals under the age of 18individuals under the age of 18.” .”
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 914914 Jurisdiction & Coordination with FTCJurisdiction & Coordination with FTC
915915 Regulation RequirementRegulation Requirement
By June 22, 2012 the FDA will issueBy June 22, 2012 the FDA will issueregulations that require the testing regulations that require the testing
andandreporting of all tobacco productreporting of all tobacco productconstituents, ingredients and constituents, ingredients and
additives,additives,including smoke constituents.including smoke constituents.
Small manufacturers have two years Small manufacturers have two years fromfrom
the date the above regulations arethe date the above regulations arepromulgated. Furthermore, a promulgated. Furthermore, a
minimumminimumfour year period is provided before four year period is provided before
testtestresults are required.results are required.
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 916916 Preservation of State & Local Preservation of State & Local AuthorityAuthority
917917 Tobacco Product Scientific AdvisoryTobacco Product Scientific AdvisoryCommitteeCommitteeTo be composed of 12 diverse To be composed of 12 diverse
members allmembers allof whom are required to have of whom are required to have
knowledgeknowledgein at least one of “medicine, medicalin at least one of “medicine, medicalethics, science, or technology ethics, science, or technology
involving theinvolving themanufacturer, evaluation or use of manufacturer, evaluation or use of
tobaccotobaccoproducts”: products”: 7 from the medical field7 from the medical field1 from government1 from government1 from the general public1 from the general public1 from tobacco manufacturing 1 from tobacco manufacturing (non-voting)(non-voting) 1 from small tobacco manufacturing 1 from small tobacco manufacturing (non-(non-
voting)voting)1 from tobacco growers1 from tobacco growers (non-voting) (non-voting)
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
FSPTCA – Implication for FSPTCA – Implication for Tobacco GrowersTobacco Growers
Tobacco growers will attend and Tobacco growers will attend and participate at TPSAC meetings, participate at TPSAC meetings, although will not have an official vote although will not have an official vote when important decisions are being when important decisions are being made.made.
The issue of “evidence-based science” The issue of “evidence-based science” to draw conclusions and eventually to draw conclusions and eventually regulationsregulations
MentholMenthol cigarettes cigarettesDissolvableDissolvable tobacco products tobacco products
SectionSection DescriptionDescription 918918 Drug Products Used to Treat Drug Products Used to Treat TobaccoTobacco
DependenceDependence
By June 22, 2012, the FDA is By June 22, 2012, the FDA is required torequired to
submit to Congress “a report thatsubmit to Congress “a report thatexamines how best to regulate, examines how best to regulate,
promotepromoteand encourage the development ofand encourage the development ofinnovative products and treatments” innovative products and treatments”
thatthatresult in total abstinence, reducedresult in total abstinence, reducedconsumption, and harm reduction consumption, and harm reduction
fromfromcontinued use.continued use.
919919 User FeesUser FeesTo be paid by tobacco manufacturers To be paid by tobacco manufacturers
on aon a quarterly basis, beginning October 1, quarterly basis, beginning October 1, 2009.2009.
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
FSPTCA – Implication for FSPTCA – Implication for Tobacco GrowersTobacco Growers
Although user fees are direct costs for Although user fees are direct costs for manufacturers, the average cost for manufacturers, the average cost for these fees will amount to less than these fees will amount to less than 5¢5¢ per pack.per pack.
The true cost increases for The true cost increases for manufacturers will come when they manufacturers will come when they modify their manufacturing processes modify their manufacturing processes to conform to specifications listed in to conform to specifications listed in the new FDA regulations.the new FDA regulations.
SectionSection DescriptionDescription 201201 Cigarette Label and Advertising Cigarette Label and Advertising WarningsWarnings
By September 22, 2010, By September 22, 2010, nine new nine new cigarettecigarette
package warning labelspackage warning labels are required to are required to bebe
displayed on manufactured packages displayed on manufactured packages on aon a
random basis.random basis.
