(This Legislative Bulletin summary is based on a summary prepared by the Senate Health, Education, Labor, and Pensions (HELP) Committee.)
On June 2, 2009, the Senate is expected to proceed to consideration of H.R.1256, the Family Smoking Prevention and Tobacco Control Act. It is anticipated that the text of H.R.1256 will be replaced by a Senate substitute comprised of S.982, the Family Smoking Prevention and Tobacco Control Act and the provisions on federal retirement that are contained in H.R.1256 with a few modifications and corrections.
The Senate substitute will give the Food and Drug Administration (FDA) the legal authority necessary to reduce youth smoking, prevent the sale of tobacco to minors, help current smokers quit, reduce the toxicity of tobacco products, and stop the tobacco industry from misleading the public with their understated claims about the dangers of using tobacco products. Specifically, the legislation would:
- Authorize the FDA to regulate tobacco products by creating a new chapter in the Federal Food, Drug, and Cosmetic Act (FFDCA).
- Authorize the FDA to restrict tobacco advertising to stop marketing practices that target children and mislead the public. Authority to regulate the sale, distribution, and advertising of cigarettes and smokeless tobacco shall be “consistent with and to the full extent permitted by the First Amendment.”
- Prevent sale of tobacco products to youth by providing FDA with the authority to limit tobacco sales to face-to-face transactions, in which the age of the purchaser is verifiable. Self-service displays and vending machine sales of tobacco would no longer be permissible, except in adult-only facilities.
- Codify 1996 FDA rule to reduce youth tobacco use by giving a rule already developed by FDA the force of law. In 1996, FDA conducted an extensive rulemaking process to determine effective methods to reduce youth smoking. The rulemaking process included 700,000 public comments, resulting in a rule regarding the sale and advertisement of cigarettes. Due to litigation, the rule was never implemented. Rather than engaging in yet another lengthy rulemaking process and delaying the protection of our children from the dangers of tobacco use, the bill gives the rule the force of law.
- Require stronger warning labels for all tobacco packages and advertising, including an unambiguous description of the health problems that may result from tobacco use. The FDA would have the authority to update the warning labels regularly to ensure a strong impact.
- Prevent misrepresentation by tobacco manufacturers of the addictiveness of nicotine in their products. Industry documents overwhelmingly demonstrate that tobacco manufacturers not only knew their products were addictive; they relied on this addictive nature in their marketing strategies and chemically manipulated the nicotine in their products to make them even more addictive. The legislation gives FDA the authority to prevent such misrepresentations in the future.
- Authorize the removal of hazardous ingredients to ensure that the inherent risk of using tobacco products is not unnecessarily increased. The bill would also provide FDA with the authority to help those who are addicted overcome their addiction, and make tobacco products less toxic to those who are unable or unwilling to quit.
- Set standards for so-called “reduced risk” products by requiring manufacturers to submit the products for FDA analysis before making such a marketing claim. Statements by tobacco company executives indicate development of what they believe to be “reduced risk” products is on the horizon. Tobacco manufacturers must not be permitted to make such health claims about their products until they are verified by FDA.
- Ensure tobacco companies, not American taxpayers, bear the cost of regulation by establishing a user fee on tobacco manufacturers and importers, based on their market share.
The bill would be cost-neutral and make important federal retirement reforms. These new regulatory activities would be fully-funded by user fees collected from tobacco product manufacturers. Because the provisions of this legislation are expected to effectively reduce smoking, the Congressional Budget Office (CBO) has determined that the bill would reduce federal tobacco tax receipts by $845 million over the next 10 years.
In order to ensure that the legislation meets the strong pay-as-you go budget rules in the Senate, the Family Smoking Prevention and Tobacco Control Act has been combined with the Federal Retirement Reform Act of 2009 into a single bill. The legislation would modernize the Thrift Savings Plan (TSP) for federal employees, allow employees to make contributions to a qualified Roth program as part of the TSP, make other retirement reforms, and increase the monthly indemnity allowances for certain survivors of deceased members of the Armed Forces. These provisions generate a net increase in revenue for the federal government and ensure that the legislation is “deficit-neutral.”
