On September 10, 2019, the Food and Drug Administration (FDA) issued a warning letter to Juul asserting that the vaping manufacturer had violated federal law by illegally marketing its e-cigarettes as safer than other products. Citing evidence uncovered at a July 2019 House Subcommittee hearing as well as industry documents, FDA claims that Juul marketed its products as modified-risk tobacco products (MRTPs) without an FDA order allowing the product to be marketed as such. Therefore, FDA concluded, Juul’s products are adulterated.
At first blush, this seems like a heavy-hitting letter. FDA warning letters are an effective enforcement tool because they intimidate regulated entities and carry the threat of further enforcement. FDA likely hopes Juul will bring itself into compliance with federal law by ceasing to market its products as lower-risk.
However, enforcement letters carry no legal weight in and of themselves. Should Juul continue to market its products as lower-risk, there may be a long legal battle implicating the First Amendment.
Just last year, one in five high school students and one in 20 middle school students across the country used electronic cigarettes (e-cigarettes). According to the 2018 National Youth Tobacco Survey, more than 3.6 million middle and high school students used electronic cigarettes, more than double the number of youth using e-cigarettes in 2017. This increase is concerning given what is known about the adverse health effects of e-cigarettes. Recent research shows that nicotine has a negative effect on the developing brain. Other chemicals found in e-cigarettes are toxic to cells and have been linked to cardiovascular and lung diseases, including cancer.
Diverse strategies have emerged to curb the youth e-cigarette epidemic, including million-dollar campaigns from CVS Health and school policies implementing random nicotine testing. Most notable is the recent ordinance passed by San Francisco, the first city to institute a large-scale sales restriction. The city-wide ban prevents residents from purchasing any e-cigarettes in stores or online until products have undergone a premarket review by the U.S. Food and Drug Administration (FDA). The ban is motivated in part to decrease youth access to e-cigarettes. From 2016 to 2017, current e-cigarette use among California high school students increased from 8.6% to 10.9%, according to the California Student Tobacco Survey.The San Francisco ban is not the first law implemented to impact youth access to e-cigarettes. California state law sets various online purchasing requirements for e-cigarettes: online purchasers must provide proof of age, distributors must deliver to verified mailing addresses, and online purchaser age must be verified by a third-party service. These laws were in place in 2016 and 2017, but it is unclear whether these state laws had any impact on the 2.3% increase in youth vaping because, problematically, there is no current research exploring the link between the laws and youth e-cigarette use.
Since their introduction to the United States market in 2006, electronic cigarettes (e-cigarettes) have quickly transformed from a novelty product into a widely used device for the delivery of nicotine and flavored vapors. In 2017, a nationally representative study found that 35.8% of high school seniors reported trying “vaping,” or using e-cigarettes, in comparison to the 26.6% who reported their use of traditional, combustible cigarettes. The study also found that 18.5% of eighth graders reported trying vaping. Youth acceptance of vaping has concerned public health advocates, who worry that the impacts of the successful campaign against tobacco could be reversed if vaping makes young people more likely to initiate smoking.
As of August 1, 2017, 49 states, the District of Columbia, and U.S. federal law regulate e-cigarettes. The Center for Public Health Law Research has released a new dataset analyzing laws controlling electronic cigarettes now available on LawAtlas.org, the Policy Surveillance Program’s website dedicated to empirical legal datasets. This research reveals several important decisions that states make when regulating e-cigarettes.
First is whether e-cigarettes are regulated in the same way as traditional tobacco products. Incorporating e-cigarettes into the existing definition of “tobacco products,” is a common practice. As of August 1, 2017, 11 states and the District of Columbia consider e-cigarettes to be a tobacco product. Additionally, 12 states, the District of Columbia, and U.S. federal law also regulate e-cigarettes similarly to traditional cigarettes by including the use of e-cigarettes in their definition of smoking. This often places e-cigarettes under the control of state clean indoor air acts, which restrict the use of e-cigarettes in the same areas where smoking traditional cigarettes is prohibited.
Another important legal distinction is whether e-cigarettes must contain nicotine. Eleven states and U.S. federal law require an e-cigarette to contain nicotine in order to be legally defined as an e-cigarette. Some e-cigarettes only deliver flavored vapor and do not deliver nicotine. Therefore, definitions of e-cigarettes that require nicotine content do not regulate e-cigarettes that only deliver flavoring. While flavorings may not contain addictive chemicals like nicotine, studies have shown that certain flavoring chemicals can produce harmful reactions in users’ lungs.
