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. H.R. 1256 signed into law on June 22, 2009
Overview of FDA Law
H.R signed into law on June 22, 2009

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

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)

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.

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)

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

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)

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

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
Food and Drug Administration

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)

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)

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

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
GREEN
Green indicates actions that local governments MAY take with least risk
The lawsuit pending against the FDA law may affect the legality of some of the items marked “green”
Use the TALC model ordinances and work with TALC to ensure that the new laws are as legally sound as possible
The lawsuit challenging the FDA law particularly affects the creation of local policies related to advertising, sponsorship, or sampling.

35. Explanation of stoplight system
YELLOW
Yellow policies require further legal research
May draw a lawsuit if adopted as a local ordinance
Some communities may be interested in setting new precedent by pursuing these indicators
If your community is particularly interested in one of the “yellow” indicators, contact TALC to discuss the related implications

36. Explanation of stoplight system
RED
Red policy ideas are not legally permissible at this time and should not be pursued.

37. Green Light Policies
These policies do not include every possible policy idea that is legal to pursue, but focuses on those which TALC and The Center received questions about following the FDA law’s passage.
[explain the 2 chart handouts]

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.

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.

45. Policies related to the sale of tobacco products
Voluntary policy refusing to sell tobacco products in a pharmacy

46. Law Banning Sale of Flavored Tobacco
The FDA law only bans cigarettes with flavorings OTHER than menthol. For example, fruit flavors, chocolate, coffee, herb or spice.
This does NOT reach flavored cigars, little cigars, spit tobacco, or hookah accessories that contain tobacco.
The FDA law does NOT prohibit local governments from working on this issue, and you can close these loopholes by banning ALL flavored tobacco products, including cigarettes, little cigars, dissolvables, and spit tobacco.
Also, a local resolution in support of the FDA banning the sale of such products is legal. (This is a separate CX indicator.)
For example, the definition of cigarette in the FDA law is open for interpretation as to whether it encompasses little cigars. Resolutions could help convince the Secretary to interpret the definition as including little cigars.
NOTE: The term “cigarette:”
Means a product that--
Is a tobacco product; and
Meets the definition of the term `cigarette' in section 3(1) of FCLAA
Any roll of tobacco wrapped in paper or in any substance not containing tobacco
Includes tobacco, in any form, that is functional in the product, which,
Because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.
sigarettes.blogspot.com

47. Law Banning All Tobacco Sampling
The FDA law prohibits the distribution of free samples of cigarettes, smokeless tobacco, or other tobacco products.
However, there is an exception allowing the distribution of ONLY smokeless tobacco in a “qualified adult-only facility.”
According to the FDA law, a qualified adult-only facility is one that:
Ensures access only to adults,
Does NOT sell, serve, or distribute alcohol, and
Is a temporary structure built for the purpose of distributing free samples of smokeless tobacco.
The FDA law has stronger restrictions than the MSA or California law, BUT there are still significant loopholes:
This provision does not cover coupons, promotional offers, or the like.
It does not cover low-cost distribution, which means that they can technically distribute samples in exchange for a penny.
It also does not prevent people from bringing in alcohol to the tent that they purchased or obtained elsewhere.
A local community can close these loopholes by passing their own sampling law with more stringent restrictions.
TALC has created a Sampling Fact Sheet and a Sampling model ordinance with a checklist to help local communities combat this problem. Be sure to consult with TALC for help with tailoring the model ordinance to your community’s needs.
(The MSA defines an adult-only-facility as a facility or restricted area that ensures access only to adults during a particular event or specified time period. California law is stronger than the MSA because in California people outside of an adult-only-facility must NOT be able to see inside.)

