October 2015 Newsletter

New York making strides towards vision of tobacco-free society
18 to 20-year-olds can no longer buy tobacco in the Aloha State
“Natural” and “additive-free” cigarette labels misleading
FDA orders “Camel Crush” and other popular cigarette brands pulled from shelves.
Tobacco companies sue FDA over product approval rules
New York and tobacco companies settle long term dispute–NY to receive $550 million
Boston becomes latest city to adopt tobacco free sports venues
(Not a) Surprise! Kids favor flavored tobacco products
Smoking rates in New York City at record low
FDA taking new approach to reach youth with anti-smoking message
The Policy Center gets a makeover

New York making strides towards vision of tobacco-free society

New York tobacco control program aims to reduce adult smoking prevalence to under 10% by 2020.

At the end of August, Dr. Harlan Juster, Director of New York’s Bureau of Tobacco Control, hosted a webinar for contractors laying out the Bureau’s five year vision and goals. The Bureau continues to focus on reducing tobacco use through population-level change, including environmental change (through policy), health systems transformation and health communications.

The work is supported by a grant from the Centers for Disease Control and Prevention (CDC). Under the project, local health organizations will educate community members and leaders about the power of policy change to reduce the morbidity and mortality associated with tobacco use. Specific goals include:

  • decrease the prevalence of tobacco use among high school age youth from 7.3% to 5.5% by March 2020;
  • decrease the proportion of the adult population reporting overall exposure to secondhand smoke from 42.2% to 32.6% by March 2020;
  • decrease the adult smoking prevalence among individuals with less than a high school education from 27.5% to 21.3% and among individuals with poor mental health from 33.7% to 26.1% by march 2020; and
  • decrease the adult smoking prevalence from 14.5% to 11.0% by March 2020.

With regard to decreasing adult smoking prevalence, Dr. Juster suggested that New York can actually accelerate these goals and achieve 10% adult smoking prevalence by 2020 through:

  • increasing cessation benefit availability/utilization;
  • increasing counseling, medication, and follow-up;
  • increasing Quitline involvement in the above;
  • increasing policies that reduce youth initiation; and
  • increasing media to support behavior change and create new social norms.

In addition to these goals, the project will continue to develop and use mass reach communication to influence tobacco free norms and reduce tobacco use, and maintain a strong surveillance and evaluation system for the tobacco control program.

New York State’s tobacco control program is a model for the country. Through its comprehensive approach to tobacco control, the Bureau and its contract organization have laid the groundwork for success; the team is well-positioned to achieve New York’s identified goals.

18 to 20-year-olds can no longer buy tobacco in the Aloha State

Hawaii becomes the first in the nation to adopt Tobacco 21 policy statewide

Beginning in 2016, Hawaii will become the first state to restrict tobacco sales and use to persons 21 years of age and older. The adoption of the new law closely follows the release of a report by the Institute of Medicine concluding that such a policy will not only reduce youth smoking but overall smoking prevalence as well.

Ninety six percent of adult smokers begin smoking before age 21. This means that only about 4% of adult smokers began smoking at age 21 or older. While federal law prohibits sales of tobacco to persons under age 18, youth are still able to acquire cigarettes, usually through social sources. These social sources primarily are peers between the ages of 18 and 21. Raising the minimum age of legal tobacco access to 21 effectively removes tobacco from the social circles of most youth, thereby delaying or, hopefully, preventing smoking initiation.

Youth are particularly susceptible to nicotine addiction, and the younger the age of smoking initiation, the greater the risk of not only addiction, but heavy daily smoking and increased difficulty quitting. High school student cigarette use has been declining across the country, but use of novel products such as electronic nicotine delivery systems (e.g., ENDS or e-cigarettes) have sharply increased in recent years. Moreover, early research suggests that youth e-cigarette use is associated with later use of traditional combustible tobacco products. States and local governments across the country are therefore considering Tobacco 21 policies, among other innovative tobacco control strategies, to prevent youth from becoming addicted to nicotine in any form.

For more information about Tobacco 21 policies and the evidence supporting it as an effective intervention, see the Public Health and Tobacco Policy Center’s fact sheet on the issue.