The dataset also captures requirements related to online purchasing and product packaging, including child-resistant packaging and nicotine concentration labeling requirements. Child-resistant packaging is important because the nicotine concentrations in the “e-liquids” vaporized by e-cigarettes are high enough to cause nicotine poisoning if ingested or even if touched. Further, online purchasing requirements are important because many e-cigarettes are purchased online and can be shipped to underage users illegally if website vendors are not scrupulous in their screening practices. As of August 1, 2017, 12 states require age verification by a third-party service for online purchases of e-cigarettes.
As medical and scientific researchers continue to publish studies on the potential public health impacts of e-cigarettes, the state regulatory landscape may evolve further. Although many studies conclude that e-cigarettes are less harmful than traditional cigarettes, their long-term effects are still unknown. To aid this research, the new policy surveillance Electronic Cigarette Laws data set serves as a resource for tracking the regulatory response of states as the consumption of e-cigarettes continues to expand.
March was an important month for tobacco control in the U.S. While historically less progressive than other countries in regulating tobacco products, three recent developments offer encouraging signs of change. They also remind us of the critical role that the U.S. Food & Drug Administration (FDA) plays in public health policymaking.
The Three ANPRMs
Last month, the FDA released three advanced notices of proposed rulemaking (ANPRM) on tobacco-related products. An ANPRM is a formal invitation for stakeholders to submit comments before a federal agency issues a proposed rule. In practical terms, an ANPRM enables stakeholders to weigh in on, and even potentially shape, a forthcoming policy by responding to specific issues for input.
Released on March 16, the first ANPRM addresses the development of a tobacco product standard for a maximum nicotine level in cigarettes. The FDA seeks comment on a number of policy design considerations including, among others: the merits of various maximum nicotine levels (e.g., 0.5mg nicotine/g); to which products a maximum nicotine level should apply (e.g., combusted cigarettes, cigars, pipe tobacco); and whether to use a stepped-down, or gradual, reduction in maximum nicotine levels.
Importantly, the FDA highlights factors that could reduce the benefits of a future policy and seeks comment on how to addresses them. For example, current smokers could switch to a tobacco product not covered under the policy or use that non-covered product in addition to the currently used (covered) product. Similarly, current smokers could increase the number of cigarettes smoked to maintain an equivalent level of nicotine overall. Read More
Loyola Chicago law professor Jordan Paradise joins us to discuss some of her recent work in life sciences law. Jordan’s recent interests span nanotechnology, synthetic biology, precision medicine, gene editing, and electronic cigarettes. Her publications have appeared in both peer-reviewed and legal publications.
We start with a review of some of the regulatory issues involving e-cigarettes, and discuss the 2016 FDA regulations. We then move into a discussion of FDA regulation of biologics and biosimilars and Jordan explains naming and substitution issues.
The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw
Last week, the American Academy of Pediatrics publicly joined the group of advocates for federal regulations on e-cigarettes. The AAP urged the government to ban the sale of e-cigarettes to everyone under age 21 and prohibit advertising to minors, and advocated for high taxes on e-cigarette products similar to those on other tobacco products. In its announcement, the AAP cited developing brains’ vulnerability to nicotine and the potential harms to long-term health as reasons for its recommendations to keep e-cigarettes away from youths. It also recommended that smoke-free laws governing secondhand smoke explicitly include e-cigarettes, saying, “[t]he aerosol emitted from e-cigarettes is not harmless; it contains a variety of toxic chemicals, including some carcinogens and significant amounts of nicotine.”
A recently released poll found that a majority of Americans (57%) believe e-cigarettes should be regulated like tobacco products, while less than 25% of respondents felt they should not be. The Food and Drug Administration proposed e-cigarette regulations in 2014, and recently sent the regulations to the Office of Management and Budget for review. While the final form of the regulations is still unknown, the proposal banned the sale of e-cigarettes to minors and required e-cigarette labels include a list of ingredients and a disclosure that they contain nicotine.
There is growing concern about the potential health risks posed by e-cigarettes. Advocates for restrictions on e-cigarettes have long warned that unregulated e-cigarettes frequently expose users to the harmful effects of nicotine, as well as toxic chemicals such as formaldehyde, benzene, and other carcinogens. There have also been warnings about the risk that e-cigarette use may lead to greater social acceptance of smoking and higher rates of tobacco use. (Despite frequent claims that e-cigarettes may help with smoking cessation, longitudinal studies consistently find no evidence that e-cigarette use increases quitting rates.) Anecdotal evidence has linked e-cigarette use to pneumonia and other lung problems. Forty percent of e-cigarette users reported having health concerns about their use.
