For as Long as the Grasses Grow and the Rivers Flow; Advocating for Direct Funding for Commercial Tobacco Prevention to Tribes

Key Messages

The following key messages are in support of the National Native Network Publication titled above. Please visit our website at www.keepitsacred.org for the full version of this document

Key Take Away Message

In order to eliminate the health disparities related to commercial tobacco prevalence rates in Native American and Alaska Native communities, it is necessary and essential that all Tribes are directly funded by the federal government for commercial tobacco prevention and control efforts.

Key Message 1

Rates of commercial tobacco use among American Indian and Alaska Native (AI/AN) populations are disproportionately higher than all other U.S. populations.

• Unpublished data from tribes that have fielded the Alaska Native and American Indian Adult Tobacco Survey suggest that smoking prevalence rates are much higher than those published by NHIS, ranging from 28% to over 79%.
• Initiation and regular usage of commercial tobacco among AI/AN youth begins significantly earlier than among the rest of the U.S. population. Unpublished findings from American Indian Adult Tobacco Surveys suggest that initiation and regular use among AI/AN youth begins between the ages of 6 to 12 years of age. By the time these children reach high school, prevalence rates among high school students in Bureau of Indian Affairs (BIA) funded schools who regularly smoke cigarettes is 57%.

Key Message 2

American Indians and Alaskan Natives are the most under-funded population for tobacco prevention and control efforts; however, they have the highest commercial tobacco use prevalence rates of any race. This is thereby reflected in the health of Native communities.

• Funding directed to states for commercial tobacco prevention and control are expected (not mandated) to trickle down to tribes within each state, yet funding to tribes is less than adequate to address the enormous burden of commercial tobacco related disease and prevalence rates within Tribes.
• The Center for Disease Control and Prevention, through the Office of Smoking and Health (CDC/OSH) established a framework for commercial tobacco prevention for the mainstream population that is supported through funding to all 50 states, the District of Columbia, and the US territories.
  • Through this funding, States are expected to disperse funding to their counties and communities, including Tribal communities.
  • The fact is that the majority of states do not provide any funding to tribes for commercial tobacco prevention and control even though AI/AN populations have the highest prevalence rates among all state populations.
• The National Native Network, a CDC-Office on Smoking and Health (CDC-OSH) funded initiative, recently completed a comprehensive assessment of State funding to Tribes. Findings include:
  • Forty four states in the U.S. have tribes and/or tribal organizations residing within their borders.
  • Of these forty four states, forty three receive direct funding from CDC for tobacco prevention and control.
  • Of the forty four states, thirty responded to the National Native Network’s request for information
  • Twenty nine of the thirty respondents receive direct tobacco funding from CDC.
  • Only 30% (n=9) of the respondent states provide tobacco specific funding to tribes/tribal organizations within their boundaries, accounting for 53 tribes out of the nearly 600 tribes in the U.S.
  • Clearly, AI/AN tribes are the most under-funded population for tobacco prevention and control efforts and the high prevalence rates reflect the chronic under-funding.
• Of the 565 federally recognized Tribes, 34 State recognized Tribes and 34 Urban Indian Health Programs Nationwide, the Center for Disease Control and Prevention, Office of Smoking and Health (CDC/OSH), through grant application, currently funds:
  • 1 National Native Network (Inter-Tribal Council of MI)
  • 8 Tribal Support Centers (2010-2015)
  • 2 Communities Putting Prevention to Work – 2 Grants (CPPW – 2010-2012)
  • 11 Community Transformation Grants (2011-2012)
• Federally recognized Tribes are on a government-to-government basis, yet the Federal government funds all 50 states for tobacco prevention and control within the states. It may be concluded that Tribes are viewed as a sub-group within the state where this funding is concerned.
• Furthermore, most Tribes are unable to attain funding from states, which is often distributed by form of grant application.
  • Tribes often lack infrastructure/staffing, data, and grant writing capabilities
  • Grant criteria include mainstream practices that do not often fit with cultural practices and Tribal processes (i.e. increasing taxes on tobacco)
  • Tribes have unique Tribal processes and cultural practices – one size does not fit all
  • In some cases, Tribes are expected to give up sovereignty to receive and implement grant funding from states

Key message 3

The Federal Government has an obligation in ensuring tribal self-governance, a form of governance that has proven to enhance health and prevention services in Native communities.

• There are government-to-government relations between federally recognized Tribes and the Federal Government which are in place through federal law and Supreme Court rulings which protects our lands, self-governance and social services, as well as the health of our people.
• The Self Determination Act reinforced the government-to-government relationships as described in the Constitution, which determined that tribes are separate sovereign entities from states and that states do not have the inherent power to regulate tribes.

Summary and Defining Statement

The National Native Network makes a stand to support and advocate for the distribution of funding from the federal government go directly to all tribes, through respective tribal organizations, for the purpose of commercial tobacco prevention and control within tribal communities in which to honor the government-to-government relations which are in place through federal law and Supreme Court rulings which protects our lands, self-governance and social services, as well as the health of our people.

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“For As Long As the Grasses Grow and Rivers Flow: Advocating for Direct Tobacco Funding to Indian County”

Title refers to the signing of the treaties between the tribes and U.S. government.
“The officials were informed that when they smoked of the pipe they were partaking of a vow to the creator and were bound to it ‘For As Long As The Grasses Grow and Rivers Flow’, which basically meant forever.”

We are moving in the right direction, but our work is not done. To bring real change to tribal nations, we must continue to work together, on a nation-to-nation basis, in order to realize a future where Native people live long and healthy lives in safe communities, where they are able to pursue economic self-sufficiency, and where their children and grandchildren can have an equal opportunity at pursuing the American dream. We will continue to look to the wisdom and experience of tribal leaders to inform our policy agenda.

-- Kimberly Teehee, a member of the Cherokee Nation, is Senior Policy Advisor for Native American Affairs, White House Domestic Policy Council.

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Indian Health Service

Year 2013 Profile

Based on 2000-2013 data -- Numbers are approximate

•   The Indian Health Care System:
   Indian Health Service (IHS) direct health care services

  IHS services are administered through a system of 12 Area offices and 168 IHS and tribally managed service units.

  •   Tribally-operated health care services
    Titles I and V of the Indian Self-Determination and Education Assistance Act (Public Law 93-638, as amended), provide Tribes the option of exercising their right to self-determination by assuming control and management of programs previously administered by the federal government. Since 1992, the IHS has entered into agreements with tribes and tribal organizations to plan, conduct, and administer programs authorized under Section 102 of the Act. Today, over half of the IHS appropriation is administered by Tribes, primarily through self-determination contracts or self-governance compacts.

  •   Urban Indian health care services and resource centers
    There are 33 urban programs, ranging from community health to comprehensive primary health care services. Approximately 600,000 American Indians and Alaska Natives reside in counties served by urban Indian health programs.

•   Population Served:
   Members of 566 federally recognized Tribes
   2 million American Indians and Alaska Natives residing on or near reservations

•   Annual Patient Services (Tribal and IHS facilities):

 Inpatient Admissions:  Outpatient visits:
 Dental Services:

48,575 12,772,553 3,736,054

•   Appropriations:
   FY 2012 IHS budget appropriation: $4.3 billion  FY 2011 IHS budget appropriation: $4.07 billion

•   IHS Third-Party Collections: FY 2011 - $694 million; FY 2012 - $744 million

•   Per Capita Personal Health Care Expenditures Comparison:  IHS expenditure on user population: $2741
   Total U.S. population expenditure : $7239

•   Human Resources:
   Total IHS employees:15,930 (70% are American Indian/Alaska Native)
   Includes approximately 2640 nurses, 820 physicians, 670 pharmacists, 640 engineers/sanitarians, 340 physician

  assistants/nurse practitioners, and 310 dentists.

•   Facilities

  Additional information on the IHS is available at http://www.ihs.gov and http://www.ihs.gov/index.cfm?module=About January 2013

ISSUE

BASIS FOR HEALTH SERVICES

An awareness of the legal basis for the federal obligation to provide health care to American Indians and Alaska Natives is important when designing health care programs, developing federal budgets, coordinating with other agencies, and obtaining regulation waivers for selected Indian programs.

BACKGROUND

The trust relationship establishes a responsibility for a variety of services and benefits to Indian people based on their status as Indians, including health care. This relationship has been defined in case law and statute as a political relationship that further distinguishes Indians from racial classification for purposes of affirmative action laws and other federal statutes that establish federally funded programs for the general public.

Treaties between the United States Government and Indian Tribes frequently call for the provision of medical services, the services of physicians, or the provision of hospitals for the care of Indian people.  Even before these treaties, the United States Constitution specifically addressed the federal government’s primacy role in dealing with Indians in the commerce and treaty clauses. Supreme Court cases, such as Cherokee Nation v. Georgia (1831), specifically address the relationship between Tribes, states, and the federal government. Out of this case and others, the guardian/ward relationship was created that forms the basis of the trust relationship.

The Snyder Act of 1921 (25 USC 13) and the permanent reauthorization of the Indian Health Care Improvement Act [enacted in 2010 as part of the Patient Protection and Affordable Care Act (P.L. 111- 148)] provide specific legislative authority for Congress to appropriate funds specifically for the health care of Indian people. In addition, numerous other laws, court cases, and Executive Orders reaffirm the unique relationship between tribal governments and the federal government.

STATUS

There still exists a belief that American Indians and Alaska Natives are not citizens of their states and are not eligible for state programs and benefits. American Indians and Alaska Natives, as citizens of the United States, are eligible to participate in all public, private, and state health programs available to the general population. In addition, they also have treaty rights to federal health care services though the Department of Health and Human Services. The federal trust responsibility to uphold the treaty responsibility for health care to Indians is accomplished by consulting with Indian Tribes and then actively advocating for policy, legislative, and budgetary planning for Indian health care.

ADDITIONAL INFORMATION

For referral to the appropriate spokesperson, contact the IHS Public Affairs Staff at 301-443-3593.

