Effective FDA Authority Over Tobacco Products Is Necessary to Protect Our Children, Protect the Public Health and to Reduce the Toll from Tobacco June 2009

Goals of Presentation Brief History of Bill Who Supports Why Needed What it Does

A Bill Whose Time Has Come 15 Years In the Making 1996 – FDA asserts jurisdiction, but in 2000 the Supreme Court held only Congress could give FDA authority over tobacco 1998 – Comprehensive tobacco bill led by John McCain included FDA authority over tobacco – garnered 57 votes; Senators Harkin, Chafee and Graham had similar legislation as did Senator Conrad 2001 – Kennedy-DeWine bill – forerunner of current legislation; Senator Dodd introduced similar legislation

A Bill Whose Time Has Come 2004 – Kennedy-DeWine reintroduced bill similar to current bill; PASSED SENATE 2007 – Kennedy reintroduces with Cornyn; 60 cosponsors and passes HELP Committee 2008 – Companion bill passes House but too late for Senate to act 2009 – Bill passes House a second time 298 – 112 on April 2nd; Senate HELP Committee passes S.982 by a vote of on May 20th

Who Supports – Over 1000 Organizations 88 National Health Organizations American Cancer Society American Heart Assoc. American Lung Assoc Campaign for Tobacco-Free Kids American Medical Assoc National Medical Assoc Nat’l Hispanic Medical Assoc Nat’l Council of La Raza American Dental Assoc American Public Health Assoc American Academy of Pediatrics American College of Physicians American College of Prev Medicine Lance Armstrong Fdn. Other National Organizations AARP SEIU Hadassah Families USA Nat’l Education Assoc. Nat’l Faith Organizations American Baptist Churches USA Disciples of Christ Ethics and Religious Liberty Comm, Southern Baptist Convention United Church of Christ United Methodist Church Presbyterian Church Evangelical Lutheran Church in America Religious Action Center of Reform Judaism

KEY SUBSTANTIVE ELEMENTS 1.Require the Industry to provide information to the Gov’t that allows Gov’t to better inform consumers 2.Restrict marketing that appeals to kids, misleads adults, deceptively encourages tobacco use 3.Strengthen restrictions on sales to youth

KEY SUBSTANTIVE ELEMENTS 4. More Accurately Inform consumers A. Improved warning Labels B. More accurate testing of tar, nicotine and other harmful substances C. Standards to prohibit unsubstantiated health claims 5. Regulation of the Contents of the Product to protect consumers 6. Protect and Expand State authority

Why do we need more information?

Increased Nicotine Levels in Cigarettes Average Nicotine Yields Per Cigarette Harvard School of Public Health, % increase from 1997 to 2005

Disclosures to FDA and the Public – Sec 904 Disclosures to FDA Requires tobacco companies to disclose to FDA anything they add and chemicals found in both the product and the product’s smoke whether added or occurring naturally– by quantity – including nicotine. Requires disclosure of industry research and can require additional research Requires companies to notify FDA of changes to a product Health Information Disclosure to Public Right of FDA to disclose critical information to the public with the flexibility to insure that it is not misleading

Why Do We Need to Restrict Tobacco Marketing?

Magazine Ad for Camel No. 9 Stiletto, Fall 2007

Limiting Marketing and Sales of Tobacco Products – Sec 906 and 102 Imposes specific limits on industry marketing, sales, and promotions, including but not limited to marketing that appeals to young people Provides FDA the authority to issue new regulations further restricting tobacco marketing up to the limit of the Constitution Expands power of States: Permits States to Restrict Time, Place and Manner of tobacco marketing

Section 102 – Puts in place Specific Advertising Restrictions Previously Adopted by FDA Ban remaining tobacco brand sponsorships of sports and entertainment events Ban free giveaways of any non-tobacco items with the purchase of a tobacco product or in exchange for coupons Ban free samples of cigarettes and the sale of cigarettes in packages that contain fewer than 20 cigarettes Ban outdoor tobacco advertising near schools and playgrounds after further FDA review

Section 102 – – Puts in place Specific Advertising Restrictions Previously Adopted by FDA Limit in-store point-of-sale tobacco advertising to black-and-white text only Limit advertising in publications with significant teen readership (more than 15 percent or 2 million) to black-and-white text only Restrict vending machines and self-service displays to adult-only facilities

SEC. 906( d) The Secretary may by regulation impose additional restrictions on the advertising and promotion of a tobacco product consistent with and to the full extent permitted by the first amendment to the Constitution.

Why Do We Need to Improve Efforts to Prevent Illegal Sales to Minors In 1996 FDA established nation wide standards requiring retailers to verify age for over-the-counter sales and provided funds for states to enforce By 2000, all 50 states and three territories contracted with FDA to train state personnel to perform compliance checks In 1997, 8 states conducted compliance checks. By 2000, 43 states conducted compliance checks Between 2006 and 2007, 27 states reported increases in sales to minors

Why do We Need the Power to Regulate the Content of Tobacco Products

TOBACCO PRODUCTS ARE EXEMPT FROM FDA PROTECTIONS NO product review NO ingredient review NO ingredient disclosure –The ammonia, arsenic and other toxic chemicals found in cigarettes remain unregulated and unreported to consumers EXAMPLE: A new ingredient in Marlboro cigarettes can simply be added to the product - no tests needed, no disclosure necessary, no questions asked