The new warnings need to occupy The new warnings need to occupy 50%50% ofof
the upper portion of the front and rear the upper portion of the front and rear ofof
the pack, under transparent clear the pack, under transparent clear wrapping.wrapping.
By June 22, 2011, the FDA will issueBy June 22, 2011, the FDA will issueregulations requiring regulations requiring color graphiccolor graphicwarning labelswarning labels showing the health showing the healthconsequences of smoking with consequences of smoking with
whateverwhateversize and format requirements the FDA size and format requirements the FDA “determines appropriate.” “determines appropriate.”
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 202202 Authority to Revise Cigarette Authority to Revise Cigarette WarningWarning
Label StatementsLabel Statements
203203 State Regulation of Cigarette State Regulation of Cigarette AdvertisingAdvertising
and Promotionand Promotion
204204 Smokeless Tobacco Labels andSmokeless Tobacco Labels andAdvertising WarningsAdvertising Warnings
205205 Authority to Revise Smokeless Authority to Revise Smokeless Tobacco Tobacco
Warning Label StatementsWarning Label Statements
206206 Tar, Nicotine and Other SmokeTar, Nicotine and Other SmokeConstituent Disclosure to the PublicConstituent Disclosure to the Public
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 301301 Labeling, Recordkeeping,Labeling, Recordkeeping,
Record InspectionRecord Inspection
By June 22, 2010, the “label, By June 22, 2010, the “label, packaging,packaging,
and shipping containers of tobaccoand shipping containers of tobaccoproducts other than cigarettes”products other than cigarettes”manufactured for interstate manufactured for interstate
commerce incommerce inthe U.S. need to display “Sale Only the U.S. need to display “Sale Only
AllowedAllowedin the United States” and for in the United States” and for
cigarettecigarettemanufacturing the same display ismanufacturing the same display isrequired by September 22, 2010.required by September 22, 2010.
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
SectionSection DescriptionDescription 302302 Study and ReportStudy and Report
By December 22, 2010, By December 22, 2010, the the ComptrollerComptroller
General is required to deliver a General is required to deliver a report report toto
the Senate Health, Education, Labor the Senate Health, Education, Labor andand
Pensions Committee and the HousePensions Committee and the HouseEnergy and Commerce Committee Energy and Commerce Committee ononcross-border trade in tobacco cross-border trade in tobacco
products,products,including illicit trade and trade ofincluding illicit trade and trade ofcounterfeit tobacco productscounterfeit tobacco products, as well , as well
asascross-border advertising, cross-border advertising,
disseminateddisseminatedfrom the U.S. to other countries and from the U.S. to other countries and
totomake recommendations “on themake recommendations “on themonitoring of such trade” and themonitoring of such trade” and theprevention or elimination of suchprevention or elimination of suchadvertising.advertising.
The Family Smoking The Family Smoking Prevention and Tobacco Prevention and Tobacco
Control ActControl Act
FSPTCA TimelineFSPTCA TimelineJune 22, 2009June 22, 2009 The Secretary of Health and Human Services The Secretary of Health and Human Services began assessing fees on tobacco manufacturers began assessing fees on tobacco manufacturers and importers – fees collected quarterly – October and importers – fees collected quarterly – October 1, 2009.1, 2009.
September 22, 2009September 22, 2009
Ban on flavored cigarettes (not Ban on flavored cigarettes (not mentholmenthol) took ) took effect.effect.
March 19, 2010March 19, 2010 The CTP issued final rule regarding The CTP issued final rule regarding advertising advertising and marketing restrictionsand marketing restrictions. .
March 22, 2010March 22, 2010
The 12-member The 12-member Tobacco Products Scientific Tobacco Products Scientific Advisory Committee Advisory Committee was appointedwas appointed..
FSPTCA Timeline - FSPTCA Timeline - DELAYSDELAYS
December 22, 2009December 22, 2009 (1) Cigarette manufacturers to submit list of all (1) Cigarette manufacturers to submit list of all additives by brand/subbrand/quantity.additives by brand/subbrand/quantity.(2) Cigarette manufacturers to submit (2) Cigarette manufacturers to submit documents relating to health effects of tobacco documents relating to health effects of tobacco products.products.
