The “Family Smoking
Prevention and Tobacco
Control Act”
Darryl Jayson
Vice President
Tobacco Merchants Association
2010 U.S. Tobacco Forum
June 10, 2010
Raleigh, North Carolina
The Family Smoking Prevention
and Tobacco Control Act
(HR 1256)


HR 1256 was signed by President Obama on
June 22, 2009.
HR 1256 grants the US Food & Drug
Administration (FDA) the authorization to
regulate the manufacture, sale and
distribution of tobacco products.
The Family Smoking Prevention
and Tobacco Control Act
Section
4b
Description
Agricultural Activities
“The provisions of this division (or an
amendment made by this division) which
authorize the Secretary to take certain
actions with regard to tobacco and tobacco
products shall not be construed to affect
any authority of the Secretary of
Agriculture under existing law regarding
the growing, cultivation, or curing of raw
tobacco.”
The Family Smoking Prevention
and Tobacco Control Act
Section
901
Description
FDA Authority Over Tobacco Products
While the FDA does have the authority to
regulate all tobacco products, this Act does
not apply to tobacco leaf:
(1) that is not in the possession of a
manufacturer of tobacco products; or
(2) of the producers of tobacco leaf,
including tobacco growers, tobacco
warehouses, and tobacco grower
cooperatives.
Nor shall any FDA employee have any
authority to enter onto a farm owned by a
producer of tobacco leaf without the
written consent of such producer.
FSPTCA – Implication for
Tobacco Growers


The FDA cannot directly affect tobacco
growing or its practices.
Indirectly, it is not as clear as manufacturer
leaf requirements could change over time.
The Family Smoking Prevention
and Tobacco Control Act
Section
901

Description
FDA Authority Over Tobacco Products
By September 22, 2009, the FDA must
create the “Center for Tobacco Products”
By an as-of-yet undetermined date, create
an office to assist small manufacturers
(those that employ less than 350 employees
in total for all entities)
902
Adulterated Tobacco Products
Defined as a tobacco product that consists
of “any filthy, putrid or decomposed
substance” or a “contaminated” product or
one “prepared, packed or held under
insanitary [sic] conditions”
The Family Smoking Prevention
and Tobacco Control Act
Section
903
904
Description
Misbranded Tobacco Products
Defines as those tobacco products with
labeling that is “false or misleading in any
particular;” those failing to provide an
“accurate statement of the quantity”.
Submission of Health Information
Cigarette manufacturers are required to
provide to the FDA:
Ingredient Disclosure
Smoke Constituents
All health-related and marketingrelated internal studies
Information concerning additives
The Family Smoking Prevention
and Tobacco Control Act
Section
905
Description
Annual Registration
On or before December 31st each year,
tobacco products manufacturers must
register their facilities & tobacco products.
906
General Provisions
Sets out general requirements with regard
to notices of proposed rulemakings,
public comment, and other aspects of
rulemakings.
Requires that all aspects of manufacturing,
including “preproduction design
validation” meet “good manufacturing
practices”.
The Family Smoking Prevention
and Tobacco Control Act
Section
907
Description
Tobacco Product Standards
Tobacco products will need to meet a
standard based on (1) nicotine yields; (2)
“construction, components , ingredients,
additives, constituents, including smoke
constituents, and properties”; and (3) as
determined by regulations related to
as-of-yet undefined testing on a sample.

