FDA Says Graphic Warnings Won’t Be Ready Before 2021
Expedited schedule provided in response to District Court ruling in Massachusetts On September 5, 2018, a federal District Court in Massachusetts ordered FDA to provide an expedited schedule to comply with the 2009 Family Smoking Prevention and Tobacco Control Act’s mandate to implement a rule requiring graphic health warnings on packages of tobacco products. The agency responded with an expedited schedule, stating in court documents that the agency anticipates adopting new labels in May of 2021. Before implementing a final rule requiring the warnings, FDA must first complete “outstanding studies, the publication of the proposed graphic warnings rule for public comment, [and] review of public comments,” as described by the Court. Public health advocacy groups had brought this suit in 2013, claiming the FDA impermissibly delayed rulemaking, to the detriment of public health. Researchers in 2013 found that had the U.S. implemented graphic warnings in 2012, the number of adult smokers could have decreased by 5.3-8.6 million in 2013. A recent report found that 118 other countries, home to more than half of the global population, require pictorial health warnings. The FDA may appeal the trial court’s ruling, and tobacco companies and others will inevitably challenge and thus delay implementation of the final warnings issued by the agency.
Non-Tobacco Hookah Bars in NYC Prepare for New Regulations
Amendments to the City’s Smoke-Free Air Act will go into effect on October 22, 2018 Under a 2017 change to New York City’s Smoke-Free Air Act, business establishments that wish to continue selling non-tobacco shisha must register with and obtain a permit from the Health Department by October 22, 2018. Non-tobacco shisha is a blend of herbs that does not contain tobacco or nicotine and is used in the same manner as tobacco-shisha; use of the product poses a health risk to consumers and those exposed to its emissions. Unacceptably, shisha that is marketed and sold as non-tobacco has been found to contain tobacco or nicotine. Businesses are eligible to apply only if already in operation by October 16, 2017, and if more than half of their revenue comes from the sale of smoking products. A business obtaining a permit will need to post health warnings and restrict entry to adults age 21 and older. The non-tobacco hookah bars must also comply with age verification requirements and health regulations regarding the sanitization of hookah pipes. Notably, permitted businesses are allowed to sell herbal shisha that contains characterizing flavors such as fruit, chocolate, menthol (mint), or other spices. The Smoke-Free Air Act amendments will prevent youth smoking initiation and protect public health. The City estimates that 5.6 percent of middle school students and 16.4 percent of high school students have experimented with hookah smoking. Hookah smoking, whether or not the shisha contains nicotine, exposes the user to carbon monoxide and other toxic chemicals known to increase the risks of some cancers, heart disease, and lung disease.
Forced to Grapple with Youth Vaping Epidemic, FDA Reconsiders Regulatory Approach to E-cigarettes
In an apparent shift, the agency steps up enforcement activity and threatens to reconsider premarket review deadlines In light of rapidly rising youth use of flavored vapor products, the U.S. Food and Drug Administration (FDA) is stepping up enforcement actions against both online and brick-and-mortar retailers that have illegally sold e-cigarettes to youth. Moreover, the agency recently announced that JUUL and other major e-cigarette manufacturers have 60 days to submit youth prevention plans to the agency, or face formal FDA product review before permissibly re-entering the market. Previously, FDA had extended the compliance date for e-cigarette manufacturer submission of applications to bring new tobacco products to market to August 8, 2022. The agency extended the deadline for premarket applications in part to allow for continued rapid innovation of this new class of products, positing that design improvements would promote significant migration of adult smokers to non-combustible products. Unfortunately, the inadvertent (albeit predictable) outcome has been ballooning youth interest in vapor products and a wave of teenagers addicted to nicotine. Now, in an apparent turnaround of the agency’s regulatory approach, FDA is “seriously reconsidering” earlier compliance dates for the submission of product applications. Yet this turning point will only be realized if FDA follows up with regulatory action requiring immediate review of products that have recently entered the market, including those that were introduced after the cutoff date of August 8, 2016. “We’re especially focused on the flavored e-cigarettes.” said FDA Commissioner Scott Gottlieb. “And we’re seriously considering a policy change that would lead to the immediate removal of these flavored products from the market.” Meanwhile, the market is awash with unregulated e-cigarettes, and health authorities are raising the alarm as youth e-cigarette use continues to surge. It remains to be seen whether the agency chooses to promulgate timely rules and regulations, and whether any rule will be sufficiently impactful to reverse the trend of rising youth e-cigarette use.