January 1, 2010January 1, 2010 (1) Companies to register tobacco product (1) Companies to register tobacco product establishments.establishments.(2) Cigarette manufacturers to submit product (2) Cigarette manufacturers to submit product lists and report any changes.lists and report any changes.
FSPTCA TimelineFSPTCA Timeline
By June 22, 2010By June 22, 2010
(1)(1) Cigarette manufacturers to comply with Cigarette manufacturers to comply with advertising and marketing restrictions in Final advertising and marketing restrictions in Final Rule.Rule.(2) Descriptor (“light”, “mild”, “low”) ban(2) Descriptor (“light”, “mild”, “low”) ban
[Color?][Color?](3) Smokeless tobacco products:(3) Smokeless tobacco products:
““Sale only allowed in United States” labelSale only allowed in United States” labelInformation, including domestic/foreignInformation, including domestic/foreigncontent on labelcontent on labelNew warning statements on New warning statements on
advertisements andadvertisements andwarning label changeswarning label changes
FDA Draft Guidances for these measures were FDA Draft Guidances for these measures were released by the Center for Tobacco Products on released by the Center for Tobacco Products on June 3-4, 2010.June 3-4, 2010.
FSPTCA TimelineFSPTCA Timeline
By October 1, 2010By October 1, 2010
(1) (1) The CTP to develop and publish an action The CTP to develop and publish an action plan to plan to enforce restrictions on cigarette enforce restrictions on cigarette promotion and advertising to youthpromotion and advertising to youth. .
By December 22, 2010By December 22, 2010
(1) (1) The Comptroller General (GAO) to issue The Comptroller General (GAO) to issue report onreport on cross-border tobacco trade. cross-border tobacco trade.
FSPTCA TimelineFSPTCA Timeline
By June 22, 2011By June 22, 2011 (1) The CTP to issue regulations regarding (1) The CTP to issue regulations regarding color graphic warning labels/regulationscolor graphic warning labels/regulations..
(2) Pesticide limitations (2) Pesticide limitations for tobacco.for tobacco.
By October 1, 2011By October 1, 2011
(1) (1) The CTP to issue regulations regarding The CTP to issue regulations regarding the the remote sale/distribution of tobacco products.remote sale/distribution of tobacco products.
(2) (2) The TPSAC to issue its report on The TPSAC to issue its report on mentholmenthol cigarettes.cigarettes.
FSPTCA – Implication for FSPTCA – Implication for Tobacco GrowersTobacco Growers
Many elements of the current leaf Many elements of the current leaf requirements by domestic cigarette requirements by domestic cigarette makers will remain unchanged.makers will remain unchanged.
The U.S. cigarette industry will The U.S. cigarette industry will continue to decline but not disappear continue to decline but not disappear over timeover time, thereby reducing leaf , thereby reducing leaf quantity needs.quantity needs.
FSPTCA – Implication for FSPTCA – Implication for Tobacco GrowersTobacco Growers
An opinionAn opinion: The regulations created : The regulations created and enforced by the Center for Tobacco and enforced by the Center for Tobacco Products must Products must notnot contribute to contribute to increases in illicit trade. increases in illicit trade.
For example, a sales prohibition of For example, a sales prohibition of mentholmenthol cigarettes would create a 27% cigarettes would create a 27% gap in the U.S. domestic cigarette gap in the U.S. domestic cigarette market, which potentially could be market, which potentially could be filled by illegal imported, untaxed and filled by illegal imported, untaxed and unregulated product. unregulated product.
The “PACT” Act The “PACT” Act (SB.1147)(SB.1147)
The “Prevent All Cigarette Trafficking The “Prevent All Cigarette Trafficking Act of 2009” or “PACT Act” was signed Act of 2009” or “PACT Act” was signed by President Obama on by President Obama on March 31, 2010 March 31, 2010 and goes into effect on June 30, 2010.and goes into effect on June 30, 2010.