January 2013

Regulatory Gaps & Options Taxation

•   Regulatory Gap: The price of tobacco products has a demonstrable effect on their use.10 As cigarette taxes have risen, cigarette consumption, especially among youth, has decreased.11 Tax increases have not affected all tobacco products equally, however. Although cigarettes and little cigars are almost indistinguishable, little cigars can be purchased for substantially less than cigarettes, making them more attractive to price- sensitive populations.12 In many jurisdictions, little cigars are subject to a percentage-of- wholesale-price tax (also known as an ad valorem tax), rather than a fixed excise tax, which is typically applied to traditional tobacco products and is substantially higher.13 In fact, the wholesale price of little cigars is so low that even a reasonably high tax rate leaves them dramatically cheaper than cigarettes.14

•   Regulatory Options: The Tobacco Control Act preserves state authority to tax tobacco products, including little cigars.15 Thus, states can raise the price of little cigars by increasing taxes to ensure that little cigars are priced comparably to their substantial equivalent – cigarettes. Given the proven impact of price on tobacco product use,16 increased taxes can be an effective way to reduce sales of little cigars.

  Coupons, Discounts, & Rebates

•   Regulatory Gap: Tobacco manufacturers use coupons and other price-related incentives to make products such as little cigars more attractive to consumers, particularly young people.17 Heavily discounted little cigars represent a gap in regulation and a public health hazard.

•   Regulatory Options: The Tobacco Control Act preserves state and local government authority to regulate the sale and distribution of tobacco products, including their price.18 Local and state governments could consider restricting or prohibiting the redemption of coupons for little cigars in retail stores, or restricting other tobacco price-related marketing practices, such as price discounts to tobacco retailers and wholesalers, tobacco retailer incentive programs, and retail value-added deals (e.g., buy-one-get-one-free offers).19

  While legal challenges to such policies can be anticipated in light of the tobacco industry’s heavy investment in price-related marketing strategies, a federal district court has recently upheld a local law prohibiting the sale of discounted tobacco products.20 In early 2012, Providence, Rhode Island enacted an ordinance prohibiting licensed tobacco dealers from selling discounted tobacco products through coupon redemption and multi- pack offers.21 Tobacco industry stakeholders challenged the law on First Amendment and federal and state preemption grounds. In December 2012, a federal district court upheld the pricing ordinance, concluding that its prohibition against certain industry price discounting practices did not violate the First Amendment and was not preempted by federal or state law.22

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Although this decision has been appealed, and even if upheld, would not be controlling in all jurisdictions, Providence’s early success may help support state or local laws to prohibit the deeply discounted sale of little cigars.

Minimum Pack Size

•   Regulatory Gap: Unlike cigarettes, which are sold in packs of twenty,23 federal law does not require little cigars to be sold in any minimum pack size. When little cigars are sold individually or in smaller quantities, the product price is lower than when the products are sold as part of a pack. These lower-priced products have a direct appeal to minors.24

•   Regulatory Options: To combat price disparities caused by small packs of little cigars, and ensure that these products have a price compatible with cigarettes, state and local governments could create a standard minimum pack size for little cigars sold, thus limiting the sale of little cigars sold individually or in small quantities.25

  Flavoring

•   Regulatory Gap: Another disparity exists in the way flavored little cigars are regulated versus flavored cigarettes. Under the Tobacco Control Act, tobacco companies are prohibited from producing cigarettes containing any characterizing flavor other than tobacco or menthol.26 This prohibition is limited to flavored cigarettes, however. Tobacco companies can continue to market little cigars with flavors like cherry, grape, strawberry, wine, vanilla and chocolate – fruit, candy and alcohol flavors that are clearly intended to appeal to youth.27 As a result, approximately one in five high school senior males is a cigar smoker,28 and in some states, cigar use among adolescent males actually exceeds the prevalence of cigarette smoking in this population.29 The 2012 Surgeon General’s report, Preventing Tobacco Use among Youth and Young Adults, highlights the need to address this rise in the use of flavored cigars, particularly among the young.30

•   Regulatory Options: As noted above, the Tobacco Control Act clearly indicates that state and local governments can regulate the sale and distribution of tobacco products.

  In 2009, New York City enacted an ordinance prohibiting the sale of flavored non- cigarette tobacco products with a characterizing flavor other than menthol, mint, or wintergreen, except in certain “tobacco bars.”31 Smokeless tobacco companies sued the city, arguing that the ordinance imposed manufacturing standards on their products in conflict with federal law. In 2010, the federal district court for the Southern District of New York ruled in favor of the city, denying the tobacco companies’ request to delay enforcement of the law.32 The court stated that the Tobacco Control Act gives the federal government exclusive authority over tobacco product manufacturing standards, but preserves state and local authority to regulate the sale and distribution of tobacco products. The court then found that the New York City ordinance was a sales restriction,

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not a product standard. In 2011, the court affirmed the reasoning of its previous decision and dismissed the complaint.33

In early 2012, Providence, Rhode Island enacted a similar ordinance prohibiting the sale of flavored tobacco products, except in “smoking bars.”34 Several tobacco industry stakeholders sued the city, arguing that the ordinance was preempted by the Tobacco Control Act because it attempted to establish a product standard, and also violated the First Amendment because it limited their ability to describe their products. Like the New York court, the federal district court in Rhode Island concluded that the ordinance was a sales restriction, not a product standard, and thus was not preempted under the Tobacco Control Act.35 The court also concluded that Providence’s ordinance did not limit the plaintiffs’ First Amendment rights, finding that it was simply an economic regulation on the sale of a particular product.36

Although both of these decisions are on appeal and, even if upheld, would not be precedential in all jurisdictions, New York City’s and Providence’s initial successes may help support similar state or local laws to prohibit or significantly restrict the sale of flavored little cigars.

Free Samples

•   Regulatory Gap: Under the Tobacco Control Act, tobacco manufacturers are restricted from distributing free samples of “cigarettes, smokeless tobacco or other tobacco products.”37 Some sections of the Tobacco Control Act, however, suggest that the law applies only to “cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco,”38 which would mean the restriction on free samples does not apply to little cigars.39 At present, it appears that the FDA has taken the position that the law’s sampling restrictions apply only to cigarettes and smokeless tobacco products.40

•   Regulatory Options: State and local governments could prohibit the distribution of all free samples of other tobacco products, including little cigars.41

  Youth Access

•   Regulatory Gap: Under federal law, retailers cannot “sell cigarettes or smokeless tobacco to any person younger than eighteen years of age.”42 Since little cigars are neither cigarettes nor smokeless tobacco, they are not covered under this law.

•   Regulatory Options: State and local governments could consider passing stronger, more comprehensive youth access laws to include little cigars. They could also raise the minimum age to purchase tobacco products, as several states already have.43

  Point-of-Sale Warnings, Marketing Restrictions, & Broad Sales Prohibitions

 Regulatory Gap: The Federal Cigarette Labeling and Advertising Act44 limits the authority of state and local governments to regulate the advertising and promotion of

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cigarettes; however, no federal statute limits the authority of local or state governments to regulate the advertising and promotion of non-cigarette tobacco products, including little cigars. In addition, as discussed above, the Tobacco Control Act expressly preserves state and local government authority to regulate the sale of tobacco products. Therefore, state and local governments are able to warn consumers of the dangers of using little cigars, regulate the advertising or promotion of little cigars, and regulate the sale of little cigars without risking federal preemption concerns.

 Regulatory Options: To determine the most effective options for regulating the sale and marketing of little cigars or for warning consumers about the use of little cigars, state and local governments need to analyze their jurisdiction-specific needs, priorities, and goals. Possible policy options include posting health warnings at the point-of-sale,45 imposing marketing restrictions, and prohibiting the sale of all little cigars.46 Although federal statutes should not pose a barrier for state and local policies restricting the sale and marketing of little cigars, such laws will most certainly be challenged on the basis that they violate state or federal constitutional provisions related to free speech or interstate commerce.47 Although it is important to work with an attorney when pursuing any policy options, the legal issues surrounding the First Amendment are complicated, and jurisdictions must consult with legal counsel before pursuing these types of policies.

Contact Us

Please feel free to contact the Tobacco Control Legal Consortium at (651) 290-7506 or publichealthlaw@wmitchell.edu with any questions about the information included in this fact sheet or to discuss local concerns you may have about implementing these policy options.

The Tobacco Control Legal Consortium provides information and technical assistance on issues related to tobacco and public health. The Consortium does not provide legal representation or advice. This document should not be considered legal advice or a substitute for obtaining legal advice from an attorney who can represent you. We recommend that you consult with local legal counsel before attempting to implement any of these measures.

Last Updated: February 2013

Notes

1 Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (codified as amended in relevant part at 21 U.S.C. §§ 301, 321, 387), available at www.govtrack.us/congress/bills/111/hr1256/text.

2 Michael Freiberg, Options for State and Local Governments to Regulate Non-Cigarette Tobacco Products 21 ANNALS HEALTH L. 407, 413 (2012) (citing Am. Legacy Found., Cigars, Cigarillos & Little Cigars 2 (2009), available at http://publichealthlawcenter.org/sites/default/files/resources/phlc-lreview- freiberg-regulating-otp-2012.pdf).

3 Ctrs. for Disease Control & Prevention, Smoking & Tobacco Use: Cigars, available at http://www.cdc.gov/tobacco/data_statistics/fact_sheets/tobacco_industry/cigars/ (last visited Feb. 20,

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2013). Note that cigarillos (classified as large cigars) by federal tax code, are longer, slimmer versions of a large cigar. Cigarillos generally do not have filters, but often have wood or plastic tips. Id.

4 Freiberg, supra note 2, at 413. 5 15 U.S.C. §1332(7).

6 See Nat’l Cancer Institute, Cigar Smoking & Cancer, available at http://www.cancer.gov/cancertopics/factsheet/Tobacco/cigars (last visited Feb. 20, 2013).

