September 2016 Newsletter

David bests Goliath
What is “plain packaging” and why is it becoming so popular abroad?
Is your home really smoke-free?
FDA regulation of “other tobacco products” begins
Updated statistics on tobacco use in the United States (2013-2014)
Teens are trying e-cigarettes because they’re “cool and fun”
LGBT group backs cigarette tax increase in California
E-cigarettes as a gateway to smoking: evidence is mounting
NAACP delegates support state and local regulation of menthol cigarettes
Is that e-cigarette really nicotine-free?
New York registers partial victory in cigarette trafficking case
New CDC data shows persistent racial and ethnic disparities in smoking rates

David bests Goliath

Uruguay successfully fends off Big Tobacco in trade agreement dispute over graphic health warnings.

When Uruguay adopted a series of public health measures in 2009 that, in part, required graphic health warnings to cover at least 80 percent of cigarette packs, it didn’t take long for Big Tobacco to file suit. Tobacco companies tend to have enormous resources to file suits and routinely use litigation or the threat of litigation to bully governments considering effective tobacco control measures. In this instance, Phillip Morris International, whose annual profits exceed Uruguay’s gross domestic product, sued Uruguay for $25 million, alleging that its cigarette packaging restriction violated the country’s 1991 trade agreement with Switzerland (where PMI is located). (Uruguay’s legal defense has been supported by philanthropic funds set up by Michael Bloomberg and Bill Gates.)

Specifically, PMI argued that Uruguay’s tobacco controls measures impermissible interfered with PMI’s intellectual property and trademark rights by requiring:

  • Graphic health warnings to increase from 50 to 80 percent of cigarette packs;
  • No more than one brand variation be offered for sale at a single store (g., a store could sell Marlboro, but not “Marlboro Light” or “Marlboro Gold”)

Seven years later, a U.S.-based tribunal which arbitrated the case has recently determined that Uruguay’s public health measures did not violate its treaty obligations. Additionally, the tribunal ordered PMI to pay Uruguay $7 million and reimburse other costs associated with the case.

What is “plain packaging” and why is it becoming so popular abroad?

Recent legislation in many countries restricts eye-catching tobacco packaging.

Great Britain and Ireland are among the latest countries to adopt public health measures that require cigarettes to be sold in drab packaging featuring large graphic health warnings. “Plain packaging” is a public policy that potentially will be very effective in reducing smoking, particularly by youth. The World Health Organization recommended the policy in the 2004 Framework Convention on Tobacco Control, the world’s first public health treaty (to which the U.S. is a signatory, but not a party since the agreement has not been ratified by the Senate).

The policy counters the incredible investment by tobacco companies into developing eye-catching packaging to attract new users (overwhelmingly youth under age 18). Research has found that the cigarette pack itself can be a status symbol—something that is used as an accessory by teens. It is the pack that makes the brand, since few smokers can accurately identify their preferred brand by taste. Moreover, teens are more susceptible to brand marketing which is important for tobacco companies since few adult smokers ever switch brands. (For more about the messages conveyed by cigarette packs, see Tina Rosenberg’s recent column in the New York Times.)

Australia was the first country to adopt the plain packaging and large graphic health warnings in 2011—and it appears to be working to reduce smoking. The industry immediately sued in Australian courts and lost. Thereafter, the industry relied on an international treaty between Australia and Hong-Kong to challenge the measure but failed to convince an arbitration panel to overturn the law.

In the United States, the Family Smoking Prevention and Tobacco Control Act includes a requirement that cigarette labels and advertising use only black text on white background (with some narrow exemptions) and include graphic health warnings on 50 percent of all packaging (and 20 percent of all advertising). While an appellate court upheld the requirement for the graphic health warnings, it overturned the requirement for so-called “tombstone” labeling and advertising. (Separately, the U.S. Food and Drug Administration has been forced to redesign its chosen graphic health warnings after the initial ones were invalidated.)

The industry has experienced a series of setbacks in its fight against plain packaging and graphic warning requirements. Emboldened by recent decisions, France has adopted legislation requiring plain packaging and Canada, India, Malaysia, New Zealand, Norway, Sweden, and Turkey, among others, are considering plain packaging requirements.

Is your home really smoke-free?

CDC finds apartment dwellers exposed to secondhand smoke even if they prohibit smoking in their own units.

It will come as no surprise to our readers that a recent study by Centers for Disease Control and Prevention (CDC) researchers found that people living in multi-unit housing are exposed to secondhand smoke even if they prohibit smoking in their own homes. Not only is tobacco use higher among those living in multi-unit housing than those living in single-family homes, but also, more than a third of those who maintain smoke-free homes are nevertheless exposed to secondhand smoke.

