FDA Releases List of Authorized E-Cigarette Products

A one-page list of vaping items that the FDA has approved for sale in the US is available for download. The list is meant for "tobacco retailers looking for information on what e-cigarettes are legal to sell," according to the agency. "As of August 2023, FDA has authorized 23 tobacco-flavored e-cigarettes and devices," the FDA stated in a tweet outlining the list.

That isn't quite accurate, though. First off, out of the twenty-three "e-cigarettes and devices" (whoa!?), twelve are refills. Additionally, some of the approved devices come in numerous versions, each with a few tiny tweaks that don't affect how the user interacts with the device. Thus, two NJOY Dailys, two Vuse Ciros, and two Vuse Vibes. Lastly, one of the gadgets isn't an electronic cigarette at all.

What Are "E-cigarettes"? Are Heated Tobacco Products?

Yes, it is correct. Heated tobacco products (HTPs, also called heat-not-burn products) like the Logic Vape leaf Tobacco Vapor System and its approved refills evaporate solid capsule refills that contain actual tobacco. The FDA's approval of HTPs for marketing is perfectly OK, but if it thinks that HTP devices are e-cigarettes, why doesn't it also include Philip Morris International's IQOS HTP device and refills on the list of approved "e-cigarettes"?

The FDA approved PMI's first IQOS device in 2019 under the premarket tobacco application (PMTA) procedure. A modified risk tobacco product (MRTP) was later approved by the FDA. In 2019, the government approved refills for three distinct IQOS HeatSticks, two of which included menthol flavors. An upgraded IQOS device was approved by the FDA in 2021, and three more HeatSticks with tobacco flavors were approved by the FDA earlier this year. That makes a total of eight IQOS-approved products.

Why leave off eight additional "e-cigarettes and devices" from the agency's impressive list when the IQOS authorizations would add them? Because HTP products aren't e-cigarettes, it can't be. Logic Vapeleaf HTP products, after all, are on the FDA's list.

Since FDA Commissioner Robert Califf and Center for Tobacco Products (CTP) Director Brian King have made the prohibition of menthol a cornerstone of their confused (and confusing) war on low-risk nicotine products, is the FDA trying to downplay its authorization of low-risk IQOS products in menthol flavors?

Or is it that King and Califf don't want to bring up the fact that the agency has approved so many IQOS SKUs with their buddies in tobacco control? More IQOS products have FDA approval than there are vaping devices that use e-liquid and have been approved for sale by the agency.

Six Vaporizers That Are Available To Customers Have Been Approved By The FDA.

In actuality, the regulatory body has only approved more IQOS refills since King assumed leadership of the CTP in July 2022—not a single e-liquid-based vaping product.

Three products have been removed from the list, though. Three marketing given orders (MGOs) issued by the FDA for the Vuse Ciro device are essentially null and void because R.J. Reynolds has discontinued selling the device and refills. The FDA marketing denial order (MDO) for Ciro menthol refills was no longer appealed by RJR due to the product's little commercial significance, a fact the agency was fully aware of when it compiled its list.

So let's compile a true list of "e-cigarettes approved by the FDA." The three Logic Vapeleaf products are not e-cigarettes, so we will disregard them. Next, since the two Vuse Vibe Power Units are nearly identical, we'll remove authorizations for devices that are no longer in production (so long, Ciro).

The actual FDA-approved (and accessible) list of e-cigarettes is as follows:

• Logic Pro plus two refills with a smoke flavor
• Logic Power plus one refill with a tobacco taste
• NJOY Daily: two tobacco-flavored nicotine strengths NJOY Ace: three tobacco-flavored refills
• Vuse Solo plus two refills with a tobacco taste
• Vuse Vibe plus one refill with a tobacco taste

That's six devices—or seven, if you insist on counting the somewhat different NJOY Dailys—with nothing but artificial tobacco flavors to fill them.

Are Unapproved And Illegal The Same Thing?

The FDA has declined to consider approving any vaping product that consumers find enjoyable, including those that people use to replace cigarettes, which are harmful and flammable.

The following is a list of vapor goods that the agency has not approved:

• E-liquid in bottles: 0
• Tanks, pods, and open-system (refillable) devices: zero
• Other flavor vapes besides tobacco: 0
• People who prefer disposable vapes: 0
• Popular vapes in online retailers: 0
• Popular vapes in convenience stores: zero
• Worldwide popularity of vapes: 0
• Manufacturers of vapes other than Big Tobacco: 0

Recall that numerous goods in the vape business are being challenged in federal courts, even though the FDA has refused approval for millions of separate products. Hundreds more PMTAs are still being reviewed by the FDA; no decision has been reached as of yet.

Despite not having a particular selling authorization, the FDA has made it clear via both words and deeds that it will not take enforcement action against the companies as long as their PMTAs or legal challenges are pending. Ultimately, unless the FDA chooses to take action against thousands of items with unclear authorization status, its list of approved products is meaningless. Right now, unapproved does not always equate to unlawful.