Tobacco use in the United States is killing our citizens, costing us billions of dollars in health care costs, and reducing our economic productivity. Nearly 20 percent of American adults, or more than 43 million people, are addicted to cigarettes. Tobacco use kills more than 400,000 Americans each year, and an additional 50,000 nonsmokers die prematurely each year due to exposure to secondhand smoke. Americans’ health suffers from tobacco use, with 8.6 million Americans currently suffering from a smoking-caused illness. Health care costs for these individuals are staggering, with $96 billion in total annual public and private health care expenditures attributable to smoking. Estimates indicate that American taxpayers shoulder $68 billion of those costs due to expenditures made by Medicare, Medicaid, and other federal health programs.
In addition, our national economy loses approximately $98.6 billion in productivity losses due to cigarette smoking and exposure to tobacco smoke, making the total economic burden of smoking approximately $192 billion per year. In contrast, in Fiscal Year 2007, the nation invested a mere $595 million in comprehensive, state-based tobacco prevention and control programs, 325-times less than the total economic burden of smoking.
One of the keys to reducing the staggering toll of tobacco on our nation is to protect our children from exposure to tobacco products and its marketing. Sadly, the pattern of tobacco use by children mirrors that of their parents, with 20 percent of high school students classified as current smokers, or 3.5 million children. The tobacco industry refers to our children as “replacement smokers,” and each day, more than 3,500 children try smoking for the first time, and more than 1,000 children because regular, daily smokers. The tobacco industry has no economic incentive to reduce smoking by children, because youth smoking generates approximately $2 billion in revenue for tobacco manufacturers annually, and these child smokers replace the adult smokers who are dying as a result of their addiction. Flavors, like fruit or candy, make cigarettes more attractive to children and easier to smoke.
Tobacco, one of the most dangerous products sold in the United States, is currently exempt from oversight by the very agency that regulates nearly every other product consumed by Americans. FDA does regulate nicotine-replacement therapies that help smokers quit, and it has the necessary scientific expertise, regulatory experience, and public health mission to appropriately regulate tobacco products. Finally, a 2007 report by the Institute of Medicine entitled, “Ending the Tobacco Problem: A Blueprint for the Nation,” stated, “The committee concludes that product regulation by the FDA will advance tobacco control efforts in the United States and around the world. The proposed tobacco control legislation embodies the principles that should govern the regulation of tobacco products in the coming years.”
When the Senate moves to this legislation, it will take up H.R.1256, which is the House counterpart to S.982. It is then expected that an amendment in the nature of a substitute will be offered. Division A of the substitute amendment will be named the Family Smoking Prevention and Tobacco Control Act and will contain the entire text of S.982, as reported by the HELP Committee. Division B of the substitute amendment will be named the Federal Retirement Reform Act and will include the provisions on federal retirement that are contained in H.R.1256 with a few modifications and corrections.
DIVISION A – FAMILY SMOKING PREVENTION
AND TOBACCO CONTROL ACT
(This Legislative Bulletin is based on a section-by-section prepared by the Senate HELP Committee.)
Title I – Authority of the Food and Drug Administration
The Senate substitute creates a new chapter (Chapter IX) within the Federal Food, Drug, and Cosmetic Act (FFDCA) to regulate tobacco products. Provisions within the new chapter include:
- FDA authority over tobacco products. The Senate substitute states that tobacco products and modified risk products will be regulated under the newly created authority provided by this legislation and not be subject to regulation as drugs or devices. The FDA does not have authority to regulate tobacco growers. The substitute amendment also establishes a new Center for Tobacco Products within FDA, and an office within the new Center to assist small tobacco product manufacturers in complying with the requirements of the legislation.
- Adulterated tobacco products. Tobacco products are deemed to be adulterated if they contain filthy, decomposed, or otherwise contaminated substances, or if the tobacco product comes into contact with such substances during preparation or packaging. In addition, if the product does not meet established standards, the manufacturer has not paid required user fees, or if the appropriate marketing review has not taken place, the product will also be deemed to be adulterated.