48. Voluntary Policy Refusing Tobacco Company Event Sponsorship
The next few slides discuss voluntary policies that reflect the free choices of people or groups. Voluntary policies are always OK. A law banning tobacco company sponsorship usually gets a yellow light—we will discuss those kinds of policies in a few minutes.
I used this image as an example of a voluntary policy. I’m sure you are all familiar with the story about the Alicia Keyes concert in Jakarta: when she was informed by Tobacco Free Kids that her concert was sponsored by tobacco companies, she refused the sponsorship and asked Philip Morris to remove all signage from the concert area.
BUT businesses adopting a voluntary policy would have the most impact. For example, rodeos or stadiums could voluntarily refuse all tobacco sponsorships for any events held there.
tobaccofreekids.org/pressoffice/aliciakeys/index.shtml

49. Voluntary Restriction on Time, Place, or Manner of Ads/Promotions
These newspapers (and others) have all voluntarily agreed to stop accepting tobacco advertising.
Another example is a chain of stores voluntarily refusing to post tobacco advertising.
Voluntary restrictions are a good approach because it gets around the First Amendment and FCLAA issues. However, they only affect those businesses willing to agree to them AND the businesses can retract these restrictions at any time.

50. Voluntary Policy Refusing Tobacco Marketing or Sponsorship in AOFs
As I mentioned earlier, the FDA law defines a qualified adult-only facility as one that:
Ensures access only to adults,
Does not sell, serve, or distribute alcohol, and
Is a temporary structure built for the purpose of distributing free samples of smokeless tobacco.
This appears to be written with outdoor tents at rodeos and similar sporting events in mind, however, other possibilities are not prohibited, such as a temporary enclosed area located adjacent to a bar or other similar venue, such as a sampling tent set up in the outdoor patio or a parking lot.
Examples of voluntary policies include a local bar owner deciding to prohibit placement of such a structure on her property if it is affiliated with a tobacco company. Also, a venue for outdoor events, like a rodeo or fair, could decide to prohibit tobacco sampling tents.

51. Law Requiring That Tobacco Be Shelved Behind Opaque Containers
The FDA law does not prohibit a local law requiring that tobacco be kept in opaque containers or otherwise kept out of children’s views, but a local law would still have to allow some means for tobacco companies to communicate with adult customers.
Communities interested in pursuing this should work with TALC to make sure the law complies with the First Amendment.

52. Reporting Violations of the MSA or FDA law
The state Attorney General is authorized to enforce the provisions of the MSA and STMSA
Communities may report violations of the FDA law to the FDA. One example is how the FDA is accepting reports of violations of the ban on flavored cigarettes:
Dedicated phone line
Online reporting form
Letter by mail
We anticipate that as other parts of the FDA law go into effect, similar enforcement mechanisms will be established for other violations.
As Justin mentioned earlier, although communities cannot directly enforce the FDA law, a strong local tobacco retailer licensing policy may be a mechanism for monitoring violations of the FDA law if the policy prohibits violations of local, state, or federal tobacco control laws.
I’m now going to turn things over to Leslie, who will review the CX indicators that get a yellow light from us.

53. Yellow Light Policies

54. Law Restricting Time, Place, Manner of Advertising and Promotions
As we discussed a few minutes ago, the tobacco companies sued the FDA on First Amendment grounds for restricting their advertisements and promotions. If a state, city or county passed a law restricting tobacco advertisements or promotions, the tobacco companies could also sue it. Cities/counties that are interested in pursing advertising/promotions ordinances may do so, but need to be fully prepared to defend the law in court if necessary.
Distinguish again from voluntary policies.
Distinguish from ban on only some kinds of ads (e.g., ban on ads for menthol or snus only)

55. FCLAA Preemption 1st Amendment NOT changed by FDA law
Why Are Time, Place, Manner Restrictions Risky if the FDA Law Says They’re OK?
FCLAA Preemption
1st Amendment
Changed by FDA law
NOT changed
by FDA law

56. Time, Place, & Manner Restrictions
Lorillard v. Reilly (2001)
4-part Central Hudson test applied:
Tobacco ads legal? Yes
Substantial government interest?
Yes, protecting
kids from tobacco
Four-part Central Hudson test:
Speech must concern lawful activity and not be misleading
Need substantial governmental interest
Protecting children from tobacco advertising: sufficient
Protecting adults from bad decisions: probably not
Regulation must directly advance the governmental interest
Does the law solve the problem?
Law must be no more extensive than necessary
Does the law keep adults from tobacco messages?

