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Public Health Advocacy Institute

at Northeastern University School of Law

360 Huntington Avenue, 117CU

Boston, MA 02115

tobacco@tobaccopolicycenter.org

You are here: Home > About Us > Newsletters > May 2019 Newsletter

May 2019 Newsletter

New York State to Tax Vapor Products, Register Retail Dealers
New York State to Raise the Minimum Legal Sales Age for Tobacco Products to 21
Suffolk County to Prohibit Tobacco Sales at Pharmacies
San Francisco to Stay the Course, Further Restrict Tobacco Product Sales
Roundup: Tobacco Controls Currently Before Congress
IQOS Gets the Green Light from FDA
FDA Issues Draft Guidance Regarding Sales of Certain Flavored Tobacco Products
Public Health Advocacy Institute Prepares Class Action Lawsuit Against Juul
Federal Court Expedites Cigarette Health Warning Requirements
Why Aren’t We Seeing Health Warnings on Cigar Packages and Ads?

New York State to Tax Vapor Products, Register Retail Dealers

State lawmakers address key gaps in existing tobacco controls
Amid a growing public health crisis of youth e-cigarette use in New York State, the legislature agreed to Governor’s Cuomo’s budget proposal to tax the sale of vapor products at 20 percent. Vapor products are broadly defined to include any aerosol manufactured for use in an electronic cigarette or similar product, regardless of whether it contains nicotine. The new law is a fiscal and public health win: research shows that high tobacco product prices deter experimentation and promote cessation.

Further, retail dealers intending to sell vapor products in the state will be required to register with the New York State Department of Taxation and Finance. Retailers will need to annually register with the department, regardless of whether they are already registered to sell other tobacco products. The registration fee will be $300, in line with the fee for the tobacco dealer registration. This provision will allow local communities and agencies tasked with enforcing the state’s tobacco controls to identify and inspect these retailers—who until now have been flying under the radar.

According to a 50-state survey of e-cigarette regulations, two other states (Minnesota and Pennsylvania) impose a tax that varies by wholesale price, while several others impose a tax by volume of e-liquid.

New York State to Raise the Minimum Legal Sales Age for Tobacco Products to 21

New York is 13th state to raise the age
Building on the momentum of local laws throughout the state, New York’s legislature passed a bill raising the minimum legal sales age for tobacco products to 21. Local policies are in place in 16 counties, plus New York City, covering about three-quarters of the state’s population and active tobacco retailers. Governor Cuomo is expected to sign the bill.

The bill, once signed, will amend the state’s Adolescent Tobacco Use Prevention Act (ATUPA), which applies to all tobacco and nicotine products, in addition to herbal cigarettes and smoking paraphernalia. The existing law also restricts distribution of these products for no charge, a provision which will also be strengthened by the bill. Penalties for violating the law range from $300-$1000 for a first-time violation, with subsequent violations resulting in fines of up to $1,500 and potential suspension of the retailer’s registration to sell tobacco products.

State lawmakers can now turn their attention to addressing the root cause of youth tobacco use: ubiquitous tobacco marketing. To learn more about where youth are exposed to this marketing (hint: community stores!), and policy solutions to reduce exposure to tobacco marketing (hint: restrict tobacco sales!), visit our resources at www.tobaccopolicycenter.org.

Suffolk County to Prohibit Tobacco Sales at Pharmacies

Legislature acts to remove incongruent health messaging in the County’s retail environment
Following the lead of Rockland, Albany, and Erie Counties, in addition to New York City, Suffolk County recently became the fifth jurisdiction in New York State to prohibit tobacco sales by stores that contain a registered pharmacy. In finding that “selling tobacco products is directly at odds with a pharmacy’s mission as a health-oriented business,” the Legislature acknowledged the role of the retail environment in driving tobacco use.

Tobacco-free pharmacy laws reduce the density of tobacco outlets, which is known to be associated with higher tobacco use. Suffolk County has the highest number of pharmacies currently selling tobacco products of any county in the state. By our estimate, the new law will eliminate tobacco sales from nearly one hundred stores, reducing the County’s overall tobacco retail density by about 6.6 percent.

Effective this fall, the new law will apply to all tobacco products, including e-cigarettes, e-liquids, and smoking paraphernalia such as rolling papers. Tobacco users will still be able to access FDA-approved nicotine replacement therapies at pharmacies in the County. Violating the new law could trigger a $2,000 fine after appearing at a hearing before the Suffolk County Commissioner of the Department of Health Services.

San Francisco to Stay the Course, Further Restrict Tobacco Product Sales

Comprehensive proposals seek to reduce availability of e-cigarettes
On July 7, 2017, San Francisco became the first city to prohibit sales of all flavored tobacco products, including menthol cigarettes and all flavored e-cigarette products. Now, San Francisco looks to expand and clarify its sales policy. On March 19, 2019, the Board of Supervisors introduced a bill that would extend the flavor ban to online or mail-order sales.

Additionally, the bill prohibits the sale of e-cigarettes that do not have an approved marketing order from the FDA. As you’ll recall, the 2009 Tobacco Control Act requires a marketing order for the sale of “new tobacco products,” which includes all types of e-cigarettes. However, FDA is allowing e-cigarettes to be sold without a marketing order for the foreseeable future.

In a separate bill, the City seeks to clarify that an existing law prohibiting tobacco product sales on City property applies to e-cigarettes. The bill also prohibits the distribution or manufacture of tobacco products (including e-cigarettes) on City property. Notably, the bill would not apply retroactively, so would not affect Juul Labs Headquarters, which currently rents space from the Port of San Francisco. Both proposals are pending review by the San Francisco Board of Supervisors.

Roundup: Tobacco Controls Currently Before Congress

Bills range from Industry-friendly to comprehensive public health proposals
In response to epidemic levels of youth e-cigarette use, yet potentially tempered by Industry lobbying, members of Congress are working to introduce legislation to prevent tobacco use by adolescents. A number of bills seek to raise the sales age for tobacco products to 21 years nationwide. Others include restrictions on online sales and/or the use of flavors in tobacco products other than cigarettes. Here’s a summary of some of the key bills introduced this year in Congress:

  • R. 2084: Stopping Consumption of Tobacco by Teens “SCOTT” Act of 2019 would prohibit the sale of tobacco products to anyone under the age of 21 and require enhanced age verification for online sales of tobacco products, including e-cigarettes. It also includes a new definition of “vapor product” that would apply to heated cigarettes, allowing the tobacco industry to circumvent regulations that apply only to cigarettes with their newer heated cigarette products like IQOS.
  • R.7337: Stop Tobacco Sales to Youth Act of 2018, was introduced to amend the Prevent All Cigarette Trafficking (“PACT”) Act to include electronic cigarettes and pipe tobacco.
  • R. 2339: Reversing the Youth Tobacco Epidemic Act of 2019 would prohibit the sale of tobacco products to anyone under the age of 21; prohibit online sales of tobacco products; extend advertising restrictions that currently apply to cigarettes and smokeless tobacco to other tobacco products, including e-cigarettes; and require the FDA to issue a final rule to implement graphic health warnings on cigarette packs and advertising, as required by the 2009 Tobacco Control Act (this final rule has also recently been ordered to be completed by March 15, 2020, by a federal court in Massachusetts).
  • 1048: Preventing Opportunities for Teen E-Cigarette and TobaccoAddiction of 2019 would provide $100 million in annual funding to CDC for five years to prevent youth e-cigarette use through education and policy initiatives.
  • R.2411: Tobacco to 21 Act of 2019 would prohibit the sale of tobacco products to anyone under the age of 21. The bipartisan bill is free of special interest provisions that would benefit the tobacco industry, and is therefore supported by public health groups.
  • R.293: Youth Vaping Prevention Act of 2019 would seek to create tax parity between tobacco product categories and would prohibit the use of characterizing flavors (including menthol) in tobacco products other than cigarettes.

In addition to these bills, Senate Majority Leader Mitch McConnell plans to introduce a bill next month proposing to raise the minimum legal sales age for tobacco products to 21. Reporters and public health groups expect that the bill may include special interest provisions to benefit the tobacco industry, such as measures that block other kinds of effective tobacco controls and/or penalize youth. Health groups have released a model policy that reflects best practices for Tobacco 21, and experts suggest that when writing a federal proposal for raising the age, less is more.

IQOS Gets the Green Light from FDA

Marketing order is the agency’s first authorization of a new tobacco product
The FDA gave tobacco giant Philip Morris International (PMI) the green light to begin marketing its heated cigarette product, IQOS, in the United States. IQOS is a device that heats a tobacco stick, releasing a tobacco- or menthol-flavored emission that contains less toxins than the smoke from combusted cigarettes. The marketing order is especially noteworthy as it represents the agency’s first premarket authorization of any new tobacco product (i.e. one without an existing comparable “predicate” product serving as a baseline for evaluation).

According to FDA, the IQOS fits the federal definition of a cigarette, with important implications for restrictions on its marketing. Through the terms of the marketing order, the agency will require PMI to require that digital marketing for IQOS target adults, and that the company limit youth access to the product online. Analysts expect the product to be on the market in Atlanta, GA around July 2019 and that sales will rapidly expand throughout the U.S.

Importantly, the marketing order does not allow PMI to claim that the product is less risky than conventional cigarettes. FDA is still evaluating PMI’s separate application to market IQOS as a “modified risk tobacco product.” Finally, despite IQOS having been marketed in other countries to appeal to youth, FDA concluded that “[a]vailable data, while limited… indicate that few non-tobacco users would be likely to choose to start using IQOS, including youth.”