- Misbranded tobacco products. Tobacco products will be deemed misbranded if their label is false or misleading, or if they are not correctly labeled or advertised. The Secretary of Health and Human Services (‘the Secretary’) may also require prior approval of statements made on tobacco product labels.
- Submission of health information. The Senate substitute requires, within six months of passage, submission to the Secretary by brand and quantity of ingredients, the compounds, substances, and additives included in the tobacco, paper, filter, or other parts of a tobacco product. Submission is also required of the content, delivery, and form of nicotine, and any documents developed after enactment relating to health, toxicological, behavioral, or physiological effects of tobacco products. Requires submission to the Secretary at least 90 days prior to market introduction of a list of constituents, including smoke constituents, and requires submission of this information for existing tobacco products within three years of enactment. Within three years of enactment and annually thereafter, the Secretary will publish a list of harmful and potentially harmful constituents in each brand, in a way that is not misleading to citizens.
- Annual registration. Requires registration of every entity engaged in any tobacco manufacturing process, including foreign entities. Authorizes the Secretary, in consultation with the Secretary of the Treasury, to create a system for the identification of tobacco products. Ninety days before market introduction of a new product, the manufacturer must report to the Secretary that it has complied with pre-market review requirements (see Section 910) or that the product is substantially equivalent to an existing product and is not subject to pre-market review.
- General provisions regarding control of tobacco products. The Senate substitute allows for rulemaking with public comment, ensures limited confidentiality of certain information reported to the Secretary, and authorizes the Secretary to issue regulations restricting the sale and distribution of tobacco products, including access to, advertising and promotion of such products, to the full extent consistent with the First Amendment. The substitute amendment does not permit the Secretary to require that tobacco products be available only by prescription, to prohibit face-to-face sale by a category of retail outlets, or to establish a national minimum age to purchase tobacco products greater than 18. In addition, the Secretary is required to issue regulations on sales that do not take place face-to-face within two years of enactment.
- Product standards. The Senate substitute allows the Secretary to adopt performance standards for tobacco products if appropriate to protect public health, and creates a level playing field between domestic and foreign tobacco growers with regard to any tobacco product standard. If adopted, the Secretary would periodically review the standards, with consideration of new medical, scientific, or other data. The substitute amendment prohibits the use of flavors, herbs, and spices in cigarettes, when used as a “characterizing flavor” of the tobacco product or smoke. The substitute requires the Secretary to refer consideration of the impact of menthol in cigarettes to the Tobacco Products Scientific Advisory Committee, and requires the Committee to report its findings within a year. The Secretary is not permitted to ban all cigarettes, all smokeless tobacco products, all cigars (little cigars or other), all pipe tobacco, or all “roll your own” tobacco products, and may not require the reduction of nicotine in any tobacco product to zero.
- Notification and other remedies. The Senate substitute authorizes the Secretary to provide “notice” (such as through public service announcements) if a tobacco product presents an “unreasonable risk of substantial harm,” and to recall a tobacco product if the product contains a manufacturing or other defect that would cause serious adverse health consequences or death and is not ordinarily contained in tobacco products on the market.
- Records and reports on tobacco products. The substitute amendment authorizes the Secretary to require tobacco manufacturers and importers to maintain records ensuring that tobacco products or not adulterated or misbranded.
- Application for review of certain tobacco products. The Senate substitute requires pre-market review for all new tobacco products, unless the Secretary determines the product is substantially equivalent to an existing product. Such application must contain all information published, known, or which should reasonably be known concerning studies on the health risks of the product. The Secretary shall approve or deny the application with 180 days, and may withdraw or suspend an application if necessary.