The sale of flavored cigarettes is
prohibited (except for menthol), effective
September 22, 2009.
FSPTCA – Implication for
Tobacco Growers
Over time, tobacco growers may be asked by
manufacturers to:
Further restrict nitrosamines
Remove other, as of-yet-unknown,
constituents in tobacco leaf
(possibly created during the curing
process)
Use, restrict or limit certain pesticides,
herbicides or other chemicals currently
used in tobacco growing
The Family Smoking Prevention
and Tobacco Control Act
Section
907
Description
Tobacco Product Standards
Not later than one year after the
establishment of the TPSAC, this
committee will submit a report and
recommendations on “the impact on the
use of menthol in cigarettes on the public
health… among children, African
Americans, Hispanics and other racial and
ethnic minorities.”
The Secretary is not, however, limited in
his/her “authority to take action.”
The Family Smoking Prevention
and Tobacco Control Act
Section
907
Description
Tobacco Product Standards
Not later than 2 years after its
establishment, the TPSAC will issue a
report and recommendations on the
impact on the public health of dissolvable
tobacco products. Again, the Secretary’s
authority is not limited.
Beginning June 22, 2011, manufacturers
are prohibited from using either domestic
or foreign tobacco with pesticide residue
levels above a given tolerance.
The Family Smoking Prevention
and Tobacco Control Act
Section
907
Description
Tobacco Product Standards
Section 3: LIMITATION ON POWER
GRANTED TO THE FDA
“Because of the importance of a decision of the
Secretary to issue a regulation -(A) banning all cigarettes, all smokeless tobacco
products, all little cigars, all [large] cigars, all pipe
tobacco, or all roll-your-own tobacco products; or
(B) requiring the reduction of nicotine yields of a
tobacco product to zero,
the Secretary is prohibited from taking such actions
under this Act.”
The Family Smoking Prevention
and Tobacco Control Act
Section
908
Description
Notification & Other Remedies
Grants the FDA the authority to first issue
a notification order, if the Secretary
determines that a tobacco product
“presents an unreasonable risk of
substantial harm,” and second to issue a
recall notice.
909
Records & Reports on Tobacco Products
All manufacturers and importers are
required to maintain records and make
whatever reports are mandated under
regulation to ensure that the products are
neither misbranded nor adulterated.
The Family Smoking Prevention
and Tobacco Control Act
Section
910
Description
Application for Review of Tobacco Products
All tobacco products (including those in test
markets) that were not commercially
marketed in the U.S. as of February 15, 2007
or those that have undergone any
modification after February 15, 2007 are
considered “new tobacco products,” and are
subject to premarket reviews.
911
Modified Risk Tobacco Products
Pre-market approval is required though for
claims to be made with regard to relative
risk additional barriers need to be cleared
using as its basis the scientific evidence
presented by the applicant.
The Family Smoking Prevention
and Tobacco Control Act
Section
912
Description
Judicial Review
Any person adversely affected by the
regulation implementing the “tobacco
standard” or has his/her application for
review denied has 30 days to file a petition
for judicial review with the U.S. Court of
Appeals District of Columbia.
913
Equal Treatment of Retail Outlets
The FDA is required to issue regulations
bearing on advertising restrictions for
“retail establishments for which the
predominant business is the sale of
tobacco products” “accessible to
individuals under the age of 18.”
The Family Smoking Prevention
and Tobacco Control Act
Section
914
915
Description
Jurisdiction & Coordination with FTC
Regulation Requirement
By June 22, 2012 the FDA will issue
regulations that require the testing and
reporting of all tobacco product
constituents, ingredients and additives,
including smoke constituents.
Small manufacturers have two years from
the date the above regulations are
promulgated. Furthermore, a minimum
four year period is provided before test
results are required.
The Family Smoking Prevention
and Tobacco Control Act
Section
916
917
Description
Preservation of State & Local Authority
Tobacco Product Scientific Advisory
Committee
To be composed of 12 diverse members all
of whom are required to have knowledge
in at least one of “medicine, medical
ethics, science, or technology involving the
manufacturer, evaluation or use of tobacco
products”:
7 from the medical field
1 from government
1 from the general public
1 from tobacco manufacturing (non-voting)
1 from small tobacco manufacturing (non-voting)
1 from tobacco growers (non-voting)
FSPTCA – Implication for
Tobacco Growers