57. Time, Place, & Manner Restrictions
3. Regulations directly advance interest?
Outdoor ad limits – maybe
Indoor ad limits - no
More extensive than necessary?
Yes, retailers have some right to advertise product legal for adults
Regulations eliminated nearly 100% of ads
Result: Mass. smokeless regulations
unconstitutional
Four-part Central Hudson test:
Speech must concern lawful activity and not be misleading
Need substantial governmental interest
Protecting children from tobacco advertising: sufficient
Protecting adults from bad decisions: probably not
Regulation must directly advance the governmental interest
Does the law solve the problem?
Law must be no more extensive than necessary
Does the law keep adults from tobacco messages?

58. Law Requiring Counter-ads or Point of Sale Health Warnings
New York has recently passed such a law and the tobacco companies have announced their intent to sue. The outcome of that case (if it is filed) will determine whether such policies should be pursued by other jurisdictions.
Even if the tobacco companies don’t sue in NY, if your community passes a similar law your city or county might be sued. [Maybe discuss difference between compelled speech and restrictions on advertising?] If you decide to do this, work with TALC to develop the strongest legal language in your ordinance that is most likely to withstand a lawsuit.

59. Law Banning Tobacco Promotions or Marketing at Adult Facilities
Distinguish from voluntary policy
Distinguish from sampling

60. Laws Restricting Price Manipulation Strategies
Examples:
Retail value added schemes (two for the price of one)
Buydowns
Multi-pack offers

61. Law Prohibiting Tobacco Company Event Sponsorship
Distinguish from voluntary policy.

62. Law Prohibiting Sale of Tobacco Products in a Pharmacy
This policy is not affected by the FDA law. However, there is still one pending lawsuit challenging San Francisco’s ordinance banning the sale of tobacco in pharmacies. The outcome of that lawsuit will determine whether this policy is legal in California. (other states’ ability to pass pharmacy ordinances will differ)

63. Enforcing Existing Local Laws Restricting Tobacco Advertising
Some communities already had laws on the books restricting tobacco advertising before the Lorillard case made those laws unenforceable.
The FDA law has language making those laws enforceable again.
However, more research is needed to determine whether enforcing those laws will open up communities to lawsuits from the tobacco industry.

64. Red Light Policies
The following RED LIGHT policies are NOT legal at this time and should NOT be undertaken

65. Banning Ads For Certain Tobacco Products
Although it might be legal to ban ALL tobacco advertising, it is not ok to ban advertising for certain tobacco products but not others.
A law banning advertising only for certain products, such as a law disallowing ads for menthols, would have to apply evenly to all tobacco products.

66. Requiring Package Warning Labels in Additional Languages
FCLAA preempts state and local governments from requiring health-related statements on cigarette packaging that are additional to those required by the federal law.
Therefore, requiring EITHER warning labels in additional languages OR…

67. Requiring Additional Warnings on Cigarette Packages
…additional warning labels in English are illegal.
fodey.com

68. Laws Regarding Subjects Reserved for the FDA Only
No requirements relating to:
tobacco product standards
premarket review
adulteration, misbranding, labeling
registration
good manufacturing standards
modified risk tobacco products
The FDA law expressly says that certain types of limits on tobacco are off-limits to states—only the FDA may create standards in these areas. These are not areas that local tobacco control efforts have traditionally focused on, and no one in California that I know of has been working in these areas.
Now that you know which policies are ok to work on locally, we’ll let you know how TALC and the Center can help you get started! (Vanessa)
“No State or political subdivision of a State may establish ... any requirement which is different from, or in addition to, any requirement under the provisions of this chapter relating to tobacco product standards, premarket review, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk tobacco products.”

69. How Can the Center Help?
(916)

70. Need training?

71. Need a little help with directions?

72. Need a quick tune-up?

74. How Can TALC Help? Research legal issues
FREE legal technical assistance throughout California
Research legal issues
Create model ordinances
Customize ordinances for
communities
Consult on specific
tobacco-related issues
Support public health departments, gov’t attorneys, elected officials, community based organizations

75. Questions for the Center:
Questions for TALC: