The New FDA Law: A Green Light for Local Policies?

1. The New FDA Law: A Green Light for Local Policies? The Center For Tobacco Policy & Organizing Kimberly Weich Reusche Justin Garrett Vanessa Marvin Technical Assistance Legal Center Leslie Zellers Elisa Laird-Metke

2. Agenda • Welcome and Overview • TCP Perspective: April Roeseler • Overview of FDA Legislation & Lawsuit • Green Light, Yellow Light, Red Light  Policies • How TALC and the Center can Help • Questions

3. Overview of FDA Law H.R. 1256 signed into law on June 22, 2009 www.cbsnews.com/blogs/2009/06/22/politics/politicalhotsheet/entry5104008.shtml

4. New Authority over Tobacco Products • Restrictions on marketing of tobacco products • Restrictions on youth access to tobacco products • Authority over tobacco product standards • Require more accurate information for consumers www.fda.gov/TobaccoProducts/default.htm

5. Restrictions on Marketing of Tobacco Products Ban giveaways of branded products, such as T-shirts, with purchase of tobacco product (12 months after enactment)

6. Restrictions on Marketing of Tobacco Products Prohibit free samples of cigarettes and smokeless tobacco except in certain restricted situations (12 months)

7. Restrictions on Marketing of Tobacco Products Ban remaining tobacco-brand sponsorship of sports and entertainment events (12 months) www.notobaccoads.org/asp_sponsorship.asp

8. Restrictions on Marketing of Tobacco Products Ban outdoor advertising near schools and playgrounds (12 months)

9. Restrictions on Marketing of Tobacco Products • Limit advertising to black and white text only for: • Outdoor advertising • Point of sale advertising (except in adult-only facility) • Publications with significant teen readership • (12 months)

10. Restrictions on Youth Access to Tobacco Products • Ban on vending machines or self-service displays (12 months) • Federal enforcement of prohibition of sales to anyone under age 18 (9 months)

11. Restrictions on Youth Access to Tobacco Products • Regulations to prevent sale of tobacco products to youth via Internet (18 months) • Regulations to prevent promotion and marketing of tobacco products to youth via Internet (18 months)

12. Authority over Tobacco Product Standards FDA has authority to issue product standards to promote public health, which can include eliminating or reducing certain ingredients (upon enactment)

13. Authority over Tobacco Product Standards • All new products (introduced or modified after Feb. 15, 2007) can be reviewed by FDA. • Starting 30 months after enactment, all new products must be submitted to the FDA for review before being sold. www.trinketsandtrash.org

14. Authority over Tobacco Product Standards • Tobacco companies must provide list of ingredients and additives to FDA (6 months) • FDA will establish a list of harmful or potentially harmful constituents (30 months)

15. Authority over Tobacco Product Standards • Tobacco companies must provide to the FDA a list of all harmful or potentially harmful constituents by brand and quantity (36 months) • FDA will require new testing and reporting of tobacco products (42 months)

16. Authority over Tobacco Product Standards FDA implements ban on flavored cigarettes (went into effect September 22, 2009) www.trinketsandtrash.org

17. Authority over Tobacco Product Standards • The flavored cigarette ban does not apply to menthol cigarettes • Menthol report 1-year after scientific advisory committee appointed www.trinketsandtrash.org

18. Require More Accurate Information for Consumers Prohibit use of “light,” “low,” and “mild” in marketing and labeling for all new tobacco products (30 days) and for existing tobacco products (12 months) www.trinketsandtrash.org

19. Require More Accurate Information for Consumers • Larger and strong warning labels on smokeless tobacco products and advertisements (12 months) • Larger and graphic warning labels for cigarettes • Regulation within 24 months after enactment • Implementation 15 months later http://whyquit.com/whyquit/addicts.html

20. Where does the funding for the Center for Tobacco Products come from? • Original allocation of $5 million to begin administrative and implementation functions • On October 1, 2009, the FDA started collecting user fees from tobacco companies based on each company’s share of the U.S. tobacco market.

21. What tobacco products are covered by the law? • Most restrictions apply specifically to cigarettes or smokeless tobacco products • FDA has authority over all tobacco products and can issue regulations on cigars, hookah, pipe tobacco, etc.

22. Who is responsible for enforcement of the law? • In most cases the FDA is responsible for enforcement but local agencies can report possible violations to the FDA. • For the youth access provisions, the FDA will likely partner with state enforcement agencies

23. More Information about the FDA Law • Tobacco Control Legal Consortium • http://tclconline.org/FDA-fact-sheets.html • Food and Drug Administration • www.fda.gov/TobaccoProducts/default.htm

24. Lawsuit Challenging FDA Law • Brought by 5 tobacco companies (including RJR and Lorillard) and 1 tobacco retailer chain. • 3 of the 4 companies signed • the MSA, 2 did not. • Suit was filed in federal court • in Western Kentucky.