The U.S. Surgeon General has concluded there is no safe level of exposure to secondhand smoke. While cigarette smoking has decreased for decades, use of other tobacco products—including other combustible products like little cigars, as well as emerging products like electronic cigarettes—has remained unchanged or increased. Public health measures prohibit smoking in many public places, including many common areas in apartment buildings, but few policies prohibit smoking in individual residential units. This is a significant gap in public health policy because secondhand smoke can infiltrate an individual apartment or condo from other units through walls, ductwork, windows, and vents, among other routes.

The recent study found that 34.4 percent of residents with smoke-free rules in their own homes experienced secondhand smoke incursions. These incursions disparately impact those with lower income, women, younger adults, non-Hispanic blacks, and Hispanics. The U.S. Department of Housing and Urban Development (HUD) recently proposed rules that would require HUD-funded buildings to prohibit smoking in multi-unit buildings. Some local housing departments and some private developers have adopted smoke-free policies as well, but the great majority of multi-unit housing still permits smoking in individual units.

For information about implementing smoke-free rules for multi-unit buildings, see our Smoke-Free Housing resources.

FDA regulation of “other tobacco products” begins

Enforcement of some provisions of “deeming” rules began in August.

Earlier this year, the Food and Drug Administration (FDA) extended its authority to categories of tobacco products which the Family Smoking Prevention and Tobacco Control Act (FDA Act) did not automatically place under the agency’s jurisdiction. Specifically, the FDA “deemed” any product “made or derived from tobacco that is intended for human consumption” (including e-cigarettes, cigars, hookah and pipe tobacco, and dissolvable tobacco products) to be products properly regulated by the agency under the FDA Act.

While enforcement of the rules is staggered to permit manufacturers of newly deemed tobacco products to prepare and implement necessary changes, the FDA began enforcing the following rules as of August 8, 2016:

  • Minimum sales age of 18;
  • Prohibition on distribution of free samples;
  • Prohibition of vending machine sales (unless in adult-only facility);
  • Regulation of adulterated products;
  • Prohibition on false or misleading advertising; and
  • Required premarket review of products claiming they are “modified risk” (products using prohibited descriptors such as “light” or “mild” may continue to be marketed and sold until next year).

Soon after the publication of the FDA’s final rules, several manufacturers of newly deemed tobacco products, as well as an e-cigarette user, challenged the rules in several federal courts across the country. In sum, the plaintiffs broadly claim:

  • The FDA interpreted “tobacco product” too broadly (e., e-cigarettes should not be included);
  • The agency’s cost-benefit analysis overemphasized the benefits of the rule and underestimated the costs to affected manufacturers, which will be costly and overly burdensome;
  • Because the “substantial equivalence” review process (a streamlined pathway that permits expedited approval for products that are “substantially equivalent” to products marketed in the S. as of February 15, 2007) is largely unavailable to e-cigarette manufacturers (because e-cigarettes were not widely available in the U.S. prior to the grandfather date), the rules are “arbitrary and capricious” in violation of federal law;
  • The rule violates the free speech rights of e-cigarette manufacturers by prohibiting distribution of free samples;
  • The rule violates the free speech rights of e-cigarette and cigar manufacturers by restricting what manufacturers may truthfully say about their products and/or requiring warning labels;
  • The rule violates the equal protection and due process clauses of the U.S. Constitution by treating e-cigarettes similar to combustible tobacco products;

The plaintiffs in each case have asked the courts to issue preliminary injunctions to stop the rules from taking effect until the litigation is resolved. As of publication, no court has issued an injunction.

For more detailed information on specific lawsuits, see our Tobacco Litigation page.

Updated statistics on tobacco use in the United States (2013-2014)

Novel products are gaining in popularity among young adults.

Emerging tobacco products like e-cigarettes and hookah are increasing in popularity and undermining decades of declining smoking rates, according to the Centers for Disease Control and Prevention (CDC). More than a quarter of adults in the U.S. (58.8 million people in total) use some kind of tobacco product every day, some days, or rarely.

Young adults ages 18-24 are especially prone to use emerging tobacco products, including e-cigarettes, water pipes, and hookah. This age group accounted for nearly a quarter of the total amount of e-cigarette users, and more than half of the total water pipe/hookah users. Experimentation with and initiation of tobacco products increasingly occurs during young adulthood, and may be influenced by targeted marketing of e-cigarette brands.

