January 3, 2019

Stanton A. Glantz, PhD

What FDA’s proposed steps to protect youth from e-cigarettes do and don’t do

To much fanfare (New York Times, Washington Post, CNN), on November 15, 2018 FDA announced several actions (Statement from FDA Commissioner Scott Gottlieb)to address dramatic increases (link1, link2) in youth e-cigarette and nicotine use.  FDA wants to reduce kids’ access to flavored tobacco products and even talked about finally banning menthol in cigarettes and other tobacco products.

The good news is that FDA is recognizing that flavors and e-cigarettes are a big problem for kids, but, on closer inspection, most of FDA’s proposals will have little immediate impact. 

The proposals themselves are convoluted and rambling, but fail to specify implementation details or action dates.

In the short term FDA seems to be relying on companies to voluntarily remove flavored products from stores with easy youth access. 

After about three months, the FDA will prohibit sales of most flavored e-cigarettes in stores that kids can legally enter (unless they put the e-cigarettes in a separate area closed to kids, something some stores are already doing to get around local flavor bans in cities with "adult only space" loopholes) and this restriction does not apply to popular mint and menthol flavored e-cigarettes (or tobacco flavored e-cigarettes) at all.

Another huge loophole is the fact that FDA would allow all flavored e-cigarettes to still be available online if sold with “heightened age verification processes .” The problem is that the evidence shows that no such system exists that actually effectively prevents youth from purchasing tobacco products online

The FDA says it is going to move to issue regulations that would ban sales of flavored cigars and ban menthol in cigarettes and cigars.  (FDA did try to do this in the 2016 “Deeming Rule,” but the Obama White House blocked it.)  This is long overdue, but will require a lengthy process of notice-and-comment rulemaking that will take years to finalize and implement.

FDA’s proposal to remove e-cigarettes that are targeting kids with kid-friendly labeling and marketing should and could be implemented immediately, along with other restrictions that would quickly attack the expanding problem.

In the meantime, communities are responding to this delay by simply passing local ordinances prohibiting the sale of flavored tobacco products while the FDA continues to deliberate.  States are also starting to consider similar action.  That is where is the problem of flavored e-cigarettes is actually being addressed.


What does FDA’s proposed policy framework purport to do?

  • Prevent youth access to flavored products
  • Curtail youth access to tobacco products via online sales
  • Advance a product standard that would ban flavors in all cigars
  • Disallow marketing of ENDS products that appeals to youth
  • Advance a Notice of Proposed Rulemaking that would ban menthol in cigarettes and cigars

What would FDA’s proposed steps actually do, and what are the implications?

Flavored (except for tobacco, mint, and menthol flavors) e-cigarettes (including e-liquids, cartridge-based systems, and cigalikes) would be required to be sold in age-restricted, in-person locations.

  • Sales of non-flavored and tobacco, mint, and menthol flavored e-cigarette products would not be affected.
  • Sales of any flavored e-cigarettes in vape shops or other age-restricted locations would not be affected.
  • FDA would implement this policy by reversing a discretionary compliance policy currently followed that had extended the date for enforcing premarket authorization requirements for newly deemed tobacco products (such as e-cigarettes, hookah, and cigars) to August 8, 2022, and thereby allowed sales of these tobacco products that have not yet obtained premarket authorization orders. Under the proposed revision of that compliance policy, physical locations where youth under 18 are permitted would be prohibited immediately from selling flavored e-cigarettes (except for tobacco, mint, and menthol flavored products) unless those products had first obtained premarket authorization from FDA.  (To date the only premarket authorization orders that have been issued were in 2015 for eight Swedish Match smokeless tobacco snus products.) Stores or manufacturers who violate this policy would be subject to enforcement actions for not having a required FDA marketing authorization order in effect. Possible enforcement actions include warning letters, civil money penalties, no-tobacco sales orders, criminal prosecution, seizure, and/or injunction. 
  • The proposed revised compliance policy would not apply to any e-cigarettes (including flavored e-cigarettes) sold in age-restricted locations or in age-restricted sections of general access retail stores where under-aged youth are permitted. Additionally, the revised compliance policy would not apply to any non-flavored e-cigarettes or to e-cigarettes with tobacco, mint, or menthol flavors sold in any location.
  • In its November 15, 2018 statement, FDA said they “hope” that within the next 90 days, manufacturers will choose to voluntarily remove flavored ENDS products from stores where youth can access them.  This language suggests that for at least 90 days, FDA does not intend to enforce this new policy.