“Natural” and “additive-free” cigarette labels misleading

After urging by public health groups, FDA issues warning letters to makers of Winston, Nat Sherman and Natural American Spirit cigarettes.

On August 27, 2015, the Food and Drug Administration (FDA) warned three tobacco manufacturers that their use of the descriptors “natural” and “additive-free” violates the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Under section 911 of the Act, manufacturers must obtain approval from the FDA before marketing their products as less harmful than other tobacco products. In its warnings to the makers of Natural American Spirit, Winston and Nat Sherman cigarettes, the FDA contends that the use of the words “natural” or “additive-free” imply that those cigarettes present a lower risk of tobacco-related disease than other tobacco products. Since the FDA has not approved the products as “modified risk tobacco products” under the Tobacco Control Act, such claims violate the law.

This is a meaningful development since it represents FDA’s first attempts to reign in misleading marketing claims by Big Tobacco and, significantly, targets one of the fastest growing brands on the market (American Spirit). “The FDA’s job is to ensure tobacco products are not marketed in a way that leads consumers to believe cigarettes with descriptors like ‘additive-free’ and ‘natural’ pose fewer health risks than other cigarettes, unless the claims have been scientifically supported,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

These misleading labels have been known to public health and enforcement agents for some time. For example, in 2000, prior to enactment of the Tobacco Control Act (and, therefore, FDA’s authority over tobacco product manufacture and marketing), American Spirit manufacturer settled deceptive advertising charges with the Federal Trade Commission by printing a statement: “No additives in our tobacco does NOT mean a safer cigarette” on all of its products that made an additive-free claim. In 2010, the company settled with 33 state attorneys general similar claims that its labeling of products as “organic” misled consumers to believe that the products were safer than cigarettes made without organically grown tobacco. Natural American ads also include a statement that “Organic tobacco does NOT mean a safer cigarette.”

The FDA’s action closely follows receipt of a letter submitted by public health and tobacco control advocates, including the Policy Center as a member of the Tobacco Control Legal Consortium, urging the FDA to exercise its authority to crack down on American Spirit’s misleading marketing claims. The letter was prompted by the brand’s new national campaign intensifying its emphasis that its products are “100% additive-free” and “organic” in a manner that minimized the disclosures required by the company’s previous agreements.

On September 29, 2015, Japan Tobacco Group agreed to purchase the American Spirit trademark for use outside the U.S..

Shortly after the warnings were issued, a class action lawsuit was filed by smokers of American Spirit cigarettes against their manufacturer claiming that the company’s description of the product as “additive-free,” “natural,” and “organic” deceives consumers into believing American Spirits are safer than other brands. Additionally, the plaintiffs claim that the company adds ammonia to actually increase nicotine delivery, making them more addictive than some other brands (such as Camel, Winston and Marlboro). In addition to punitive damages, the plaintiffs are asking the companies to pay for medical monitoring and smoking cessation programs for them.

The tobacco companies had 15 days to reply to the warning letters to either dispute the FDA’s conclusion or detail their plans for corrective action. American Spirit manufacturer has submitted an explanation of its marketing strategy to the FDA and asked for a meeting to provide additional information. Neither the makers of Winston nor Nat Sherman cigarettes have publicly announced their responses to the warnings.

FDA orders “Camel Crush” and other popular cigarette brands pulled from shelves

Agency determines Reynolds American failed to prove four products comply with federal law.

In September 2015, the Food and Drug Administration (FDA) ordered four cigarette brands removed from retail shelves because they are “not substantially equivalent” (NSE) to so-called predicate products. Under the Tobacco Control Act, tobacco products that were not on the market as of February 15, 2007 must receive FDA approval to remain on the market. A manufacturer seeking agency approval for such a product must submit information for scientific review. In this case, Reynolds American, Inc. (RAI) failed to establish that the products at issue were substantially equivalent to their pre-2007 (predicate) products. The four recalled brands are Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13.

“These decisions were based on a rigorous, science-based review designed to protect the public from the harms caused by tobacco use,” Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, said in a statement. “The agency will continue to review product submissions and exercise its legal authority and consumer protection duty to remove products from the market when they fail to meet the public health bar set forth under law.”

