March 2017 Newsletter

FDA Proposes a Product Standard for Smokeless Tobacco
Cigar Industry Continues to Challenge Federal Deeming Rule
Point of Sale Policies Taking Off in New York
Public Housing Is about to Get Healthier
Industry Obstructionism Continues
New York City Vindicated in Smoke Free Air Act Amendment
A Closer Look: Marketing Restrictions and the First Amendment
Neighborhood Conversations Highlight Tobacco Marketing Disparities
Youth Smoking at Record Low
Turning Back the Clock on FDA Regulation

FDA Proposes a Product Standard for Smokeless Tobacco

Public comments can be submitted until April 10, 2017

In a first for the federal Food and Drug Administration (FDA), a proposed rule seeks to limit the amount of N-nitrosonorcinotine (NNN), which is a carcinogen found in smokeless tobacco products. The Family Smoking and Tobacco Prevention Act of 2009 grants FDA the authority to regulate the ingredients and constituents of tobacco products, and this is the agency’s first attempt to do so.

Smokeless tobacco products contain varying levels of NNN, but those that have higher levels are associated with higher risk of cancers. FDA estimates that 12,700 new cases of oral cancer could be prevented by the proposed rules, and that 2,200 deaths from oral cancer could be avoided in the next 20 years. Economic benefits of the proposed standard (estimated to include $228.66 million to $2.46 billion in gains from reduced oral cancer mortality) far outweigh the costs of compliance (estimated to be between $17.91 million and $42.72 million); and the benefits are likely to be underestimated.

Rulemaking is a participatory process, and you have the power to make your voice heard on the issues you care about through public comments. For this proposed rule, comments are due by April 10, 2017. Unlike petitions, pledges, or other calls to action, each public comment must be reviewed during the rulemaking process. Public comments should include evidence and data supporting your position, which may be experiential and may draw on your personal knowledge. For more information about how to submit comments in response to proposed agency rules, see our publication Participatory Rulemaking.

Cigar Industry Continues to Challenge Federal Deeming Rule

Lobbying groups file suit and push legislation in Congress

Three lobbying groups representing major cigar companies jointly sued the Food & Drug Administration (FDA), challenging the agency’s authority to regulate cigars. The plaintiffs—Cigar Association of America, International Premium Cigar and Pipe Retailers Association, and Cigar Rights of America—take issue with FDA’s analysis of the cost to business of its rule “deeming” cigars to fall under its regulatory authority. They also challenge the rule’s grandfather date, health warnings, and regulation of pipes as “components” of tobacco products, among other things.

On February 13, 2017, the plaintiffs filed a Motion for Summary Judgment asking the court to immediately rule in their favor. Should the plaintiffs prevail, FDA would continue to enforce all other parts of the rule even if a court were to grant injunctive relief for one specific part (i.e. cigars only).

This litigation isn’t the cigar industry’s only strategy to avoid regulation. A budget rider introduced by Representative Bill Posey on January 13th (H.R. 564) would exempt large and premium cigars from FDA oversight, and could even allow exemptions for some flavored cigars. More than 40 public health organizations signed a letter opposing H.R. 564 urging that FDA should retain authority over all tobacco products, including cigars.

Point of Sale Policies Taking Off in New York

2017 is already a record-setting year for local tobacco sales regulation

After many years of tireless advocacy, local New York communities are appreciating the value of—and adopting–point of sale policies.

Rockland County is the first in the state to restrict pharmacies from selling tobacco products. Doing so will allow pharmacies to better align their mission as healthcare providers with their product availability, and will reduce smoking initiation by youth. Removing tobacco from pharmacies also helps current smokers who are trying to quit—removing a trigger when they seek cessation products and medications.

Orange County and North Hempstead, New York are the latest municipalities to raise the minimum legal sales age for tobacco to 21 years old. This policy delays and prevents youth smoking initiation by removing the most important source of tobacco for teens—their friends and acquaintances of legal age (the vast majority of whom are ages 18-21). Pressure is building to implement a state-wide Tobacco 21 law that would cover all residents of New York State.

The City of Buffalo, Town of Niskayuna, and the Village of Tannersville now regulate the location of tobacco outlets. Tannersville created a 1000 foot buffer zone around schools, in which no new tobacco retailer may locate. Buffalo recently updated its zoning law, or Green Code, to promote healthy communities; tobacco, hookah, and vaping products will not be sold by new retailers locating in any residential zones of the City. Niskayuna also updated its zoning code and prohibits new tobacco outlets from locating within 1000 feet of schools. Over time, as stores change ownership, stop selling tobacco, or close altogether, the overall retail density of tobacco outlets in each municipality will likely decrease. Lower tobacco retail density is good for public health—because reducing the outlet density reduces exposure to tobacco marketing, which is known to drive youth smoking initiation.

