The proposed U.S legislation contains many aspects that are potentially unacceptable to consumers; although it seeks to ensure
the continuance of a tobacco market it is biased entirely towards the interests of Tobacco Control, U.S tobacco farmers, the
big tobacco companies and the protection of revenues from taxation of the product. No concern is given in any part of the act
to the requirements or interests of the consumer.
The following is a discussion solely on the key aspects of the proposed act with regard to the effects upon the development and
promotion of less hazardous cigarettes.
(42) Permitting manufacturers to make unsubstantiated statements concerning modified risk tobacco products, whether express or
implied, even if accompanied by disclaimers would be detrimental to the public health.
(43) The only way to effectively protect the public health from the dangers of unsubstantiated modified risk tobacco products
is to empower the Food and Drug Administration to require that products that tobacco manufacturers sold or distributed for
risk reduction be reviewed in advance of marketing, and to require that the evidence relied on to support claims be fully
verified.
(44) The Food and Drug Administration is a regulatory agency with the scientific expertise to identify harmful substances in
products to which consumers are exposed, to design standards to limit exposure to those substances, to evaluate scientific
studies supporting claims about the safety of products, and to evaluate the impact of labels, labeling, and advertising on
consumer behavior in order to reduce the risk of harm and promote understanding of the impact of the product on health. In
connection with its mandate to promote health and reduce the risk of harm, the Food and Drug Administration routinely makes
decisions about whether and how products may be marketed in the United States.
This part of the act sets out the details of permissible marketing of less hazardous cigarettes. Great lengths are taken to
provide excuses as to why less hazardous cigarettes were previously prohibited from being marketed with a reintroduction of
the arguments against 'low tar' and 'light' cigarettes, the clear inference being that the tobacco companies misled the
public, so future claims can only be made after approval by the Food and Drug Administration. In reality: tobacco companies,
politicians, health authorities and the tobacco control movement are all to blame for the fact that a natural evolution towards
market driven, safer products of choice has been blocked for 30 years.
(36) It is essential that the Food and Drug Administration review products sold or distributed for use to reduce risks or
exposures associated with tobacco products and that it be empowered to review any advertising and labeling for such products.
It is also essential that manufacturers, prior to marketing such products, be required to demonstrate that such products will
meet a series of rigorous criteria, and will benefit the health of the population as a whole, taking into account both users
of tobacco products and persons who do not currently use tobacco products.
With the Institute Of Medicine's acceptance of a dose/response relationship and their admission that lower risk tobacco products
are feasible the stage is set for the large tobacco companies working in partnership with health bodies to produce progressively
less hazardous cigarettes. In allowing the large manufacturers to market safer cigarettes this act will ensure that money is
spent on development due to the marketing advantage over existing brands. Monopolies may well be achieved by those large
manufacturers on new safer brands but only if those new products are acceptable choices for consumers.
It is of interest to note that the act stipulates the benefits to health should be for both smokers and non-smokers. The
reduction of particles of interest may very quickly therefore have wider implications for the already fallacious claims about
passive smoke.
There are three relevant purposes of the Act with regard to LHC's:
(4) to provide new and flexible enforcement authority to ensure that there is effective oversight of the tobacco industry's
efforts to develop, introduce, and promote less harmful tobacco products;
(5) to vest the Food and Drug Administration with the authority to regulate the levels of tar, nicotine, and other harmful
components of tobacco products;
(7) to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure that they are not sold
or accessible to underage purchasers;
Item 4 allows the Tobacco Industry to market safer brands under the control of the FDA and direction of the Institute of Medicine.
Item 5 gives control of levels of 'components' to the FDA. Nicotine could be increased or reduced under this clause but not
removed. In reality reductions of nicotine on new safer brands would be counter productive because, as the Institute Of Medicine
recognises, nicotine must be retained at pleasurable levels in order to be acceptable to consumers. It is however possible that
some would argue for a reduction of nicotine levels in existing brands in order to increase market share of new safer brands
with higher levels of nicotine. It is also possible that existing brands could be gradually squeezed out of the market if they
do not meet introduced standards of component levels. This could result in monopoly markets for safer brands that are not driven
by consumer choice although the safer product would still need to be acceptable to the consumer to ensure continued sales.
