Mini Gautam, B.S.L LL.B from ILS Law College and currently pursuing LLM in International Financial Law from Kings College London.
Anshuman Chanda, B.S.L LL.B from ILS Law College and currently pursuing LLM in Tax Law from Kings College London.
Family Smoking Prevention and Tobacco Control Act, 2009
An Analysis of the US Law
The Family Smoking Prevention and Tobacco Control Act, 2009 amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration (FDA), including through disclosure, annual registration, inspection, recordkeeping, and user fee requirements. The Act was signed into law on June 22, 2009 by President Barack Obama.
Enforcement of the Act
Any violation of this Act pertaining to advertising is deemed to be an unfair or deceptive act or practice under section 5(a) of the Federal Trade Commission (FTC) Act. The Chairman of FTC is required to coordinate with the Secretary concerning enforcement of the FTC Act for the advertisement of cigarettes or smokeless tobacco. The Secretary is also required to consult with the Chairman in revising the label statements and requirements for tobacco products under the FTC Act. (s.914)
Authority- The Act grants the federal government authority to regulate tobacco products Directs the Secretary to establish within FDA: (1) the Center for Tobacco Products to implement this Act and to be established not later than 90 days after its commencement; and (2) an identifiable office to provide technical and other non financial assistance to assist small tobacco product manufacturers in complying with this Act (s.901).
Tobacco Products Scientific Advisory Committee.- Not later than 6 months after the date of enactment, the Secretary shall establish a 12-member advisory committee known as the Tobacco Products Scientific Advisory Committee to provide advice, information, and recommendations to the Secretary, including on the effects of altering nicotine yields from tobacco products and whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved. (s.917)
Application of the Act.-The Act shall not:
· Prohibit federal agencies, states, political subdivisions, or Indian tribes from enacting additional or more stringent measures, except requirements relating to tobacco product standards, pre market review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products;
· Prohibit state, tribal, or local taxation of tobacco products; and
· Modify or affect the liability of any person under the product liability laws of any state.(s.916)
Definition of Tobacco product.- A tobacco product is defined as any product made or derived from tobacco that is intended for human consumption. A tobacco product is prohibited from being marketed in combination with any other article or product regulated under Federal Food, Drug, and Cosmetic Act (FFDCA).
Labeling and Advertising.
Label.- Section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333) is amended. Cigarette packages must contain one of the following labels:
‘‘WARNING: Cigarettes are addictive.”
‘‘WARNING: Tobacco smoke can harm your children.”
‘‘WARNING: Cigarettes cause fatal lung disease.”
‘‘WARNING: Cigarettes cause cancer.”
‘‘WARNING: Cigarettes cause strokes and heart disease.”
‘‘WARNING: Smoking during pregnancy can harm your baby.”
‘‘WARNING: Smoking can kill you.”
‘‘WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.”
‘‘WARNING: Quitting smoking now greatly reduces serious risks to your health.” -s.201(a)(1)
Graphic Label Statements.- Not later than 24 months after the date of enactment, the Secretary shall issue regulations that require colour graphics depicting negative health consequences of smoking. s.201(d)
Placement of Label.- Each label shall be located in the upper portion of the front and rear panels of the package, directly on the package underneath the cellophane or other clear wrapping. The word ‘WARNING’ shall appear in capital letters and all text shall be in conspicuous and legible 17-point type, unless the text of the label statement would occupy more than 70 percent of such area, in which case the text may be in a smaller conspicuous and legible type size, provided that at least 60 percent of such area is occupied by required text. The text shall be black on a white background, or white on a black background, in a manner that contrasts, by typography, layout, or color, with all other printed material on the package, in an alternating fashion. s.201(a)(2)
Advertising.- Advertisement is prohibited if it does not bear the label specified above. The standards for advertising are as follows.-
ü For press and poster advertisements, each such statement and (where applicable)
any required statement relating to tar, nicotine, or other constituent (including a smoke constituent) yield shall comprise at least 20 percent of the area of the advertisement and shall appear in a conspicuous and prominent format and location at the top of each advertisement within the trim area. The Secretary may revise the required type sizes in such area in such manner as he deems appropriate.
ü The word ‘WARNING’ shall appear in capital letters, and each label statement shall appear in conspicuous and legible type.