Public Housing Is about to Get Healthier

HUD smoking restrictions effective as of February 3, 2017

As we detailed in our last newsletter, the U.S. Department of Housing and Urban Development issued new rules prohibiting smoking of tobacco products in public housing complexes and administrative buildings, as well as within 25 feet of each building. The new restrictions do not apply to the use of e-cigarettes and similar devices but do apply to all lit tobacco products, such as cigarettes, cigars, pipes and hookah. The rule became effective on February 3, 2017, and local housing agencies have 18 months from that date to implement and begin enforcing the new federal smoking rule.

The new rule will have the biggest impact in New York State, home to the largest public housing agency in the country (New York City). The New York Times reported last year that the City’s housing agency “has lagged behind some of its smaller counterparts in adopting smoke-free policies.”

Industry obstructionism continues

Tobacco companies continue to fight court order to publish corrective statements following RICO case

Tobacco companies found to have violated the Racketeer Influenced and Corrupt Organizations (RICO) Act more than a decade ago continue to fight court-ordered remedies stemming from the case. In 2006, Senior U.S. District Judge Gladys Kessler found that the major tobacco companies violated the RICO Act by concealing known health risks of smoking from consumers. In 2012, Judge Kessler ordered companies to publish statements about the dangers associated with tobacco use. The statements are intended to “correct” false information perpetuated by the tobacco industry and comprise five categories, including: (1) Adverse Health Effects of Smoking; (2) Addictiveness of Smoking and Nicotine; (3) Lack of Significant Health Benefit from Smoking “Low Tar,” ”Light,” “Ultra Light,” “Mild,” and “Natural” Cigarettes; (4) Manipulation of Cigarette Design and Composition to Ensure Optimum Nicotine Delivery; and “Adverse Health Effects of Exposure to Secondhand Smoke.” Importantly, the statements have been approved by a federal appeals court.

At issue in the most recent challenge by tobacco companies is the preamble that must appear before each published statement. Specifically, each statement must be preceded by “A Federal Court has ordered Altria, R.J. Reynolds Tobacco, Lorillard, and Philip Morris USA to make this statement about the health effects of smoking. Here is the truth:”. According to a prior ruling by the appellate court, the statements must look to the future (to prevent future RICO violations) and not reference prior bad acts of the companies; tobacco companies argue that “Here is the truth” violates that ruling and references their prior attempts to mislead consumers.

The court heard arguments in early November 2016 on the issue of the preamble. For more information about the history of this litigation, see our summary.

New York City Vindicated in Smoke Free Air Act Amendment

Court finds city did not violate the state constitution in amendment process

Earlier this year, the New York Supreme Court’s Appellate Division agreed with a lower court’s dismissal of a challenge to New York City’s inclusion of e-cigarettes in its Smoke-Free Air Act. NYC Citizens Lobbying Against Smoker Harassment (C.L.A.S.H.) sued the city in 2014 alleging that including e-cigarettes into the Smoke-Free Air Act, which addresses the use of combustible tobacco, violated the “one-subject rule”-a state constitutional principle prohibiting the inclusion of different topics into the same bill or law. C.L.A.S.H. argued that including e-cigarettes changed the intent of the law, because e-cigarettes do not emit smoke.

The “one-subject rule” was added to the state constitution in 1846, after Aaron Burr included a clause authorizing him to found a bank within a charter application for a drinking water company. It is designed to prohibit deception in the legislative process—by publically describing a proposal as one thing, but including a very different subject within it.

The courts found that New York City’s Smoke-Free Air amendment was not deceptive because the devices are similar, and the clear intent of the bill was identified in its title “A Local Law to amend the administrative code … in relation to the regulation of electronic cigarettes.”

“The regulation of electronic cigarettes was the only subject of the bill and that subject was clearly stated in its title,” the ruling said. “Therefore, the bill met the transparency requirement of the one-subject rule and adequately apprised the City Council and members of the public of its contents and purpose.”

A Closer Look: Marketing Restrictions and the First Amendment

The evidence is clear: Tobacco marketing causes youth to begin using tobacco, and it undermines quit attempts by regular users. So why not simply prohibit the marketing altogether, rather than restricting tobacco sales? These questions frequently arise as we educate community members and decisionmakers about industry activity. While there’s no black and white answer, in a nutshell, we suggest local governments proceed with extreme caution when considering proposals to reduce exposure to tobacco marketing through direct marketing regulation.