To prevent tobacco-related morbidity and mortality, CDC recommends that states fully implement comprehensive tobacco control programs that focus on all forms of tobacco product use. Recommended interventions include price increases, anti-tobacco mass media campaigns, smoke-free laws, and improvement of cessation access in conjunction with FDA regulation of tobacco products.

Teens are trying e-cigarettes because they’re “cool and fun”

Motivation varies between kids and adults.

A survey of more than two thousand teens ages 14-15 years old in Ontario shows that more than 70 percent of those who had tried e-cigarettes did so because the products were “cool/fun/something new.”

These results stand in stark contrast to motivating factors for e-cigarette use among adults, who may use e-cigarettes as a cessation device to quit smoking, or alongside their use of regular cigarettes. In fact, 82.5 percent of the surveyed youth who did use e-cigarettes had not smoked a regular cigarette in the past 30 days. Yet future transition to conventional tobacco use remains a major concern.

Seven out of ten teenagers surveyed knew about e-cigarettes, and nearly a quarter of those said they learned about them from retail advertising at stores. Another 30 percent had heard about them from their friends.

According to the authors of the study, “use of e-cigarettes was associated with lower self-identified health level, greater stress level and a lower estimated household income,” revealing potential risk factors within the adolescent population. “Our findings support the ongoing implementation of strict regulations to help reduce e-cigarette use among adolescents,” they conclude.

LGBT group backs cigarette tax increase in California

May reduce smoking among high-use population

A November ballot initiative in California proposes to raise the cigarette tax by two dollars per pack across the state—and the proposition just got backing from its first LGBT minority rights group, Equality California.

Among U.S. adults, 23.9 percent of LGBT adults smoke cigarettes compared with only 16.6 percent of heterosexual adults, according to the CDC. In California, the difference is even greater: the LGBT smoking rate of 27.4 percent is more than double the heterosexual smoking rate of only 12.9 percent. Nationwide, more than 30,000 LGBT people die from tobacco-related causes each year, according to the American Cancer Society.

“Historically, trans and queer folks had very limited gathering spaces, and many of those spaces have been centered around bars,” says Ben Hudson, executive director of an LGBT-focused health clinic in Sacramento. “Folks who experience a lot of micro-aggressions and are living in a world that’s not necessarily accepting of who they are may use smoking to relieve that stress.”

Building a coalition in support of the ballot initiative will be critical, because major tobacco companies have historically spent big to prevent similar initiatives in California. These industry opposition campaigns have paid off; currently, Californians pay only 87 cents per pack in state taxes, compared to $4.35 in New York.

E-cigarettes as a gateway to smoking: evidence is mounting

E-cigarettes associated with smoking initiation among youth

Building upon previous analyses, a recent study found that e-cigarette users had 6.17 times the odds of initiating cigarettes as never e-cigarette users. The prospective cohort design of the study allowed the researchers to follow e-cigarette users and non-users over time, to see how many later began smoking conventional cigarettes. The association between e-cigarette use and smoking initiation was even stronger among groups that never intended to begin smoking, revealing that “cigarette use was not simply a marker for individuals who would have gone on to smoke regardless of e-cigarette use.”

The data “paint a bit of a dire picture about the state of adolescence tobacco control right now,” says Jessica Barrington-Trimis, lead author of the study. Previously unregulated, e-cigarettes only recently came under federal control via new deeming regulations that allow the Food and Drug Administration to regulate these and other tobacco products.

E-cigarettes lead to smoking initiation through several mechanisms, according to the study’s authors. Flavored liquids in e-cigarettes can lessen the harshness of nicotine and desensitize users’ lungs, while regular nicotine use can lead youth and young adults to eventually seek other, more effective ways of obtaining nicotine. The rapidly increasing rate of e-cigarette use among teenagers and young adults is also normalizing this behavior already within social environments.

NAACP delegates support state and local regulation of menthol cigarettes

African Americans most likely to use menthol products

Delegates to the 107th Annual Convention of the National Association for the Advancement of Colored People (NAACP) recently agreed that state and local regulation of menthol cigarettes should be supported nationally. Tobacco use is the leading cause of death among African-Americans in the U.S.

The resolution will move to the NAACP Board of Directors for possible ratification in October. If ratified, official NAACP policy will endorse state and local efforts to restrict the sale of flavored tobacco products, including menthol cigarettes, throughout the U.S.