25. Lawsuit Challenging FDA Law • Suit challenges 10 specific provisions of FDA law: • Tombstone advertising requirements • Ban on outdoor advertising • Sponsorship ban • Ban on sampling • Ban on brand name merchandise • Ban on promotional items with purchase

26. Lawsuit Challenging FDA Law • Suit challenges 10 specific provisions of FDA law: • 7. New package warning labels • 8. Ban on saying tobacco is “approved by the FDA” • 9. Ban on marketing tobacco with other products regulated by the FDA • 10. “Reduced harm” claims about certain products

27. Lawsuit Challenging FDA Law • The suit also challenges • FDA’s right to create further restrictions on • advertising and • promotion.

28. Lawsuit Challenging FDA Law • Challenge is based on 3 grounds: • The law is too vague to understand exactly what is prohibited • (violation of the Due Process clause of the Constitution) www.creditscorecowboy.com/blog/2008_10_01_archive.html

29. Lawsuit Challenging FDA Law • 2. By requiring larger warning labels and tombstone advertising, the government is illegally taking something (in this case package space and color in trademarks) that belongs to the tobacco companies • (violation of the Takings Clause of the • Constitution) www.burglaralarm.me.uk/

30. Lawsuit Challenging FDA Law • 3. The law prevents tobacco companies from communicating truthful information to their adult customers (violation of First Amendment free speech protections) • Same argument that won in prior case (Lorillard v. Reilly) • Some of the new FDA restrictions challenged here are similar to those challenged in Lorillard, but many are different www.ehow.com/how_4732940_talk-much.html

31. Lawsuit Challenging FDA Law Will the lawsuit succeed? Hard to say.

32. Lawsuit Challenging FDA Law • Implications for communities right now • It is still legal to pursue local policies in any of the challenged areas—there is no impact on California unless the Supreme Court makes a ruling in the case • If the Supreme Court ultimately rules any part of the FDA law unconstitutional, similar local laws would become unenforceable

33. CX Indicators Which are ok to pursue?

34. Explanation of stoplight system

35. Explanation of stoplight system

36. Explanation of stoplight system

37. Green Light Policies

38. Policies Not Impacted by FDA Most of the CX indicators are not impacted by the new FDA law

39. Policies Not Impacted by FDA FDA law specifically does not preempt states and local authorities from certain polices: “measure relating to or prohibiting the sale, distribution, possession, exposure to, access to, advertising and promotion of, or use of tobacco products by individuals of any age, information reporting to the State, or measures relating to fire safety standards for tobacco products. No provision of this chapter shall limit or otherwise affect any State, tribal, or local taxation of tobacco products.”

40. Enforcement of secondhand smoke laws Enforcing compliance with smokefree workplaces, local outdoor secondhand smoke ordinances, tribal government policies, etc.

41. Secondhand Smoke Policies All policies restricting smoking such as prohibiting smoking in outdoor dining, worksites, entryways, recreation areas, public events, housing units, etc.

42. Enforcement of sale and distribution laws Enforcing prohibitions against sales to minors, compliance with STAKE Act warning signs, prohibition of self-service displays, etc. http://www.cagrocers.com/images/stakeactsign.jpg

43. Policies related to the sale of tobacco products • Local tobacco retailer licensing ordinances • Can include language that allows penalties for violations of federal laws www2.tbo.com/content/2009/sep/07/fla-cigarette-sales-down-after-price-hike/

44. Policies related to the sale of tobacco products Policies that regulate the number, location or density of tobacco retailers through CUP, zoning or retailer license, policies that permit carton only sales of cigarettes, and policies that prohibit the sale or distribution of tobacco products. http://contexts.org/socimages/2009/08/13/comparing-tobacco-warnings-in-germany-and-the-u-s/

45. Policies related to the sale of tobacco products Voluntary policy refusing to sell tobacco products in a pharmacy www.boston.com/bostonworks/galleries/best_jobs?pg=3

46. Law Banning Sale of Flavored Tobacco www.trinketsandtrash.org sigarettes.blogspot.com

47. Law Banning All Tobacco Sampling

48. Voluntary Policy Refusing Tobacco Company Event Sponsorship tobaccofreekids.org/pressoffice/aliciakeys/index.shtml

49. Voluntary Restriction on Time, Place, or Manner of Ads/Promotions

50. Voluntary Policy Refusing Tobacco Marketing or Sponsorship in AOFs www.smoke-free.ca/filtertips04/goldclub.htm