Commercial Speech and the First Amendment

The First Amendment of the U.S. Constitution protects speech—but not all speech is protected equally. Commercial speech is the communication of information for economic reasons, including promotions and advertising intended to increase demand for consumer products. The degree to which such speech is protected by the First Amendment is subject to debate. When deciding whether a certain law violates the First Amendment’s commercial speech protections, the most commonly applied test is the four-pronged test developed in a case called Central Hudson (the “Central Hudson test”). Central Hudson Gas & Electric Corp. v. Pub. Serv. Comm’n of N.Y., 447 U.S. 557, 564 (1980).

What’s the test?

  1. Is the product legal? Is the communication not misleading?

This is the “threshold question” that must be addressed before considering whether commercial speech deserves First Amendment protection. While local governments do not have to concede this point, courts have held that tobacco advertising and promotion, despite its generally misleading character, meets this part of the test (although specific statements that are false or misleading may not be protected).

  1. Does the government have a good reason for adopting the speech restriction?

The court will evaluate whether the government has a “substantial interest” in adopting the law. Local governments have a long-recognized and substantial interest in protecting the health and safety of their residents, and therefore this prong of the test is easily met when the interest at stake is reducing tobacco use.

  1. Does the restriction directly advance the government’s interest?

This part of the test focuses on the effectiveness of the law in achieving the government’s substantial interest. Under this third prong, the government must show that the proposed law will have a “material” impact on the harm it seeks to address.

Recently, this prong has been more difficult for governments to meet. While courts have historically considered studies, reports, anecdotes (local and non-local), historical evidence, and even “common sense” when evaluating this part of the test, recent cases suggest the courts are looking for more substantial and direct evidence supporting the specific restriction adopted and its relationship to the specific desired outcome. For example, courts have not necessarily given adequate weight to evidence of such things as the impact of violent imagery on youth behavior to support the state’s interest in limiting youth exposure to such imagery. Thus, the substantial evidence upon which we rely concerning the impact of tobacco marketing on tobacco use may not be enough to convince every court.

  1. Could a more limited restriction not advance the government’s interest?

The government must balance its interest in protecting children and public health with the tobacco companies’ need to truthfully communicate about their products to adults. Courts generally prefer solutions that do not restrict commercial speech over those that do, and therefore they look for a relatively ‘tight fit” between a regulation and the harm being redressed.

In recent years, this prong too has become more difficult for governments to meet. While many lower courts look for a reasonable fit between the government’s regulation and goal, there is a trend of applying a heightened scrutiny, meaning a court may ask whether the speech restriction is the least restrictive means to accomplish the government’s goals.

While the Central Hudson test is still the black letter law (i.e., the test applied to commercial speech regulations), a recent decision may have added an additional element to this test: a commercial speech regulation may not restrict “disfavored speech by disfavored speakers.” Sorrell v. IMS Health, 564 U.S. 552 (2011). It’s unclear how the Sorrell decision will affect tobacco advertising regulations, but it is clear that regulating commercial speech is more challenging now than ever before. Indeed, as a matter of Supreme Court precedent, it is not even clear whether strict scrutiny (the highest level of judicial review) or Central Hudson’s intermediate-scrutiny-plus now applies to commercial speech regulation.

In sum, recent case law has created some confusion and concern about how courts will apply the Central Hudson test to a direct regulation of tobacco marketing, and what evidence will be persuasive in demonstrating that the regulation directly advances the government’s interest in safeguarding public health. The totality of recent First Amendment litigation indicates the current climate of the court is unfriendly—even antagonistic—toward commercial speech restrictions. State and local governments proposing to reduce residents’ exposure to tobacco marketing should approach direct advertising regulation with extreme caution, particularly since there are other means to reduce such exposure through policies that do not implicate the First Amendment.

Neighborhood Conversations Highlight Tobacco Marketing Disparities

Capital District Tobacco-Free Communities reports impact of retail environment and tobacco use on residents

Our friends over at Capital District Tobacco-Free Communities (CDTFC) recently reported their findings about the disparate impact of tobacco on Albany residents. The evidence collected highlights the tobacco industry’s influence on the community, and supports the need for policy change to reduce tobacco use and improve health equity.