Among other things, the PACT Act Among other things, the PACT Act amends the Jenkins Act to include amends the Jenkins Act to include smokeless tobacco and prohibits the smokeless tobacco and prohibits the mailing of cigarettes and smokeless mailing of cigarettes and smokeless tobacco through the U.S. Postal tobacco through the U.S. Postal Service.Service.
C-32C-32
A Canadian bill officially titled:A Canadian bill officially titled:“The Cracking Down on Tobacco “The Cracking Down on Tobacco Marketing Aimed at Youth Act”Marketing Aimed at Youth Act”
Received Royal Assent on Received Royal Assent on October 8, October 8, 20092009
Scheduled to go into effect on Scheduled to go into effect on July 5, July 5, 20102010
C-32C-32 to ban the sale of flavored to ban the sale of flavored cigarettes, cigarillos and blunt wraps, cigarettes, cigarillos and blunt wraps, with the exception of with the exception of mentholmenthol..
C-32C-32
Would ban all flavors in cigarettes, Would ban all flavors in cigarettes, cigarillos and blunt wraps, cigarillos and blunt wraps, regardless regardless of whether the flavor was of whether the flavor was “characterizing” or not“characterizing” or not
Would ban non-characterizing flavors Would ban non-characterizing flavors such as licorice and cocoasuch as licorice and cocoa
Would effectivelyWould effectively ban the import of U.S. ban the import of U.S. cigarettes and burley leaf into Canadacigarettes and burley leaf into Canada
C-32: Future C-32: Future ImplicationsImplications
Since Canada is a Virginia flue-cured Since Canada is a Virginia flue-cured cigarette market, cigarette market, C-32C-32 can be can be interpreted as interpreted as protectionistprotectionist in that it in that it would restrict trade in regular tobacco would restrict trade in regular tobacco products to the benefit of the domestic products to the benefit of the domestic industry. industry.
The TobReg working group of the The TobReg working group of the Framework Convention on Tobacco Framework Convention on Tobacco Control (FCTC) is examining Control (FCTC) is examining C-32C-32 as it as it may apply to Article 9 (may apply to Article 9 (Regulation of Regulation of the contents of tobacco productsthe contents of tobacco products ). ).
U.S. Burley Leaf & Cigarette Exports to Canada(MT, Million of Pieces)
14.3
387.5
65.5
418.1
10.8
377.7
0.0
352.2
0.0
47.8 57.084.0
0.0
133.2
0.0
49.4
2.321.20
100
200
300
400
500
2001 2002 2003 2004 2005 2006 2007 2008 2009YTD
Burley Leaf Cigarettes
Source: TMA’s Tobacco Trade Barometer (2002-09)
C-32: Future C-32: Future ImplicationsImplications
Does the FDA have the authority to Does the FDA have the authority to extend its current flavor cigarette ban extend its current flavor cigarette ban to “non-characterizing” flavors?to “non-characterizing” flavors?
Will EU nations follow Canada’s lead Will EU nations follow Canada’s lead and implement a similar flavor ban?and implement a similar flavor ban?
How does competition get affected How does competition get affected around the world as a “total” flavor ban around the world as a “total” flavor ban affects some multinational cigarette affects some multinational cigarette makers over others?makers over others?
FCTC and U.S. LawFCTC Checklist:
(Article 5) General Obligations (Article 6) Price and Tax
Measures [SCHIP] (Article 8) Protection from ETS
[State/Local] (Article 9) Contents of Tobacco
Products [FDA] (Article 10) Tobacco Product
Disclosure [FDA] (Article 11) Packaging & Labeling of Tobacco
Products [FDA] (Article 12)Education, Communication,
Training & Public Awareness [Health Care]
(Article 13)Tobacco Advertising, Promotion & Sponsorship [FDA]
(Article 15) Illicit Trade in Tobacco Products [CCTA, PACT Act, FDA/GAO…STOP?]
(Article 16) Sales to and By Minors [FDA, State]
(Article 19) Liability [MSA, Progeny Engle, History]
THANK YOUTHANK YOU
609-275-4900, Ext. 216609-275-4900, Ext. 216