7 See Frank Baker et al., Health Risks Associated with Cigar Smoking, 284 (6), J. AM. MED. ASS’N 735, 737-39 (2000).

8 See Nat’l Cancer Institute, supra note 6.
9 Id; see also Campaign for Tobacco-Free Kids, The Rise of Cigars and Cigar-Smoking Harms (2012),

available at http://www.tobaccofreekids.org/research/factsheets/pdf/0333.pdf.

10 U.S. Dep’t of Health & Human Servs., Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General 522-30 (2012), available at http://www.cdc.gov/tobacco/data_statistics/sgr/2012//.

11 Id. at 522.
12 See, e.g., Little Cigars, http://www.buylittlecigars.com/ (last visited Feb. 20, 2013); Cigarette Prices by

State, http://cigarette-prices-by-state.com/ (last visited Feb. 20, 2013). 13 See Freiberg, supra note 2, at 419.

14 See Freiberg, supra note 2, at 419-20. In Minnesota, for instance, the price difference is stark, even though the state has a relatively high “other tobacco product” tax rate of 70 percent. Id. at 419. A pack of twenty premium-brand filtered little cigars costs less than two dollars in Minnesota, while a pack of twenty cigarettes costs over five dollars.14 Id. (citing MINN. STAT. § 297F.05, subd. 1 (2010); MINN. STAT 256.9658, subd. 3(b) (2010)). In 2011, legislation was introduced to correct this imbalance. H.F. 743, 87th Sess. (Minn. 2011), available at http://wdoc.house.leg.state.mn.us/leg/LS87/HF0743.0.pdf; S. 493, 87th Sess. (Minn. 2011), available at https://www.revisor.mn.gov/bin/bldbill.php?bill=S0493.0.html&session=ls87.

15 21 U.S.C. § 387p(a)(1).
16 U.S. Dep’t of Health & Human Servs., supra note 10, at 522-30. 17 Id.

18 21 U.S.C. § 387p(a)(1). See Marlo Miura, Tobacco Control Legal Consortium, Regulating Tobacco Product Pricing: Guidelines for State and Local Governments 5 (2010), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs-pricing-2010.pdf.

19 See Tobacco Control Legal Consortium, Cause and Effect: Tobacco Marketing Increases Youth Tobacco Use – Findings from the 2012 Surgeon General’s Report on Youth and Young Adult Tobacco Use 27-28 (2012), http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide-SGReport- Findings-Youth-Marketing-2012.pdf; Miura, supra note 18. See also Tobacco Control Legal Consortium, Price-Related Promotions for Tobacco Products: An Introduction to Key Terms and Concepts (2011), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs-pricerelatedpromotions- 2011_0.pdf.

20 Nat’l Ass'n of Tobacco Outlets, Inc. v. City of Providence, No. 12–96–ML, 2012 WL 6128707 (D.R.I. Dec. 12, 2012).

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21 PROVIDENCE, R.I. CODE §§ 14-300, 14-303.
22 Nat’l Ass'n of Tobacco Outlets, Inc. v. City of Providence, 2012 WL 6128707 at *5-7, 11. 23 21 C.F.R. § 1140.14.

24 See, e.g., Tobacco Control Legal Consortium, Regulating Tobacco Products Based on Pack Size (2012), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide-regulating- packsize-2012.pdf.

25 Freiberg, supra note 2, at 428.

26 See U.S. Food & Drug Admin., Flavored Tobacco, http://www.fda.gov/TobaccoProducts/ProtectingKidsfromTobacco/FlavoredTobacco/default.htm (last visited Feb. 20, 2013) (containing links to resources related to 2009 law prohibiting the manufacture and sale of cigarettes containing certain characterizing flavors).

27 See, e.g., Prime Time Little Cigars, http://www.gothamcigars.com/cigars/little-cigars/prime-time-little- cigars.html (last visited Feb. 20, 2013).

28 U.S. Dep’t Health & Human Servs., Youth Risk Surveillance – U.S., 2001, MORBIDITY AND MORTALITY WKY. REP. 16 (June 18, 2012), available at www.cdc.gov/mmwr/pdf/ss/ss6104.pdf.

29 Id.
30 See U.S. Dep’t of Health & Human Servs., supra note 10.

31 N.Y.C. CODE § 17-713, 715 (prohibiting the sale of smokeless tobacco products that have as a component part tastes or aromas relating to "any fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, herb or spice.").

32 U.S. Smokeless Tobacco Mfg. Co. v. City of New York, 703 F. Supp. 2d 329, 344-45 (S.D.N.Y. 2010) (denying plaintiffs’ motion for a preliminary injunction, finding them unlikely to prevail on the merits of their federal preemption claim; concluding that the Tobacco Control Act gives the federal government the exclusive authority to regulate the manufacture of tobacco products, while reserving to the states the power to regulate the sale and distribution of tobacco products).

33 U.S. Smokeless Tobacco Mfg. Co. v. City of New York, No. 09 Civ. 10511, 2011 WL 5569431 (S.D.N.Y. Nov. 15, 2011) (affirming reasoning of preliminary injunction order that the ordinance is an allowable sales restriction, denying plaintiffs’ motion for summary judgment, granting defendant’s cross-motion for summary judgment, and dismissing the complaint).

34 PROVIDENCE, R.I. CODE §§ 14-308, 14-309, and 14-310.

35 Nat’l Ass'n of Tobacco Outlets, Inc. v. City of Providence, No. 12–96–ML, 2012 WL 6128707 at *12- 13 (D.R.I. Dec. 12, 2012).

36 Id. at *8.
37 21 C.F.R. § 1140.16(d)(1). 38 21 U.S.C. § 387a(b).

39 Freiberg, supra note 3, at 422-23. See also Public Health Law and Policy & Tobacco Control Legal Consortium, Comments on the FDA’s “Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents” (May 20, 2011), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fdacomments- cigarsinsamplingrestrictions-2011.pdf.

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40 See, e.g., U.S. Food & Drug Admin., Docket No. FDA-2010-D-0277, Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents 3 (2011), available at http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM2482 41.pdf.

41 See, e.g., Tobacco Control Legal Consortium, Tobacco Coupon Regulations and Sampling Restrictions – Tips and Tools (2011), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc- guide-tobcouponregsandsampling-2011.pdf.

42 21 C.F.R. § 1140.14(a).

43 See Tobacco Control Legal Consortium, Raising the Minimum Legal Sale Age for Tobacco and Related Products (2012), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide- minimumlegal-saleage-2012_0.pdf. See also ALASKA STAT. ANN. § 11.76.100(a)(2) (minimum age of 19 to purchase tobacco); N.J. STAT. ANN. § 2A:170-51.4 (same); UTAH CODE ANN. § 76-10-104 (same).

44 15 U.S.C. § 1331 et seq.
45 See 23-34 94th St. Grocery Corp. v. New York City Bd. of Health, 685 F.3d 174, 183-85 (2d Cir. 2012)

(affirming a district court

46 Freiberg, supra note 2, at 438.

47 For additional information, see the Tobacco Control Legal Consortium’s publications on First Amendment and Commerce Clause issues in the regulation of tobacco products, available at http://publichealthlawcenter.org/topics/special-collections/federal-regulation-tobacco-collection.

Regulatory Gaps & Options Taxation

•   Regulatory Gap: Many state tax laws define tobacco products in a way that potentially excludes snus. For example, laws that limit the definition of “tobacco products” to products that are smoked or chewed would arguably not apply to snus, which does not fall into either of these categories.6 If snus is not covered by a state’s tobacco laws, it would not be subject to a tobacco tax. Also, even if a state’s tobacco tax laws do cover snus, the tax rate may be substantially lower than that of more traditional tobacco products .7 Snus may be subject to a percentage-of-wholesale-price tax (also known as an ad valorem tax), rather than a fixed excise tax, which is often applied to traditional tobacco products and is considerably higher.8 Studies have shown a correlation between lower cost tobacco products and greater access to those products by minors.9

•   Regulatory Option: The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act),10 the federal law granting the Food and Drug Administration (FDA) the authority to regulate tobacco products, expressly preserves the authority of state and local governments to levy taxes on tobacco products.11 Thus, states and localities could broaden or clarify existing definitions of “tobacco products” in their tax laws to ensure that snus is covered and taxed at a comparable rate as traditional tobacco products.

  Coupons, Discounts, & Rebates

•   Regulatory Gap: Tobacco manufacturers use coupons and other price-related incentives to make novel tobacco products such as snus more attractive to consumers, particularly young people.12 Numerous studies have shown that youth are particularly sensitive to increases in the price of tobacco products.13 The Surgeon General has concluded that the tobacco industry’s extensive use of price-related marketing practices has led to higher rates of tobacco use among young people than would have occurred in the absence of these practices.14

•   Regulatory Options: The Tobacco Control Act preserves state and local government authority to regulate the sale and distribution of tobacco products, including their price.15 Local and state governments could consider restricting or prohibiting the redemption of coupons for snus and similar tobacco products in retail stores, or restricting other tobacco price-related marketing practices, such as price discounts to tobacco retailers and wholesalers, tobacco retailer incentive programs, and retail value-added deals (e.g., buy- one-get-one-free offers).16

  While legal challenges to such policies can be anticipated in light of the tobacco industry’s heavy investment in price-related marketing strategies, a federal district court has recently upheld a local law prohibiting the sale of discounted tobacco products.17 In early 2012, Providence, Rhode Island enacted an ordinance prohibiting licensed tobacco dealers from selling discounted tobacco products through coupon redemption and multi-

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pack offers.18 Tobacco industry stakeholders challenged the law on First Amendment and federal and state preemption grounds. In December 2012, a federal district court upheld the pricing ordinance, concluding that its prohibition against certain industry price discounting practices did not violate the First Amendment and was not preempted by federal or state law.19

Although this decision has been appealed, and even if upheld, would not be controlling in all jurisdictions, its promising initial result may help support similar state or local laws to prohibit the deeply discounted sale of emerging tobacco products like snus.

