Unintended Consequences Threatens Public Health Amidst Regulatory Efforts

Despite concerted global efforts to curb tobacco use through regulatory policies, the proliferation of illicit tobacco products via underground markets presents a significant challenge to public health and law enforcement alike.

The surge in unregulated and hazardous products stems directly from poorly conceived tobacco regulatory policies. Rushed implementations often neglect the potential unintended consequences and the emergence of illicit trade in tobacco and vape products. These products sidestep quality control, health standards, taxation, and age restrictions, exacerbating consumer risks while nullifying regulatory efforts.

For years, experts have sounded the alarm on the allure of lower prices and unhindered access to illicit tobacco, undermining the core objectives of regulatory measures intended to reduce tobacco use and negative impacts on public health. The unregulated nature of the black market further compounds the problem, exposing consumers to potentially harmful substances and widening health disparities, especially among vulnerable populations, such as people with low incomes, youth, and minority groups.

This concerning trend has been exacerbated by lawmakers’ and regulators’ oversight in engaging stakeholders and thoughtfully assessing the ramifications of their proposed policies. These ‘regulate first, ask questions later’ policies are being seen worldwide, with plain-packaging policies in Southeast Asian countries being directly linked to increases in black-market consumption, as less visible products are overlooked or unattractive to consumers. While policy-makers would say that was the purpose, it ignores the secondary reaction of consumers: not to stop consuming products, but instead to pursue unregulated goods in black markets.

One has to look no further than what is happening in Massachusetts with the rapid expansion and consideration of generational tobacco bans after the Massachusetts Supreme Judicial Court upheld Brookline, Massachusetts’ 2020 bylaw. While it was celebrated as a victory for the anti-tobacco lobby, it is more likely to deprive the locality of tax dollars while pushing consumers to pursue the same goods in neighboring jurisdictions and online. 

Similar unconsidered regulations capturing premium cigars have been at the forefront of CRA’s efforts in the last decade. The Food and Drug Administration’s (FDA) process to regulate premium cigars was found to be arbitrary and capricious by a federal judge, and their regulatory authority was struck in its entirety last summer. This was the culmination of an eight-year process led by CRA, in which the FDA was held to have misrepresented data and failed to properly consider all the regulatory options. This prolonged process incurred significant government expenses in both regulatory procedures and legal battles, resulting in a tarnished reputation for FDA

Despite experiencing a resounding setback in the courts, the FDA persists in its regulatory efforts in this sector. After the courts found their regulatory process to be arbitrary and capricious and vacating the regulation of premium cigars, the FDA introduced a proposed rule known as the Tobacco Products Manufacturing Practice (TPMP) rule.

The proposed TPMP rule reflects a lack of lessons learned from past failures, with vaguely defined provisions unsupported by scientific evidence and lacking consideration of the practicality of implementation or a comprehensive cost-benefit assessment. The FDA’s rushed approach has overlooked crucial aspects such as analyzing costs for small businesses as required by the Regulatory Flexibility Act and providing essential industry support for compliance. The unrealistic imposition of pharmaceutical-grade production standards disregards the traditional artisanal methods of premium cigar production. Furthermore, while hinting at extensive testing requirements, FDA failed to provide a formal Environmental Assessment or address potential environmental impacts adequately, as required under the the National Environmental Policy Act of 1969. This oversight not only affects foreign manufacturing facilities but also creates unnecessary technical trade barriers. 

In sum, the FDA’s continued justification of regulations that are both excessively burdensome and lacking in scientific support, practicality, and evidence highlights the agency’s inclination towards rash decision-making devoid of thorough foresight or analysis.

Moving forward, to counter the unintended consequences that are becoming more frequent, government agencies, law enforcement bodies, public health organizations, and industry trade groups must work together to develop evidence-based strategies that balance public health imperatives and the inadvertent consequences of regulatory actions. By incorporating these lessons into policymaking, decision-makers can combat the harmful unintended consequences of their regulatory decisions.