FDA Warning Letter Trends

Recent warnings from the CTP focus overwhelmingly on the vapor industry.

FDA Warning Letters Increase for Vapers

As the tobacco industry and the U.S. Food and Drug Administration (FDA) begin working closely together to comply with the agency’s deeming regulations, it has become more relevant to review one of the Center for Tobacco Products (CTP)’s primary and most transparent tools for enforcing the new regulatory scheme: warning letters. The CTP issues a warning letter when it believes a manufacturer, importer, distributor or retailer is not in compliance with the current regulatory scheme. While the tobacco industry works tirelessly to meet the numerous pending deadlines imposed by the deeming regulations, the CTP is simultaneously spending more time in the field working with the industry to remedy deeming regulation violations.

Warning letters issued to members of the industry are publicly available. This is akin to a double-edged sword. On the one hand, it means that alleged mishaps of those in the industry are also publicly available. On the other, the industry can review these letters for a perspective into the CTP’s enforcement decisions and use it as a learning experience to ensure the industry is complying with the regulatory scheme. Most recently, the theme of the warning letters being issued seems to focus on retailers selling vapor products to individuals who are not of legal age to purchase them.

By way of background, over the course of 2016, the CTP issued roughly 150 warning letters to various manufacturers, distributors and retailers of tobacco and vapor products, compared to roughly 130 warning letters issued in 2015. Although there is only a slight difference in the overall number of warning letters issued between the two years, in 2016 more than 70 percent of all warning letters issued were issued between the effective date of the deeming regulations and the end of that calendar year, a roughly three-month period. In addition, the vast majority of these warning letters pertained to violations of the deeming regulations that included newly deemed covered tobacco products, including cigars, hookah tobacco and electronic nicotine-delivery systems (ENDS), which encompass e-liquids and other vapor products.

In particular, the majority of the warning letters issued in 2016 dealt with a single issue: the retail sale of flavored e-liquids and other vapor products on retailers’ e-commerce websites to individuals under 18 years of age. Because these actions constituted the sale of covered tobacco products to a person under 18 years in violation of the deeming regulations, the CTP informed the affected retailers that such e-liquids and vapor products were misbranded pursuant to 21 U.S.C. 387c(a)(7)(B) and that the retailers’ continued sale of the e-liquids and vapor products in question would subject them to such penalties as seizure of goods, injunctions, and/or civil money fines. This should serve as a stern reminder to the newest members of the industry and the e-cigarette/vapor community that sales to minors are absolutely forbidden. Moreover, prohibiting the sale of deemed products to only people of age is of the utmost importance to both the industry and the FDA.

Warning letters issued in 2017 were not that much different, though two patterns seem to emerge: (1) the number of warning letters issued to members of the industry is down to roughly 80, nearly a 50 percent drop in the number of letters issued from the previous year; and (2) the overwhelming majority of the warning letters issued still pertain solely to the retail sale of e-liquids and other ENDS products that were purchased by minors through a retailer’s e-commerce website, and as such were labeled as misbranded under the regulations.

There are two ways to view this information. First, the industry is overwhelmingly complying with the regulations, except for an apparent issue concerning the online sales of e-liquids and other vapor products. Second, the CTP is choosing to focus on this one sector of the industry with regard to enforcement of the deeming regulations. Given how involved the FDA is in the industry, it is more likely the former.

In any event, a review of the warning letters issued by the CTP over the last few years should serve as a candid reminder to members of the industry to only sell deemed and all other tobacco and vapor products to people of legal age.

Contributed by Andrew Schmidt, an associate general counsel
in Kretek International’s legal department.

This story first appeared in the January/February 2018 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.

subscribe to tobacco business