FDA TOBACCO REGULATION (HR 1256) BY SECTION
SEC. 907 TOBACCO PRODUCT STANDARDS
Tobacco Product Standard: One year from the publication in the Federal Register of the tobacco product standard, unless the Secretary decides an earlier date is necessary “for the protection of public health” and provided that such standard is technically achievable and will not cause “economic loss to, and disruption or dislocation of domestic and international trade” which could cause the effective date to increase by one year, tobacco products will need to meet a standard based on 1) nicotine yields; 2) “construction, components , ingredients, additives, constituents, including smoke constituents, and properties”; 3) as determined by regulations related to defined testing on a sample or individual basis,; on measurements that show whether the product meets or exceeds the standard regardless of its foreign-grown tobacco content. To develop such a standard, the Secretary will 1) consult with other government agencies; 2) determine the technical feasibility of achieving the standard; 3) determine the potential increase in demand for contraband or other tobacco products not faced with meeting the standard; and 4) follow specified rules for the rule-making. The Secretary “may” refer the standard to the TPSAC who would have 60 days to make its report and recommendation.
Flavored Cigarettes: Effective 9/22/2009 prohibits the sale of flavored cigarettes, except menthol and tobacco, defined to be additives or constituents (including a smoke constituent) identified as a “characterizing flavor” and specifically cites “…orange, clove…vanilla, coconut, licorice, cocoa, chocolate” among others, though the Secretary is not limited from taking action with regard to “any artificial or natural flavor, herb or spice” whether characterizing or not.
Menthol Cigarettes: Not later than one year after the establishment of 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.”
Dissolvable Tobacco Products: 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.
Pesticide Residues: Beginning 06/22/2011, manufacturers are prohibited from using either domestic or foreign tobacco with pesticide residue levels above a given tolerance;
Administrator’s Prerogative: “If appropriate for public health,” the Secretary may adopt additional standards and may revise or revoke the existing standard and any party who objects to the new standard on the grounds that it “will not reduce or eliminate the risk of illness or injury may provide for the Secretary’s consideration scientific evidence” as to this claim.
Administrator’s Limits: The Secretary may not ban any types of tobacco products or require the reduction of nicotine yields of any tobacco product to zero.
SEC. 909 RECORDS AND 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 as defined above. Requires manufacturers and importers to report any serious adverse health experiences by consumers and provides for the method of such reporting taking into account issues of patient privacy and risks to the population among others and requires reports on corrective actions taken.
SEC. 910 APPLICATION FOR REVIEW OF CERTAIN TOBACCO PRODUCTS
All tobacco products (including those in test markets) that were not commercially marketed in the United States as of February 15, 2007 or those that have undergone any modification (change in design, component, part, constituent including smoke constituent or in the content, delivery or form of nicotine or any other additive or ingredient) after February 15, 2007 are considered “new tobacco products,” and are subject to premarket reviews unless the product has been shown to be “substantially equivalent” to other tobacco products on the market as of February 15, 2007 per the report establishing “substantial equivalence” described in Section 905 and below or by a decision by the Secretary that the product change was “minor” based on a filed report which would also need to indicate if there were any adverse health effects. Defines “substantially equivalent” to mean that the “materials, ingredients, design, composition, heating source, or other features of the product,” are the “same” as products on the market as of February 15, 2007 or have “different characteristics” but not to the degree that “clinical data” are deemed “necessary by the Secretary…because the product does not raise different questions of public health.” Provides a listing of the contents that would need to be filed in an application for “substantial equivalence” including all information “known to the applicant concerning investigations…made to show the health risks of such tobacco products and whether such tobacco product presents less risk” (see Sec. 911 for Modified Risk Tobacco Products); a full statement of the components, ingredients, additives and properties and the principles of operating the product; a full description of the methodologies used for manufacturing and/or packing the product; references to elements of the tobacco standard defined above and a statement regarding the product meeting such standard; product samples along with labeling need to be provided; and anything else the Secretary requires. Upon receipt of the application the Secretary or the applicant, may refer the application to the TPSAC. The Secretary is required to respond within 180 days of the receipt of the application to issue either a favorable or unfavorable order (note that no tobacco products are formally “approved” given the safety issues) and must provide a detailed response if the product is denied introduction and, if practicable, what the applicant needs to do to gain a favorable order to allow introduction. By 06/22/2011 the Secretary is required to issue regulations or guidance for the filing of an application for a “new tobacco product.”