Item 7 retains the status quo and protects the financial interests of all sides of the argument by ruling out the prohibition
of tobacco.
(c) Revenue Activities- The provisions of this Act (or an amendment made by this Act) which authorize the Secretary to take
certain actions with regard to tobacco products shall not be construed to affect any authority of the Secretary of the Treasury
under chapter 52 of the Internal Revenue Code of 1986
Safer cigarettes will not be detrimental to tax revenue. The act provides provision for continued taxation of tobacco products
by leaving authority over it with the Secretary of the Treasury.
(1) The term `tobacco product' means any product made or derived from tobacco that is intended for human consumption, including
any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a
component, part, or accessory of a tobacco product).
(2) The term `tobacco product' does not mean an article that is a drug under subsection (g)(1), a device under subsection (h),
or a combination product described in section 503 (g).
(4) A tobacco product may not be marketed in combination with any other article or product regulated under this Act (including
a drug, biologic, food, cosmetic, medical device, or a dietary supplement).'.
(c) Tobacco Dependence Products- A product that is intended to be used for the treatment of tobacco dependence, including
smoking cessation, is not a modified risk tobacco product under this section if it has been approved as a drug or device by the
Food and Drug Administration
(3) CIGARETTE- The term `cigarette'--
(A) means a product that--
(i) is a tobacco product; and
(ii) meets the definition of the term `cigarette' in section 3(1) of the Federal Cigarette Labeling and Advertising Act; and
(B) includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco
used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as
roll-your-own tobacco.
The above defines what constitutes a tobacco product under the terms of this act to ensure that tobacco cannot be eliminated in
favour of alternate methods of delivery of nicotine that may be marketed as safer cigarettes.
(3) LIMITATION ON POWER GRANTED TO THE FOOD AND DRUG ADMINISTRATION
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 cigars other than little 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 FDA will not have the power to ban tobacco or to remove nicotine from the product. This effectively kills prohibition in
favour of regulated safer tobacco products.
(1) MODIFIED RISK TOBACCO PRODUCT
The term `modified risk tobacco product' means any tobacco product that is sold or distributed for use to reduce harm or the
risk of tobacco-related disease associated with commercially marketed tobacco products.
(A) IN GENERAL- With respect to a tobacco product, the term `sold or distributed for use to reduce harm or the risk of
tobacco-related disease associated with commercially marketed tobacco products' means a tobacco product--
(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially
marketed tobacco products;
(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or
(III) the tobacco product or its smoke does not contain or is free of a substance;
The above defines what constitutes a modified risk tobacco product and that may be marketed as such.
(d) Filing- Any person may file with the Secretary an application for a modified risk tobacco product. Such application shall
include--
(1) a description of the proposed product and any proposed advertising and labeling;
(2) the conditions for using the product;
(3) the formulation of the product;
(4) sample product labels and labeling;
(5) all documents (including underlying scientific information) relating to research findings conducted, supported, or
possessed by the tobacco product manufacturer relating to the effect of the product on tobacco-related diseases and
health-related conditions, including information both favorable and unfavorable to the ability of the product to reduce risk or
exposure and relating to human health;
(6) data and information on how consumers actually use the tobacco product; and
(7) such other information as the Secretary may require.
Tobacco manufacturers must file an application to the FDA meeting the above criteria in order to market tobacco products
identified as reduced risk products.
(1) MODIFIED RISK PRODUCTS- Except as provided in paragraph (2), the Secretary shall, with respect to an application submitted
under this section, issue an order that a modified risk product may be commercially marketed only if the Secretary determines
that the applicant has demonstrated that such product, as it is actually used by consumers, will--
(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and
(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not
currently use tobacco products.
The act will force tobacco manufacturers to submit lists of all component levels of existing brands. These will be used as
markers to judge claims of new reduced risk brands. As the less hazardous cigarette program demonstrated: it is well within
technical capabilities to reduce exposures to chemicals within tobacco smoke significantly.