Free Samples

 Regulatory Gap: Under the Tobacco Control Act, tobacco manufacturers, distributors, and retailers are generally restricted from distributing free samples of “cigarettes, smokeless tobacco or other tobacco products.”20 Snus that consist of moist powdered tobacco would appear to fall under the Tobacco Control Act’s definition of “smokeless tobacco,” which presumably means the restriction on free samples would apply to them.21 Under an exception in the Tobacco Control Act, free samples of smokeless tobacco may be distributed in “qualified adult-only facilities” as that term is defined under federal regulations.22 The sample must be limited to one package containing 0.53 ounces of smokeless tobacco or eight individual portions of smokeless tobacco, whichever weighs less.23 Given the low weight of many snus, this provision could create a significant loophole.24

 Regulatory Options: Although the Tobacco Control Act allows limited free sampling of smokeless tobacco products, it expressly states that it does not affect the authority of a state or local government to prohibit or further restrict the distribution of free samples of smokeless tobacco.25 State and local governments could prohibit the distribution of free samples of all non-cigarette tobacco products, including snus, in all locations.26

Minimum Pack Size

•   Regulatory Gap: Unlike cigarettes, which are sold in packs of twenty,27 the Tobacco Control Act does not require snus to be sold in any minimum pack size. When snus are sold in smaller quantities, the product price is lower than when the products are sold as part of a pack. As a result, these lower-priced products have a direct appeal to minors.28

•   Regulatory Options: To combat price disparities caused by small packs of snus, and ensure that these products have a price comparable to cigarettes, state and local governments could create a standard minimum pack size for snus sold, thus limiting the sale of snus sold in small quantities.29

  Flavoring

 Regulatory Gap: Another disparity exists in the way flavored snus is regulated versus flavored cigarettes. Under the Tobacco Control Act, tobacco companies are prohibited

3

from producing cigarettes containing any characterizing flavor other than tobacco or menthol.30 This prohibition is limited to flavored cigarettes, however. Tobacco companies can continue to market snus tobacco which comes in fruit and mint flavors that are clearly intended to appeal to youth.31

 Regulatory Options: As noted above, the Tobacco Control Act clearly indicates that state and local governments can regulate the sale and distribution of tobacco products.

In 2009, New York City enacted an ordinance prohibiting the sale of flavored non- cigarette tobacco products with a characterizing flavor other than menthol, mint, or wintergreen, except in certain “tobacco bars.”32 Smokeless tobacco companies sued the city, arguing that the ordinance imposed manufacturing standards on their products in conflict with federal law. In 2010, the federal district court for the Southern District of New York ruled in favor of the city, denying the tobacco companies’ request to delay enforcement of the law.33 The court stated that the Tobacco Control Act gives the federal government exclusive authority over tobacco product manufacturing standards, but preserves state and local authority to regulate the sale and distribution of tobacco products. The court then found that the New York City ordinance was a sales restriction, not a product standard. In 2011, the court affirmed the reasoning of its previous decision and dismissed the complaint.34

In early 2012, Providence, Rhode Island enacted a similar ordinance prohibiting the sale of flavored tobacco products, except in “smoking bars.”35 Several tobacco industry stakeholders sued the city, arguing that the ordinance was preempted by the Tobacco Control Act because it attempted to establish a product standard, and also violated the First Amendment because it limited their ability to describe their products. Like the New York court, the federal district court in Rhode Island concluded that the ordinance was a sales restriction, not a product standard, and thus was not preempted under the Tobacco Control Act.36 The court also concluded that Providence’s ordinance did not limit the plaintiffs’ First Amendment rights, finding that it was simply an economic regulation on the sale of a particular product.37

Although both of these decisions are on appeal and, even if upheld, would not be precedential in all jurisdictions, New York City’s and Providence’s initial successes may help support similar state or local laws to prohibit or significantly restrict the sale of snus.

Youth Access

 Regulatory Gap: Under federal law, retailers cannot “sell cigarettes or smokeless tobacco to any person younger than eighteen years of age.”38 Although snus would likely qualify as “smokeless tobacco” under federal law, the FDA has yet to exercise its authority to exercise jurisdiction over these products.39 Also, many state and local youth access laws are unlikely to include snus in that they are limited to products that are chewed or smoked.

4

 Regulatory Options: State and local governments could consider passing stronger, more comprehensive youth access laws to include snus, and also raising the minimum age to purchase such products.40

Point-of-Sale Warnings, Marketing Restrictions, & Broad Sales Prohibitions

•   Regulatory Gap: The Federal Cigarette Labeling and Advertising Act41 limits the authority of state and local governments to regulate the advertising and promotion of cigarettes; however, no federal statute limits the authority of local or state governments to regulate the advertising and promotion of non-cigarette tobacco products. In addition, as discussed above, the Tobacco Control Act expressly preserves state and local government authority to regulate the sale of tobacco products. Therefore, state and local governments are able to warn consumers of the dangers of using snus, regulate the advertising or promotion of snus, and regulate the sale of snus without risking federal preemption concerns.

•   Regulatory Options: To determine the most effective options for regulating the sale and marketing of snus or for warning consumers about the use of snus, state and local governments need to analyze their jurisdiction-specific needs, priorities, and goals. Possible policy options include posting health warnings at the point-of-sale,42 imposing marketing restrictions, and prohibiting the sale of snus.43 Although federal statutes should not pose a barrier for state and local policies restricting the sale and marketing of snus, such laws will most certainly be challenged on the basis that they violate state or federal constitutional provisions related to free speech or interstate commerce.44 Although it is important to work with an attorney when pursuing any policy options, the legal issues surrounding the First Amendment are complicated, and jurisdictions must consult with legal counsel before pursuing these types of policies.

  Contact Us

  Please feel free to contact the Tobacco Control Legal Consortium at (651) 290-7506 or publichealthlaw@wmitchell.edu with any questions about the information included in this fact sheet or to discuss local concerns you may have about implementing these policy options.

  The Tobacco Control Legal Consortium provides information and technical assistance on issues related to tobacco and public health. The Consortium does not provide legal representation or advice. This document should not be considered legal advice or a substitute for obtaining legal advice from an attorney who can represent you. We recommend that you consult with local legal counsel before attempting to implement any of these measures.

  Last Updated: February 2013

5

Notes

1 See, e.g., WORLD HEALTH ORG. FRAMEWORK CONVENTION ON TOBACCO CONTROL, CONTROL AND PREVENTION OF SMOKELESS TOBACCO PRODUCTS 2, 5 (2012), available at http://apps.who.int/gb/fctc/PDF/cop5/FCTC_COP5_12-en.pdf.

2 See Michael Freiberg, Options for State and Local Governments to Regulate Non-Cigarette Tobacco Products, 21 ANNALS OF HEALTH LAW 407, 414 (2012), available at http://publichealthlawcenter.org/sites/default/files/resources/phlc-lreview-freiberg-regulating-otp- 2012.pdf.

3 See, e.g., Snus Authority, Snus Brands & Flavors List, http://snusauthority.com/blog/snus-brands-and- flavors (last visited Feb. 20, 2013).

4 Freiberg, supra note 2, at 414.

5 U.S. Dep’t of Health & Human Servs., Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General 522-30 (2012), available at http://www.cdc.gov/tobacco/data_statistics/sgr/2012//.

6 Freiberg, supra note 2, at 414. 7 Seeid.at416–21.
8 Id. at 416.
9 Id.

10 Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (codified as amended in relevant part at 21 U.S.C. §§ 301, 321, 387), available at www.govtrack.us/congress/bills/111/hr1256/text.

11 21 U.S.C. § 387p(a)(1).

12 U.S. Dep’t of Health & Human Servs., supra note 5, at 522-30. See also Tobacco Control Legal Consortium, Cause and Effect: Tobacco Marketing Increases Youth Tobacco Use – Findings from the 2012 Surgeon General’s Report on Youth and Young Adult Tobacco Use 20 (2012), http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide-SGReport-Findings-Youth- Marketing-2012.pdf.

13 U.S. Dep’t of Health & Human Servs., supra note 5, at 528, 530. 14 Id. at 530.

15 21 U.S.C. § 387p(a)(1). See Marlo Miura, Tobacco Control Legal Consortium, Regulating Tobacco Product Pricing: Guidelines for State and Local Governments 5 (2010), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs-pricing-2010.pdf.

16 See Tobacco Control Legal Consortium, Cause and Effect, supra note 12, at 27-28; Miura, supra note 15. See also Tobacco Control Legal Consortium, Price-Related Promotions for Tobacco Products: An Introduction to Key Terms and Concepts (2011), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs-pricerelatedpromotions-2011_0.pdf.

17 Nat’l Ass'n of Tobacco Outlets, Inc. v. City of Providence, No. 12–96–ML, 2012 WL 6128707 (D.R.I. Dec. 12, 2012).

18 PROVIDENCE, R.I. CODE §§ 14-300, 14-303.
19 Nat’l Ass'n of Tobacco Outlets, Inc. v. City of Providence, 2012 WL 6128707 at *5-7, 11.

6

7

20 21 C.F.R. § 1140.16(d)(1).

21 Freiberg, supra note 2, at. 425-26. See also Public Health Law and Policy & Tobacco Control Legal Consortium, Comments on the FDA’s “Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents” (May 20, 2011), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fdacomments- cigarsinsamplingrestrictions-2011.pdf.

22 21 U.S.C. § 387a-1(a)(2)(G)(d)(2)(A); 21 C.F.R. § 1140.16(d)(2)(iii)(A)-(F). 23 21 C.F.R. § 1140.16(d)(2)(iv).
24 Freiberg, supra note 2, at 424.
25 21 U.S.C. § 387a-1(a)(2)(G)(d)(2)(B).

26 See, e.g., Tobacco Control Legal Consortium, Tobacco Coupon Regulations and Sampling Restrictions – Tips and Tools (2011), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc- guide-tobcouponregsandsampling-2011.pdf.

27 21 C.F.R. § 1140.14.

28 See, e.g., Tobacco Control Legal Consortium, Regulating Tobacco Products Based on Pack Size (2012), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide-regulating- packsize-2012.pdf.