ü The text of the label statement shall be black if the background is white and white if the background is black. The label statements shall be enclosed by a rectangular border that is the same color as the letters of the statements and that is the width of the first downstroke of the capital ‘W’ of the word ‘WARNING’ in the label statements.
ü The text of such label statements shall be in a typeface pro rata to the following requirements:
# 45-point type for a whole-page broadsheet newspaper advertisement;
# 39-point type for a half-page broadsheet newspaper advertisement;
# 39-point type for a whole-page tabloid newspaper advertisement;
# 27-point type for a half-page tabloid newspaper advertisement;
# 31.5-point type for a double page spread magazine or whole-page magazine advertisement;
# 22.5-point type for a 28 centimeter by 3 column advertisement; and
# 15-point type for a 20 centimeter by 2 column advertisement.
ü The label statements shall be in English, except that:
· In the case of an advertisement that appears in a publication that is not in English, the statements shall appear in the predominant language of the publication; and
· In the case of any other advertisement that is not in English, the statements shall appear in the same language as that principally used in the advertisement. s.201(b)
Authority to Revise Warning Label Statements.- The Secretary has the authority to alter label requirements to promote greater public understanding of the risks associated with the use of tobacco products. States or localities are allowed to impose specific bans or restrictions on the time, place, and manner, but not the content, of the advertising or promotion of any cigarettes. (s.202, 203)
Smokeless Tobacco Products.- The Comprehensive Smokeless Tobacco Health Education Act of 1986 is amended to apply the same restrictions on labeling and advertising to smokeless tobacco products. (s.204)
Disclosure to the Public.- The Secretary is to determine whether manufacturers should be required to include on the label and advertisements the tar and nicotine yields of the product. The Secretary is to determine disclosure of the level of constituents in a tobacco product if such disclosures would benefit the public health or increase consumer awareness of the health consequences of the use of tobacco products (s.206)
Adulterated tobacco product.- A tobacco product is deemed to be adulterated if
· It contains any filthy, putrid, or decomposed substance or is contaminated by any added poisonous or deleterious substance that may render the product injurious to health;
· It has been prepared, packed, or held under unsanitary conditions;
· Its package is composed of any poisonous or deleterious substance;
· The manufacturer or importer of the product fails to pay the assessed user fee;
· It fails to meet specified tobacco product standards;
· It does not have required premarket review;
· It fails to meet applicable requirements or conditions on manufacturing, packing, or storage; or
· It fails to conform to requirements for modified risk tobacco products (s.902)
Misbranded tobacco product.- A tobacco product is deemed to be misbranded if:
· Its labeling, packaging, or advertising contains any false or misleading information;
· Its label or advertising fails to contain all required information displayed prominently and conspicuously, including its established name, manufacturer, and contents and adequate directions and warnings;
· It was manufactured, prepared, or processed in an establishment not registered with the Secretary; or
· There is any failure to submit the required information or notices to the Secretary s.903(a)
Prior Approval of Label Statements.- The Secretary is allowed to require prior approval of all label statements on tobacco products to ensure that such statements: (1) do not violate misbranding provisions; and (2) comply with other provisions of this Act s.903(b)
Submission of information to the Secretary.- Requires tobacco product manufacturers or importers to submit to the Secretary:
· A listing of all ingredients, including ingredients added by the manufacturer to the tobacco, paper, or filter, by brand and quantity not later than 6 months after the enactment of the Act;
· A description of the content, delivery, and form of nicotine in each tobacco product;
· A listing of all constituents, including smoke constituents, identified by the Secretary as harmful or potentially harmful to health in each tobacco product, beginning 3 years after the date of enactment of the Act; and
· All documents developed that relate to the health, toxicological, behavioral, or physiologic effects of tobacco products and their constituents, ingredients, components, and additives, beginning 6 months after the date of enactment.
