February 2016 Newsletter

Who Still Smokes?
FDA Authorizes Marketing of New Tobacco Product
FTC Proposes Study of Electronic Cigarettes Sales and Marketing
 Safe at Home
 Hawaii Begins Enforcement of Tobacco 21 Law
 Australia’s Plain Packaging Law Survives Challenge
 Child Resistant Packaging for Liquid Nicotine
 E-Cigarettes are Picking Up Where Traditional Cigarettes Left Off
 FDA May (Again) Rely on Menthol Report

Who Still Smokes?

Rates for uninsured and adults covered by Medicaid more than twice those for adults with private insurance

The Centers for Disease Control and Prevention published a study in November highlighting the disparities in tobacco use.  While the overall adult smoking rate has hit a national low of 16.8% (declining from a rate of 20.9% in 2005), the rate of decline is uneven across subpopulations. According to the 2014 National Health Interview Survey results, American adults who are uninsured (27.9%) or whose health care is covered by Medicaid (29.1%) smoke at rates more than double those for adults with private health insurance (12.9%) or Medicare (12.5%) coverage.

Other groups with a higher burden of tobacco use include persons who have less than a high school education (43.0%), live below the federal poverty level (26.3%), live with a disability or other limitation (21.9%), or are lesbian, gay or bisexual (23.9%). The Healthy People 2020 goal is to reduce cigarette smoking prevalence to less than 12%.

“These findings underscore the importance of ensuring that proven strategies to prevent and reduce tobacco use reach the entire population, particularly vulnerable groups,” said Brian King, Ph.D., deputy director for research translation, CDC Office on Smoking and Health and an author of the study. Comprehensive smoke-free laws, higher prices for tobacco products, high-impact mass media campaigns, and barrier-free access to quitting help are all important. They work to reduce the enormous health and financial burden of tobacco use and secondhand smoke exposure among Americans.”

While the study did not examine the specific impact of tobacco control policies, we know that comprehensive tobacco control policies work. Innovative evidence-based policies targeting industry practices within the retail environment can complement existing tobacco controls. For more information about such policies, please review the Policy Center’s publications or contact us with questions at tobacco@tobaccopolicycenter.org.

FDA Authorizes Marketing of New Tobacco Product

Swedish Match products approved under pre-market review process

A new tobacco product may soon hit the U.S. market. In November 2015 the FDA authorized eight types of snus smokeless tobacco manufactured by the company Swedish Match North America, Inc. The move is noteworthy since it is the first time the FDA has authorized the marketing of new tobacco product since given that responsibility by the 2009 Family Smoking and Tobacco Control Act (Tobacco Control Act).

The Tobacco Control Act seeks to restrict the introduction of new tobacco products to the U.S. market. Products already available prior February 15, 2007 may continue to be sold; products that were not on the market by that date must apply to the FDA to enter the market as either a new product or a product that is “substantially equivalent” to an existing marketed product.

Swedish Match completed the FDA’s premarket application process for a new product, providing data necessary for the FDA to evaluate whether introducing this tobacco product to the market is “appropriate for the protection of the public health.” The FDA’s evaluation considers whether the new product, if “marketed as described in the manufacturer’s application, would result in a low likelihood of new initiation, delayed cessation or relapse…[and] would likely provide less toxic options if current adult smokeless tobacco users used them exclusively.”

The company has submitted applications seeking permission to market some of the products as “modified risk” products, but such a determination is made through a different process and is not covered by the November marketing orders.

“The law is clear. Companies must apply to the FDA first, and then the FDA uses a rigorous scientific review to determine if new tobacco products should come to market under this pathway. Today’s action demonstrates that the premarket tobacco application process is a viable pathway under which products can be marketed as long as the public health can be protected,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “As other manufacturers seek to market new tobacco products, the FDA will remain committed to upholding the important public health standards under the law.”

FTC Proposes Study of Electronic Cigarettes Sales and Marketing

Commission requests public comment on information to be collected

In November 2015, the Federal Trade Commission (FTC) announced its plans to study electronic cigarette (or electronic nicotine delivery systems (ENDS)) marketing and sales information. For decades, the FTC has annually collected marketing data from the major cigarette and smokeless tobacco manufacturers and reported them in aggregate. (The Public Health and Tobacco Policy Center summarizes these annual reports in a fact sheet.) The agency sought comments on the proposal, including whether and how to collect, analyze and report ENDS marketing and sales information. Comments were due December 28, 2015.

New York contractors with questions about this proposal should contact the Policy Center.

Safe at Home

HUD proposes new rules requiring housing units go smoke-free

The U.S. Department of Housing and Urban Development (HUD) took an historic step towards reducing involuntary exposure to secondhand smoke by proposing a new rule that would require all federally-funded public housing authorities to be smoke-free indoors. The rule is a response to acknowledgement by the U.S. Surgeon General (and others) that there is no safe level of exposure to secondhand smoke and that, most exposure to secondhand smoke occurs in the home, particularly for children.

The proposed rule is similar to one already in place in many affordable and market-rate multiunit properties across the country. It would prohibit smoking anywhere inside a building, including in individual residences, decks and anywhere else indoors. Under the proposed rule, residents who smoke are not required to quit; they just need to go outside and away from the building to smoke. The rule would apply to anyone on the property, including current residents, staff and guests. No one would be allowed to smoke tobacco inside after the effective date.

The proposal is primarily intended to eliminate the problem of toxic smoke drifting from a smoker’s home in the other homes located in the building. The problem of drifting secondhand smoke in multiunit dwellings is well documented. Smoke moves under doors, through ventilation systems, wall fixtures, and other pathways, involuntarily exposing those in its path to its hundreds of toxins. The rule proposed by HUD would require all federally-funded public housing authorities to implement this rule within 18 months after the public comment period ends and the rule is finalized. Other affordable housing is not covered by this proposal.

HUD has invited public comment on its proposal and will review all comments submitted by January 19, 2016. New York contractors with questions about this proposal and HUD’s next steps should contact the Policy Center.

Hawaii begins enforcement of Tobacco 21 law

Other states considering adopting the policy

On January 1, 2016, Hawaii became the first state to restrict tobacco sales to and use by persons 21 years of age and older. Approximately 96% of smokers begin before the age of 21. Tobacco 21 policies remove an important social source of cigarettes for adolescents (peers ages 18-21) thereby delaying or preventing smoking initiation and nicotine addiction.

The Department of the Navy, which has a significant presence in Hawaii but is generally exempt from state laws, announced that it will enact a policy that complies with the new law. According to a press release, all shore-based Navy and Marine Corps Exchanges in the state were to stop selling tobacco products to anyone under the age of 21, effective January 1st.

Last year, the Institute of Medicine published a report concluding that Tobacco 21 policies can reduce the number of people who smoke and, therefore, the number of people who suffer illness and death as a result of smoking. Importantly, the IOM found that Tobacco 21 will be most effective if incorporated into a comprehensive tobacco control program (rather than adopted as a stand-alone policy). For more information about Tobacco 21 policies and how they can be incorporated into a tobacco control program, contact the Policy Center.

Australia’s Plain Packaging Law Survives Challenge

Big Tobacco fails to convince tribunal to rule the public health measure a violation of a trade agreement

Since 2012, Australia requires all tobacco products to be sold in plain, drab-colored packaging devoid of logos and other brand imagery. Moreover, the packs must include large graphic health warnings. Almost immediately after the requirement was proposed, Philip Morris International, British American Tobacco and Imperial Tobacco formed the Alliance of Australian Retailers which spent millions of dollars campaigning against the measure. After the law was passed, British America Tobacco filed suit, but Australia’s highest court upheld the law in 2012.

At nearly the same time, Philip Morris announced it would take a different tact and challenge the requirements as a violation of Australia’s 1993 Bilateral Investment Treaty with Hong Kong. In its challenge, the company alleged that the plain packaging restriction constituted a breach of Australia’s commitment to fairly treat the company’s Australian and Asian investments (namely, Philip Morris trademarks).

In December 2015, a Tribunal of the Permanent Court of Arbitration unanimously agreed with Australia’s position that the Tribunal had no jurisdiction to hear Philip Morris’ claim. The court has yet to publish its decision, but will do so once confidential information has been removed from the written document.

Australia credits its strict tobacco control laws, including plain packaging, with declining tobacco use in the country. “Smoking in Australia is falling in adults, in children and by tobacco volume sales,” said Michael Moore, chief executive of the Public Health Association of Australia. “Now the tobacco companies have lost another crucial legal bid to stop this life-saving measure. The message is loud and clear – plain packaging works, and it is here to stay.”

The Ireland and the United Kingdom have adopted plain packaging requirements which will become effective in 2017. Several other countries, including France, Norway and Turkey are considering plain packaging requirements of their own.

Child Resistant Packaging for Liquid Nicotine

President Obama signs law designed to protect kids from accidental poisoning

Child-resistant caps are often required for substances that can be attractive to but dangerous for children, such as medications and harmful chemicals. Liquid nicotine, used in electronic nicotine delivery systems (ENDS) such as e-cigarettes, has come under increased scrutiny in the face of a rising number of child nicotine poisonings (2,300 in 2014). In fact, a mere teaspoon of a high concentration of liquid nicotine can kill a child. Liquid nicotine (sometimes called e-juice) is often packaged with bright, attractive colors and images to reflect its kid-friendly flavors, like berry, cotton candy, and cheesecake (to name just a few). The new law will require that liquid nicotine sold to consumers meet child-resistant packaging standards set by the Consumer Product Safety Commission.

After the poisoning death of a New York toddler in 2014, New York adopted its own law requiring all liquid nicotine be sold in child-resistant packaging. Several other states have adopted similar laws, which may have prompted Congress to set a nationwide standard (which has been supported by ENDS trade organizations).

E-cigarettes Are Picking Up Where Traditional Cigarettes Left Off

Most kids exposed to e-cigarette advertising

The Centers for Disease Control and Prevention (CDC) recently found that nearly 70% of middle and high school students (approximately 18.3 million) have reported seeing e-cigarette marketing in at least one setting in 2014. They were most likely to see marketing in retail stores, but also viewed e-cigarette marketing on the internet, on television, movies, newspapers and magazines.

What is perhaps most disturbing is that e-cigarette ads are taking forms that are no longer available to traditional tobacco products, including TV commercials featuring celebrities. “It’s the Wild West out there when it comes to e-cigarette advertising,” said CDC Director, Tom Frieden, to the Washington Post. “It’s no coincidence that as the advertising has skyrocketed, the use of e-cigarettes has skyrocketed.”

The Surgeon General has concluded that tobacco marketing causes youth tobacco initiation. E-cigarette companies (some of which are Big Tobacco companies) are now using the same themes and strategies Big Tobacco has successfully employed to recruit new (youth) users of cigarettes and other tobacco products. The Tobacco Master Settlement Agreement imposed significant restrictions on traditional tobacco product advertising; subsequently, there was a steady decline in youth smoking. Unrestricted e-cigarette marketing could reverse this trend by influencing youth to try e-cigarettes. Notably, e-cigarette advertising jumped from $6.4 million in 2011 to an estimated $115 million in 2014. Not surprisingly, in 2014, e-cigarettes became the most popular tobacco product among middle and high school students; in fact, e-cigarette use among youth tripled between 2013 and 2014, negating declines in the use of more traditional forms of tobacco.

E-cigarette use among youth is particularly concerning for several reasons. Nicotine is especially harmful to youth as it is highly addictive and can harm adolescent brain development. Further, current use trends suggests e-cigarette use among youth increases the likelihood of adolescent experimentation with other tobacco products, including traditional cigarettes. The CDC reports that approximately three out of every four teen smokers become adult smokers, so it is especially important to prevent youth experimentation with any nicotine product.

In 2014, the Food and Drug Administration proposed “deeming” regulations to begin asserting its authority over e-cigarettes, including their marketing. The proposal has been stalled for months awaiting White House approval.

FDA May (again) Rely on Menthol Report

Court rules TPSAC recommendation for ban on menthol products did not harm tobacco companies

On January 15, 2016, the U.S. Circuit Court of Appeals for the D.C. Circuit overturned a lower court’s ruling that the Food and Drug Administration (FDA) failed to follow proper protocol when it created its Tobacco Product Scientific Advisory Committee (TPSAC) to study and make recommendations for the regulation of menthol products. Plaintiffs Lorillard Tobacco Co. (Lorillard) and R.J. Reynolds Tobacco Co. (R.J. Reynolds) claimed three of the committee’s scientists had conflicts of interests that would harm the companies in future litigation.

The Family Smoking and Tobacco Control Act banned the manufacture of flavored cigarettes (e.g., fruit, candy and clove), but exempted menthol cigarettes. It also directed the FDA to establish TPSAC to study the impact of menthol cigarettes on the public health “including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities. In 2010, TPSAC undertook its study and, in 2011, issued a report with a recommendation that banning menthol cigarettes would improve public health.

Immediately, Lorillard and R.J. Reynolds sued the agency alleging that three members of TPSAC had conflicts of interest stemming from their service as paid expert witnesses in anti-tobacco litigation and their employment with pharmaceutical companies that make smoking-cessation products. The companies argued, in part, that the named scientists could use confidential information disclosed during the course of the study to testify against them in future cases, as well as to influence the report to assist them with their work.  In July of 2014, Judge Richard Leon granted Lorillard’s Motion for Summary Judgement and ordered the FDA not to consider TPSAC’s report, and to reconstitute the committee.

The FDA appealed the decision, and a three-judge panel recently concluded that the plaintiff companies incurred no injury, but merely speculated that an injury may occur in the future. Moreover, the court pointed out that if the scientists disclosed confidential information in the manner proposed by the companies, they would be subject to criminal penalties.

As the FDA considers whether and how to regulate menthol cigarettes in the interest of public health, it may now rely on TPSAC’s conclusion that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes. The agency may also rely on its own July 2013 independent scientific review, which likewise concluded menthol flavoring makes it easier to start smoking, harder to quit and overall has a negative effect on public health. It’s unclear when—or even if—the FDA will act on the evidence.