Tobacco growers will attend and participate
at TPSAC meetings, although will not have
an official vote when important decisions
are being made.
The issue of “evidence-based science” to
draw conclusions and eventually
regulations
Menthol cigarettes
Dissolvable tobacco products
The Family Smoking Prevention
and Tobacco Control Act
Section
918
Description
Drug Products Used to Treat Tobacco
Dependence
By June 22, 2012, the FDA is required to
submit to Congress “a report that
examines how best to regulate, promote
and encourage the development of
innovative products and treatments” that
result in total abstinence, reduced
consumption, and harm reduction from
continued use.
919

User Fees
To be paid by tobacco manufacturers on a
quarterly basis, beginning October 1, 2009.
FSPTCA – Implication for
Tobacco Growers


Although user fees are direct costs for
manufacturers, the average cost for these
fees will amount to less than 5¢ per pack.
The true cost increases for manufacturers
will come when they modify their
manufacturing processes to conform to
specifications listed in the new FDA
regulations.
The Family Smoking Prevention
and Tobacco Control Act
Section
201
Description
Cigarette Label and Advertising Warnings
By September 22, 2010, nine new cigarette
package warning labels are required to be
displayed on manufactured packages on a
random basis.
The new warnings need to occupy 50% of
the upper portion of the front and rear of
the pack, under transparent clear wrapping.
By June 22, 2011, the FDA will issue
regulations requiring color graphic
warning labels showing the health
consequences of smoking with whatever
size and format requirements the FDA
“determines appropriate.”
The Family Smoking Prevention
and Tobacco Control Act
Section
202
Description
Authority to Revise Cigarette Warning
Label Statements
203
State Regulation of Cigarette Advertising
and Promotion
204
Smokeless Tobacco Labels and
Advertising Warnings
205
Authority to Revise Smokeless Tobacco
Warning Label Statements
206
Tar, Nicotine and Other Smoke
Constituent Disclosure to the Public
The Family Smoking Prevention
and Tobacco Control Act
Section
301
Description
Labeling, Recordkeeping,
Record Inspection
By June 22, 2010, the “label, packaging,
and shipping containers of tobacco
products other than cigarettes”
manufactured for interstate commerce in
the U.S. need to display “Sale Only Allowed
in the United States” and for cigarette
manufacturing the same display is
required by September 22, 2010.
The Family Smoking Prevention
and Tobacco Control Act
Section
302
Description
Study and Report
By December 22, 2010, the Comptroller
General is required to deliver a report to
the Senate Health, Education, Labor and
Pensions Committee and the House
Energy and Commerce Committee on
cross-border trade in tobacco products,
including illicit trade and trade of
counterfeit tobacco products, as well as
cross-border advertising, disseminated
from the U.S. to other countries and to
make recommendations “on the
monitoring of such trade” and the
prevention or elimination of such
advertising.
FSPTCA Timeline
June 22, 2009
The Secretary of Health and Human Services began
assessing fees on tobacco manufacturers and
importers – fees collected quarterly – October 1, 2009.
September 22, 2009
Ban on flavored cigarettes (not menthol) took effect.
March 19, 2010
The CTP issued final rule regarding advertising and
marketing restrictions.
March 22, 2010
The 12-member Tobacco Products Scientific Advisory
Committee was appointed.
FSPTCA Timeline - DELAYS
December 22, 2009
(1) Cigarette manufacturers to submit list of all
additives by brand/subbrand/quantity.
(2) Cigarette manufacturers to submit documents
relating to health effects of tobacco products.
January 1, 2010
(1) Companies to register tobacco product
establishments.
(2) Cigarette manufacturers to submit product lists
and report any changes.
FSPTCA Timeline
By June 22, 2010
(1) Cigarette manufacturers to comply with
advertising and marketing restrictions in Final Rule.
(2) Descriptor (“light”, “mild”, “low”) ban
[Color?]
(3) Smokeless tobacco products:
“Sale only allowed in United States” label
Information, including domestic/foreign
content on label
New warning statements on advertisements and
warning label changes
FDA Draft Guidances for these measures were
released by the Center for Tobacco Products on June
3-4, 2010.
FSPTCA Timeline
By October 1, 2010
(1) The CTP to develop and publish an action plan to
enforce restrictions on cigarette promotion and
advertising to youth.
By December 22, 2010
(1) The Comptroller General (GAO) to issue report
on cross-border tobacco trade.
FSPTCA Timeline
By June 22, 2011
(1) The CTP to issue regulations regarding color
graphic warning labels/regulations.
(2) Pesticide limitations for tobacco.
By October 1, 2011
(1) The CTP to issue regulations regarding the
remote sale/distribution of tobacco products.
(2) The TPSAC to issue its report on menthol
cigarettes.
FSPTCA – Implication for
Tobacco Growers