In 2006, Nobleza Piccardo, a main tobacco company in Argentina, had filed a claimed against the government of the Province of Santa Fe because a law sanctioned by the Provintial Congress completely banned the advertising and promotion of tobacco products in the Province (Santa Fe is one of the main Provinces of Argentina). Nobleza Piccardo argued that those restrictions infringed upon free speech and upon commercial freedom. It also claimed that, under the Argentine National Constitution, the Province is not allowed to pass legislation of that kind because the National Congress had already passed law 23.344, which regulated tobacco advertising (but did not ban it); once National Congress did so, Provintial Congresses cannot further legislate on the issue.
In its October 27 ruling, the Supreme Court held that nothing in the National Constitution provides National Congress with an exclusive power to legislate on health matters. Furthermore, Provintial legislation may complement federal legislation on the matter.
On the free speech and commercial freedom argument, the Court held that there is a tendency in other jurisdictions to restrict or even completely ban tobacco advertising. According to the Court, the restrictions established by the law are justified because they are proportionate to the public health concerns it wants to address; in addition, they follow internationallly accepted standards on the matter.
In his vote, Judge Lorenzetti, President of the Supreme Court, wrote that restricting tobacco advertising does not infringe upon free speech because tobacco advertising is not related to the working of republican and democratic institutions. Thus, Lorenzetti says, it would be wrong to analyze the restrictions established by the provintial law with the strict scrutiny test used in free speech cases. This claim, of course, is very important and will deserve much more discussion by the Supreme Court in future decisions. But the main teaching of the case is that, for the first time, the Supreme Court clearly states that tobacco control measures are a matter of human rights. This is, no doubt, a very important step.
Last week, the New England Journal of Medicine published a study finding that smokers using reduced nicotine cigarettes smoked 30% fewer cigarettes and had reduced cravings at the end of the study compared to smokers using standard cigarettes. The lower-nicotine cigarettes had 0.4 mg of nicotine/gram compared to 15.8 mg of nicotine/gram for the standard cigarettes. Commentators were quick to point out that such studies could provide the evidence FDA needs to establish new nicotine standards for combustible cigarettes.
FDA has explicit authority from Congress to set low nicotine standards for cigarettes. The Family Smoking Prevent and Tobacco Control Act (FSPTCA) allows FDA to set “tobacco product standards,” including provisions for “nicotine yields of the product” where such standards are “appropriate for the protection of public health.” With a mountain of evidence showing that combustible cigarette addiction can lead to cancer, heart disease, and death, FDA should have no problem proving that nicotine standards for combustible cigarettes are appropriate.
FDA may have a harder task trying to show that nicotine reduction standards for other tobacco products are “appropriate for the protection of public health.” As one commentator noted, if the nicotine in combustible cigarettes declines, addicted smokers might switch to other nicotine-containing products, including smokeless-tobacco products, e-cigarettes, and e-pipes. Currently, no study has conclusively shown that smokeless tobacco products are safe or unsafe. Some studies suggest that smokeless tobacco products may lead to smoking later in life, while other studies show that smokeless tobacco may be helpful for smokers hoping to quit.
Some of the behavioral changes that the Affordable Care Act seeks to bring about are prompted directly by the Act or a federal agency acting pursuant to the Act. The “individual mandate” that people buy health insurance is one example; individuals who do not change their behavior to comply with that particular provision of the law are subject to a tax penalty imposed by the IRS.
But much of the work of the ACA is done through regulatory intermediaries that are themselves incentivized by the Act to find ways to bring about the end-user behavioral changes that the ACA is really after. Medicaid expansion is a straightforward example–under the ACA the federal government does not provide insurance coverage to those who make less than 133% of the federal poverty line, rather, it incentivizes states to do so. Accountable Care Organizations are another somewhat more roundabout example: the Act incentivizes doctors to form organizations that will themselves incentivize doctors to coordinate care and patients to obtain more value-maximizing services.
Like any principal-agent relationship, regulating through an intermediary has benefits and costs. The intermediary (state, employer, insurer, doctor, etc.) may be differently positioned than the federal government to obtain information about, and influence the behavior of, the actors whose collective behavior we ultimately care about, for better or worse. And certain intermediaries may be differently responsive to the concerns of those impacted by the policies they enact than the federal government, again for better or worse. Read More
The Food and Drug Law Journal is pleased to announce a forthcoming symposium—Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics, and Tobacco Products—to be held at the Georgetown University Law Center (GULC) on Friday, October 30, 2015, and co-sponsored by the Food and Drug Law Institute and GULC’s O’Neill Institute for National and Global Health Law.