Additional Information.- The Secretary is allowed to request additional information from a tobacco product manufacturer or importer relating to: (1) research activities or findings on the effects of tobacco products and their constituents and on whether the health risk can be reduced if the manufacturer employs known or available technology; and (2) marketing research or practices used by manufacturers or distributors.-s.904(a)
Time for Submission.-
· The above required information shall be provided at least 90 days prior to the delivery for introduction into commerce, a product that is not already in the market on the date of enactment of the Act;
· If a tobacco product manufacturer adds new additive or increases an existing one, he shall atleast 90 days prior to such change inform the Secretary in writing;
· If a tobacco product manufacturer eliminates or decreases an existing additive or adds or increases an additive which the Secretary designates as not human or animal carcinogen or otherwise harmful to health, he shall within 60 days advise the Secretary in writing.- s.904(c)
Data List.- The Secretary is required to publicly display not later than 3 years after the date of enactment of the Act and thereafter annually, publish a list (that is understandable and not misleading to a lay person) of harmful or potentially harmful constituents in each tobacco product by brand and quantity.s.904(d)
Registration.- Owners and operators of both domestic and foreign establishments need to register with the Secretary and submit a list of all tobacco products manufactured in prescribed form and manner-
· Owners and operators of establishments in the United States engaged in the manufacture, preparation, compounding, or processing of a tobacco product are required to register annually with the Secretary on or before December 31 of each year.
· Owners and operators of new or additional establishments shall register immediately.
· The Secretary is allowed to prescribe a uniform system for the identification of tobacco products, which registrants must use. The Secretary is also required to make such registration information available to the public and to inspect registered establishments every two years.
· Requires foreign establishments to register and ensure that adequate and effective means are available to determine whether their tobacco products conform with FFDCA requirements.
Every person so registered shall submit a report to the Secretary once during the month of June and once during the month of December-
· A list of the tobacco products included after the previous list has been filed.
· If since the date of the last report made, manufacture of any tobacco product has been discontinued.
· If since the date of report of discontinuance, manufacture has been resumed (s.905)
Confidentiality of Information.-Prohibits the disclosure of privileged or confidential trade secrets and commercial financial information that is obtained by the Secretary s.906(c)
Restrictions.- The Secretary is allowed to restrict:
· The sale or distribution of tobacco products if appropriate for the protection of the public health; and
· The advertising and promotion of tobacco products consistent with, and to the full extent permitted by, the First Amendment.
The following restrictions cannot be made:
· Limit the sale or distribution of a tobacco product to written or oral authorization by a practitioner licensed to prescribe medicine;
· Prohibit the sale of a tobacco product in face-to-face transactions by a specific category of retail outlets; or
· Establish a minimum age of sale of tobacco products to any person older than 18 years of age.- s.906(d)
Regulations.- The Secretary is required to promulgate regulations to prevent the sale and distribution of tobacco products to minors through means other than a direct, face-to-face exchange between a retailer and a consumer within 18 months of the date of enactment. -s.906(d)(3)
Good Manufacturing Practices.-The Secretary is required to prescribe regulations to protect the public health and assure that tobacco products are in compliance with this Act by requiring good manufacturing practices or hazard analysis and critical control point methodology.- s.906(e)
The Secretary is required to:
· Provide a reasonable period for manufacturers to conform to good manufacturing practices; and
· Not require any small tobacco product manufacturer to comply with such regulations for at least four years. s.906(e)(1)(B)
The Secretary is allowed to grant exemptions and variances from such regulations under certain circumstances.
Tobacco Product Standards.-
# Beginning 3 months after the date of the enactment, the Act prohibits a cigarette or any of its components from containing as a constituent or additive any artificial or natural flavor (other than tobacco or menthol) or any herb or spice (including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee) that is a characterizing flavor of the tobacco product or tobacco smoke.-s.907(a)(1)(A)
# Beginning 2 years after the date of enactment a tobacco product manufacturer is prohibited from using tobacco, including foreign grown tobacco, that contains a pesticide chemical residue at a level greater than any tolerance applicable to domestically grown tobacco.-s.907(a)(1)(B)
The Secretary is allowed to adopt additional tobacco product standards as appropriate to protect the public health, which may include standards for:
# Reducing nicotine yields;
# Reducing or eliminating other constituents or harmful components; and
# Product testing.- s.907(a)(4)
The Secretary is allowed to amend or revoke a tobacco product standard.- s.907(a)(5)
Limitation on powers.- The Secretary is prohibited from:
· Banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products; or
· Requiring the reduction of nicotine yields of a tobacco product to zero.-s.907(b)(3)
Notification.-The Secretary is to notify the public if a tobacco product poses an unreasonable risk of substantial harm to the public health. The Secretary is further required to order a cease in distribution and a recall of a tobacco product if there is a reasonable probability that it contains a defect not ordinarily contained in tobacco products that would cause serious, adverse health consequences or death. The order shall provide the person subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of the issuance of the order - s.908
Records and Reports.- Manufacturers and importers are required to comply with record keeping and reporting requirements established by the Secretary, such as informing the Secretary of any information that reasonably suggests that a marketed tobacco product may have caused or contributed to a serious unexpected adverse experience. The Secretary is also to require prompt notification by manufacturers and importers of any corrective action taken or any removal from the market of a tobacco product to reduce a health risk posed by the product or to remedy a violation of this Act that may present such a risk.- s.909
Pre market Review.
Pre market approval is required of all new tobacco products (products not substantially equivalent to an existing tobacco product) commercially marketed after February 15, 2007. "Substantially equivalent" is defined as having the same characteristics or having different characteristics but not raising different questions of public health.
Application for pre market approval.- An application process for pre market approval of a new tobacco product is set forth. Health information must be included. The Secretary may refer to the Tobacco Products Scientific advisory Committee for recommendations.
Order.- Not later than 180 days on receipt of the application, the Secretary is authorized to: (1) allow, prohibit, or restrict distribution of such a tobacco product; and (2) temporarily suspend an application if the probability that continued distribution would cause serious, adverse health consequences or death is greater than that for tobacco products on the market.-s.910.
Modified Risk Tobacco Products
The sale of any modified risk tobacco product is prohibited unless an order is issued by the Secretary.
Definition.-A "modified risk tobacco product" is defined as any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related diseases associated with commercially marketed tobacco products, specifically products where:
· The labeling or advertising represents that the product presents a lower risk of tobacco-related disease or is less harmful than other tobacco products, contains a reduced level of or presents a reduced exposure to a substance, or is free of a substance;
· The labeling or advertising uses descriptors such as "light," "mild," or "low"; or
· The product manufacturer has taken action reasonably expected to result in consumers believing that the product or its smoke presents a lower risk of disease, is less harmful, presents a reduced exposure, or is free of a substance.- s.911(b)(1)
Application.- An application maybe filed with the Secretary for a modified risk tobacco product.- s.911(b). Not later than 60 days after receiving the application, the Secretary may refer it to the Tobacco Products Scientific Advisory Committee for its recommendations.- s.911(f)
Order.- The Secretary is to issue an order that a modified risk tobacco product may be commercially marketed only if the Secretary determines that an applicant has demonstrated that such product, as it is actually used by consumers, will:
· Significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and
· Benefit the health of the population as a whole including users and nonusers of tobacco.
Secretary is allowed to issue an order allowing the sale of a tobacco product that may not be commercially marketed as a modified risk tobacco product for five years if certain requirements are met, including that: (1) such order would be appropriate to promote the public health; and (2) issuing such an order is expected to benefit the health of the population as a whole.
Advertising and labeling.- The Secretary is to require that advertising and labeling concerning modified risk tobacco products enables the public to understand the information and its significance in the context of total health and in relation to all of the diseases and health-related conditions associated with the use of tobacco products.s.911(h)(5)
Post-market Surveillance.- The Secretary is to require results of post market surveillance and studies to be submitted annually. s.911(g)(2)(C)(iii)
Withdrawal of Authorization.- The Secretary may withdraw authorization for allowing sale if the conditions stipulated are not complied with s.911(j).
Testing Regulations.- The Secretary, acting through the Commissioner of FDA, is required to promulgate regulations under this Act within 3 years that require the testing and reporting of tobacco product constituents, ingredients, and additives that the Secretary determines should be tested to protect the public health. The Secretary is furnished with the authority to conduct or require the testing, reporting, or disclosure of tobacco product constituents. The imposition of such testing regulations on small tobacco product manufacturers is delayed till the end of a 2 year period following the final promulgation of these rules. A further period of 4 years is given to the small tobacco manufacturers for testing and reporting all of its tobacco products (s.915)
User Fees.- The Secretary is required to assess a quarterly user fee on manufacturers and importers of tobacco products based on the class of tobacco product and the company market share to pay for the costs of tobacco regulation activities. The fees shall be assessed and collected with respect to each quarter of each fiscal year. FDA funds (excluding user fees) used before October 1, 2009, on such activities be reimbursed. (s.919)
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