29 Freiberg, supra note 2, at 428.

30 See U.S. Food & Drug Admin., Flavored Tobacco, http://www.fda.gov/TobaccoProducts/ProtectingKidsfromTobacco/FlavoredTobacco/default.htm (last visited Feb. 8, 2013) (containing links to resources related to 2009 law prohibiting the manufacture and sale of cigarettes containing certain characterizing flavors).

31 See, e.g., Snus Authority, Snus Brands & Flavors List, http://snusauthority.com/blog/snus-brands-and- flavors (last visited Feb. 20, 2013).

32 N.Y.C. CODE § 17-713, 715 (prohibiting the sale of smokeless tobacco products that have as a component part tastes or aromas relating to "any fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, herb or spice.").

33 U.S. Smokeless Tobacco Mfg. Co. v. City of New York, 703 F. Supp. 2d 329, 344-45 (S.D.N.Y. 2010) (denying plaintiffs’ motion for a preliminary injunction, finding them unlikely to prevail on the merits of their federal preemption claim; concluding that the Tobacco Control Act gives the federal government the exclusive authority to regulate the manufacture of tobacco products, while reserving to the states the power to regulate the sale and distribution of tobacco products).

34 U.S. Smokeless Tobacco Mfg. Co. v. City of New York, No. 09 Civ. 10511, 2011 WL 5569431 (S.D.N.Y. Nov. 15, 2011) (affirming reasoning of preliminary injunction order that the ordinance is an allowable sales restriction, denying plaintiffs’ motion for summary judgment, granting defendant’s cross-motion for summary judgment, and dismissing the complaint).

35 PROVIDENCE, R.I. CODE §§ 14-308, 14-309, and 14-310.

36 Nat’l Ass'n of Tobacco Outlets, Inc. v. City of Providence, No. 12–96–ML, 2012 WL 6128707 at *12- 13 (D.R.I. Dec. 12, 2012).

37 Id. at *8.

38 21 C.F.R. § 1140.14(a).
39 Freiberg, supra note 2, at 434.

40 See Tobacco Control Legal Consortium, Raising the Minimum Legal Sale Age for Tobacco and Related Products (2012), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide- minimumlegal-saleage-2012_0.pdf.

41 15 U.S.C. § 1331 et seq.
42 See 23-34 94th St. Grocery Corp. v. New York City Bd. of Health, 685 F.3d 174, 183-85 (2d Cir. 2012)

(affirming a district court

43 Freiberg, supra note 2, at 438.

44 For additional information, see the Tobacco Control Legal Consortium’s publications on First Amendment and Commerce Clause issues in the regulation of tobacco products, available at http://publichealthlawcenter.org/topics/special-collections/federal-regulation-tobacco-collection.

8

Regulatory Gaps & Options Flavoring

•   Regulatory Gap: Under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act),8 the federal law giving the Food and Drug Administration (FDA) the authority to regulate tobacco products, tobacco companies are prohibited from producing cigarettes containing any characterizing flavor other than tobacco or menthol.9 This prohibition is limited to flavored cigarettes, however. The tobacco smoked in hookah pipes regularly comes in flavors such as fruit, mint, and vanilla. 10 As a result, hookah smoking has grown in popularity, particularly among the young, who often find the smell, taste, and smoothness of the sweetened tobacco in hookahs more appealing than that in cigarettes.11

•   Regulatory Options: Although the Tobacco Control Act prohibits state and local governments from regulating tobacco product standards, states and localities can regulate the sale and distribution of tobacco products.12

  In 2009, New York City enacted an ordinance prohibiting the sale of flavored non- cigarette tobacco products with a characterizing flavor other than menthol, mint, or wintergreen, except in certain “tobacco bars.”13 Smokeless tobacco companies sued the city, arguing that the ordinance imposed manufacturing standards on their products in conflict with federal law. In 2010, the federal district court for the Southern District of New York ruled in favor of the city, denying the tobacco companies’ request to delay enforcement of the law.14 The court stated that the Tobacco Control Act gives the federal government exclusive authority over tobacco product manufacturing standards, but preserves state and local authority to regulate the sale and distribution of tobacco products. The court then found that the New York City ordinance was a sales restriction, not a product standard. In 2011, the court affirmed the reasoning of its previous decision and dismissed the complaint.15

  In early 2012, Providence, Rhode Island enacted a similar ordinance prohibiting the sale of flavored tobacco products, except in “smoking bars.”16 Several tobacco industry stakeholders sued the city, arguing that the ordinance was preempted by the Tobacco Control Act because it attempted to establish a product standard, and also violated the First Amendment because it limited their ability to describe their products. Like the New York court, the federal district court in Rhode Island concluded that the ordinance was a sales restriction, not a product standard, and thus was not preempted under the Tobacco Control Act.17 The court also concluded that Providence’s ordinance did not limit the plaintiffs’ First Amendment rights, finding that it was simply an economic regulation on the sale of a particular product.18

  Although both of these decisions are on appeal and, even if upheld, would not be precedential in all jurisdictions, New York City’s and Providence’s initial successes may

2

help support similar state or local laws to prohibit or significantly restrict the sale of flavored tobacco products, including hookah tobacco.

Free Samples

•   Regulatory Gap: Under the Tobacco Control Act, tobacco manufacturers are restricted from distributing free samples of “cigarettes, smokeless tobacco or other tobacco products.”19 Some sections of the Tobacco Control Act, however, suggest that the law applies only to “cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco,”20 which would mean the restriction on free samples does not apply to products smoked in hookah pipes.21 At present, it appears that the FDA has taken the position that the law’s sampling restrictions apply only to cigarettes and smokeless tobacco products.22

•   Regulatory Options: State and local governments could prohibit the distribution of all free samples of all tobacco products, including hookah tobacco.23

  Youth Access

•   Regulatory Gap: Under federal law, retailers cannot “sell cigarettes or smokeless tobacco to any person younger than eighteen years of age.”24 Since products smoked in hookah pipes are neither cigarettes nor smokeless tobacco, they are not covered under this law. In fact, some materials smoked in hookahs are not even made from tobacco.25

•   Regulatory Options: State and local governments could consider passing stronger, more comprehensive youth access laws to include hookah tobacco and other non-tobacco products smoked in hookahs. States could also raise the minimum age to purchase tobacco products, as several states have done for cigarettes.26

  Use Restrictions

•   Regulatory Gap: Although hookah smoking is just as harmful as smoking cigarettes or cigars, the use of hookahs may not be adequately covered under smoke-free laws. For example, some smoke-free laws define smoking in terms of “tobacco products” only. Under such laws, it would be permissible to smoke non-tobacco products in hookahs in public.27 Also many smoke-free laws prohibit only the direct burning of a tobacco or plant product.28 Since hookahs indirectly heat the tobacco over a flame, smoking them may not be prohibited under these laws. Finally, many smoke-free laws exempt establishments that primarily sell tobacco and related products. Some hookah bars claim that they are tobacco products shops and qualify for this exemption.29

•   Regulatory Options: To address these loopholes, state and local governments could consider adopting smoke-free laws that broadly define “smoking” as the direct burning or indirect heating of any tobacco or plant product intended for inhalation, so they encompass hookahs.30 Governments might also want to draft laws that specifically define hookahs and explicitly prohibit their use in public places. In addition, because hookah establishments can sometimes be considered tobacco product shops, smoke-free

3

laws should not include these exemptions. At a minimum, smoke-free laws should stipulate that establishments that serve food or beverages for on-premises consumption, as many hookah lounges do, are not eligible for exemption as tobacco product shops.

Point-of-Sale Warnings, Marketing Restrictions, & Broad Sales Prohibitions

•   Regulatory Gap: The Federal Cigarette Labeling and Advertising Act31 limits the authority of state and local governments to regulate the advertising and promotion of cigarettes; however, no federal statute limits the authority of local or state governments to regulate the advertising and promotion of non-cigarette tobacco products, including hookah tobacco. In addition, as discussed above, the Tobacco Control Act expressly preserves state and local government authority to regulate the sale of tobacco products. Therefore, state and local governments are able to warn consumers of the dangers of using hookahs, regulate the advertising or promotion of hookah tobacco, and regulate the sale of hookah tobacco without risking federal preemption concerns.

•   Regulatory Options: To determine the most effective options for regulating the sale and marketing of hookah tobacco or for warning consumers about the use of hookahs, state and local governments need to analyze their jurisdiction-specific needs, priorities, and goals. Possible policy options include posting health warnings at the point-of-sale,32 imposing marketing restrictions, and prohibiting the sale of all hookah tobacco.33 Although federal statutes should not pose a barrier for state and local policies restricting the sale and marketing of hookah tobacco, such laws may be challenged on the basis that they violate state or federal constitutional provisions related to free speech or interstate commerce.34 Although it is important to work with an attorney when pursuing any policy options, the legal issues surrounding the First Amendment are complicated, and jurisdictions must consult with legal counsel before pursuing these types of policies.

  Contact Us

  Please feel free to contact the Tobacco Control Legal Consortium at (651) 290-7506 or publichealthlaw@wmitchell.edu with any questions about the information included in this fact sheet or to discuss local concerns you may have about implementing these policy options.

  The Tobacco Control Legal Consortium provides information and technical assistance on issues related to tobacco and public health. The Consortium does not provide legal representation or advice. This document should not be considered legal advice or a substitute for obtaining legal advice from an attorney who can represent you. We recommend that you consult with local legal counsel before attempting to implement any of these measures.

  Last Updated: February 2013

4

Notes

1 In this fact sheet, “hookah” is used as a general term to describe all types of water pipes. A wide range of water pipe products are available, each with its own health risks. See Michael Freiberg, Options for State and Local Governments to Regulate Non-Cigarette Tobacco Products, 21 ANNALS OF HEALTH LAW 407, 408 (2012), available at http://publichealthlawcenter.org/sites/default/files/resources/phlc-lreview- freiberg-regulating-otp-2012.pdf.

