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

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

H.R. 1256 signed into law on June 22, 2009 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

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

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

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

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

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

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)

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)

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)

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)

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

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)

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)

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

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

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

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

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.

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.

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

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

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.

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

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

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

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

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/

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

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

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

CX Indicators Which are ok to pursue?

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.

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

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

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]

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

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.”

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

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

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

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/

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/

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

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 www.trinketsandtrash.org

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.)

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

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.

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

Law Requiring That Tobacco Be Shelved Behind Opaque Containers www.timesunion.com/AspStories/story.asp?storyID=727790 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.

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.

Yellow Light Policies

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) http://xroads.virginia.edu/~UG00/3on1/tobaccoads/polimage.htm

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

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?

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?

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. www.diseaseproof.com/AFPsmoke.jpg

Law Banning Tobacco Promotions or Marketing at Adult Facilities Distinguish from voluntary policy Distinguish from sampling www.smoke-free.ca

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

Law Prohibiting Tobacco Company Event Sponsorship Distinguish from voluntary policy.

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) www.rawbw.com/~jpk/stand/Pictures.html

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.

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

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. www.trinketsandtrash.org

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…

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

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.”

How Can the Center Help? www.center4tobaccopolicy.org (916) 554-5864

Need training?

Need a little help with directions?

Need a quick tune-up?

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 http://www.flagstaff.az.gov/index.aspx?NID=527

Questions for the Center: jgarrett@alac.org www.center4tobaccopolicy.org Questions for TALC: talc@phlpnet.org www.phlpnet.org/tobacco-questions