(A) IN GENERAL- The Secretary may issue an order that a tobacco product may be introduced or delivered for introduction into
interstate commerce, pursuant to an application under this section, with respect to a tobacco product that may not be
commercially marketed under paragraph (1) if the Secretary makes the findings required under this paragraph and determines
that the applicant has demonstrated that--
(i) such order would be appropriate to promote the public health;
(ii) any aspect of the label, labeling, and advertising for such product that would cause the tobacco product to be a modified
risk tobacco product under subsection (b) is limited to an explicit or implicit representation that such tobacco product or
its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure
to a substance in tobacco smoke;
(iii) scientific evidence is not available and, using the best available scientific methods, cannot be made available without
conducting long-term epidemiological studies for an application to meet the standards set forth in paragraph (1); and
(iv) the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a
measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in
subsequent studies.
Less hazardous cigarettes can be marketed to the public under the direction of the FDA if a reduction or removal of a substance
or exposure to it is demonstrated. Long term epidemiological studies are not required, as any reductions of substances could be
argued to reduce risk, making it reasonably likely that future studies would show reductions in morbidity or mortality.
(C) CONDITIONS OF MARKETING-
(A) the relative health risks to individuals of the tobacco product that is the subject of the application;
(B) the increased or decreased likelihood that existing users of tobacco products who would otherwise stop using such products
will switch to the tobacco product that is the subject of the application;
(C) the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product
that is the subject of the application;
(D) the risks and benefits to persons from the use of the tobacco product that is the subject of the application as compared to
the use of products for smoking cessation approved under chapter V to treat nicotine dependence;
The act seeks to distance itself from the perception of promoting smoking by allowing advertising and the conditions of
marketing are worded to demonstrate that the act is designed to encourage existing smokers onto safer products rather than to
attract new smokers.
(h) Additional Conditions for Marketing-
(1) MODIFIED RISK PRODUCTS-
The Secretary shall require for the marketing of a product under this section that any advertising
or labeling concerning modified risk products enable the public to comprehend the information concerning modified risk and to
understand the relative significance of such information 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.
(2) COMPARATIVE CLAIMS-
(A) IN GENERAL- The Secretary may require for the marketing of a product under this subsection that a claim comparing a tobacco
product to 1 or more other commercially marketed tobacco products shall compare the tobacco product to a commercially marketed
tobacco product that is representative of that type of tobacco product on the market (for example the average value of the top
3 brands of an established regular tobacco product).
(B) QUANTITATIVE COMPARISONS- The Secretary may also require, for purposes of subparagraph (A), that the percent (or fraction)
of change and identity of the reference tobacco product and a quantitative comparison of the amount of the substance claimed
to be reduced shall be stated in immediate proximity to the most prominent claim.
A method of marketing new safer brands will be by comparison with existing brands. Products can then presumably be marketed with
claims such as; "x% safer than another brand" or "contains x% less 'substance' than another brand".
(1) SCIENTIFIC EVIDENCE
Not later than 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary
shall issue regulations or guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing
review of modified risk tobacco products. Such regulations or guidance shall--
(A) to the extent that adequate scientific evidence exists, establish minimum standards for scientific studies needed prior to
issuing an order under subsection (g) to show that a substantial reduction in morbidity or mortality among individual tobacco
users occurs for products described in subsection (g)(1) or is reasonably likely for products described in subsection (g)(2);
(B) include validated biomarkers, intermediate clinical endpoints, and other feasible outcome measures, as appropriate;
(C) establish minimum standards for postmarket studies, that shall include regular and long-term assessments of health outcomes
and mortality, intermediate clinical endpoints, consumer perception of harm reduction, and the impact on quitting behavior and
new use of tobacco products, as appropriate;
(D) establish minimum standards for required postmarket surveillance, including ongoing assessments of consumer perception;
(E) require that data from the required studies and surveillance be made available to the Secretary prior to the decision on
renewal of a modified risk tobacco product; and
(F) establish a reasonable timetable for the Secretary to review an application under this section.
Within 2 years of the act a scientific criteria will be set for marketing of less hazardous tobacco along with the ongoing
effects of the product after release.
(2) CONSULTATION- The regulations or guidance issued under paragraph (1) shall be developed in consultation with the Institute
of Medicine, and with the input of other appropriate scientific and medical experts, on the design and conduct of such studies
and surveillance.
The criteria for scientific evidence will be developed in consultation with the Institute of Medicine.
Link to full text of the act