The Harm From Cigarettes Comes from Many Potential Sources Cigarettes contain 69 known cancer causing agents falling into five major classes In addition to the known cancer causing agents, cigarettes contain literally hundreds of constituents that separately contribute to the risk of heart disease, lung disease and other serious diseases

IS THE INCREASE IN ADENOCARCINOMA A RESULT OF CHANGES IN CIGARETTE DESIGN? David Burns and Christy Anderson, UCSD School of Medicine These data suggest that up to one half of current lung cancer occurrence may be attributable to changes in cigarette design and correspondingly that current lung cancer rates might be reduced by up to 50% through regulatory control of cigarette design and composition. Abstract for Poster Presentation: Society for Research on Nicotine and Tobacco (SRNT) Joint Conference of SRNT and SRNT-Europe, April 30, 2009, Dublin, Ireland

Product Regulation- Authority to set Toxicant Standards - Sec 907 Gives FDA authority to require manufacturers to reduce or eliminate harmful substances, including substances found in tobacco smoke - whether they are added or occur naturally Gives FDA authority to reduce nicotine levels to below the point they cause addiction Applies to BOTH existing and new products – NO tobacco products exempted or grandfathered The Standard: Protection of the Public Health Focuses on both Individual Harm and Population Effect

SEC. 907 TOBACCO PRODUCT STANDARDS Limitations on FDA Authority FDA can’t ban all cigarettes, all smokeless tobacco products, … or all roll your own tobacco products; or Require the reduction of nicotine yields of a tobacco product to zero.

What the Bill Does to More Accurately Inform consumers 1.Improved warning Labels – Sections – cigarettes Sections – smokeless 2.More accurate testing of tar, nicotine and other harmful substances - Section Standards to prohibit unsubstantiated health claims – Section 911

Meaningful Warning Labels – Sec Cigarettes - Replaces current small, hard to read warning labels with larger, more specific warning labels covering 50% of the top half of the front and back of each pack with graphics depicting the health consequences of tobacco use Smokeless - Replaces current small, hard to read warning labels with larger, more specific warning labels covering 30% of the top half of the front and back of each package Gives FDA the authority to revise the warning labels.

Cigarette pack now Cigarette pack under FDA Regulation Front Back Front Back WARNING LABEL WARNING LABEL

Current Product Testing – Low Tar Deception Since the mid 1960’s the only reported testing of cigarettes has been for tar, nicotine and CO – by a machine test originally overseen by the FTC. FTC has concluded that these test results do not accurately show how much tar and nicotine consumers receive. NCI has found that products labeled Low Tar based on these tests are not less hazardous. “Low Tar” claims based on these tests mislead consumers. Therefore – change is needed.

Sec 915 – Product Testing SEC 206 Replacing FTC Test Method FDA is authorized to promulgate regulations that require new testing in a manner to be set by FDA. The testing will go beyond tar and nicotine to include tobacco product constituents, ingredients, and additives, including smoke constituents. The regulations may require that tobacco product manufacturers disclose the results of the testing … that the Secretary determines the disclosures will not mislead consumers about the risk of tobacco related disease.

Prohibiting Unproven Health Claims Section 911 Prohibit claims until science is adequate to reach meaningful conclusions Does not prohibit introduction of potentially less hazardous products A rigorous scientific standard to avoid mistakes but that doesn’t discourage scientific innovation Terms like Light and Low Tar are Banned as Misleading Permits comparisons between product categories, such as between cigarettes and smokeless tobacco Post-market surveillance

SEC 911 MODIFIED RISK TOBACCO PRODUCTS Health Claims When a Manufacturer represents that a tobacco product is less harmful than other tobacco products; What Must Be Shown The product, 1) as it is used by consumers, 2) will significantly reduce the risk of tobacco-related disease 3) to individual tobacco users; and 4) 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.

Protects and Expands States Rights

Sec 916 – State/Federal Balance No State preemption of measures relating to the sale, distribution, possession, exposure to, access to, or advertising and promotion of tobacco products or measures relating to fire safety or State, Tribal, or local taxation of tobacco products Expands power of States: Permits States to restrict Time, Place and Manner of tobacco marketing

Sec 916 – State/Federal Balance What is preempted? Requirements relating to: 1) tobacco product standards, 2) premarket approval, 3) adulteration, 4)misbranding, 5) labeling, 6) registration, 7) good manufacturing standards, or 8) reduced risk products

In the near term …. No FCLA preemption of state/local efforts to restrict marketing -- immediate No health claims without review – immediate though FDA must gear up Review of new products – immediate though FDA must gear up No flavored cigarettes -- three months No “light,” “low,” “mild,” descriptors – one year Youth access provisions – contracts with states – 12 months Marketing restrictions – magazines, points of sale, sponsorship, etc months Broader advertising authority – immediate New Warning labels on smokeless within twelve months; graphic warnings on cigarettes – no more than 39 months FDA to begin receiving information from industry – 6 months So Now What Happens

In the longer term …. Product Standards (for existing AND new products) Technically could do immediately but realistically Need to develop the science Make sound decisions to protect public health So Now What Happens

We become the watchdogs Bring issues to FDA attention Press FDA to act aggressively Provide strong arguments during public comment Continue to develop the science to inform FDA action Take full advantage of opportunities presented by FCLA repeal What is Our Role?