The products at issue entered the market during a provisional period established by the Tobacco Control Act. Under the terms of the law, RAI requested that the products be allowed to remain on the market and submitted an application asserting the products were equivalent to predicate products. Through its application, the company was required to demonstrate that changes in the chemistry, engineering and/or ingredients did not raise new public health concerns. RAI failed do so. In the case of Camel Crush Bold, the company failed to demonstrate that the unique menthol capsule in the filter did not affect consumer perception and use also contributed to the decision.

As a result of the order, the retailers’ inventory of the product is considered adulterated and misbranded. Retailers are therefore no longer permitted to sell or distribute the product. In this particular case, the FDA announced it will take no enforcement action on existing retailer inventory for 30 days. Once it does begin enforcing the order, the agency is authorized to pursue fines, criminal charges, product seizures and other remedies.

Anyone can report potential violations by using the FDA’s Potential Tobacco Product Violation Reporting Form.

Tobacco companies sue FDA over product approval rules

Industry alleges FDA’s guidelines overreach authority

On September 30, 2015, Philip Morris, USA, R.J. Reynolds Tobacco, and other tobacco companies filed a lawsuit in federal court claiming that the FDA’s newly-issued guidelines for industry violate the companies’ First Amendment rights. The companies hope to block implementation of the guidelines.

The FDA guidelines explain that if a tobacco company significantly changes a product’s label or changes the number of units in each package, approval by the agency may be required before those changes are implemented in the marketplace. The tobacco companies argue in their complaint that the FDA’s new rules restrain the expression of protected free speech in violation of the U.S. Constitution.

Under the Family Smoking Prevention and Tobacco Control Act, the FDA has the authority to review tobacco products before they are marketed to determine whether they are “substantially equivalent” to a predicate product already on the market as of February 2007. The recently-issued guidelines explain the circumstances in which the FDA would consider a product a “new tobacco product” subject to pre-market review. Specifically, if a label is modified in such a way that consumers perceive the product to be a new product (e.g., because of a new name, logo, product descriptors or distinct colors), the product may be subject to review.

These same complaining tobacco companies filed a largely similar lawsuit in April when the FDA first sought to clarify its policy concerning approval of new and existing tobacco products. In response to the legal challenge, the FDA suspended enforcement of the provisions of the policy at issue and agreed to evaluate the companies’ concerns. This prompted the companies to withdraw their lawsuit. The FDA issued revised policy guidelines on September 8, but the industry alleges the FDA is exceeding its authority in considering not simply the characteristics of the products, but how products are described.

If the lawsuit is successful, tobacco companies will have greater flexibility to change packaging regardless of the potential public health consequences. If the lawsuit fails, the FDA will have greater power to regulate tobacco product labeling and packaging.

New York and tobacco companies settle long term dispute-NY to receive $550 million

Will New York and its counties designate the funds for tobacco control?

The major tobacco companies, including RJ Reynolds Tobacco and Philip Morris USA, settled with New York State on disputes from 2004-2014. The settlement will release to NY State around $550 million in disputed past payments that were held in escrow accounts.

The origin of the dispute is in the 1998 tobacco Master Settlement Agreement (MSA), wherein settling companies made payments to the states to help recover states’ Medicaid and other health-related costs incurred as a result of smoking. As a result, company costs to sell cigarettes increased and placed settling companies at a disadvantage as compared with companies who did not join the settlement (including New York Native American cigarette manufacturers). To even the playing field, New York and other states passed a statute forcing non-settling manufacturers to make payments into escrow accounts that were comparable to what these companies would have paid to the states had they participated in the MSA. The statute thereby effectively raised cigarettes sale prices of the non-settling manufacturers in the same way the MSA raised the sale price of cigarettes manufactured by the settling companies.

The statute also stated that if the settling companies’ market share of cigarettes fell below a certain percentage (which it did) and the fall was deemed attributable to the MSA (which it was), then the settling companies could reduce their payments owed to any state that had failed to “diligently enforce” the statute. Beginning in 2003, the settling companies argued New York (and other states) had failed to diligently enforce the statute and they began placing their payments into an escrow account, out of reach of the states, until the dispute was resolved.

