Yesterday, the Senate confirmed Dr. Robert Califf for his second, non-consecutive term as Commissioner of the U.S. Food and Drug Administration (FDA), bringing a drawn out and contentious process to a close. Califf will be the second-ever FDA Commissioner to serve non-consecutive terms, and the first to have been confirmed by the Senate on two separate occasions.
Prior to his first term as Commissioner during the Obama administration, Califf, a cardiologist, served as the FDA’s Deputy Commissioner for Medical Products and Tobacco.
In addition to fielding scrutiny over mifepristone access, reviewing opioid regulations, and handling COVID-19 vaccine and treatment approvals in the midst of a pandemic, Califf will be overseeing the FDA at a time when public health advocates are anticipating agency action on several tobacco issues.
Two major developments expected in this area include a menthol ban and greater regulation of e-cigarettes.
The latest attempt of the U.S. Food and Drug Administration (FDA) to make a dent in the country’s intractable tobacco problem is a set of color graphic warnings that will appear on cigarette packages and advertisements beginning in June of 2021.
The legal battle surrounding the graphic warnings and other attempts to regulate commercial speech in the food and drug context illustrate the courts’ enduring failure to appreciate the full extent and substantiality of the government’s interest in promoting public health.
The failure to control the COVID-19 pandemic in the United States rests, in part, on the individualist nature of our public health responses.
Public health simply does not work well when we base our interventions on the individual level. This is known as “methodological individualism,” and the evidence suggests it is both ineffective and can expand existing health inequalities. It is problematic in any public health context, but especially in pandemic response and control.
Take, for example, the ongoing debate over mask mandates. Multiple governors have refused to issue mask mandates, instead simply requesting that people don masks. The objection, interestingly, is not to the idea of masking as a public health intervention, but to the existence of a mandate itself.
Yet a model of public health which consists of nothing more than pleading with individuals to avoid behaving in ways injurious to public health would be an abject failure. Imagine if, instead of imposing minimum requirements for clean water, we simply asked regulated industries to avoid polluting watersheds. Or perhaps instead of passing laws discouraging or even criminalizing obviously harmful behavior, we simply asked people to avoid driving drunk.
The U.S. government has ratified a record-breaking $2 trillion stimulus package just as it has soared past 100,000 coronavirus cases and 1,500 deaths (as of March 27). The U.S. now has the most cases of any country—this despite undercounting due to continuing problems in testing Americans on account of various scientific and policy failures.
Coronavirus has scared Americans. Public health officials and physicians are urging people to stay at home because this disease kills. Many have invoked the language of war, implying a temporary battle against a foreign foe. This framing, though it may galvanize quick support, disregards our own systematic policy failures to prevent, test, and trace coronavirus, and the more general need to solve important policy problems.
Coronavirus is an acute problem at the individual level, but nationally it represents a chronic concern. No doubt, developing innovative ways to increase the number of ventilators, recruit health care workers, and improve hospital capacity will save lives in the short-term — despite mixed messages from the federal government. But a long-term perspective is needed to address the serious problems underlying our country’s systemic failures across public health.
The rules also could have reduced nicotine in cigarettes to non-addictive levels. Nicotine is the addicting substance largely responsible for continued smoking. If nicotine were “decoupled” from smoking, smokers might turn to other sources of nicotine, rather than continuing to smoke. Smoking is the leading cause of preventable death in the U.S., killing about 500,000 Americans each year, or just about the number of Americans who died in World War I and World War II combined.
Part of the difficulty in regulating e-cigarettes is that, unlike cigarettes, they offer benefits and harms that differ across generations. This concern is called intergenerational equity. How can a solution be crafted that serves all Americans?
By The Temple University Center for Public Health Law Research
This week, the Center for Public Health Law Research and Trust for America’s Health (TFAH) published the first two of 13 comprehensive datasets on laws that can support cost-savings for states and promote health and well-being. Researchers from Center used the scientific policy surveillance process to create datasets that provide states with detailed information about the current state of U.S. laws.
We spoke with Adam Lustig, MS, the manager of the Promoting Health & Cost Control in States (PHACCS) project at TFAH.
CPHLR: These new datasets are the first two of 13, what other topics are being mapped, and how were these topics chosen?
Adam Lustig: We are incredibly excited for the release of the remaining eleven datasets through the summer of 2020. For a preview of things to come, we anticipate releasing datasets on Smoke-Free policies, Alcohol Pricing Strategies, Complete Streets, Ban the Box, and Earned Income Tax Credit in the first quarter of 2020. Following those datasets, we will publish the remaining datasets on School Nutrition Programs, Earned Sick Leave, Paid Family Leave, Rapid Re-Housing, Universal pre-K, and Housing Rehabilitation Loan and Grant Programs throughout the summer of 2020.
CPHLR: These first two datasets, and one forthcoming on alcohol pricing, focus specifically on harm reduction for substance use. Why are harm reduction strategies integral to cost control? Read More
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