The U.S. Food and Drug Administration (FDA) has announced it is formally allowing the marketing of RJ Reynolds’ tobacco-flavored Vuse e-cigarettes as “appropriate for the protection of the public health.” This is the first FDA PMTA order to allow the legal marketing of an e-cigarette. All other e-cigarettes currently on the market are illegal products, with FDA permitting most of them to stay on the market until FDA makes a decision on their pending applications to receive PMTA orders.
Allowing the marketing of certain tobacco-flavored e-cigarettes is probably “appropriate for the protection of the public health” (as required by the Tobacco Control Act). But FDA’s PMTA Order for the tobacco-flavored Vuse e-cigarettes does not adequately protect the public health and FDA’s underlying Decision Summary does not adequately show that such marketing is “appropriate.”
If using Vuse e-cigarettes is significantly less harmful than smoking, as FDA assumes, the only way Vuse could reduce tobacco-related harms is if smokers switch entirely or near-completely to using the e-cigarettes instead. Any other use will increase health harms to users (and exposed non-users). In particular, Vuse use by youth or adults who would not otherwise use any tobacco-nicotine product will increase health harms. Smokers can also increase their health harms if they use Vuse instead of quitting all use or engage in dual use (Vuse use plus smoking) instead of quitting smoking or without large smoking reductions.
Yet the FDA PMTA Order fails to include readily available measures to ensure the Vuse e-cigarettes are labeled, marketed, and sold in ways that will prevent and reduce all the possible harm-increasing ways the e-cigarettes can be used – without significantly impeding their harm-reducing use.
Most notably, the order includes only relatively weak, incomplete marketing and sale restrictions to protect against the e-cigarette’s marketing attracting youth, adult nonusers, and former smokers who have successfully quit.
- The order requires age and ID verification only to prevent digital sales and digital advertising from reaching persons under the federal minimum age for purchasing tobacco products (21). Nothing is done to prevent digital advertising and sales to adults who do not currently use tobacco products.
- The order does not prohibit advertising on TV and radio but only restricts such advertising programs for which youth are no more than 15% of the total audience. So Vuse could advertise on a TV program with a reported audience of 10 million viewers only if 1.5 million were youth. And youth who see such TV ads could easily copy them and post them on YouTube or other social media.
- The order allows marketing through manufacturer-supported partners, influencers, bloggers, or brand ambassadors as long as there is a disclaimer stating “sponsored by RJ Reynolds.”
- The order does not prevent RJR from marketing Vuse by encouraging celebrities, social media stars, bloggers, and others to use Vuse publicly and then post pictures or videos of themselves using Vuse on youth-accessible social media. While free samples are prohibited by existing law, nothing in the order prevents RJR from providing celebrities and other influencers with close-to-free Vuse e-cigarettes to help encourage their public use and related social media promotion.
- FDA notes favorably that RJR has said it intends to use the following measures to reduce the youth appeal of its marketing materials: no testimonials by sports figures or celebrities or any person with special appeal to youth; no people in any ads under age 25; no characters, images, or themes designed to target youth in ads; no ad content related to youth or youth-oriented activities; no ad content that suggests that using Vuse is essential to social prominence, distinction, success or sexual attraction; and no content depicting persons engaging in a physical activity requiring stamina or athletic conditioning beyond normal recreation. But FDA’s order does not require the actually implementation of these measures. It says only that: “We encourage you to implement these measures because they are likely to help further mitigate risks to youth.”
- Similarly, the orders says: “We also encourage you take additional steps to limit youth exposure to your print and point-of-sale advertising, including, for example, 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.” But FDA does not require RJR to do that.
As for the e-cigarettes’ labeling, FDA’s Decision Summary states only that the Vuse labeling was not found false or misleading and that it complies with the Deeming Rule’s warning label requirement (i.e., states that the product contains nicotine, which is addictive). So, it appears that the Vuse labeling will not state that they are “For Use Only By Adults as a Smoking Substitute.” Nor that the e-cigarettes be sold with instructions for use that explain how the products must be used to possibly reduce user harms and risks – and how all other uses will increase user harms and risks.
FDA’s failure to place stronger restrictions and requirements on the Vuse e-cigarettes’ labeling and advertising might come from concerns that they would be challenged in court as violating First Amendment constraints on government regulation of commercial speech. However, if FDA reasonably determined that additional restrictions or requirements were necessary to protect the public health more effectively, prevent increases in youth tobacco use, or otherwise make the marketing of the Vuse e-cigarettes more “appropriate for the protection of the public health,” they would certainly be constitutionally valid.
Although FDA recognizes that the marketing of the Vuse e-cigarettes will likely prompt some otherwise non-using youth and adults to use Vuse and become addicted, regular nicotine users, FDA says that allowing the product’s marketing is still “appropriate for the protection of the public health” because the harm reductions secured by smokers switching to Vuse will likely be larger than the new youth and nonuse adult harms and risks. But FDA does not reveal how much new harm to youth and to adult nonusers (or to smokers) it is willing to accept as an “appropriate” byproduct of the Vuse marketing also securing harm-reductions from smokers replacing or sharply reducing their smoking through using Vuse.
