CRA at FDLI: Why Engagement in Federal Regulatory Forums Matters More Than Ever

This month, Cigar Rights of America (CRA) attended the 2026 Food and Drug Law Institute (FDLI) annual conference, an important gathering that brings together federal regulators, public health officials, legal experts, and industry stakeholders to examine the evolving landscape of tobacco and nicotine product regulation. FDLI is a valuable, real-time window into how federal regulators, particularly the U.S. Food and Drug Administration (FDA) and its Center for Tobacco Products (CTP), are thinking about the future of regulation. 

Across both days of the conference, a clear theme emerged: FDA is moving toward a more modern, data-driven, and iterative regulatory framework. Agency officials emphasized increased use of artificial intelligence in product review processes, ongoing efforts to address the backlog of premarket applications, and a broader push for greater transparency and predictability in the PMTA pathway (see note 1 below). There was also a noticeable shift toward more direct engagement with industry, including expanded pre-submission meetings and pilot programs designed to facilitate real-time communication.

At the same time, the agency’s core policy priorities remain firmly focused on reducing combustible cigarette use. FDA officials highlighted continued interest in product standards, such as very low nicotine levels and restrictions on certain additives—as well as enhanced enforcement against illicit products, particularly within the ENDS market. Discussions also reinforced the agency’s broader harm-reduction framework, with a focus on transitioning consumers to authorized non-combustible alternatives.

However, these conversations also surfaced ongoing challenges. Stakeholders repeatedly raised concerns about the cost and complexity of regulatory compliance, particularly for smaller manufacturers, as well as the growing competitive imbalance created by illicit market participants. There was also a notable emphasis on risk communication, including persistent public misperceptions about nicotine and the need to more clearly articulate the concept of a “continuum of risk” (see note 2 below)—the idea that not all tobacco products carry the same level of harm.

For the premium cigar industry, these discussions are especially important.

As federal regulators continue to refine their approach, there is a real risk that broad, category-wide policies could fail to account for the fundamental differences between premium cigars and other tobacco products. Handmade premium cigars do not fit neatly into the frameworks designed for mass-market, inhaled, or frequently used products. Ensuring that this distinction is recognized—both in policy and in practice—requires consistent engagement in the very forums where these frameworks are being developed.

CRA’s presence at FDLI is part of a broader strategy to do exactly that: to monitor regulatory direction, engage directly with policymakers, and ensure that decisions are informed by accurate data, real-world use patterns, and the perspectives of small businesses and adult consumers.

The conversations taking place today will shape the policies of tomorrow. In a post-Mehta regulatory environment, where the definition, and distinctly reduced risk of premium cigars have been clearly affirmed, engagement is more important than ever. By attending FDLI and engaging with policy-makers face-to-face, CRA helps ensure that premium cigars are not swept into frameworks that were never intended to apply to them.

Note 1: The PMTA pathway stands for the Premarket Tobacco Product Application pathway, which is the process established by the U.S. Food and Drug Administration under the Family Smoking Prevention and Tobacco Control Act for manufacturers to obtain authorization to market new tobacco products in the United States.

Note 2: The continuum of risk in tobacco products is the idea that not all tobacco or nicotine products carry the same level of health risk—they exist on a spectrum. At one end are the most harmful products, and at the other are less harmful (but not risk-free) alternatives.