Payments to each state are based on the volume of cigarette sales a company makes in that state, with the stated purpose of defraying a state’s cost spent on tobacco related illness. New York’s smoking rate (and therefore cigarettes sales) has declined at a faster rate than anticipated at the time the statute was put in place. While this translates to receiving fewer dollars from tobacco companies, fewer smokers also translates to fewer state dollars spent on smoking related medical costs and other economic loss, such as lost productivity. This economic benefit of fewer smokers is in addition to building healthier population and making New York a nicer place to live, work and play. New York Bureau of Tobacco Control continues to support its tobacco control partners and by all appearances remains committed to accelerating the state’s declines in tobacco use, an endeavor accomplished in large part through sustained efforts by its contractors.

Boston becomes latest city to adopt tobacco free sports venues

Smokeless tobacco use prohibited in Fenway Park as of next season

Beginning next season, Red Sox fans taking in a home game will no longer see players chewing tobacco during the game. As of April 2016, Boston will prohibit smokeless tobacco and other tobacco products in all professional and amateur sports venues—including Fenway Park. With the new law (adopted in September 2015), Boston became the second city (behind San Francisco) to create a tobacco-free environment for athletes and spectators.

Earlier in the year, the Boston City Council heard testimony on the health hazards of smokeless tobacco, including oral, pancreatic and esophageal cancer. Additionally, proponents testified that smokeless tobacco has been marketed to youth and its use often leads to smoking.

The Boston law prohibits smokeless tobacco and other tobacco products (not including electronic nicotine delivery systems like e-cigarettes) at sites used for professional, college, high school, and amateur events, including open spaces, enclosed structures, and parking lots. The policy must be posted at every entrance and in dugouts, bullpens, training rooms, locker rooms, press boxes, and restrooms. Those who violate the law face a $250 fine per offense.

Los Angeles is also preparing legislation that would prohibit smokeless tobacco from amateur and professional sports venues.

(Not a) Surprise! Kids favor flavored tobacco products

CDC publishes new data from 2014 National Youth Tobacco Survey showing youth also using multiple products, increasing risk of addiction

In 2014, an estimated 4.6 million middle and high school students reported current use of tobacco products (within the last 30 days). Over three and a quarter million of those students (70%) reported using at least one flavored product in the last 30 days. These products were most often e-cigarettes (1.58 million), followed closely by flavored hookah tobacco (1.02 million) and flavored cigars (910,000). Additionally, 900,000 students reported using menthol cigarettes. The popularity of flavored products among so many different types of tobacco products strongly suggests flavorings are attractive to youth.

The 2014 data also indicate that high school students using smokeless tobacco products were most likely to frequently use tobacco (≥ 20 days during the preceding 30 days) (42%), followed by cigarette smokers (31.6%), e-cigarette users (15.5%) and cigar smokers (13.1%). (A similar pattern was found among middle school students). Students also reported a high level of multiple tobacco product use, even among those infrequently using tobacco products (1-5 days of the preceding 30 days). More than 77.3% of cigar smokers, 76.3% of cigarette smokers, 63% of smokeless tobacco users and nearly 55% of e-cigarette users reported using 2 or more types of tobacco products. This is particularly concerning because reported symptoms of dependence are 2-3 times higher among multiple-product users than for single product users.

The 2014 data should concern policymakers and inform new tobacco controls. We know that early age of initiation and progression to regular use of tobacco products is associated with heavier use, long-term use and greater difficulty quitting. Moreover, use of multiple products increases user exposure to nicotine and other harmful constituents of tobacco products. Informed by this new evidence that flavored products are attractive to youth (particularly when considered with previous studies indicating the same), and that even those youth experimenting with tobacco (infrequent users) are using multiple tobacco products, increasing their risk of addiction, state and local governments should implement tobacco controls known to prevent youth initiation at more effective levels. Policies such as those increasing the price of tobacco products, reducing exposure to retail tobacco marketing, increasing the age of access to tobacco and restricting the sale of flavored tobacco products will reduce youth initiation and progression to daily tobacco use.

