Premium Cigars Escape FDA Regulation for Now

The FDA failed to consider whether premium cigars warranted a different regulatory approach than cigarettes.

Cigar smokers have reason to celebrate as a federal judge has vacated the Food and Drug Administration's (FDA) authority to regulate premium cigars. The ruling concludes years of litigation tracing back to the FDA's decision in 2016 to extend its authority under the Tobacco Control Act of 2009, imposing potentially burdensome regulations on the industry. Wednesday's ruling from Judge Amit P. Mehta in the United States District Court for the District of Columbia strikes down the FDA's 2016 deeming regulation, handing a decisive victory to cigar makers.

The central issue of the case was whether the FDA adequately considered whether there is empirical justification for regulating premium cigars as stringently as other tobacco products, such as cigarettes and oral tobacco. Plaintiffs contended that the FDA ignored information on the differential usage patterns and health effects of premium cigars that had been submitted to the agency and misrepresented data on the prevalence of youth cigar smoking. Mehta agreed, holding in July 2022 that the FDA's deeming rule was arbitrary and capricious.

The ruling only vacates the FDA's authority over premium cigars, leaving regulations on machine-made cigars, little cigars, and flavored cigars intact. Products classified as premium cigars must meet a list of requirements:

"(1) are wrapped in whole tobacco leaf; (2) contain a 100 percent leaf tobacco binder; (3) contain at least 50 percent (of the filler by weight) long filler tobacco; (4) are handmade or hand rolled; (5) have no filter, nontobacco tip, or nontobacco mouthpiece; (6) do not have a characterizing flavor other than tobacco; (7) contain only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weigh more than 6 pounds per 1,000 units."

In short, this means that most of the cigars one would find at a specialty tobacconist will qualify as premium, while the cheaper cigars sold in convenience stores will not.

Cigar makers are delighted by the news. "Finally, this cottage industry is saved from illegal, ambiguous and overreaching regulations," Rocky Patel told Cigar Aficionado. "Now we can focus on making great quality cigars and you will have the freedom to enjoy them for many years to come."

Health groups such as the American Lung Association are predictably less enthused. In a joint amicus brief urging the court to reject an exemption for premium cigars, they contended that "such an exemption will create the misimpression that premium cigars are safer tobacco products because they are unregulated."

Of course, no one seriously denies that smoking cigars poses some health risks. Inhaling smoke from combusted tobacco is inherently riskier than abstaining. Yet there is also substantial evidence that the risk profile of premium cigars is very different from that of cigarettes. The more alkaline smoke of cigar tobacco is less likely to be deeply inhaled. Surveys show that smokers of premium cigars are more likely to be occasional rather than daily users. As a 1998 monograph from the National Cancer Institute notes, "Most cigarette smokers smoke every day. In contrast, as many as three-quarters of cigar smokers smoke only occasionally, and some only smoke a few cigars per year. This difference in frequency of exposure translates into lower disease risks."

Despite this information having been submitted during the public comment period, the FDA failed to consider whether it warranted a different regulatory approach than the one applied to cigarettes. Given that premium cigars by definition consist entirely of cured tobacco leaves rolled into tubes of various sizes, it's difficult to imagine compelling health benefits to applying strict regulatory scrutiny to individual products. Indeed, the FDA itself has acknowledged that premium cigars are its "lowest enforcement priority" relative to other nicotine and tobacco products that are used more frequently by youth.

Cigar makers argued that even if their products are a low enforcement priority for the agency, regulatory uncertainty and potentially high costs of compliance could deter companies from investing in bringing new cigars to market. This week's ruling removes that uncertainty, helping to preserve a dynamic market for premium cigars.

In the long run, regulatory threats to premium cigars remain. It's possible that the FDA could appeal the ruling or issue a new deeming regulation addressing the deficiencies in its first attempt. If the agency follows through on a controversial proposal to mandate very low levels of nicotine in cigarettes and small cigars, it might also seek to apply the same standard to premium cigars to prevent existing cigarette smokers from switching.

It's worth noting the irony that the present court ruling makes it far easier to introduce a new combustible premium cigar than it is to introduce a new electronic cigarette, despite the latter containing no actual tobacco and demonstrating tremendous potential to save lives as a substitute for cigarettes. To date, only 23 components of vapor products have received authorization from the FDA out of millions of applications, suppressing the legal market for e-cigarettes and encouraging a flood of illicit products. This is an additional source of ongoing litigation for the agency, whose marketing denial orders have been challenged in court by dozens of companies.

There are sound legal, economic, and epidemiological reasons for exempting premium cigars from FDA regulation, but this ruling is yet another example of how cigar smokers are treated better under the law than users of other nicotine and tobacco products. Smoking bans often make exemptions for cigar lounges while forbidding vapes, cigarettes, and hookahs, and comprehensive prohibitions on the sale of tobacco products (like the one implemented in Beverly Hills) carve out exceptions for cigars. There's more than a whiff of classism to American tobacco law, as consumers of high-end cigars are granted the freedom to smoke what they like while vapers and cigarette smokers are kicked to the curb or denied the right to purchase their preferred products.

In the May 2022 issue of Reason, I reported on the various policies that are bringing the U.S. into an era of nicotine prohibition in which entire classes of tobacco products are forbidden from sale, leading to illicit markets, criminalization, and other harmful unintended consequences. This week's ruling overturning the FDA's authority averts that future for premium cigars for at least a little while. Although the threat of eventual prohibition remains, this win for freedom is reason enough for many to light up a cigar in celebration.