CDTFC collected detailed information about tobacco marketing, product availability, and pricing in 37 tobacco retail outlets. They also facilitated “Neighborhood Conversations” with small groups of residents in the neighborhoods in which the most tobacco retailers were located. The goal was to obtain an accurate picture of the tobacco retail environment in neighborhoods with the highest poverty rates, and determine how this environment affected residents. CDTFC found that retailers in these neighborhoods dedicated significant space for display of inexpensive cigars and cigarillos and flavored products. Moreover, menthol products were heavily marketed, and deeply-discounted off-brand cigarettes were widely available in these stores. Staff also found that residents of these high-poverty neighborhoods are significantly affected by tobacco use, experiencing difficulty quitting and involuntary exposure to secondhand smoke in their homes.

Most of the participants in the Neighborhood Conversations expressed support for tobacco sales regulations, including regulating the number, location and type of outlets permitted to sell tobacco products. CDTFC has shared their findings with local policymakers who have the power to implement public health interventions to promote healthy communities for their constituents.

Youth Smoking at Record Low

E-cigarette popularity rising

There’s a reason New York is recognized as a leader in tobacco control. The Department of Health recently found that the high school smoking rate in 2016 was the lowest on record at 4.3 percent, down from 27.1 percent in 2000.

The Department’s survey also revealed, however, a sharp increase in e-cigarette use by high school students. 20.6 percent of those surveyed reported e-cigarette use, compared to 10.5 percent in 2014. This is of great concern; nicotine exposure during adolescence may have lasting adverse consequences for brain and cognitive development, can cause addiction, and may lead to sustained tobacco product use. In fact, adolescent e-cigarette use is associated with increased likelihood of cigarette initiation among never smokers and higher levels of cigarette use among youth who use both types of tobacco products.

E-cigarette marketing is contributing to the rapid rise in youth use. E-cigarette marketing is largely unrestricted, pervasive, and reminiscent of the heyday of unregulated cigarette marketing. In fact, e-cigarette marketers employ strategies similar to traditional cigarette companies –– marketing that ultimately proved to obscure the devastating health effects of cigarettes, target youth, and cause our young people to initiate tobacco use.

Fortunately, New York state and local policymakers can do something about this. Governor Cuomo included e-cigarette regulation in his 2018 budget proposal. Specifically, he has proposed restricting e-cigarette use through the New York State Clean Indoor Air Act, requiring e-cigarette retailers to register with the state’s Department of Taxation and Finance alongside all other tobacco retailers, and taxing e-liquids at $0.10 per milliliter.

For more information about what local communities can do to reduce the impact of e-cigarettes, see our technical report, Local Regulation of E-cigarettes.

Turning Back the Clock on FDA Regulation

Federal legislation would remove grandfather date for FDA deeming rule.

In a rare show of bipartisanism, Congressmen Tom Cole and Sanford Bishop in February re-filed legislation entitled, the “FDA Deeming Authority Clarification Act of 2017.” The bill aims to reverse Food and Drug Administration regulations as applied to products newly “deemed” to fall under the agency’s regulatory authority, including e-cigarettes, cigars and pipe tobacco.

In May 2016, the FDA published its final rule deeming all products meeting the definition of “tobacco products” to fall under the agency’s jurisdiction. A consequence of this determination is that products that were not on the market as of February 15, 2007 are considered to be new tobacco products and must comply with certain reporting requirements and apply for FDA authorization in order to remain on the market. Simply stated, if a new tobacco product is similar enough to a product on the market as of the 2007 “grandfather date,” the pathway to market may be easier; a manufacturer must demonstrate that the product is “substantially similar” to the older product. Otherwise, manufacturers must provide evidence that the new product will not negatively affect public health, among other requirements.

Of particular interest is the application of the rule to e-cigarettes and similar products, which were not widely available in the U.S. until 2009 (and products that are currently marketed are quite different from earlier devices). Thus, proponents of the newly refiled bill claim that the FDA rules harm public health by making it difficult for allegedly “reduced harm” products that could provide a path for smokers to reduce their reliance on cigarettes or quit altogether. It should be noted, however, that no e-cigarette or similar device has been authorized to market itself as a “reduced harm” product.

Opponents of the bill point out that changing the grandfather date would leave on the market products about which little is known. It also means that fruit- and candy-flavored e-liquids, popular among youth, would remain on the market without the appropriate review by the FDA. Youth use e-cigarettes more than any other tobacco product, and the products threaten to undermine the impressive declines in youth tobacco use over the last decade. The adolescent brain is uniquely vulnerable to the effects of nicotine and can become addicted at very low levels of exposure. Public health advocates are concerned that e-cigarettes may act as a “gateway” to use of conventional tobacco products.

It’s as yet unclear what momentum the bill will have given competing congressional priorities. Under an Administration pushing for fewer regulations, however, the legislation is definitely one to watch.