All e-cigarettes, including all flavors, would be permitted to be sold online with “heightened measures for age verification.”

  • Unflavored and tobacco, mint, and menthol flavored ENDS products can continue to be sold online, regardless of whether they have obtained premarket authorization orders, and regardless of whether the websites use “heightened measures for age verification processes.”
  • No purportedly “robust age verification scheme has been demonstrated to effectively prevent underage youth from purchasing restricted products online (link1, link 2. link3).
  • In its November 15, 2018 statement, FDA said they “hope” that within the next 90 days, manufacturers will choose to voluntarily remove flavored ENDS products from online sites that do not have “sufficiently robust age-verification procedures.”  This language suggests that for at least 90 days, FDA does not intend to enforce this new policy.
  • FDA’s language suggests modest expectations for this policy.  The November 15, 2018 statement says FDA will “seek to curtail” sales of flavored e-cigarettes (except for tobacco, mint, and menthol flavored products) by identifying “heightened measures for age verification,” and will make best practices available “soon” so sites can“quickly adopt them.”   FDA does not indicate how it would identify such “heightened measures,” how it would determine the effectiveness of such measures, when the best practices would be made available, how soon sites would be required to adopt them, and whether or how FDA intends to enforce against sites that do not adopt heightened measures for age verification.
  • FDA will continue to enforce against online sales of any e-cigarettes (including non-flavored or tobacco, mint, or menthol flavors) to minors if and when FDA sees them.

Sales of flavored cigars that are not ‘grandfathered” (i.e., were not on the market as of February 15, 2007) would no longer be permitted without premarket authorization orders, regardless of the location in which the products are sold.

  • As with the proposed flavored e-cigarette policy, FDA would implement this policy by reversing the compliance policy that currently extends the compliance date to August 8, 2021 (combustible products such as cigars had an earlier compliance date than non-combustible products such as e-cigarettes).
  • FDA intends to propose a product standard that would ban flavors in all cigars because this revised compliance policy would not apply to grandfathered cigars.
  • The comment period for FDA’s advanced notice of proposed rulemaking (ANPRM) for a product standard for flavors in tobacco products closed in July 2018, and FDA intends to prioritize issuance of this proposed rule.  Nevertheless, the formal rulemaking process is slow, so grandfathered flavored cigars could continue to be sold without premarket authorization orders.

FDA will “pursue” removal from the market e-cigarettes that are marketed to youth and/or are appealing to youth, including using cartoon characters or candy or soda brand names favored by kids.

  • FDA has recently issued several warning letters (link1, link2) to online retailers and manufacturers who are engaging in these activities. Recipients are asked to take corrective actions within 15 days, such as discontinue sales of products that violate labeling and advertising restrictions, and are warned that failure to fully comply may result in FDA initiating further action without notice, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.
  • Despite authority to do so, FDA has not prohibited companies from using e-cigarette brand names on non-e-cigarette products or from sponsoring sports and cultural events. These restrictions currently are imposed on cigarettes and smokeless tobacco products (21 CFR 1140.16).

FDA will “accelerate” a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars.

  • Menthol flavored e-cigarettes would not be included in the ban.
  • As FDA acknowledged, FDA started the process to ban menthol in cigarettes many years ago (in July 2013) with an ANPRM, and it will take many more years for any menthol ban to be implemented..

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