In 2017, the FDA announced a new plan for the regulation of tobacco products, which included bold initiatives; reducing nicotine and prohibiting flavors. However, these initiatives will undoubtedly take years before finalization. Less well known, the FDA simultaneously announced it would make immediate, drastic changes to the implementation of premarket review for e-cigarettes and other newly deemed products. These changes have harmed public health and contributed to the youth e-cigarette epidemic.

In March 2019, the FDA announced that it would take the first step towards addressing the youth e-cigarette epidemic by issuing a draft guidance outlining changes in premarket review. Specifically, the FDA announced that it would target (non-mint/menthol) flavored e-cigarettes that are sold in ways that are especially accessible to youth or any e-cigarette that uses targeted advertising or marketing to lure youth. The FDA also announced targeted enforcement against all flavored cigars. However, many public health advocates see the FDA’s draft guidance as a half-measure that will not truly curb the youth e-cigarette epidemic. One glaring oversight is that the FDA has taken no targeted action to address JUUL or JUUL-knockoffs, which are undeniably driving this epidemic. Instead, the FDA’s proposals leave JUUL products both in youth accessible stores and online. Also, the FDA's exemption of mint/menthol is unacceptable for equity reasons. At the time that this abstract is being submitted, this guidance has not been finalized, but should this session be added to the program, all information presented will include all relevant developments prior to the conference.

issue: Flavored products exacerbate the tobacco public health crisis: They are designed and marketed to attract new (overwhelmingly young) users, retain consumers trying to quit, and promote dual/poly tobacco use. Flavored tobacco products (FTPs) widen health disparities, exposing users to toxins not found in unflavored products. Further, these products are driving soaring rates of youth e-cigarette use. Accordingly, momentum is building for state and local policy responses to address the problem of FTPs.

description: Responsive local laws restrict the sale of FTPs. Enacted policies vary by community, differently exempting specific flavors, product categories or retailers. These tailored exemptions can reflect community desires, but may more typically reflect anticipated legal challenges to broader restrictions. More recently, however, local governments are enacting increasingly comprehensive sales restrictions, including complete sales prohibitions. We proffer these prohibitions stand on firm legal ground across legal jurisdictions, yet we lack a final legal determination.

lessons Learned: This presentation will discuss state and local authority to restrict sales of FTPs. We will examine federal limits on state authority (preemption), and other likely legal challenges. With these in mind, we will also present considerations for drafting and enforcing a FTP sales policy, including for defining and identifying the target products.

recommendations: Restricting access to FTPs is an effective public health measure. Federal law does not preempt state or local governments from regulating sales of tobacco products. Attorneys with tobacco control expertise can provide guidance for a carefully crafted, well-implemented policy that will maximize potential to withstand legal challenge.

States and municipalities are grappling with youth e-cigarette use. Fueled by emerging and ever-evolving products, youth e-cigarette use has reached epidemic levels. The FDA recently announced a crackdown on the e-cigarette industry, but thus far the agency’s actions have been more smoke than fire. Between the FDA’s recent e-cigarette enforcement efforts and the delayed tobacco product "Deeming Rule," local health departments have been left wondering what the appropriate role is for local policymaking to prevent youth e-cigarette use.

In response to the e-cigarette epidemic and federal inaction, Chicago added another tool to its tobacco control playbook: litigation.

Since e-cigarettes first entered the market, Chicago has been proactive with youth e-cigarette prevention, passing numerous innovative tobacco control policies to make the products less affordable, less accessible, and less attractive to youth. While the City’s efforts have reduced the youth smoking rate to six percent, there is concern that e-cigarettes could cause these gains to backslide. These concerns necessitated a new strategy – one to hold the industry accountable.

Starting Fall 2018, the respective Chicago Departments of Law, Public Health, and Business Affairs and Consumer Protection began an initiative to file suit against online e-cigarette retailers for illegal sales to minors and subpoena information from e-cigarette manufacturers related to youth-targeted marketing. This presentation will discuss the City’s new strategy of litigating (in addition to regulating) e-cigarettes, including how the marketing and/or sale of e-cigarettes to underage individuals can be treated as a violation of local consumer protection laws.

Reports by the U.S Surgeon General and the CDC indicate that youth e-cigarette use increased tenfold between 2011 and 2015. While the long-term effects of the dangerous chemicals inhaled by using e-cigs are not yet fully known, we can look to other studies to predict the harmful effects for users. By examining past and current civil litigation, including the tobacco, chemical flavoring and asbestos litigation, we may be able to stop the harm and prevent more illness in the future.

What we know e-cig users inhale:

• Flavorings such as diacetyl and 2,3-pentanedione, chemicals linked to serious lung disease.
• Formaldehyde, used as embalming fluid, and known to cause cancer.
• Harmful heavy metals, such as nickel, tin, and lead that lead to serious health complications, especially when exposed to developing bodies and minds.
• Nicotine, a chemical that is addictive and harmful.

What we know about the effects of the inhalants:

Diacetyl and 2,3-pentanedione exposure: Several forms of severe lung disease are caused by exposure to the chemicals diacetyl and 2,3-pentanedione, both of which are used as flavorings for food products. These chemicals are known to damage the airways and tissue of the lungs and cause severe and long term lung-damage, including a rare lung disease called bronchiolitis obliterans.

Heavy metal exposure: Heavy metal poisoning after long-term exposure can be acute or chronic. Whether your symptoms come on slowly or abruptly, you may feel confused, feel sick generally and ultimately suffer brain damage.

Preemption is the constitutional doctrine that federal law is supreme over any conflicting state or local law. A state may preempt a local government from passing laws or addressing specific issues in certain fields. It may be express or implied. In Maryland, there is no express preemption limiting the authority of local governments from passing laws regulating tobacco products. However, in 2013, the Maryland Court of Appeals, the State's highest court, ruled that state law preempted a county regulation requiring cigars to be sold in packages of at least 5. In Altadis U.S.A v. Prince George's County, 431 Md. 307 (2013), the Court found implied preemption, concluding that the state occupied the field of tobacco regulation.

Since Altadis was decided almost 6 years ago, local jurisdictions have hesitated to pass laws regulating tobacco. Consequently, locals focused on passing laws restricting sales and use of Electronic Nicotine Delivery Systems (ENDS), which aren’t included in the state’s definition of tobacco products and don’t evoke the same preemption concerns.

While often a state legislature is the source of preemption in tobacco regulation, the Maryland legislature may become the source of freedom from preemption. Presently, the legislature is considering a bill which will address local preemption in at least one jurisdiction. This may have implications throughout the state.

This presentation will analyze efforts made by local Maryland jurisdictions since Altadis, chronicle previous efforts to reverse the preemption legislatively, and examine the outcome of the 2019 legislative session as it relates to tobacco and anti-preemption.