Smoking rates in New York City at record low

Smoking rate fell to 13.9% in 2014

According to the latest Community Health Survey, the number of New York City residents who smoke has dropped to 13.9%, the lowest rate on record. The result is a significant reversal of the 2013 rates, which had spiked to 16.1%, the highest since 2007.The decrease follows closely behind the announcement that the smoking rate across the state is also at its lowest on record at 14.5%.

City officials attribute the reduced smoking rates to a decade’s worth of efforts. During that time, New York City has prioritized tobacco control and implemented significant policy changes. Those changes include cigarette excise tax increases, restrictions on tobacco price discounting and the sale of flavored tobacco products, smoke-free outdoor air policies, graphic anti-smoking media campaigns and an increase in the minimum age to access tobacco products from 18 to 21. City officials are confident the numbers will continue to decline since the more recent policies (restrictions on price discounting and raising the minimum age of legal tobacco access) were implemented only recently, and are not reflected in the 2014 numbers.

Smoking rates did not decline equitably across age groups. While the percentage of young adult smokers ages 18-24 (who typically have the highest smoking rates) has remained relatively unchanged over the last few years, the percentage of adult smokers (25-to-44 year olds) who smoke dropped from 19.4% in 2013 to 16.1% in 2014. The percentage of adults ages 45-64 also decreased from 17.6% in 2013 to 14.8% in 2014. Additionally, disparities in smoking prevalence exist and persist by education level (those with less than a college education smoke at far higher rates than those with a college education or more), gender (men smoke at higher rates than women), and household income (smoking rates are higher among those in the lowest income category compared with the highest income category).

The Community Health Survey is a cross-sectional telephone survey that gives a comprehensive look at the health of adult New Yorkers. Approximately 8,500 randomly selected adults aged 18 and older from all five boroughs of New York City are annually sampled. Interviews are conducted over landline and cell phones in four languages. Community Health Survey results are analyzed and disseminated in order to track the health of New Yorkers, inform health program decisions, and contribute to the understanding of the relationship between health behavior and health status.

FDA taking new approach to reach youth with anti-smoking message

“Fresh Empire” uses hip-hop stylings to persuade youth not to smoke

The FDA is launching a new $128 million anti-smoking campaign aimed at preventing youth from smoking. Research indicates that teens who identify with the hip hop culture are more likely to smoke than their peers. While the ads formally began in the spring in a limited market, the “Fresh Empire” ads entered its next phase and aired during the BET awards on October 13th.

“Unfortunately, the health burdens of tobacco use disproportionately affect minority teens – particularly African American and Hispanic youth,” said Dr. Jonca Bull, the FDA’s Assistant Commissioner for Minority Health in a statement. “The ‘Fresh Empire’ campaign will help reach teens at a key point in their lives when experimenting with smoking can lead to addiction.”

“We know from our research that remaining in control is an important pillar of hip-hop culture. But smoking represents a loss of control, so tobacco use is actually in conflict with that priority,” Mitch Zeller, director of the FDA’s Center for Tobacco Products said in a statement. “The ‘Fresh Empire’ campaign underscores that important message to hip-hop youth, empowering this at-risk peer crowd to live tobacco free.”

The ads, which can be viewed here, will continue to run for the next two years in 36 major markets.

The Policy Center gets a makeover

We are now the Public Health and Tobacco Policy Center

As contractors have noticed, the Policy Center has undergone a few changes. Notably, the Center’s name has evolved to emphasize our focus on Public Health and Tobacco Policy. Additionally, the Center’s logo has been updated to reflect our new affiliation with the Public Health Advocacy Institute at Northeastern University School of Law. Over time, our resources will be modified to reflect the Center’s new branding; new resources already reflect our current name and logo.

Our changes are largely cosmetic—the Center continues to provide superior policy support services for New York tobacco control staff and contractors. Headed by Ilana Knopf and assisted by Kerry Snyder, the Center is available to provide technical assistance to contractors and the communities with whom they work. Please visit our recently refreshed website and browse our on-line library of New York-tailored public health policy resources! We are located at www.tobaccopolicycenter.org.