R.J. Reynolds Urges FDA to Focus Enforcement Efforts on Disposable Vapes

The manufacturer of Vuse e-cigarettes has submitted a formal citizen petition to the FDA, requesting that it concentrate its enforcement efforts on vaping products on disposables, which currently account for the majority of sales in the convenience store/gas station sector of the American vaping market. RAI Services Company filed the petition on February 6 and on February 8, the FDA uploaded it to Regulations.gov for public comment.

The parent business of R.J. Reynolds Tobacco business and several other Reynolds-owned enterprises, such as R.J. Reynolds Vapor Company, the manufacturer of Vuse e-cigarettes, is Reynolds American Inc. (RAI), which includes RAI Services Company as its regulatory compliance division. British American Tobacco, the company that sells Vuse globally, owns RAI.

Because of its best-selling product, the pod-based Vuse Alto, Vuse is the most well-known brand in the c-store vape industry. Additionally, it is the only brand with three FDA-approved devices: the Vuse Solo, Ciro, and Vibe. There are no well-liked Reynolds-approved Vuse products on the market, and none of them come in tastes other than menthol or tobacco.

To "better protect public health," the Reynolds citizen petition requests that the FDA amend its enforcement guidelines to give priority to "illegally marketed disposable electronic nicotine delivery system ('ENDS') products."

It is somewhat ironic that the company that makes Newport and Camel cigarettes is pleading with the government to remove its rivals off store shelves in the interest of public health. Reynolds has, however, previously urged the FDA to eliminate its rivals in the vaping sector.

Reynolds enumerates its favored targets for FDA enforcement.

Reynolds is essentially requesting that the FDA reorganize its enforcement priorities to focus on the largest rivals of Vuse at the moment. Reynolds wants the FDA to remove the following goods from its list:

• "Any flavored disposable ENDS (apart from those flavored with menthol or tobacco);"

• "Any disposable ENDS that come from a source other than tobacco that contains nicotine that is not approved for premarket;

• "Any disposable ENDS that weren't on the list but contained nicotine derived from tobacco the market as of August 8, 2016, or for which the producer either neglected to apply by September 9, 2020, or by that date, if you filed a PMTA to the FDA, but obtained a decision that isn't being contested in court;

• "Any disposable ends that the manufacturer has not included—or is not including—in the product sufficient safeguards against minors' access; and

• “Any disposable ENDS targeted to, or whose marketing is likely to promote use by, minors.

R.J. Reynolds does not sell disposable vapes, vaping products in flavors other than tobacco or menthol (Vuse flavors have applied for MDOs or have received marketing denial orders), products with synthetic nicotine, or products that have been issued an MDO but have not challenged it in court (RJR is suing the FDA over MDOs for Vuse menthol refills).

True, the majority of disposable vapes are available in a murky legal space. Many have not filed for authorization at all, while some have premarket tobacco applications (PMTAs) pending with the FDA and some have been denied but are still on sale.

The FDA probably knows that taking legal action against many of them would be futile, which is why it hasn't done so yet. Many of these products are sold by enigmatic, hard-to-identify companies. The majority of them are merely importers and resellers; the real manufacturers are in China. The importer can alter the product's name, address, or both throughout the period it takes the FDA to do research on a particular product and issue a warning notice.

There's a new "disposable loophole"

Regarding its intended enforcement plan, Reynolds states that "such a policy will close an existing loophole in FDA's current tobacco enforcement efforts, especially when it comes to youth."

The FDA's February 2020 enforcement advice, which exempted some disposable e-cigarettes with flavors other than tobacco and menthol from regulation, contains the "loophole" Reynolds is referring to. But as far as the attorneys at Reynolds are aware, that regulation only applied to otherwise legal items that satisfied further FDA requirements and had been on the market prior to the Deeming Rule's implementation on August 8, 2016.

The goal of the 2020 FDA enforcement advisory was to keep legacy disposables like blu disposables and the NJOY Daily on the market while their PMTA applications were being processed (the FDA later approved the Daily). Not every throwaway gadget was allowed to remain on the market by the agency without fear of enforcement. As the FDA informed Puff Bar in its July 2020 warning letter, any product that wasn't already on the market before August 8, 2016, needs FDA authorization before being sold.

The manufacturer of the most widely used vaping product in the US is now spreading the tobacco control fallacy that the FDA's enforcement strategy fueled the proliferation of Puff Bars and other disposables. This lie was first propagated by indolent journalists. By the way, the only reason the Vuse Alto is still available on the market is due to FDA enforcement discretion. The Alto PMTA is still being examined by the agency.

Additionally, Reynolds calls synthetic nicotine a "loophole." It's just a product that the FDA couldn't regulate until last year when Congress gave it to them.

Selling cigarettes that theoretically employ non-menthol coolants in a place where the sale of menthol cigarettes was recently outlawed could be considered a legal loophole. Reynolds is trying to persuade the US Supreme Court to consider its challenge to the state statute, so that's what it's doing in California.

Reynolds claims that fentanyl is "laced" into disposables!

The tobacco firm claims that disposable vapes have been discovered to be "laced" with fentanyl in its closing argument in its citizen petition, and it is urging action on that premise.

The assertion is based on a single local newspaper article that cites the superintendent of schools as saying that the devices in question were "injected" with heroin and fentanyl. That was most likely done by the gadgets' owners rather than a manufacturer.

What would stop somebody from tampering with or poisoning any consumable product with fentanyl or any other harmful substance? In fact, wouldn't it be possible to inject fentanyl into a Vuse device just as easily? Is it not possible to apply fentanyl to a Newport cigarette?

Such statements would be absurd if they didn't originate from a strong business that is determined to crush its rivals. Furthermore, R.J. Reynolds is not new to asking the FDA for assistance in beating the vaping competitors.

Reynolds previously requested FDA-assistance to eliminate vapor competition

In 2014, RAI Services pushed the FDA to outlaw all open-system (refillable) vaping products in a comment on a draft version of the proposed Deeming Rule.

Reynolds stated, "Open-system products are highly customizable, in contrast to closed-system products." Therefore, it is impossible to determine whether consistency in product composition and quality can be maintained, or to determine how well such a product will work.

The tobacco business went on to say that since vape shops all "assembled hardware" (such as coils in tanks and tanks connected to mods) and some mixed e-liquids on-site, they may be considered producers.

Reynolds provided the FDA with a design that would dismantle the problematic independent vaping market, complete with rules the tobacco firm believed small businesses could not possibly follow.

The FDA paid attention. The final Deeming Rule was crammed with unnecessary and trivial regulations that small vape companies had to abide by. The FDA's emphasis on the open-system market contributed to the early pod-based vapes' dominance in the vapor industry—including the JUUL—and gave the agency a lot of heartburn in the years that followed.

Comments on Reynolds' citizen petition are welcome.

A citizen petition with the FDA is not the same as one on Change.org. According to the Code of Federal Regulations, there is a legal process by which people or businesses can request that the FDA "issue, amend, or revoke a regulation or order" or "take or refrain from taking any other form of administrative action."

The American Vapor Manufacturers Association (AVM) petitioned the FDA in June of last year, requesting that it utilize its enforcement discretion to postpone taking legal action against vaping companies that had submitted PMTAs for goods that contained synthetic nicotine.

Reynolds' citizen petition is available for public comment on Regulations.gov and has been docketed. Anyone who wants to read it through can download it from that page.