Closer Look: NYC Tobacco-Free Pharmacies Policy Will Reduce Retail Density
In the short term, the policy may also widen disparities in retail density between neighborhoods In 2017, New York City passed a comprehensive package of tobacco controls designed to reduce the availability and accessibility of tobacco products and promote health equity. Effective January 1, 2019, one of those policies prohibits stores that contain a pharmacy from obtaining a retail dealer license to sell tobacco products in the City. Tobacco-free pharmacy policies eliminate an incongruent health message sent by a healthcare resource offering tobacco products for sale, and promote a community tobacco-free norm. Further, by reducing the density of stores selling tobacco products, tobacco-free pharmacy policies may thereby reduce availability and visibility of tobacco products, which are factors impelling use. A recent evaluation of the density of tobacco retailers by New York City neighborhood shows that the City’s tobacco-free pharmacy policy is expected to reduce overall density by 6.8 percent. The researchers then assessed how the policy might affect neighborhood-level differences in retail density by calculating changes in the number of store per 1,000 residents in each neighborhood. The authors found that the tobacco-free pharmacy law, evaluated as a standalone policy, may widen neighborhood-level disparities in tobacco retail density in the short term. In other words, neighborhoods with higher income levels, greater educational attainment, and more non-Hispanic white residents are likely to benefit more immediately from the tobacco-free pharmacy policy in New York City. Yet these disparities may narrow over the long term, as the tobacco-free pharmacy policy prevents tobacco sales by newly opened stores. In the case of New York City, additional concurrently-enacted retail policies will also influence the differences in retail density by community district, with potential health equity effects. For instance, community district retail caps will halve the number of tobacco retailers in each district, as compared to the baseline number of retailers after the pharmacy retailers are removed. The bottom line is that tobacco products do not belong in pharmacies. Overall, fewer stores selling tobacco is beneficial to public health, especially among those most burdened by tobacco use—and removing tobacco sales from pharmacies is one way to achieve lower tobacco retail density and alleviate health disparities.
Big Tobacco Targets Teens Through Social Media
Paid marketing content on social media does not follow FTC guidance for endorsements A two-year investigation by the Campaign for Tobacco-Free Kids concluded that tobacco companies’ social media campaigns violate Federal Trade Commission guidance. In partnership with other public health advocacy groups, Campaign petitioned the FTC to issue an order requiring tobacco companies to disclose their paid content on social media platforms. Petitioners request that tobacco companies clearly indicate their paid content with visible hashtags on pictures and videos, such as #sponsored, #promotion, or #ad. Tobacco company social media marketing “is a really effective way to get around existing laws to restrict advertising to young people,” says Robert V. Kozinets of the University of Southern California, who led the research. “The most surprising thing to me was the level of sophistication of these different global networks. You get incredible campaigns, the likes of which I’ve never seen before.” The investigation revealed tobacco industry tactics in recruiting social media influencers with a large number of existing followers, organizing events and contests designed to coordinate with their social media campaigns, and instructing influencers to use specific hashtags. The investigation conducted interviews with influencers and reviewed documents, finding that in some cases, tobacco companies instructed influencers to cover up required health warnings.
New York Lawsuit Seeks to Block Smoke-Free Public Housing Rule
Public housing residents sue the U.S. Department of Housing and Urban Development On July 23, 2018, N.Y.C. Citizens Lobbying Against Smoker Harassment (“CLASH,” a smokers’ rights organization) and six public housing residents brought suit against the U.S. Department of Housing and Urban Development (HUD), challenging the agency’s final rule prohibiting tobacco use in public housing agencies. The final rule took effect on July 30, 2018, and is expected to protect more than 400,000 New York City residents from exposure to secondhand smoke. Plaintiffs claim that the HUD rule violates several constitutional rights of public housing tenants, including by allegedly authorizing PHA staff members to enter a resident’s unit to conduct an investigation into suspected use of tobacco, by depriving tenants from engaging in a lawful activity within their homes, and by requiring state PHAs to implement and enforce a federal policy. Plaintiffs request the court vacate the HUD rule, or in the alternative, modify the Rule so as to remove the prohibition on the use of tobacco products in individual housing units. According to the final rule, PHA policies must prohibit the use of combustible tobacco products in (and within 25 feet of) all public housing living units and common areas, as well as PHA administrative office buildings. Read more our litigation summary about this case here.
Massachusetts is the First State to Prohibit Pharmacy Sales of Tobacco
New law includes electronic cigarettes and vaping products Building on the momentum of local tobacco controls, Massachusetts became the first state to enact a state-wide prohibition on the sale of tobacco products in pharmacies and health care institutions, and the sixth state to raise the Minimum Legal Sales Age for tobacco products to 21. Pharmacy and health care institution sales of tobacco products send an incongruent message, and normalize tobacco sales and use. Prohibiting tobacco sales in pharmacies is an effective way to reduce tobacco retailer density, limit exposure to harmful tobacco marketing, and encourage cessation among current tobacco users. The new law applies to all tobacco products, including electronic cigarettes. Local jurisdictions are often workshops for progressive tobacco controls, and may drive momentum towards statewide action. Such was the case in Massachusetts—more than 160 cities and towns passed similar local laws in the decade preceding the statewide tobacco-free pharmacy law. To learn more about tobacco-free pharmacy laws and the local level, see our Tobacco Retail Licensing technical report.
Changes to Policy Center Website
We recently made some changes to our website! The new version of our website organizes Center publications by topical category, providing additional search tools that retain the ability to search publications by resource type. Our hope is that the new design will better showcase the publications available in each of our Tobacco Control and Chronic Disease subcategories, and that publications will be easier to find. Please also see our newly organized pages summarizing Tobacco Litigation. Please let us know if you have any questions or feedback regarding the website changes by emailing email@example.com. Thank you!