- Modified risk tobacco products. Modified risk tobacco products are defined as “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.” Companies will not be allowed to make any health claims about their products unless those claims have been independently verified by the FDA and determined to be “in the interest of public health.” The substitute prohibits the sale or distribution of a modified risk tobacco product without an order from FDA regarding commercial marketing of the product, includes limits on the sale, distribution and promotion of these products, and outlines specific requirements that tobacco manufacturers must meet before selling such a product, including a public application with public comment period and referral of the application to the Tobacco Products Advisory Committee for its recommendation.
- Judicial review. The Senate substitute states that anyone adversely affected by an FDA regulation relating to performance standards or pre-market review may, within 30 days, file a petition for judicial review with a United States Court of Appeals, and that remedies provided will be in addition to, not in lieu of, other remedies provided by law.
- Equal treatment of retail outlets. To ensure a level playing field among all retailers, the Secretary shall issue regulations requiring that all retailers comply with any advertising restriction applicable to retail establishments accessible to individuals under the age of 18.
- Jurisdiction of and coordination with the Federal Trade Commission (FTC). The Senate substitute ensures that the FTC’s authority regarding the advertising, sale, or distribution of tobacco products is not limited or diminished by the Act, and that violations of the substitute will also be considered unfair or deceptive practices under the Federal Trade Commissions Act.
- Regulation requirement. Within three years of enactment, the Secretary is required to issue a regulation requiring the testing, reporting, and disclosure of tobacco product smoke constituents, ingredients, and additives that are determined by the Secretary to be tested for public health protection. The Secretary may, through regulation, require disclosure of test results for tar and nicotine in labeling or advertising. Small tobacco manufacturers are permitted an extended amount of time to complete product testing.
- Preservation of state and local authority. The Senate substitute preserves states’ authority in regard to enacting, adopting, promulgating, and enforcing any law, rule, or regulation that is in addition to or more stringent than required under the substitute in the following areas: the sale, distribution, possession, advertising, promotion, and use of tobacco products, information about such products, and reporting to the state. In addition, product liability actions under state law are not modified by the substitute.
- Tobacco products scientific advisory committee. The Senate substitute establishes a 12-member advisory committee comprised of representatives of the public, tobacco growers, the health community, and tobacco manufacturers, small tobacco manufacturers, and tobacco growing industry interests. Representatives of the tobacco industry will not vote and may not service as Chair.
- Drug products used to treat tobacco dependence. The Senate substitute requires the Secretary to consider designating nicotine replacement products as fast track research and approval products, and requires the Commissioner of FDA to consider approving the extended use of over-the-counter nicotine replacement products.
- User fees. The Senate substitute requires the Secretary to assess a quarterly fee from tobacco product manufacturers and importers, as specified below, with the allocation of fees based on company market share.
- Fiscal Year 2009 – $85 million, subject to adjustment if enactment is after the beginning of Fiscal Year 2009
- Fiscal Year 2010 – $235 million
- Fiscal Year 2011 – $450 million
- Fiscal Year 2012 – $477 million
- Fiscal Year 2013 – $505 million
- Fiscal Year 2014 – $534 million
- Fiscal Year 2015 – $566 million
- Fiscal Year 2016 – $599 million
- Fiscal Year 2017 – $635 million
- Fiscal Year 2018 – $672 million
- Fiscal Year 2019, and each subsequent fiscal year – $712 million
In addition to creating a new chapter in the FFDCA, the Senate substitute also includes the following provisions:
- Final rule. One hundred and eighty days after passage of the Senate substitute, the Secretary shall publish a final rule regarding the advertising of and access to tobacco products. The rule will become effective one year after passage, and will be identical to the regulation promulgated by FDA in 1996, with specified minor changes.
- Study on raising the minimum age to purchase tobacco products. The Senate substitute requires that, within five years of enactment, the Secretary will submit a report to Congress on the public health implications of raising the minimum age to purchase tobacco products.
- Enforcement action plan for advertising and promotion restrictions. Within six months of enactment, the Secretary will develop and publish a plan to address the promotion and advertising of menthol and other cigarettes to youth. Within three months of enactment, the Secretary will inform state, local, and tribal governments of the authority provided, and will provide assistance to communities that wish to address underage tobacco use.