2 World Health Org., WHO Study Group on Tobacco Product Regulation, Advisory Note: Waterpipe Tobacco Smoking: Health Effects, Research Needs and Recommended Actions by Regulators 3 (2005), available at http://www.who.int/tobacco/global_interaction/tobreg/Waterpipe%20recommendation_Final.pdf .

3 Elie Akl et al, The Effects of Waterpipe Tobacco Smoking on Health Outcomes: A Systematic Review, 39 INTN’L J. OF EPIDEMIOLOGY 834 (2010).

4 World Health Org., supra note 2, at 3.

5 Id. at 3-5.

6 Id.

7 Am. Lung Ass’n, An Emerging Deadly Trend: Waterpipe Tobacco Use 2 (2007), available at http://www.lungusa2.org/embargo/slati/Trendalert_Waterpipes.pdf.

8 Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (codified as amended in relevant part at 21 U.S.C. §§ 301, 321, 387), available at www.govtrack.us/congress/bills/111/hr1256/text.

9 See U.S. Food & Drug Admin., Flavored Tobacco, http://www.fda.gov/TobaccoProducts/ProtectingKidsfromTobacco/FlavoredTobacco/default.htm (last visited Feb. 20, 2013) (containing links to resources related to 2009 law prohibiting the manufacture and sale of cigarettes containing certain characterizing flavors).

10 See, e.g., Melissa D. Blank et al., Acute Effects of Waterpipe Tobacco Smoking: A Double-Blind, Placebo-Control Study, 116 DRUG & ALCOHOL DEPENDENCE 102, 103 (2010).

11 See Am. Lung Ass’n, supra note 7, at 3.
12 See Tobacco Control Legal Consortium, Federal Regulation of Tobacco: Impact on State and Local

Authority (2009), available at http://www.publichealthlawcenter.org/sites/default/files/fda-1.pdf.

13 N.Y.C. CODE § 17-713, 715 (prohibiting the sale of smokeless tobacco products that have as a component part tastes or aromas relating to "any fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, herb or spice.").

14 U.S. Smokeless Tobacco Mfg. Co. v. City of New York, 703 F. Supp. 2d 329, 344-45 (S.D.N.Y. 2010) (denying plaintiffs’ motion for a preliminary injunction, finding them unlikely to prevail on the merits of their federal preemption claim; concluding that the Tobacco Control Act gives the federal government the exclusive authority to regulate the manufacture of tobacco products, while reserving to the states the power to regulate the sale and distribution of tobacco products).

15 U.S. Smokeless Tobacco Mfg. Co. v. City of New York, No. 09 Civ. 10511, 2011 WL 5569431 (S.D.N.Y. Nov. 15, 2011) (affirming reasoning of preliminary injunction order that the ordinance is an allowable sales restriction, denying plaintiffs’ motion for summary judgment, granting defendant’s cross-motion for summary judgment, and dismissing the complaint).

16 PROVIDENCE, R.I. CODE §§ 14-308, 14-309, and 14-310.

5

6

17 Nat’l Ass'n of Tobacco Outlets, Inc. v. City of Providence, No. 12–96–ML, 2012 WL 6128707 at *12- 13 (D.R.I. Dec. 12, 2012).

18 Id. at *8.
19 21 C.F.R. § 1140.16(d)(1). 20 21 U.S.C. § 387a(b).

21 Freiberg, supra note 1, at 425-26. See also Public Health Law and Policy & Tobacco Control Legal Consortium, Comments on the FDA’s “Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents” (May 20, 2011), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fdacomments- cigarsinsamplingrestrictions-2011.pdf.

22 See, e.g., U.S. Food & Drug Admin., Docket No. FDA-2010-D-0277, Draft Guidance for Industry: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents 3 (2011), available at http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM2482 41.pdf.

23 See, e.g., Tobacco Control Legal Consortium, Tobacco Coupon Regulations and Sampling Restrictions – Tips and Tools (2011), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc- guide-tobcouponregsandsampling-2011.pdf.

24 21 C.F.R. § 1140.14(a).

25 See, e.g., Tobacco Regulation in the West a Boom for Shisah, TOBACCO J. INT’L (2011) (“. . . Soex herbal hookah molasses is 100 percent tobacco- and nicotine –free”).

26 See, e.g., Tobacco Control Legal Consortium, Raising the Minimum Legal Sale Age for Tobacco and Related Products (2012), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc- guide-minimumlegal-saleage-2012_0.pdf. See also ALASKA STAT. ANN. § 11.76.100(a)(2) (minimum age of 19 to purchase tobacco); N.J. STAT. ANN. § 2A:170-51.4 (same); UTAH CODE ANN. § 76-10-104 (same).

27 Freiberg, supra note 1, at 437. 28 Id.
29 Id.

30 See Tobacco Control Legal Consortium, Regulating Hookah and Waterpipe Smoking (last visited Oct. 2012) (containing select legislature and policies regulating hookah use), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide-regulatinghookahs-2010.pdf).

31 15 U.S.C. § 1331 et seq.

7

32 See 23-34 94th St. Grocery Corp. v. New York City Bd. of Health, 685 F.3d 174, 183-85 (2d Cir. 2012) (affirming a district court

33 Freiberg, supra note 1, at 438.

34 For additional information, see the Tobacco Control Legal Consortium’s publications on First Amendment and Commerce Clause issues in the regulation of tobacco products, available at http://publichealthlawcenter.org/topics/special-collections/federal-regulation-tobacco-collection.

nor their safety as cigarette replacements is established.”4 In recent years, litigation between the FDA and e-cigarette manufacturers arising from concerns about their safety and regulatory status resulted in a temporary restriction on the importation of e-cigarettes into the United States.5 As a result of a 2010 ruling by the U.S. Court of Appeals for the D.C. Circuit,6 in April 2011 the FDA announced that it will regulate e-cigarettes as tobacco products under the Family Smoking Prevention and Tobacco Control Act7 – the federal law granting the FDA the authority to regulate tobacco products – “unless they are marketed for therapeutic purposes, in which case they are regulated as drugs and/or devices.”8 As of February 2013, however, the FDA has not yet regulated e-cigarettes as tobacco products. For that reason, it has become more of a priority for many state and local governments to consider regulatory options for electronic cigarettes.

Regulatory Gaps & Options Taxation

•   Regulatory Gap: Many state tax laws define the term “tobacco products” in a way that excludes e-cigarettes. Although the FDA has said it will regulate electronic cigarettes as tobacco products, it is not clear whether every product marketed as an e-cigarette contains tobacco, or even nicotine derived from tobacco.9

•   Regulatory Options: The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) expressly preserves the authority of state and local governments to levy taxes on tobacco products.10 Since e-cigarettes are a different type of product, containing electronic parts and synthetically-derived ingredients, existing tobacco tax laws may not be well-suited to them.11 Some states have addressed this issue by clarifying the definition of “tobacco products” in their tax codes so e-cigarettes are considered tobacco products for taxation purposes.12 Unless the FDA determines that e- cigarettes have genuine therapeutic uses, other states might consider, in the meantime, taxing e-cigarettes in a way that complements their existing cigarette and tobacco product taxes.13

  Coupons, Discounts, & Rebates

•   Regulatory Gap: Tobacco manufacturers use coupons and other price-related incentives to make products such as e-cigarettes more attractive to consumers, particularly young people.14 Coupons and other price discounts for electronic cigarettes are utilized in the retail environment and discounted e-cigarettes are extensively promoted online.

•   Regulatory Options: Local and state governments could consider restricting or prohibiting the retail redemption of coupons for tobacco products, including e-cigarettes and similar nicotine delivery systems, or restricting other price-related practices in the retail environment, such as payments from e-cigarette manufacturers and distributors to retailers resulting in price discounts; tobacco retailer incentive programs; and retail value- added deals (e.g., buy-one-get-one-free offers).15

2

While legal challenges to such policies can be anticipated in light of the e-cigarette industry’s investment in price-related marketing strategies, a federal district court has recently upheld a local law prohibiting the sale of discounted tobacco products.16 In early 2012, Providence, Rhode Island enacted an ordinance prohibiting licensed tobacco dealers from selling discounted tobacco products through coupon redemption and multi- pack offers.17 Tobacco industry stakeholders challenged the law on First Amendment and federal and state preemption grounds. In December 2012, a federal district court upheld the pricing ordinance, concluding that its prohibition against certain industry price discounting practices did not violate the First Amendment, and also was not preempted by federal or state law.18

Although this decision has been appealed, and even if upheld, would not be controlling in all jurisdictions, Providence’s promising early results may help support similar state or local laws to prohibit the deeply discounted sale of emerging tobacco products like e- cigarettes.

Free Samples

•   Regulatory Gap: Under the Tobacco Control Act, tobacco manufacturers are restricted from distributing free samples of “cigarettes, smokeless tobacco or other tobacco products.”19 At present, this restriction does not apply to e-cigarettes. Although the FDA has indicated that it intends to regulate electronic cigarettes as tobacco products, the agency has yet to issue regulations asserting jurisdiction over e-cigarettes or extending the Act’s prohibition on free samples to electronic cigarettes.20

•   Regulatory Options: State and local governments could prohibit the distribution of all free samples of tobacco products, including e-cigarettes and other nicotine delivery systems.21

  Flavoring

•   Regulatory Gap: Another disparity exists in the way flavored e-cigarette cartridges are regulated versus flavored cigarettes. Under the Tobacco Control Act, tobacco companies are prohibited from producing cigarettes containing any characterizing flavor other than tobacco or menthol.22 This prohibition is limited to flavored cigarettes, however. E- cigarette manufacturers can continue to market e-cigarette cartridges in a variety of candy-like flavors that appeal to youth (such as bubble gum, chocolate, and mint),23 and sell them at mall kiosks, where young people often congregate, as well as online, where safeguards against youth access can be breached more easily than in face-to-face purchases.

•   Regulatory Options: Although the Tobacco Control Act prohibits state and local governments from establishing tobacco product standards relating to the manufacture of tobacco products, it expressly preserves the authority of state and local governments to regulate the sale and distribution of tobacco products.24

3

In 2009, New York City enacted an ordinance prohibiting the sale of flavored non- cigarette tobacco products with a characterizing flavor other than menthol, mint, or wintergreen, except in certain “tobacco bars.”25 Smokeless tobacco companies sued the city, arguing that the ordinance imposed manufacturing standards on their products in conflict with federal law. In 2010, the federal district court for the Southern District of New York ruled in favor of the city, denying the tobacco companies’ request to delay enforcement of the law.26 The court stated that the Tobacco Control Act gives the federal government exclusive authority over tobacco product manufacturing standards, but preserves state and local authority to regulate the sale and distribution of tobacco products. The court then found that the New York City ordinance was a sales restriction, not a product standard. In 2011, the court affirmed the reasoning of its previous decision and dismissed the complaint.27

In early 2012, Providence, Rhode Island enacted a similar ordinance prohibiting the sale of flavored tobacco products, except in “smoking bars.”28 Several tobacco industry stakeholders sued the city, arguing that the ordinance was preempted by the Tobacco Control Act because it attempted to establish a product standard, and also violated the First Amendment because it limited their ability to describe their products. Like the New York court, the federal district court in Rhode Island concluded that the ordinance was a sales restriction, not a product standard, and thus was not preempted under the Tobacco Control Act.29 The court also concluded that Providence’s ordinance did not limit the plaintiffs’ First Amendment rights, finding that it was simply an economic regulation on the sale of a particular product.30

Although both of these decisions are on appeal and, even if upheld, would not be precedential in all jurisdictions, their promising initial results may help support similar state or local laws to prohibit or restrict the sale of flavored tobacco products, including flavored e-cigarettes

Youth Access

•   Regulatory Gap: Under federal law, retailers cannot “sell cigarettes or smokeless tobacco to any person younger than eighteen years of age.”31 As explained above, the FDA has yet to assert jurisdiction over electronic cigarettes and extend restrictions like this to e-cigarettes. Also, many state and local youth access laws do not include e- cigarettes.32

•   Regulatory Options: State and local governments could consider passing stronger, more comprehensive youth access laws to prohibit the sale of e-cigarettes to minors, require these products to be kept behind the counter, allow them to be sold only in places adults are permitted to enter, or raise the minimum legal age to purchase them.33

  Use Restrictions

 Regulatory Gap: Many smoke-free laws define the act of “smoking” as inhaling or carrying a lighted tobacco or plant product intended for inhalation. E-cigarettes, which

4

are not burned, but “vaped,” are generally not covered under these laws. Using e- cigarettes in public may lead conventional smokers to assume that smoking is permitted in such locations and nonsmokers to believe that a smoke-free law is being violated. Because of this, several health organizations recommend that the use of electronic cigarettes be prohibited in public places and workplaces.34

 Regulatory Options: Local and state governments could include e-cigarettes in their smoke- and tobacco-free restrictions by revising definitions of “smoking” or “tobacco products” to expressly cover e-cigarettes and other electronic nicotine delivery systems.

Point-of-Sale Warnings, Marketing Restrictions, & Broad Sales Prohibitions

•   Regulatory Gap: The Federal Cigarette Labeling and Advertising Act35 limits the authority of state and local governments to regulate the advertising and promotion of cigarettes; however, no federal statute limits the authority of local or state governments to regulate the advertising and promotion of non-cigarette tobacco products. In addition, as discussed above, the Tobacco Control Act expressly preserves state and local government authority to regulate the sale of tobacco products. Therefore, state and local governments are able to warn consumers of the dangers of using electronic cigarettes, regulate the advertising or promotion of e-cigarettes, and regulate the sale of e-cigarettes without risking federal preemption concerns.

•   Regulatory Options: To determine the most effective options for regulating the sale and marketing of e-cigarettes or for warning consumers about the use of these products, state and local governments need to analyze their jurisdiction-specific needs, priorities, and goals. Possible policy options include posting health warnings at the point-of-sale,36 imposing marketing restrictions, and prohibiting the sale of all electronic cigarettes.37 Although federal statutes should not pose a barrier for state and local policies restricting the sale and marketing of e-cigarettes, such laws will most certainly be challenged on the basis that they violate state or federal constitutional provisions related to free speech or interstate commerce.38 Although it is important to work with an attorney when pursuing any policy options, the legal issues surrounding the First Amendment are complicated, and jurisdictions must consult with legal counsel before pursuing these types of policies.

  Contact Us

  Please feel free to contact the Tobacco Control Legal Consortium at (651) 290-7506 or publichealthlaw@wmitchell.edu with any questions about the information included in this fact sheet or to discuss local concerns you may have about implementing these policy options.

  The Tobacco Control Legal Consortium provides information and technical assistance on issues related to tobacco and public health. The Consortium does not provide legal representation or advice. This document should not be considered legal advice or a substitute for obtaining legal advice from an attorney who can represent you. We recommend that you consult with local legal counsel before attempting to implement any of these measures.

5

Last Updated: February 2013

Notes

1 World Med. Ass’n, Statement on Electronic Cigarettes and Other Electronic Nicotine Delivery Systems (Oct. 2012), available at http://www.wma.net/en/30publications/10policies/e19/.

2 U.S. Food and & Drug Admin., Electronic Cigarettes, http://www.fda.gov/newsevents/publichealthfocus/ucm172906.htm (last visited Feb. 8, 2013).

3 U.S. Food & Drug Admin., Summary of Results: Laboratory Analysis of Electronic Cigarettes Conducted by the FDA, http://www.fda.gov/newsevents/publichealthfocus/ucm173146.htm (last visited Feb. 8, 2013).

4 See World Med. Ass’n, supra note 1.

5 Sottera v. Food & Drug Admin., 627 F.3d 891, 893 (D.C. Cir. 2010).

6 Sottera, 627 F.3d at 893 (holding that e-cigarettes and other nicotine-containing products are not drugs or devices unless they are marketed for therapeutic purposes, but that other nicotine-containing products can be regulated as “tobacco products” under the Federal Food, Drug, and Cosmetic Act).

7 Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, 123 Stat. 1776 (2009) (codified as amended in relevant part at 21 U.S.C. §§ 301, 321, 387), available at www.govtrack.us/congress/bills/111/hr1256/text.

8 See Letter from Lawrence Deyton, Dep’t Director, Food & Drug Admin., to Stakeholders, Regulation of E-Cigarettes and Other Tobacco Products (Apr. 25, 2011), available at http://www.fda.gov/newsevents/publichealthfocus/ucm252360.htm.

9 See Michael Freiberg, Options for State and Local Governments to Regulate Non-Cigarette Tobacco Products, 21 ANNALS OF HEALTH LAW 407, 412 (2012), available at http://publichealthlawcenter.org/sites/default/files/resources/phlc-lreview-freiberg-regulating-otp- 2012.pdf.

10 21 U.S.C. § 387p(a)(1).
11 See Freiberg, supra note 9, at 421.

12 See, e.g., 2010 Minn. Laws ch. 305 § 2, available at https://www.revisor.mn.gov/data/revisor/law/2010/0/2010-305.pdf.

13 See Freiberg, supra note 9, at 418, 421.

14 U.S. Dep’t of Health & Human Servs., Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General, 522-30 (2012), available at http://www.surgeongeneral.gov/library/reports/preventing-youth-tobacco-use/full-report.pdf .

15 See, e.g., Marlo Miura, Tobacco Control Legal Consortium, Regulating Tobacco Product Pricing: Guidelines for State and Local Governments (2010), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs-pricing-2010.pdf; Tobacco Control Legal Consortium, Price-Related Promotions for Tobacco Products: An Introduction to Key Terms and Concepts (2011), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-fs- pricerelatedpromotions-2011_0.pdf.

16 Nat’l Ass'n of Tobacco Outlets, Inc. v. City of Providence, No. 12–96–ML, 2012 WL 6128707 (D.R.I. Dec. 12, 2012).

17 PROVIDENCE, R.I. CODE §§ 14-300, 14-303.

6

18 Nat’l Ass'n of Tobacco Outlets, Inc. v. City of Providence, 2012 WL 6128707 at *5-7, 11. 19 21 C.F.R. § 1140.16(d)(1).

20 The Tobacco Control Act immediately gave the FDA the authority to regulate cigarettes, roll your own, and smokeless tobacco and “any other tobacco products that the Secretary by regulation deems to be subject to” the Act. The Act includes a broad definition of tobacco products that would appear to include e-cigarettes and any other tobacco product that is currently on the market. However, in order to regulate those products, the FDA has to issue a regulation that deems them subject to the Act.

21 See, e.g., Tobacco Control Legal Consortium, Tobacco Coupon Regulations and Sampling Restrictions – Tips and Tools (2011), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc- guide-tobcouponregsandsampling-2011.pdf.

22 See U.S. Food & Drug Admin., Flavored Tobacco, http://www.fda.gov/TobaccoProducts/ProtectingKidsfromTobacco/FlavoredTobacco/default.htm (last visited Feb. 8, 2013) (containing links to resources related to 2009 law prohibiting the manufacture and sale of cigarettes containing certain characterizing flavors).

23 Minutes, U.S. Food & Drug Admin., Ctr. for Tobacco Products, Tobacco Products Scientific Advisory Committee Meeting, Dissolvable Tobacco Products Session, Testimony of Curtis Wright (July 21, 2011), available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScie ntificAdvisoryCommittee/UCM270282.pdf.

24 21 U.S.C. § 387p(a)(1). See Tobacco Control Legal Consortium, Federal Regulation of Tobacco: Impact on State and Local Authority (2009), available at http://www.publichealthlawcenter.org/sites/default/files/fda-1.pdf.

25 N.Y.C. CODE § 17-713, 715 (prohibiting the sale of smokeless tobacco products that have as a component part tastes or aromas relating to "any fruit, chocolate, vanilla, honey, candy, cocoa, dessert, alcoholic beverage, herb or spice.").

26 U.S. Smokeless Tobacco Mfg. Co. v. City of New York, 703 F. Supp. 2d 329, 344-45 (S.D.N.Y. 2010) (denying plaintiffs’ motion for a preliminary injunction, finding them unlikely to prevail on the merits of their federal preemption claim; concluding that the Tobacco Control Act gives the federal government the exclusive authority to regulate the manufacture of tobacco products, while reserving to the states the power to regulate the sale and distribution of tobacco products).

27 U.S. Smokeless Tobacco Mfg. Co. v. City of New York, No. 09 Civ. 10511, 2011 WL 5569431 (S.D.N.Y. Nov. 15, 2011) (affirming reasoning of preliminary injunction order that the ordinance is an allowable sales restriction, denying plaintiffs’ motion for summary judgment, granting defendant’s cross-motion for summary judgment, and dismissing the complaint).

28 PROVIDENCE, R.I. CODE §§ 14-308, 14-309, and 14-310.

29 Nat’l Ass'n of Tobacco Outlets, Inc. v. City of Providence, No. 12–96–ML, 2012 WL 6128707 at *12- 13 (D.R.I. Dec. 12, 2012).

30 Id. at *8.

7

31 21 C.F.R. § 1140.14(a).
32 Freiberg, supra note 9, at 434.

33 See Tobacco Control Legal Consortium, Regulating E-Cigarettes – Tips and Tools (2011) (including select U.S. legislation and policies regulating e-cigarettes), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide-regecigs-2011.pdf; Tobacco Control Legal Consortium, Raising the Minimum Legal Sale Age for Tobacco and Related Products (2012), available at http://publichealthlawcenter.org/sites/default/files/resources/tclc-guide- minimumlegal-saleage-2012_0.pdf.

34 See, e.g., Americans for Nonsmokers’ Rights, Model Ordinance Prohibiting Smoking in All Workplaces and Public Places 7 (2011), available at http://www.no-smoke.org/pdf/modelordinance.pdf.

35 15 U.S.C. § 1331 et seq.
36 See 23-34 94th St. Grocery Corp. v. New York City Bd. of Health, 685 F.3d 174, 183-85 (2d Cir. 2012)

(affirming a district court

37 Freiberg, supra note 9, at 438.

38 For additional information, see the Tobacco Control Legal Consortium’s publications on First Amendment and Commerce Clause issues in the regulation of tobacco products, available at http://publichealthlawcenter.org/topics/special-collections/federal-regulation-tobacco-collection.

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12-04

Policy

STATEMENT OF POLICY
Regulation of Electronic Cigarettes (“E-Cigarettes”)

The National Association of County and City Health Officials (NACCHO) urges the FDA to enact strict regulations overseeing the sale and use of e-cigarettes and to conduct research on their health impact. Until then, NACCHO encourages local health departments (LHDs) to support local legislation that includes any or all of the following measures: 1,2

•   Use broadly-defined language to include e-cigarettes in new smoke-free legislation for indoor and outdoor environments

•   Make clear that e-cigarettes are covered by existing smoke-free laws through clarifying opinion or regulation/rule (n.b.: opening up or amending the definitions of “smoke” and “smoking” to include e-cigarettes and e-cigarette vapor may jeopardize existing laws)

•   Oppose legislation at the local or state level that exempts e-cigarettes from current smoking ban policies and regulations

•   Require tobacco retailer licenses to sell e-cigarettes, or add an additional fee for existing tobacco retailers to sell e-cigarettes

•   Establish an ordinance limiting the number of retailers or locations where e-cigarettes can be sold

•   Prohibit sales of e-cigarettes to minors

•   Ban sales of e-cigarette components that may appeal to minors, such as flavored

  cartridges

•   Advocate for state or federal regulation prohibiting sales of e-cigarettes on the internet or

  through the mail, especially in the case of minors

•   Raise excise tax on e-cigarettes as cigarettes and other tobacco products are taxed

•   Work with businesses and public locations, such as malls, to voluntarily prohibit e-

  cigarette sales on premises

  Justification

  In April 2011, the Food and Drug Administration (FDA) announced that it intends to develop regulations for e-cigarettes.3 E-cigarettes are battery-operated products designed to deliver nicotine, flavor, and other chemicals through a vapor inhaled by the user.4 Most e-cigarettes are manufactured to resemble cigarettes, cigars, and pipes5, often with an LED light at the tip that mimics the glow of a traditional cigarette.6 According to a survey by the Centers for Disease Control and Prevention, the number of Americans who had ever used e-cigarettes quadrupled from 2009 to 2010, and 1.2 percent of adults, or nearly three million people, reported using e- cigarettes in the previous month.7

NACCHO recognizes the importance of finding new tools to help smokers quit. Currently, little scientific evidence exists to show that electronic cigarettes, or e-cigarettes, are effective cessation devices. Furthermore, in 2010, a federal court ruling blocked the FDA’s attempts to regulate them as drugs or drug delivery devices, as nicotine gum and nicotine replacement therapy are regulated.8

Until further research shows that they are safe and effective, NACCHO suggests that e-cigarettes are regulated to the extent that the law allows. To that end, the FDA has the authority to regulate e-cigarettes as tobacco products under the Tobacco Control Act. According to the provisions of the act, state and local governments can take additional steps to regulate the sale and use of tobacco products and enact measures that are more restrictive than federal law.9

Further research is needed on the health risks of e-cigarettes, but available evidence suggests harmful effects. A recent study published in the European Respiratory Journal found that e- cigarette users get as much nicotine from e-cigarettes as smokers usually get from tobacco cigarettes.10 The FDA warns users of the potential health risks posed by e-cigarettes.11, 12 In addition to nicotine, an FDA laboratory analysis found that e-cigarettes contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze. Because there is little control or regulation of e-cigarette products, the amount of nicotine inhaled with each “puff” may vary substantially, and testing of sample cartridges found that some labeled as nicotine-free in fact had low levels of nicotine.13 Users can refill their own cartridges with much higher doses of nicotine, and the devices can also be filled with other harmful substances. For example, instructions for filling cartridges with marijuana hash oil can be easily accessed on the Internet.14

The use of e-cigarettes makes it difficult for business owners and officials to enforce existing smoke-free air laws.15 Their close resemblance to traditional cigarettes may cause confusion and lead people to believe that it is legal to smoke in smoke-free environments. Additionally, some e- cigarettes designed to look like everyday items, such as pens and USB memory sticks16, make it easy for youth to disguise these products in schools and other settings.

Public health experts have expressed concern that e-cigarettes may increase nicotine addiction and tobacco use in young people.17 E-cigarettes may be particularly appealing to youth due to their high-tech design, wide array of available flavors, including candy- and fruit-flavored cartridges, and easy availability online and in shopping malls.18 Because they are not taxed as tobacco products, e-cigarettes may be more easily obtained by price-sensitive youth.

There is strong public support for regulation of e-cigarettes, according to the University of Michigan C.S. Mott Children’s Hospital National Poll on Children’s Health. Among the findings, 85 percent of U.S. adults favored prohibiting the sale of e-cigarettes to minors, and 91 percent supported requiring manufacturers to test e-cigarettes for safety.19

Various federal, state, and local regulations are in place or are being considered to restrict e- cigarette use and sales. Amtrak has banned the use of electronic smoking devices, such as e- cigarettes, on trains, in stations, and in any area where smoking is prohibited.20 In a memorandum, the Air Force Surgeon General warned about safety concerns regarding electronic cigarettes and placed them in the same category as tobacco products.21 Currently, the U.S. Department of Transportation is proposing a regulation that would ban the use of e-cigarettes on aircraft by clarifying that the use of e-cigarettes is prohibited as tobacco products are prohibited.22 Several state and local government have taken steps to limit e-cigarette use in public places and prohibit the sale of e-cigarettes to minors.23 

References

1. Public Health Law & Policy. (2011). Electronic Cigarettes: How They Are - and Could Be – Regulated. Retrieved on November 11, 2011 from http://www.phlpnet.org/tobacco-control/products/electronic-cigarettes.

2. American Cancer Society Cancer Action Network, American Heart Association, American Lung Association,

   and the Campaign for Tobacco‐Free Kids. (2011). Policy Guidance Document Regarding E-Cigarettes. Retrieved on November 13, 2011 from http://naquitline.site- ym.com/resource/resmgr/news/Revised_Policy_Guidance_on_E.pdf.

3. U.S. Food and Drug Administration. (2011). Electronic Cigarettes. Retrieved on November 13, 2011 from http://www.fda.gov/newsevents/publichealthfocus/ucm172906.htm.

4. U.S. Food and Drug Administration. (2011). Electronic Cigarettes. Retrieved on November 13, 2011 from http://www.fda.gov/newsevents/publichealthfocus/ucm172906.htm.

5. Ibid.

6. Public Health Law & Policy. (2011). Electronic Cigarettes: How They Are - and Could Be – Regulated.

   Retrieved on November 11, 2011 from http://www.phlpnet.org/tobacco-control/products/electronic-cigarettes.

7. Regan, A.K., Promoff, G., Dube, S.R., Arrazola, R. (2011). Electronic nicotine delivery systems: adult use and

   awareness of the ‘e-cigarette’ in the USA. Tobacco Control. Retrieved November 11, 2011 from

   http://tobaccocontrol.bmj.com/content/early/2011/10/27/tobaccocontrol-2011-050044.abstract.

8. Public Health Law & Policy. (2011). Electronic Cigarettes: How They Are - and Could Be – Regulated.

   Retrieved on November 11, 2011 from http://www.phlpnet.org/tobacco-control/products/electronic-cigarettes.

9. Ibid.

10. Etter, J.F. and Bullen, C. (2011) Saliva cotinine levels in users of electronic cigarettes. European Respiratory Journal. Vol 38, 1219-1220.

11. U.S. Food and Drug Administration. (2011). Electronic Cigarettes. Retrieved on November 13, 2011 from http://www.fda.gov/newsevents/publichealthfocus/ucm172906.htm.

12. U.S. Food and Drug Administration. (2009). FDA and