FDA Releases Deeming Rule, Uncertainty Remains

Last week the US Food and Drug Administration (FDA) announced the final deeming rule that extended FDA authority to include e-cigarettes, cigars, and hookah tobacco. 


Among the 134 pages now published in the Federal Register, the deeming rule subjects these categories of “tobacco products” to the applicable provisions, requirements, and regulations associated with The Federal Food, Drug, and Cosmetic Act (FD&C), as amended by the Family Smoking Prevention and Tobacco Control Act (TCA).

Of the requirements resulting from the FDAs extended authority of these products, the most controversial are those associated with premarket review and authorization.  The grandfather date applied to the deeming rule stems from the FD&C, which defined “new tobacco product” to be any tobacco product that was not commercially marketed as of February 15, 2007.  For the vaping industry, this definition pulls in the vast majority of products that are currently on the market, and the high costs of premarket review and authorization will force many smaller players out of the e-liquid manufacturing business altogether.  The FDA’s own analysis reflects this reality: “…we expect the proportion of vape shops that mix e-liquids may fall during the initial compliance policy period for submission and FDA receipt of PMTAs. After this initial compliance policy period, we expect that most vape shops will continue to operate but those that have not already switched pure retailing will likely do so.”

Beyond just impacting the e-liquid manufacturers, this deeming rule also applies to Electronic Nicotine Delivery Systems (ENDS), including e-cigarettes and vaporizers, which will require premarket review and authorization.  The expected price tag per ENDS manufacturer is $827,000 to $1.21 million in the first year alone according to FDA estimates.  While cigar manufacturers that have entered the market in the last decade are expected to face lower costs associated with premarket compliance, the FDA estimates ($278,000 to $397,000 in the first year) are still prohibitive for smaller manufacturers.

One company (Nicopure Labs) has already filed suit challenging the FDA’s deeming rule, and legislation has been introduced in Congress to change the grandfather date for newly deemed products.  While these efforts offer a glimmer of hope for small businesses in the vapor industry, both approaches face challenges in resolving this challenge. 

EVS is proud to work with responsible companies of all sizes to help ensure that their age-restricted products are only sold to adult consumers, and we remain hopeful that either congress or the courts will be able to offer relief for the small and mid-size businesses at risk from the requirements of the deeming rule.

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