Title II – Tobacco Product Warnings and Smoke Constituent Disclosure
Cigarette label and advertising warnings. The Senate substituteincludes nine new, required warning labels that must appear on cigarette packages and advertisements, and must comprise 50 percent of the front and rear panels of the package, and at least 20 percent of the related advertisements. The substitute includes similar label requirements for smokeless tobacco products. The substitute clarifies that retailers will not be held responsible for packages and advertisements that they do not create.
Authority to revise cigarette warning label statements. The Senate substitute requires the Secretary to issue regulations, within two years of enactment, to require color graphics in warning labels, and gives the Secretary the authority to issue rules regarding the format, type size, and text of label requirements.
State regulation of cigarette advertising and promotion. The Senate substitute ensures that state and local governments may create specific bans or restrictions on he time, place, and manner of cigarette advertising and promotion, but may not restrict the content of advertisements or promotions.
Title III – Prevention of Illicit Trade in Tobacco Products
This title specifies labeling, recordkeeping, and records inspection requirements to track and assist in the investigation of illicit trade, smuggling, or counterfeiting of tobacco products. The Senate substitute would require that, within 18 months of enactment, the Comptroller General submit to Congress a report regarding cross-border trade in tobacco products.
DIVISION B – FEDERAL RETIREMENT REFORM ACT
The federal employee retirement provisions of the substitute amendment would –
- Provide for automatic enrollment in TSP. New federal employees who are eligible to participate in the Thrift Savings Plan (TSP) would have an option to “opt out” of, instead of “opt in” to, making contributions to the TSP at a default contribution rate of 3 percent of pay. Those who decline to “opt out” would also receive matching contributions from the employing agency. According to a 2006 survey conducted by the Federal Thrift Retirement Investment Board, 52 percent of employees enrolled in the Federal Employees Retirement System (FERS) voluntarily contribute to the TSP in their first year of eligibility, and 86 percent contribute by their sixth year.
- Create within the TSP a Roth-style investment retirement account option. Workers would have the option to invest after-tax dollars in their TSP. Those choosing the Roth option would be taxed on the income they contribute at the time of contribution, rather than on withdrawal, thus increasing income tax revenue. This option could be attractive to federal employees at both the lower and upper ends of the wage scale.
- Provide for additional self-directed investment options. The Federal Thrift Retirement Investment Board would have new authority to add a Mutual Fund Window, that would enable TSP participants to invest in the same mutual funds that are available in the private sector.
- Make other retirement reforms. The substitute amendment would include other retirement reforms, such as allowing employees covered by the newer Federal Employee Retirement System (FERS) to receive credit for unused sick leave toward their retirement annuity (similar to employees covered by the older Civil Service Retirement System) and correcting the retirement calculation for part-time service. These would raise the average retirement benefits paid to individuals.
- Increase the survivor benefit for certain widows and dependents. Under current law, survivors who are entitled to both a Survivor Benefit Plan (SBP) annuity from the Department of Defense and Dependency and Indemnity Compensation (DIC) from the Department of Veterans Affairs must have their SBP annuities reduced dollar-for-dollar for the amount of DIC they receive. This offset effects an estimated 55,000 survivors of retirees who died as a result of their service-connected injuries and survivors of service members who died on active duty. In the National Defense Authorization Act for Fiscal Year 2008, Congress authorized a monthly special survivor indemnity allowance to reduce the effects of this offset.
This provision would increase and extend the special survivor indemnity allowance by increasing the allowance to $150 per month in fiscal year 2014, $200 per month in fiscal year 2015, $275 per month in fiscal year 2016, and then would extend the allowance to include fiscal year 2017, during which the payment would be $310 per month.
These provisions would generate net increased revenue for the federal government, offsetting the reduction in excise taxes collected on tobacco products that will result from the reduction of consumption of tobacco products due to the effectiveness of the new FDA regulatory regime.