More than 70 percent of African-American smokers use menthol cigarettes, compared to half of white smokers, and the tobacco industry has a well-documented history of targeting Black communities with menthol advertising and discounts. Menthol may make it easier to inhale cigarette smoke, promoting higher absorption of harmful chemicals in the body.

To combat these harmful effects and prevent youth smoking initiation, municipalities are restricting and sale of flavored tobacco through evidence-based public health policies. For example, ordinances passed in Chicago, IL and Berkeley, CA restrict the sale of flavored tobacco products, including menthol cigarettes, within 500 and 600 feet of schools, respectively. New York City restricts the sale of flavored products to tobacco bars.

Is that e-cigarette really nicotine-free?

Study finds mislabeling and underreported nicotine levels

E-cigarette technology is rapidly developing and changing, posing many challenges for regulators. One such challenge is labeling—which should accurately convey the level of nicotine present in e-liquids used with e-cigarettes. Yet according to a recent examination of e-cigarettes obtained from stores in North Dakota, more than half of labels on these containers are inaccurate.

The nicotine level of e-liquid is only discernible through laboratory testing. Researchers examined the contents of 98 e-liquid cartridges, finding that actual nicotine levels ranged from 66 percent below the reported level to 172 percent above it, with the mean actual content exceeding the mean labeled content. These mislabeling offenses included e-liquid cartridges claiming to be “nicotine-free” that actually contained nicotine, a highly addictive drug. Furthermore, more than half of e-liquid containers were not child-resistant, presenting a danger to infants and young children.

The research has implications for regulation of e-cigarettes generally, and also the inclusion of “nicotine-free” e-cigarettes in existing tobacco controls. E-cigarettes pose health risks regardless of nicotine content, and separate regulation could prove to be an impossible enforcement challenge to regulators. Accordingly, subjecting nicotine-free and nicotine-containing e-cigarettes to the same regulatory controls may be the best solution.

“Mislabeling of nicotine in e-liquids exposes the user to the harmful effects of nicotine,” says lead study author Kelly Buettner-Schmidt. “In areas without child-resistant packaging requirements, children may be exposed to harmful nicotine.”

New York registers partial victory in cigarette trafficking case

Indian tobacco wholesaler owes state for sale of unstamped cigarettes

In a December 2012 suit against King Mountain Tobacco Company, the state of New York complained that the Washington State-based cigarette wholesaler illegally sold 25 million packs of contraband cigarettes lacking New York state excise tax stamps. On July 21, 2016, a U.S. District Court located in New York cleared the company of most trafficking charges, but said it is still liable for direct sales of unstamped cigarettes to other Indian tribes.

In regard to the trafficking charges, the state argued that the Contraband Cigarette Trafficking Act (CCTA) applies to the company; that exemptions from the law are intended only to protect Indian tribes and individuals. The Court disagreed, noting that sales occurred between two Indian countries despite the fact that they were located in different states.

However, the Court did side with the state on other claims, agreeing that King Mountain had violated New York state tax laws and failed to submit certifications for fire prevention, which was the state’s main claim, according to the office of the New York Attorney General.

“Illegal sales of untaxed cigarettes are a major public health hazard. King Mountain Tobacco is making cheap cigarettes available and encouraging young people to take up a deadly habit,” said Attorney General Eric Schneiderman in 2012. “These illegal sales deprive the state of hundreds of thousands of dollars of much needed tax revenue and put law-abiding businesses at a competitive disadvantage. New York is committed to stopping such contraband sales.”

The case will likely be further pursued in federal court.

New CDC data shows persistent racial and ethnic disparities in smoking rates

Study identified ethnic subgroups using at higher rates

Despite declining smoking rates, new CDC data show persistent racial/ethnic and gender disparities in cigarette use among adults. Specifically, the most recent smoking prevalence estimates among American Indian/Alaska Natives, Chinese, Filipino, Japanese, Korean, Vietnamese, Puerto Rican, and Cuban adults are similar to those of 2005, while other the prevalences for other groups have dropped significantly.

Tobacco use data for ethnic subgroups are usually aggregated to obtain sample sizes large enough to provide accurate estimates; in this case, researchers were able to reveal large disparities by analyzing data from multiple time periods of three years each.

According to CDC, differences among ethnic subgroups and genders may be due to variations in socioeconomic status, targeted advertising, price of tobacco products, and cultural acceptability. “Looking beyond broad racial and ethnic population categories can help better focus the strategies that we know work to reduce tobacco use among sub-groups with higher rates of use,” says Bridgette Garrett, Ph.D., associate director for health equity in the CDC’s Office on Smoking and Health.