SEC. 911. MODIFIED RISK TOBACCO PRODUCTS
As with “new 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 and “other information made available to the Secretary.” Defines a “modified risk tobacco product” (MRTP) to mean a tobacco product “sold or distributed for use to reduce harm…” compared with conventional products and the seller uses either explicit or implicit labeling to indicate 1) this lower relative risk claim, or 2) that the product or its smoke contains a reduced level of a substance, or 3) does not contain the substance at all and has been proven to do so (Note: the section implies that clinical epidemiological evidence from long-term studies, the FDA gold standard, would be necessary to achieve this proof, though it does not state this). Bans the use of such terms as “light, “mild,” or “low” “or similar descriptors or any media efforts by the manufacturer “that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk…” unless the manufacturer has the evidence needed for such claims. These provisions are effective 06/22/2010 for the date of manufacture and 07/22/2010 for shipments from manufacturers.
Labeling on “smokeless tobacco” and related label terminology such as “without smoke” is exempt from such restrictions and is not assumed to mean less risk. All nicotine replacement therapy products, referred to as “tobacco dependence products” are not MRTP’s, if they were approved by FDA as a drug or device and are subject to Chapter 5 of the FDCA.. An application for a MRTP must include: a description of the product, and its proposed labeling and advertising including samples; conditions for using product; formulation of the product; all documents, including scientific research, relating to research, both favorable and unfavorable of the product as to the product’s reduce risk or exposure and relating to human health; data on how consumers will use the product, and any other information required by the Secretary. The Secretary would refer all applications to the TPSAC which would have 60 days to report its recommendations to the Secretary. Except for trade secret or confidential data submitted, all application data would be made public as part of a notice and comment by “interested persons.” Except as covered in the “Special Rule” the Secretary can only issue an order allowing the commercialization of the product if it satisfies both the 1) individual risk test: that it “significantly reduces harm” for individual users; AND 2) it “benefits the health of the population as a whole taking into account both users and persons who do not use tobacco products” e.g., non-users who might be attracted to try it, including former users and the likelihood that those who might have otherwise quit do not do so as a result AND 3) taking into account the relative risks and benefits from the use of smoking cessation products.
Marketing of MRTP products both in advertising and labeling requires that the consumers “comprehend the information concerning modified risk and to understand the relative significance of such information” and allows for comparative claims under certain conditions including quantitative comparisons relative to substances contained.
A “Special Rule for Certain Products” provides a shorter-term emphasis on “exposure to risk” compared with actual “health risk” so as to enable the commercialization for a five year period, with extensions possible, of a tobacco product that is likely to reduce morbidity and mortality relative to other tobacco products but has not been proven to do so through long-term clinical studies provided that the applicant has demonstrated that 1) the given product either does not contain or contains less of a toxic substance or its smoke entails reduced exposure to a given substance and 2) only long-term epidemiological evidence could ascertain the scientific evidence needed to establish a product as a MRTP under the above definition and 3) that the weight of scientific evidence shows a “measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely” to be shown in subsequent post-market surveillance, and 4) the magnitude of reduced exposure to the harmful substances “is substantial” and 5) as consumers actually use the product, they will not be exposed to higher levels of other harmful substances contained in conventional products by more than “minimal” amounts and 6) consumer testing of consumer perceptions of what the product is, based on labeling and advertising, shows that consumers will not be led to believe that the product “has been demonstrated to be less harmful” or “presents less of a risk of disease than 1 or more” conventional products and 7) the population as a whole will benefit, not just the individual, including both users and non-users of tobacco products as discussed above and 8) the applicant agrees to conduct post-market surveillance and provide annual results, and studies, according to a protocol to be approved by the Secretary and submitted by the applicant within 30 days of having an order after which the Secretary has 60 days to assess the qualifications of the principal investigator doing the surveillance. Failure to conduct such surveillance is one among several provisions for withdrawing the order.
Not later than 7/22/2011 the Secretary will issues regulations or guidance or both “on the scientific evidence required for assessment and ongoing review of” MRTP’s including minimum standards for scientific studies, validated biomarkers, intermediate clinical end points among other feasible outcome measures, minimum standards for postmarket surveillance studies, among other considerations. The Secretary will develop such regulation and/or guidance with input from the Institute of Medicine (IOM) among other scientific and medical experts.
Also not later than 7/22/2011 the Secretary need to provide regulations and/or guidance for the filing of all new tobacco product applications.