On May 5, 2009, Senator Kennedy introduced the Family Smoking Prevention and Tobacco Control Act (S.982). The legislation has received bipartisan support and, at the time of this writing, has 52 cosponsors. The bill was reported favorably out of the HELP Committee on May 20, 2009.
A similar measure, the Family Smoking Prevention and Tobacco Control Act (H.R. 1256), sponsored by Rep. Waxman, was introduced in the House on March 3, 2009. H.R. 1256 was passed by the House on April 2, 2009 by a vote of 298 – 112, and was placed on the Senate Calendar.
The text of H.R.1804, the Federal Retirement Reform Act of 2009, which the House had approved by voice vote on April 1, was incorporated into the final text of H.R. 1256, which was placed on the Senate Calendar.
When the Senate proceeds to consideration of H.R. 1256, it is expected an amendment in the nature of a substitute will be offered, containing the text of S. 982 and containing provisions of federal employee retirement similar to the provisions incorporated into H.R.1256.
Comparable legislation to S.982 passed the Senate in 2004, and the first FDA tobacco legislation was introduced more than 10 years ago, after the release of the 1996 final rule in which FDA asserted jurisdiction over tobacco products. A lengthy court battle ensued, concluding with a 2000 Supreme Court ruling that legislation was required to give FDA authority to regulate tobacco products. Following this ruling, several FDA tobacco bills were introduced during the 107th Congress, without legislative activity.
In the 108th Congress, following months of discussion with public health groups, Senators DeWine and Kennedy and Representatives Davis and Waxman introduced the Family Smoking Prevention and Tobacco Control Act (S. 2461, H.R.4433). The Senate voted 78-15 to add S.2461 to a corporate tax package, but the language was removed in conference. The legislation was reintroduced in the 109th Congress (S.666, H.R.1376) and in the 110th Congress (S.625, H.R.1108), when it was ordered to be reported out of the HELP Committee, as amended, and reported out of the House Committee on Energy and Commerce and passed by the House in July 2008 by a vote of 326 – 102.
Amendments are expected during consideration of H.R.1256 by the Senate, and information will be distributed to Senate staff as it becomes available.
CongressionalBudget Office Estimate
At this time, the Congressional Budget Office (CBO) has not issued a cost estimate for S.982. CBO has issued a cost estimate for H.R.1256, House-passed legislation that is very similar to S.982, available H.R.1256.pdf" target="_blank">here. The CBO estimates that implementing H.R.1256 would cost $123 million from 2010 – 2014, but save $232 million over the ten-year budget window, from 2010 – 2019.
The Obama Administration has not issued a Statement of Administration Policy (SAP) on S.982. The Administration has release a SAP on H.R.1256, the Family Smoking Prevention and Tobacco Control Act, available here. The President strongly supported House passage of the legislation, which is very similar to S.982, the Family Smoking Prevention and Tobacco Control Act, reported by the HELP Committee on May 20, 2009.
Congressional Research Service, FDA Tobacco Regulation: The Family Smoking Prevention and Tobacco Control Act of 2009 (R40475).
Congressional Research Service, FDA Tobacco Regulation: History of the 1996 Rule and Related Legislative Activity, 1998-2008 (R40196).
Committee on Health, Education, Labor and Pensions, Hearing materials related to “The Need for FDA Regulation of Tobacco Products” (February 27, 2007), available here.
Institute of Medicine, “Ending the Tobacco Problem: A Blueprint for the Nation” (May 24, 2007), available here.
 National Center for Health Statistics, 2007 National Health Interview Survey
 Centers for Disease Control and Prevention, “Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses – United States 2000-2004,” MMWR 57(45), November 18, 2008, available here.
 Centers for Disease Control and Prevention, “Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses – United States 2000-2004,” MMWR 57(45), November 18, 2008, available here.
 2007 National Youth Risk Behavior Survey.
 Substance Abuse and Mental Health Services Administration, U.S. Department of Health and Human Services (HHS), “Results from the 2007 National Survey on Drug Use and Health,” 2008, available here.