Adult access to popular combustible cigarette alternatives will be cut off and a Big Tobacco monopoly enshrined in law if Kentucky HB 11 and its companion bill Kentucky SB 344 are passed.

Kentucky taxpayers will foot the bill and pay to enforce failed FDA regulations if this PMTA Registration is passed.

These laws would put independent vape shops out of business, hundreds of workers out of jobs, and thousands of people at risk of returning to smoking, or thwarting efforts to transition to nicotine alternative products. Only lower margin products would remain on the market, with popular disposable vapes banned. 

Please take a minute to send an email to your lawmakers urging them to oppose HB 11 / SB 344! Click here or on the banner below. 

Failed PMTA Process

PMTA Registry Laws have been backed by tobacco lobbyists in dozens of states. Check out our deep-dive, the Big Lies of Big Tobacco, for everything you need to know about these laws.

PMTA is an acronym for Premarket Tobacco Application. This is the horribly broken FDA process that has approved all of seven obsolete cigalikes and 23 SKUs, which includes a narrow selection of unpopular artificial tobacco inspired flavor profiles. 

This process threatens to deny adult vapers access to the products they prefer. Especially hard hit are marginalized groups. This is why the Center for Black Equity called on the FDA to approve a wide range of e-cigarettes to ensure Black and LGBTQIA+ Americans can access effective options.

A bipartisan group of US Senators have questioned the failing PMTA process, which faces and will continue to face numerous court challenges.

The PMTA Process was deemed busted beyond repair in a decision by the Fifth Circuit Court of Appeals in the case WAGES AND WHITE LION INVESTMENTS v. FOOD DRUG ADMINISTRATION. They summarized the entire regulatory debacle with the following memorable quote:

Altria's Past Attacks PMTA Process 

In fact, Altria themselves questioned the PMTA process in the past. It is interesting that they are in support of the FDA's flawed and incomplete application process now that it can be used to their advantage. Their PMTA Registry Bills will remove products popular with adults from the market but are structured so their products remain on the shelves.

Here are some of Altria's past statements on the PMTA process.

• Unfortunately, Center for Tobacco Products (CTP) appears to be relying on a “fatal flaw” analysis to reject applications. This approach has drawn legal challenges, fuels suspicion that CTP is adjudicating applications with a pre-determined agenda and ultimately undermines the credibility of the Center and the Agency. Further, without a full and complete review, manufacturers lack insight needed to address deficiencies and re-submit an improved application.
• Science-based engagements should be encouraged between CTP and applicants. Yet, CTP project managers and Office of Science staff appear hesitant to have substantive engagements.
• Unfortunately, how CTP is currently interpreting and implementing that standard leaves manufacturers guessing as to what scientific evidence and rationale will satisfy APPH scrutiny. Without a clearly articulated definition for “appropriate for the protection of public health,” CTP risks making arbitrary and inconsistent decisions and undermining innovative product development, research execution and, ultimately, tobacco harm reduction.

Flavor Bans Increase Cigarette Sales

PMTA Registry Laws have been backed by tobacco lobbyists in thirty-four states. If passed, the adult vaping consumer will either pay more to vape or be funneled back onto combustible cigarettes, either through the sheer expense Big Tobacco's pod kits or the lack of the adult appealing flavors that the majority of vapers prefer.

A recent FDA sponsored study found that flavor bans increase cigarette sales. Big Tobacco's prefilled pods are limited to tobacco flavors. Cigarettes of course are not impacted by these restrictions. Their motivations for supporting PMTA Registry Bills are not difficult to discern. 

Regardless of age, adult vapers overwhelmingly prefer the characterizing flavors that the FDA seems so reluctant to approve. This benefits the tobacco industry. Even the 45+ age cohort prefers flavored vapes at a rate of over 60 percent. This despite flavor bans limiting adult access to in many areas of the country. 

Consumers Pay for Big Tobacco Monopoly

There are two reasons why prefilled pods made by Big Tobacco are hemorrhaging sales to disposable vapes. The first is that prefilled pods are only available in artificial tobacco flavors, not the popular fruit and beverage inspired flavors that can be found in every single consumable product on the market.

Products ranging from kombucha to hard seltzer feature artificial flavor profiles that are very similar to those which are vilified when used in popular vape juices. It is almost impossible to imagine an adult appealing consumable product anchored on the cloying notes of fauxbacco. Possibly a coffee blend? It is a very short list. 

Then there is the price issue. The difference in cost per 30ml of e-liquid vaped is massive. The consumer is not the only beneficiary of fair competition. Products from the independent vape industry have much better margins for the wholesaler.

No editorializing or studies are needed here. It costs over $200 to vape 30ml of e-liquid from a Vuse Alto and $60 from a Lost Mary. Of course the companies trying to sell e-liquid at two hundred dollars per 30ml want rival products banned. 

Big Tobacco’s Motivation for PMTA Registry Laws

The root of the big PMTA Registry push can be found in a Barclay’s Earnings Report Guidance for Altria. Not every big tobacco giant is pursuing these serious restrictions on adult vapers. But after consecutive quarters where revenue expectations were not met, Altria has decided eliminating the competition is the easiest solution. 

To gain support for their efforts to put Americans out of work and drum up cigarette sales, Big Tobacco has turned to telling big lies about the vaping industry and American businesses that simply seek a level playing field.

But it is not all bad news for the tobacco industry, former FDA Chief Scott Gottlieb noted that declines in smoking have been effectively checked by the flavor bans and restrictions placed on vaping products. Even if MyBlu or Vuse are losing sales to disposable vapes, their legacy combustible products remain a cash cow that dominate shelf space and market share. 

Declines in smoking rates have started to stall ; if we're going to help more adults quit combustible cigarettes we have to embrace harm reduction and offer adult smokers modified risk nicotine products that don't have same risks as combusting tobacco 1/2 https://t.co/l3a1zmffqc

— Scott Gottlieb, MD (@ScottGottliebMD) February 26, 2024

The Future of Cigarette Sales

Smoking rates have been declining for almost 60 years. This progress has been checked by FDA regulations. An FTC report in the October 2021 found cigarette sales increased for the first time in a quarter century. 

Even with this recent reversal of fortune, the erosion of the core cigarette business has been severe. As reported in the Wall Street Journal:

"According to data from Marlboro maker, cigarettes’ share of the U.S. nicotine industry fell to 60% last year, down from 80% in 2018. Smokers are switching to smoke-free products such as vapes in higher numbers than expected. If the trend continues, it will only take another three years for cigarettes’ share to slip below 50%."

The table below shows where this pressure has been coming from. The US adult population has grown by some 23 million since 2011. The total number of adult nicotine users, be it tobacco, vapes or pouches, has declined. 

The CDC reported in 2023 that e-cigarette use continues to decline among high school students. The easiest way for the tobacco industry to prevent a further depletion of their customer base is to eliminate the competition through regulatory capture or PMTA Registry laws that create a de facto ban on competing products.