The maker of Vuse e-cigarettes has filed a formal citizen petition asking the FDA to focus its vaping product enforcement policy on the disposable vapes that now dominate sales in the convenience store/gas station segment of the U.S. vaping market. The petition was filed by RAI Services Company on Feb. 6, and posted by the FDA to Regulations.gov for public comment on Feb. 8.
RAI Services Company is the regulatory compliance arm of Reynolds American Inc. (RAI), the parent company of R.J. Reynolds Tobacco Company and a variety of other Reynolds-owned manufacturers, including R.J. Reynolds Vapor Company, the maker of Vuse e-cigarettes. RAI itself is owned by British American Tobacco, which sells Vuse around the world.
Vuse is the most popular single brand in the c-store vape market—mostly due to its biggest seller, the pod-based Vuse Alto. It’s also the only brand with three devices authorized by the FDA: the Vuse Solo, and the Vuse Ciro and Vibe. None of Reynolds’ authorized Vuse products are popular, and none are sold in flavors other than tobacco or menthol.
The Reynolds citizen petition asks that the FDA change its enforcement guidance to prioritize “illegally marketed disposable electronic nicotine delivery system (‘ENDS’) products” in order to “better protect public health.”
There’s some irony in the manufacturer of Camel and Newport cigarettes asking the government to clear its competition from retail shelves for the sake of public health. But it isn’t the first time Reynolds has encouraged the FDA to wipe out its vaping industry competitors.
Essentially, Reynolds is asking the FDA to revamp its enforcement priorities to target Vuse’s biggest current competitors. Reynolds has a specific list of products it would like the FDA to eliminate:
• “Any flavored disposable ENDS (except for tobacco- or menthol-flavored products);
• “Any disposable ENDS containing nicotine derived from any source other than tobacco
that lacks premarket authorization;
• “Any disposable ENDS containing nicotine derived from tobacco that was not on the
market as of August 8, 2016, or for which the manufacturer either failed to submit an
application by September 9, 2020, or submitted a PMTA to FDA by that deadline, but
received a negative action that is not being challenged in court;
• “Any disposable ENDS for which the manufacturer has failed to take (or is failing to take)
adequate measures to prevent minors’ access; and
• “Any disposable ENDS targeted to, or whose marketing is likely to promote use by,
Needless to say, R.J. Reynolds doesn’t sell disposable vapes, vaping products in flavors other than tobacco or menthol (Vuse flavors have either received marketing denial orders (MDOs), or their applications are pending), products containing synthetic nicotine, or products that received an MDO but didn’t challenge it in court (RJR is fighting the FDA in court over MDOs for Vuse menthol refills).
It is true that most disposable vapes exist in a hazy legal area. Some have premarket tobacco applications (PMTAs) pending with the FDA, some have been denied but remain for sale, and many haven’t applied for authorization at all.
The reason the FDA hasn’t taken action against many of them already is that the agency probably understands it would be a fruitless task. The companies that sell many of these products are shadowy entities, difficult to pin down. They’re mostly just importers and resellers, not actual manufacturers (those are in China). In the time it takes the FDA to research a given product and send a warning letter, the importer can change its name and address—or even change the name of the product.
“Such a policy,” writes Reynolds regarding its desired enforcement scheme, “will close an existing loophole in FDA’s current tobacco enforcement efforts, especially when it comes to youth.”
The “loophole” Reynolds refers to is in the FDA’s February 2020 enforcement guidance, which exempted from enforcement some disposable e-cigarettes in flavors other than tobacco and menthol. However, as the lawyers at Reynolds know, that policy applied only to otherwise compliant products that had been on the market since before the Deeming Rule took effect (Aug. 8, 2016), and also met other FDA criteria.
The 2020 FDA enforcement guidance was intended to allow legacy disposable products like blu disposables and the NJOY Daily to remain on the market until their PMTA submissions were adjudicated (the Daily was later authorized by the FDA). The agency didn’t give permission for every disposable device to stay on the market without fear of enforcement. In fact, any product that wasn’t already on the market before Aug. 8, 2016 must have FDA authorization before being sold, as the FDA told Puff Bar in its July 2020 warning letter.
The claim that the FDA’s enforcement policy encouraged Puff Bar and other disposables to proliferate was tobacco control mythology spread by lazy journalists—and is now being spread by the maker of the single most popular vaping device in the country. The Vuse Alto, by the way, remains on the market only because of FDA enforcement discretion. The agency is still reviewing the Alto PMTA.
Reynolds also refers to synthetic nicotine as a “loophole.” In fact, it’s simply a product that wasn’t regulated by the FDA until Congress granted that authority last year.
An actual loophole might be, say, selling cigarettes that use technically non-menthol coolants in a state that recently banned the sale of menthol cigarettes. That’s what Reynolds is doing in California while it attempts to get the U.S. Supreme Court to hear its challenge to the state law.
In Reynolds’ closing argument in its citizen petition, the tobacco company says disposable vapes have been found “laced” with fentanyl and urges action on that basis.
The claim comes from a single local newspaper story that quotes a school superintendent explaining the devices in question were “injected” with fentanyl and heroin. That was presumably done by the users of the devices—not by a manufacturer.
What would prevent any consumable product from being tampered with or poisoned by fentanyl, or any other dangerous substance? Indeed, couldn’t a Vuse device be just as easily injected with fentanyl? Couldn’t fentanyl be applied to a Newport cigarette?
Such claims would be laughable if they didn’t come from a powerful company intent on destroying its competitors. And seeking FDA help to beat the vaping competition isn’t new for R.J. Reynolds.
In 2014, commenting on a draft version of the proposed FDA Deeming Rule, RAI Services urged the agency to ban all open-system (refillable) vaping products.
“Unlike closed-system products,” said Reynolds, “open-system products are highly customizable. As a result, there is no way to adequately evaluate how such a product will work or to establish whether consistency of product composition and quality can be maintained.”
The cigarette company then explained that vape shops could be classified as manufacturers, since some mixed e-liquids on site, and all “assembled hardware” (putting coils in tanks and connecting tanks to mods, for example).
Reynolds gave the FDA a blueprint for eliminating the troublesome independent vaping industry with regulations the tobacco company thought would be beyond the ability of tiny businesses to comply with.
The FDA listened. The final Deeming Rule was chock full of petty and pointless rules that small vaping businesses were forced to follow. In fact, it was the FDA’s focus on the open-system market that helped the earliest pod-based vapes (like the JUUL) dominate the vapor market—and cause the agency endless heartburn—in the following years.
An FDA citizen petition isn’t like the petitions on Change.org. It’s a legitimate pathway, described in the Code of Federal Regulations, that allows individuals or companies to ask the FDA to “issue, amend, or revoke a regulation or order,” or “take or refrain from taking any other form of administrative action.”
Last June, the American Vapor Manufacturers Association (AVM) filed a citizen petition asking the FDA to use its enforcement discretion to delay enforcement against vaping manufacturers that submitted PMTAs for synthetic nicotine-containing products.
Reynolds’ citizen petition has been docketed on Regulations.gov, and is open for public comment. It can be downloaded there for anyone wishing to read it in its entirety.