Nor does FDA explain how much of an increase in overall youth addiction and use it expects to occur or is willing to accept as “appropriate” to secure the expected reductions in overall health harms from smoker Vuse use. This failing is especially odd as the Tobacco Control Act puts a priority not only on protecting the public health but on reducing youth tobacco use.
It is also unclear how FDA is handling the inevitable uncertainties about the relative harmfulness of using Vuse vs. smoking vs. dual use vs no tobacco-nicotine use at all. FDA admits that the absence of long-term research studies makes it impossible to determine how harmful Vuse use is or the extent to which smokers might secure harm reductions by switching. But FDA does not explain how it can make an “appropriate” finding without making any estimates about the actual size of the possible harm reductions and harm increases. Instead, FDA only provides vague language about possible harm reductions among smokers who switch completely or largely to using Vuse, and about how Vuse use by otherwise nonusers is likely to be less harmful than smoking.
Similarly, FDA does not explain how it is handling the inevitable uncertainties about predicting how youth and adult tobacco-related behaviors might change in response to Vuse marketing (compared to pulling it off the market). Yet there is no way to determine whether the Vuse marketing will produce a net public health benefit without making projections about how many smokers will switch completely or largely to using Vuse, how many otherwise non-using youth and adults will become Vuse users, how many smokers will use Vuse or engage in dual use instead of quitting all use or quitting smoking, and how many smokers who have successfully quit will relapse into using Vuse.
What will FDA do with the still pending application for the menthol-flavored Vuse Solo E-Cigarette?
FDA’s press release relating to the PMTA Order for the tobacco-flavored Vuse e-cigarettes says that FDA has also issued marketing denial orders for all Vuse e-cigarettes with flavors other than tobacco or menthol because they would likely be more popular among youth than adult smokers. It also says that FDA “is still evaluating the company’s application for menthol-flavored products under the Vuse Solo brand.” Much of FDA’s analysis underlying its favorable PMTA Order for the tobacco-flavored Vuse e-cigarettes relies heavily on the fact that tobacco-flavored e-cigarettes are not popular with youth. But, as FDA acknowledges, menthol e-cigarettes are much more popular with youth than tobacco. It is also clear that youth will turn to menthol-flavored e-cigarettes when other non-tobacco flavored e-cigarettes are less readily available. On the other hand, FDA might want menthol-flavored e-cigarettes on the market when FDA implements the planned final rules to ban menthol cigarettes and ban all cigars with menthol or other characterizing flavors so that smokers of menthol cigarettes or flavored cigars who do not quit all use in response to the new rules will switch to menthol e-cigarettes instead of switching to tobacco-flavored cigarettes or cigars.
Will FDA issue a proposed rule to apply the same marketing and sale restrictions its PMTA Order is placing on the tobacco-flavored Vuse e-cigarette to all other tobacco products?
FDA’s analysis supporting the marketing restrictions it places on the Vuse e-cigarettes to prevent youth use apply even more powerfully to the marketing of more-harmful smoked tobacco products. Moreover, FDA provided even more extensive research, data, and analysis to support the similar restrictions it placed on the marketing of the Philip Morris IQOS “heat-not-burn” cigarettes and the Swedish Match snus in the favorable PMTA and MRTP orders it previously issued for those products. That research, data, and analysis more strongly supports not only applying those same restrictions to smoked tobacco products or to all tobacco products but including much more strict restrictions in Vuse PMTA Order.
Will there be any legal challenges to this PMTA Order?
Public health groups could challenge the Vuse PMTA Order for failing to protect the public health adequately (as outlined above), and tobacco industry members could challenge the order for being unfair or arbitrary or capricious because it restricts the marketing of presumably less-harmful e-cigarettes much more strictly than existing FDA regulations restrict the marketing of presumably more harmful smoked tobacco products. Such legal action might also be necessary to prompt FDA to do better. Since receiving its extraordinary powers to regulate tobacco products in 2009, FDA has yet to issue any substantive final rule to reduce tobacco-related death and other harm other than those rules specifically required with deadlines by the Tobacco Control Act or by court order.
For More on These Issues See:
Lindblom, Eric N., “FDA Can’t Follow a Pure Harm-Reduction Approach in its Upcoming E-Cigarette PMTA Orders,” O’Neill Institute Blog (August 17, 2021).
Lindblom, Eric N., “The Tobacco Control Act’s PMTA and MRTP Provisions Mean to Protect the USA From Any New Tobacco Products That Will Not Reduce Health Harms – But FDA Isn’t Cooperating,” Journal of Health Care Law & Policy 23(2): 121-186 (Feb. 2021).
Lindblom, Eric N., “How Would an Ethically Responsible FDA Evaluate PMTA and MRTP Applications and Issue Related Orders?,” Food and Drug Law Journal 75(1): 1-38 (August 2020).
Lindblom, Eric N., “How Might Manufacturers of E-Cigarettes Get New Product and MRTP Orders from FDA More Quickly and Easily?,” Food & Drug Law Journal 73(4): 624-641 (December 2018).