Many elements of the current leaf
requirements by domestic cigarette makers
will remain unchanged.
The U.S. cigarette industry will continue to
decline but not disappear over time,
thereby reducing leaf quantity needs.
FSPTCA – Implication for
Tobacco Growers


An opinion: The regulations created and
enforced by the Center for Tobacco
Products must not contribute to increases
in illicit trade.
For example, a sales prohibition of menthol
cigarettes would create a 27% gap in the
U.S. domestic cigarette market, which
potentially could be filled by illegal
imported, untaxed and unregulated
product.
The “PACT” Act (SB.1147)


The “Prevent All Cigarette Trafficking Act
of 2009” or “PACT Act” was signed by
President Obama on March 31, 2010 and
goes into effect on June 30, 2010.
Among other things, the PACT Act amends
the Jenkins Act to include smokeless
tobacco and prohibits the mailing of
cigarettes and smokeless tobacco through
the U.S. Postal Service.
C-32

A Canadian bill officially titled:
“The Cracking Down on Tobacco Marketing
Aimed at Youth Act”

Received Royal Assent on October 8, 2009

Scheduled to go into effect on July 5, 2010

C-32 to ban the sale of flavored cigarettes,
cigarillos and blunt wraps, with the
exception of menthol.
C-32



Would ban all flavors in cigarettes,
cigarillos and blunt wraps, regardless of
whether the flavor was “characterizing” or
not
Would ban non-characterizing flavors such
as licorice and cocoa
Would effectively ban the import of U.S.
cigarettes and burley leaf into Canada
C-32: Future Implications


Since Canada is a Virginia flue-cured
cigarette market, C-32 can be interpreted as
protectionist in that it would restrict trade
in regular tobacco products to the benefit of
the domestic industry.
The TobReg working group of the
Framework Convention on Tobacco Control
(FCTC) is examining C-32 as it may apply to
Article 9 (Regulation of the contents of
tobacco products ).
U.S. Burley Leaf & Cigarette
Exports to Canada
(MT, Million of Pieces)
500
400
418.1
377.7
387.5
352.2
300
200
133.2
100
14.3
10.8
0
2001
84.0
57.0
47.8
65.5
2002
2003
0.0
2004
0.0
2005
2006
49.4
0.0
2007
Burley Leaf
0.0
2008
21.2
2.3
2009
YTD
Cigarettes
Source: TMA’s Tobacco Trade Barometer (2002-09)
C-32: Future Implications



Does the FDA have the authority to extend
its current flavor cigarette ban to “noncharacterizing” flavors?
Will EU nations follow Canada’s lead and
implement a similar flavor ban?
How does competition get affected around
the world as a “total” flavor ban affects
some multinational cigarette makers over
others?
FCTC and U.S. Law
FCTC Checklist:
 (Article 5)
 (Article 6)
 (Article 8)
 (Article 9)
 (Article 10)
 (Article 11)
General Obligations
Price and Tax Measures [SCHIP]
Protection from ETS [State/Local]
Contents of Tobacco Products [FDA]
Tobacco Product Disclosure [FDA]
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 YOU
darryl@tma.org
609-275-4900, Ext. 216