Too Little, Too Late? The FDA’s New Enforcement Guidance

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Yesterday, the U.S. Food and Drug Administration announced that it is taking the first concrete step towards addressing the youth e-cigarette epidemic by issuing a draft guidance outlining changes in its enforcement of premarket review. After months of public statements of concern about skyrocketing youth tobacco use, coupled with unwarranted optimism that the industry would voluntarily keep its products away from kids, the FDA is finally ready to take a step towards action. In the current political climate, regulatory action has many barriers and we congratulate the FDA, and especially the staff at the Center for Tobacco Products, for achieving this first step. The action announced this week does not, however, absolve the FDA for the role it played in contributing to the epidemic in the first place by delaying action and declining to stringently enforce premarket review of newly deemed products.

There is absolutely no reason for the FDA to leave menthol and mint flavored e-cigarettes in stores that allow youth to enter. The evidence is clear that menthol in tobacco products increases initiation, makes it harder to quit, and exacerbates health disparities. Removing menthol e-cigarettes from the market is one step in the right direction of removing menthol tobacco products from the market entirely. Such action will save the lives of African Americans and LGBTQ individuals who were predatorily targeted by the tobacco industry and as a result disproportionately use menthol tobacco products and bear a disproportionate level of harm. With this draft guidance, the FDA has both the opportunity and the complete authority to begin addressing this disparity and saving lives. Additionally, leaving some flavored products on the market and not others is likely to drive addicted youth to those menthol flavors where the progression to menthol cigarettes is an even greater risk. Because of this risk, the FDA must work quickly to issue a regulation eliminating all flavors in all tobacco products, including menthol. Further delay is unconscionable.

The FDA’s plan to address flavored cigars in conjunction with flavored e-cigarettes is commendable and an important preventative measure against youth progression to harmful, combustible products. Unfortunately, many combustible flavored products will continue to be sold in kid-accessible stores because they were on the market February 15, 2007, and were grandfathered and thus exempt from premarket review. While the FDA cannot use the same mechanism for addressing these products, this is further reason for the FDA to act swiftly to issue a regulation eliminating all flavors in all tobacco products, including grandfathered products.

In addition to restricting in-person sales to adult-only facilities, the FDA should prohibit online sales of all tobacco products. Although the FDA says it will require third-party, independent age verification for all online sales, we know that youth have little trouble acquiring products online. Recent survey data reveals that nearly 90 percent of underage youth who attempt to purchase JUUL online are successful. The FDA should prohibit all non-face-to-face transactions because the risk of illegal sales is too great.

A draft guidance is the tool the agency uses to communicate its thinking on a particular subject, usually for areas under the FDA’s authority that do not require rulemaking. The FDA will accept public comments on the draft guidance.It has asked in particular for comments on certain provisions, but it is appropriate to submit comments raising any concern at all with the draft guidance.

We encourage the public health community to submit comments on the importance of this action, as well as suggested improvements. If you are unsure how to submit comments, please see our resource on writing public health comments on FDA rulemaking dockets.

This language in the draft guidance was difficult to understand, even for experts like us. However, the FDA’s other press releases shed light on what the FDA intends to propose:

  • The FDA will prioritize removing from the market all non-tobacco, non-menthol or mint-flavored e-cigarettes that are sold in kid-accessible ways, including:
    • Products that are sold in stores where kids may enter at any time
    • Products that have been sold to kids after the guidance is finalized; this would include any products that youth have successfully purchased in a compliance check
    • Products sold online without limits on the quantity that can be purchased within a certain time period
    • Products sold online without enhanced age verification measures taken (like third-party, independent age verification)
  • The FDA will prioritize removing from the market any e-cigarettes (no exemptions) that are marketed, advertised, or labeled in a way that particularly targets youth.
  • The FDA will require that all non-tobacco, non-menthol, or mint-flavored e-cigarettes that remain on the market submit a premarket review application to the FDA by August 8, 2021.
  • The FDA will prioritize removing from the market any flavored cigar (not including tobacco flavor) that entered the market between February 15, 2007 and August 8, 2016.
  • The FDA is prioritizing enforcement against any newly deemed e-cigarette or cigar that entered the market after August 8, 2016 – products that have never received any type of enforcement discretion.

While these actions have the potential to begin to address the e-cigarette epidemic, this draft guidance falls short of comprehensive action, leaving the door open for e-cigarette use among youth to continue to rise. Even worse, the FDA has not set a deadline to review comments and publish final guidance. According to the draft guidance, these measures will only begin to take effect 30 days after the guidance is finalized, which could be a long time from now.The FDA should have committed to issuing a final guidance in the near future. The FDA has expressed deep concern about the staggering increase in youth e-cigarette use for months, and every day we wait for tangible action from the FDA contributes to more youth becoming addicted to nicotine, with deadly consequences.

While this announcement holds the promise of future action, it continues to be only a promise. Until the FDA publishes a final guidance, local, state, and Tribal commercial tobacco control advocates remain the primary line of defense against this epidemic. In addition to being able to act quickly, many localities have adopted restrictions that far more comprehensively and effectively reduce youth use of tobacco products than what the FDA is proposing.  These local measures include restricting the sale of menthol and other flavored tobacco products, preventing online sales to kids, and raising the minimum legal sales age to 21.

For more resources on FDA regulation of tobacco products, please visit the FDA Tobacco Action Center on our website, where you will find our latest fact sheet on premarket review and two recent 30-minute webinars on how the FDA has and should be addressing the youth e-cigarette epidemic and JUUL.

If you would like more information and analysis on this draft guidance, we will be hosting another 30-minute webinar on Wednesday, March 20 (3:00pm ET/ 2:00pm CT) to talk through the details and implications of the FDA’s proposal. Register here.

 

March 14, 2019