Much Ado About Nothing: FDA’s Lackluster Effort to Restrict Flavors

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On January 2, 2020, in response to two years of skyrocketing rates of youth use of e-cigarettes, the FDA took a small step to restrict e-cigarette sales. The FDA issued a guidance prohibiting all sales of cartridge-based e-cigarettes that are not flavored with menthol or tobacco, after a 30 day sell-off period. This means that as of February 6, 2020, many flavored e-liquid pods, including Juul and Juul-compatible products, will no longer be sold legally in the United States. The guidance is not a comprehensive response to the epidemic of youth use of flavored tobacco products; it does not restrict all flavors, does not include all e-cigarettes, and does not apply to other tobacco products such as flavored cigars. The failure to include menthol e-cigarettes and all flavored cigars in the guidance is egregious, an omission that will diminish the public health impact of the guidance and continue to fuel tobacco-caused health disparities.

The limited flavored products that the FDA will prohibit are e-cigarettes that meet the definition of “cartridge-based ENDS products.” In the guidance, this is defined as:

[A]ny type of ENDS [or e-cigarette] product that consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized through product use. For purposes of this definition, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system [ENDS].

According to the FDA, the flavor restriction will not include customizable e-cigarette products typically purchased in a vape shop (sometimes called tank systems or mod systems) nor disposable, completely self-contained e-cigarettes. Although the guidance does not restrict the sale of non-cartridge-based and cartridge-based menthol or tobacco products for now, the FDA may still remove these products from the market. The agency may act if manufacturers are not taking affirmative steps to reduce youth access to their products, using marketing and labeling strategies that particularly target youth such as cartoon characters, using social media influencers, and marketing “stealth” products – e-cigarettes made to look like other ordinary products to deceive teachers, parents, or other adults.

The failure to include all flavors is only one of the flaws of this guidance. While the FDA had originally proposed to prohibit flavored cigars as well, the agency has not followed through on that proposal. While this policy is a step in the right direction with respect to e-cigarettes, this guidance will not comprehensively address the epidemic of youth use and other significant public health concerns. First and foremost, the administration ignores the mountain of evidence that supports the removal of menthol from all tobacco products and specifically disregards the immense public health benefit for the African American community, the LGBTQ community, and other targeted communities. The choice to exempt menthol perpetuates health disparities for these communities. The evidence overwhelmingly supports prohibiting menthol as a flavor to protect public health and yet the FDA continues to allow menthol products to remain on the market.

The FDA has full authority to apply this policy to all e-cigarette types, to all flavors, and to all other newly deemed products, like cigars, but neglects to do so. In the final guidance, the administration ignores evidence that demonstrates that youth will turn to other flavored products in the absence of their “preferred” flavors. The FDA even discusses this evidence in the guidance. In 2018, 75.5% of high schoolers used fruit flavored e-cigarettes and 38.1% used mint or menthol flavored e-cigarettes. Between that survey and the following year’s survey, Juul, by far the most popular e-cigarette brand, voluntarily stopped selling fruit flavored e-cigarettes, leaving only its mint, menthol, and tobacco flavors on the market. Not surprisingly, in 2019, high schooler’s use of fruit flavored e-cigarettes fell to 66.1% and mint and menthol flavored use increased to 57.3%. This is clear evidence that if any flavored products remain accessible to youth, youth will seek out those products in an attempt to fuel their nicotine addiction. The same is likely to apply to cigars, which will continue to be available in a wide variety of flavors, including fruit, candy, and mint flavors. The FDA’s guidance asserts that it plans to take a “wait and see” approach, which is an approach that has undoubtedly contributed to the youth e-cigarette epidemic thus far. There is no justifiable reason for the administration to ignore this evidence and exclude any flavored tobacco products that can be addressed through this action.

In addition to these concerns, the administration uses weak, confusing definitions with loopholes and fails to define the term “flavored.” When the TCA prohibited the use of the words “light” on cigarette packages, the industry responded by color-coding its products: Camel Lights are now Camel Blue.  The same thing has happened in local jurisdictions that have prohibited flavors; manufacturers simply started using concept flavors. Instead of indicating the flavor on the label, a person could find the new “concept” name and know it is the same flavored product although no longer indicated on the label. Without a strong and clear definition of “flavored,” the industry is likely to employ the same tactics and exploit these loopholes.

Finally, this action is a temporary measure that must be viewed within the context of the FDA’s larger failure to effectively implement premarket review. The Tobacco Control Act gives the FDA the authority to decide if a product can be sold at all prior to its introduction to the market. For a manufacturer to legally sell a tobacco product in the United States, they must first apply to the FDA and receive authorization. In reviewing a marketing application, the FDA must consider the impact on public health, including the risks and benefits of the product to both users and non-users. This includes looking at the product’s components, ingredients, and additives, among other things. Under the Act, it is only after this review and a decision by the FDA to authorize the sale of a tobacco product that it is allowed to be sold.

Unfortunately, the FDA has allowed thousands of tobacco products to remain on the market without the required review for far too long. However, the FDA has put manufacturers on notice that in accordance with the court order in AAP v. FDA (2019), all newly deemed products subject to premarket review (including all remaining e-cigarette products, cigars, waterpipe tobacco, pipe tobacco, and others), must submit marketing applications to the FDA by May 12, 2020, and the FDA will take up to one year to process those applications. This means that on May 12, 2021, the only products legally sold in the United States will have been authorized by the FDA. For more information on how the FDA is using its premarket review authority in this action, please see our webinar, The FDA Tools to Tackle the Juul Epidemic and our fact sheet, Extensions and an Epidemic: The FDA’s Gatekeeping Authority for E-cigarettes.

This backdrop is important because if a manufacturer violates the guidance’s flavor prohibition and sells a mango flavored cartridge-based e-cigarette after the 30 day sell-off period, the FDA will remove that product from the market. However, because this action is tied to premarket review, the manufacturer can submit a marketing application and it is quite possible that the mango flavored cartridge-based product could end up back on the market. To comprehensively address flavored products, the FDA must finalize a rule prohibiting all flavors in all products – this is the only long-term solution to alluring and addicting flavors.

It is clear that flavors and the availability of products is one of the primary drivers of the youth e-cigarette epidemic. Tribal, state, and local governments have been on the forefront of addressing this concern by enacting comprehensive policies that do not include the identified gaps in the FDA’s guidance. Because many products are exempted from this action, including all menthol products, many local efforts to address flavors are better tailored to effectively reduce youth e-cigarette use. Tribal, state, and local ordinances can include all flavored tobacco products and can be permanent solutions rather than a temporary stopgap. Nothing in this FDA guidance should deter Tribal, state, and local governments from continuing to enact public health policies that are more comprehensive, more effective, and designed to prevent Big Tobacco from addicting the next generation of kids.

View our webinar: Federal Tobacco 21 and the FDA Flavors Guidance

 

Updated 1/15/2020


Natalie Hemmerich, J.D., M.P.H., is a Staff Attorney at the Public Health Law Center.