FDA Regulation of Tobacco: What does it mean? When does it start? And what’s next?

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

Overview of Key Elements 1.Requires the Tobacco Industry to provide information to the government that allows the government to better inform consumers 2.Restricts marketing that appeals to kids, misleads adults, and deceptively encourages tobacco use 3.Strengthens restrictions on sales to youth

4. Informs consumers through: Improved warning labels Better testing of tar, nicotine and other harmful substances Standards to prohibit false health claims 5. Regulates the contents of the product to protect consumers 6. Protects and expands state authority Overview Key Elements

Disclosures to the FDA Requires tobacco companies to disclose to FDA anything they add as well as chemicals found in both the product and the product’s smoke Requires disclosure of industry research and can require additional research Requires tobacco companies to notify FDA of any changes to a product Gives the FDA the right to disclose critical information to the public

Tobacco Marketing Restrictions

New Limits on the Marketing and Sales of Tobacco Products 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 further restrict tobacco marketing Expands the power of the states: Permits states to restrict time, place and manner of tobacco marketing

More Marketing Restrictions! Bans remaining tobacco brand sponsorships of sports and entertainment events Bans free giveaways of any non-tobacco items with the purchase of a tobacco product or in exchange for coupons Bans free samples of cigarettes and the sale of cigarettes in packages that contain fewer than 20 cigarettes Bans outdoor tobacco advertising near schools and playgrounds after further FDA review

…and MORE marketing restrictions! Limits in-store point-of-sale tobacco advertising to black- and-white text only Limits advertising in publications with significant teen readership (more than 15 percent or 2 million) to black-and-white text only Restricts 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, the FDA established nation wide standards requiring retailers to verify age for over-the-counter sales and provided funds for states to enforce Between 2006 and 2007, 27 states reported increases in sales to minors

Power to Regulate the Content of Tobacco Products

BEFORE NOW, TOBACCO PRODUCTS WERE 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

Harm From Cigarettes 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 ingredients that contribute to the risk of heart disease, lung disease and other serious diseases

Did you know…? Data suggests that up to one half of current lung cancer occurrence may be due to changes in cigarette design and that current lung cancer rates might be reduced by up to 50% through regulatory control of cigarette design and composition. David Burns and Christy Anderson, UCSD School of Medicine 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 gives the FDA authority to … …require product changes that the FDA finds are “appropriate for the protection of the public health” …require manufacturers to reduce or eliminate harmful substances, including those found in tobacco smoke - whether added or naturally occurring …reduce nicotine levels to below the point they cause addiction

Applies to BOTH existing and new products – NO tobacco products exempted or grandfathered

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.

How does FDA regulation affect tobacco consumers? 1.Improved warning labels for cigarettes and smokeless tobacco 2.More accurate testing of tar, nicotine and other harmful substances 3.Standards to review health claims and prohibit unsubstantiated health claims

MEANINGFUL Warning Labels 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 nowCigarette pack under FDA Regulation Front Back Front Back WARNING LABEL WARNING LABEL

Warning Labels Abroad Brazil Thailand Canada

FDA regulation = Better Product Testing 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.

FDA regulation = Better Product Testing Tests prove that products labeled Low Tar based on the current testing method are not less hazardous. “Low Tar” claims based on these tests mislead consumers. Low Tar Deception

A NEW Product Testing Method FDA is authorized to create 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 the ingredients found in smoke. The regulations may require that tobacco product manufacturers disclose the results of the testing …

Unproven Health Claims (Section 911) Prohibits claims until science is adequate to reach meaningful conclusions Bans terms like “Light” and “Low Tar” as misleading When a Manufacturer claims that a tobacco product is less harmful than other tobacco products they must prove that… …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.

Implementation When does all this new regulation start? Immediately –Preemption of state/local efforts to restrict marketing repealed –No health claims without review –Review of new products –Broader advertising authority 3 months –No candy-flavored cigarettes

Implementation 12 months –No “light,” “low,” or “mild,” descriptors –Marketing restrictions – magazines, points of sale, sponsorship, etc –New warning labels on smokeless tobacco –Scientific Advisory Committee appointed within 15 months A little further out … –Larger, stronger graphic warning labels on cigarettes Rule issued within two years Implementation – 15 months later

The Process Prelud e Solicit Public Input – current notice Scientific Advisory Committee ANPRM Petitions Meetings & workshops Draftin g Considerations & Consultation Required analysis OMB Review Propo sal Publish in Federal Register Public Comment –written & hearing FDA considers all comments Considerations & Consultation Required analysis Revise OMB review Final Rule Publish in Federal Register Effective Date Implementation Potential litigation

Opportunities for Public Input

FDA Seeks Public Input on Tobacco Regulation Docket No. FDA-2009-N-0294 Deadline: September 29, Comments –Electronic: –Written: Division of Dockets Management (HFA- 305) Food and Drug Administration, 5630 Fishers Lane, rm Rockville, MD

FDA IS NOT THE END! There’s still work to be done!

FDA Preserves States’ Rights To… Increase Tobacco Taxes Implement & Enforce Smoke-free Laws Fully fund effective comprehensive tobacco control programs Provide coverage of cessation services Take action to restrict sale & distributions of tobacco

FDA Legislation Does Nothing to Restrict States from… Prohibiting the sale of any other tobacco products to persons of any age Increasing the age of sale Restricting sales to just at certain specified locations (e.g., by prohibiting sales at pharmacies or other health facilities, or at college campuses or any other locations frequented by youth).

Supplement the new FDA requirement that all retail ads for cigarettes and smokeless consist only of black text on white background by applying the same restrictions to cigar and other tobacco product ads Restrict or eliminate “power walls” of cigarettes being offered for sale at retail outlets Limit the number or size of tobacco product ads at retail outlets; Require that all tobacco products or tobacco product ads be kept away from cash registers in order to reduce impulse purchases by smokers trying to quit. States may now do such things as…

What can YOU do? –Continue to push for … Smoke-free air laws Comprehensive tobacco control program funding Tax increases Cessation coverage Smoke-free facilities Restrictions on sale and distribution at the state level