On January 16, the U.S. Food and Drug Administration (FDA) issued a marketing granted order (MGO) for 20 ZYN Nicotine Pouch products. This marketing authorization, which was based upon a premarket tobacco product application (PMTA), marks the first instance that FDA has authorized products commonly referred to as nicotine pouches to be marketed in the U.S.
The PMTA pathway, which is only one of three pathways to market a new tobacco product, requires FDA to conclude, among other things, that permitting the product to be marketed would be "appropriate for the protection of the public health" (APPH). In issuing the MGO, FDA officials stated the evaluation of the PMTA showed that, "the authorized products pose lower risk of cancer and other serious health conditions [. . .]." FDA also highlighted evidence showing: (1) the appeal and likelihood to buy the authorized products was low among former tobacco users and never-users, including those ages 18-24; and (2) the authorized products have the potential to help a substantial proportion of adult cigarette and/or smokeless tobacco product users stop or reduce using such products. Due to this, among other factors, permitting the marketing of the ZYN Nicotine Pouches, subject to certain marketing restrictions, was deemed to be APPH.
Navigating Stringent Marketing Restrictions Imposed
Though the marketing of the ZYN Nicotine Pouches was deemed to be APPH, FDA clarified that no express or implied statements or representations of FDA approval could be made on or through any label, labeling, media, or advertising. FDA also emphasized that explicit or implicit modified risk claims cannot be made without a modified risk tobacco product application.
Additionally, FDA imposed stringent marketing restrictions including "measures to ensure ads are carefully targeted to adults ages 21 and older and the demographics of the audiences reached by the ads are tracked and measured by the manufacturer." FDA also expressed support for certain aspects of the marketing practices outlined in the PMTA intended to restrict or otherwise to reduce potential youth access and exposure to labeling and advertising. Moreover, FDA recommended the taking of additional steps to limit youth exposure to print and point-of sale advertising such as "limiting advertising to print publications where 85% or more of the readership is 21 years of age or older and/or selecting publications that do not over-index for youth."
The Road Ahead: Stricter Oversight and Compliance Expectations
The decision to authorize the marketing of ZYN Nicotine Pouches, along with the recent issuance of a Proposed Rule that would limit the level of nicotine in certain tobacco products, makes clear that FDA intends to exercise stricter oversight over how such products are marketed and sold, which may include pursuing potential enforcement. On a positive note, however, this authorization clarifies that FDA recognizes nicotine pouches are in fact a less harmful alternative to combusted cigarettes and have a role to play in reducing the use of such products by adults. Likewise, this authorization makes clear that successful submission of PMTAs for nicotine pouches is possible.
The experienced and uniquely qualified FDA and Government Relations teams at Buchanan are available to discuss these recent developments and address questions regarding the regulation of tobacco products.
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