FDA Issues Draft Guidance Regarding Sales of Certain Flavored Tobacco Products

Guidance falls short of actions needed to reduce youth tobacco use and combat health disparities In March, FDA announced potential changes to the agency’s intended timeline for enforcing premarket review requirements for new tobacco products, by issuing draft guidance to the tobacco industry. As you’ll recall, the 2009 Tobacco Control Act requires a marketing order for the sale of “new tobacco products,” which includes e-cigarettes and cigars. However, to date FDA has allowed these products to be sold without a marketing order.

In light of an epidemic of youth e-cigarette use, largely driven by flavors, FDA seeks to begin limited enforcement of the marketing order requirement and remove some flavors of e-cigarettes and some flavored cigars from most retail channels accessible to youth. For example, FDA will prioritize stopping the sale of these products in outlets where minors may enter. Additionally, the guidance moves up by one year (to August 8, 2021) the date by which some of these product manufacturers must submit premarket review applications for agency evaluation.

In typical fashion, FDA’s proposal is a piecemeal approach to addressing a leading cause of preventable death and disease. Agency guidance is late to the problem, is not binding on manufacturers, and carves out exceptions that undermine its youth deterrence objective. Mint and menthol-flavored products will remain available in all retail channels, and there is no accompanying rule to also restrict the sale of “grandparented” products such as menthol cigarettes and smokeless tobacco. You can review submitted comments on Regulations.gov.

Public Health Advocacy Institute Prepares Class Action Lawsuit Against Juul

Lawsuit demands that Juul Labs fund treatment centers for nicotine-addicted youth
Public Health Advocacy Institute (PHAI)—with whom the Policy Center shares its home at Northeastern University School of Law—initiated a potential class action lawsuit against e-cigarette manufacturer Juul Labs. In a letter to Juul Labs, the nonprofit law group seeks relief for Massachusetts adolescents that became addicted to Juul Labs’ products before they were 18 years old. The group proposes that Juul fund a statewide clinical treatment program for addicted teens seeking to quit vaping nicotine.

“The goal of this lawsuit is to make sure that these kids and their parents in Massachusetts have a place to go to deal with this addiction,” says Mark Gottlieb, PHAI’s Executive Director. “Our non-profit law firm is taking on Juul Labs so that the company with the greatest responsibility for teenage addiction to e-cigarettes pays the cost for effective treatment for these young people.”

Federal Court Expedites Cigarette Health Warning Requirements

Massachusetts District Court agrees with public health advocates that FDA has lagged in its enforcement duties
A Massachusetts federal court handed public health advocates a victory in the fight for graphic health warnings on cigarettes, as it ordered the FDA to issue a final rule by March 15, 2020. The new order—in response to a lawsuit brought by health advocacy organizations and physicians against the FDA—will expedite the agency’s “unreasonably delayed” action on this issue.

The 2009 Tobacco Control Act mandated that tobacco companies display graphic warnings on cigarette packaging and ads, and FDA implemented a rule requiring these warnings in 2011. The cigarette graphic warning requirements were challenged by the tobacco industry in two separate federal court cases on grounds the requirements violated tobacco companies’ First Amendment rights. The courts reached opposing decisions in these cases. Instead of continuing to litigate, FDA announced in 2013 they would issue a new rule on cigarette warning label requirements.

Despite the agency having ample time to fulfill the requirements of the Tobacco Control Act by issuing a new rule, FDA did not act, leading to the 2016 lawsuit in the Massachusetts federal court. In requiring expedited agency action, the federal court recognizes both the expected benefits of graphic health warnings, and the FDA’s obligation under the Tobacco Control Act to issue a final rule. According to the new schedule, we should see a proposed rule by August 15, 2019 and final rule by March 15, 2020. The FDA has not appealed this decision.

Why Aren’t We Seeing Health Warnings on Cigar Packages and Ads?

Cigar companies continue to challenge required warnings
The FDA requires that health warnings be displayed on product packages and advertisements of all tobacco products. This includes cigars, which the agency began regulating only in 2016. Cigar manufacturers quickly challenged the law, arguing, in part, that the health warning requirement “violates the First Amendment for two reasons: (1) increasing the size of the new health warnings unconstitutionally restricts speech by “crowding out” manufacturers’ and retailers’ ability to communicate with consumers, and (2) requiring manufacturers and retailers to submit a warning rotation plan to the FDA before they can communicate with consumers constitutes an unconstitutional prior restraint on speech.”

In May 2018, D.C. District Court ruled against representatives of the cigar industry, concluding that health warnings required by FDA’s 2016 Deeming Rule are constitutional and comport with the requirements of the Tobacco Control Act. With this ruling, cigar manufacturers would have been required to place health warning labels on their product packaging by August 10, 2018. However, the court subsequently granted companies’ request to comply only after their appeal. This appeal was filed in D.C. Circuit Court on February 19, 2019 and will be likely heard later this year.

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