• July 21, 2024

Registered Outcomes

 Registered Outcomes

Credit: Jet City Image

Credit: Jet City Image

U.S. states are passing vape product registry bills to combat the FDA’s lack of enforcement.

By Timothy S. Donahue

Vaping product registry bills are gaining momentum in the U.S. This surge is a direct response to the perceived lack of action from the Food and Drug Administration in curbing the influx of illegal disposable vaping products. Currently, three states have successfully implemented registry rules, with four more set to follow suit in 2025. Notably, several other states are in the process of drafting similar bills.

Critics claim that registry bills favor major tobacco companies, and many continue to condemn the premarket tobacco product application (PMTA) process as excessively onerous. They point out that it’s easier to bring new cigarettes to the market than it is to gain authorization for lower risk products such as e-cigarettes and vapes.

According to Nick Orlando, an entrepreneur and president of the Florida Smoke-Free Association, if there is any area of the vaping industry that genuinely needs reform, it is at the federal level and within the failed FDA review and approval process.

“The FDA’s Center for Tobacco Products [CTP] is supposed to comply with a statutory, 180-day deadline to review new tobacco product applications, many of which are potentially less harmful than combustible cigarettes,” said Orlando. “However, as Florida’s vape manufacturers have experienced, working through this process is often a painstaking, costly and onerous ordeal that has resulted in a backlog of thousands of applications that have sat with the CTP for years.”

Tony Abboud with the Vapor Technology Association said there are currently 13 million vapers across the U.S. Yet only six different types of FDA-authorized e-cigarettes are presently on the market. To date, the FDA has not authorized any nontobacco-flavored vaping products, rejecting millions of applications, which critics say amounts to a blanket anti-flavor policy.

When speaking about a recent state registry proposal, Abboud said only the major tobacco companies that have FDA marketing authorizations reap the benefits from legislation created to limit the number of products available to consumers. He compared registry bills to a scenario in which all beer except for Bud Lite and Miller Lite are removed from stores. “Bud and Miller would love it, right, because they are definitely going to pick up some more customers,” Abboud said.

Gregory Conley, director of legislative and external affairs at the American Vapor Manufacturers Association, said there is no need to guess why companies like Altria have dedicated massive resources toward passing PMTA registries. Altria has claimed in its investor reports that disposable vaping products are cutting into the company’s cigarette sales.

“This is not about giving a competitive advantage to [Altria subsidiary] Njoy products; it’s about selling more combustible cigarettes, which kill over 400,000 people each year,” said Conley. “Fortunately, the more politicians learn about these bills, the less they like them, which is why most states that considered these bills in 2023 and 2024 have rejected them.”

Alabama, Louisiana and Oklahoma already have PMTA registry bills in effect while laws in Kentucky, Utah, Virginia and Wisconsin are set to take effect in 2025. Many vape directories are very similar. Louisiana and Oklahoma, for example, nearly mimicked Alabama’s vaping registry rules. It should be noted that both the Alabama and Oklahoma registry rules, while technically in effect, are not currently being enforced. Bills to fund the enforcement of regulations in both states have been defeated by vaping industry advocates.

The Louisiana Office of Alcohol and Tobacco Control (ATC) released the list of vape products that have been approved for sale. The VAPE Directory can be found on the ATC’s website. The law requires vape products sold in Louisiana to submit a certification form to the ATC. The directory list is updated every first of the month.

If a product isn’t on the list, then it can’t be sold in the state. Some approved products on the list are Juul pods, Bidi Sticks and Vuse pods. Louisianna’s list contained less than 400 products when observed on June 1. In Louisiana, to be listed on the VAPE Directory, products must meet one of the following criteria:

  • Products must be on the U.S. market as of Aug. 8, 2016, and the manufacturer must have applied for a PMTA prior to Sept. 9, 2020, pursuant to federal law and the PMTA remains under review by the FDA;
  • Any vapor products or alternative nicotine products on the U.S. market that the FDA has issued a “no marketing order” but the agency or federal court has issued a stay order or injunction during the pendency of the manufacturer’s appeal or the order has been appealed and remains pending; or
  • The manufacturer has received a marketing order or other authorization under federal law for the vapor or alternative nicotine product from the FDA.

Under the Louisiana rules, the commissioner may approve a vape or alternative nicotine product without a PMTA if a manufacturer can demonstrate that the FDA has issued a rule, guidance or any other formal statement that temporarily exempts product from federal PMTA requirements and provide sufficient evidence that the product is compliant with federal rule, guidance or other formal statements.

To date, the FDA has authorized only 23 e-cigarette products, all of which are owned by major tobacco companies. The remaining brands on the market, such as the Elf Bar, Puff Bar and others, are considered unauthorized products. Limited FDA enforcement prompted states to step in with registry bills. One state, however, created a unique system for removing electronic nicotine-delivery system products from state shelves.

Florida’s Fortune

Florida has a reputation of doing things differently. The state’s creation of its vape registry rules was no exception. It didn’t start that way. The original version of Florida’s vape registry rule was like Louisiana’s. However, Orlando said that with Florida’s House Bill 1007, Governor Ron DeSantis and his team found a way to regulate the industry that would best serve the concerns of Florida’s attorney general while keeping vaping retailers in business.

Unlike other state registries, Florida will not create a list of FDA products that have marketing authorization or are currently under PMTA review. Instead, Florida Attorney General Ashley Moody is tasked with creating a registry of products deemed illegal only after an administrative review process and a public comment period. The law focuses on disposable products and allows for the sale of most open system and pod system products.

“The list does not currently have any products on it. The state must create a list, SKU by SKU, meeting specific criteria. The list and the products listed are then placed on a referral to a rules committee, which would then open up for public comment any items that made the ‘unauthorized’ list. There would also be mediation with the product owner,” explained Orlando. “The real benefit is that this process is very long, and it only deals with single-use products. You can keep a product on your store shelves until the entire process is completed.”

HB 1007 requires the state’s attorney general to submit by Oct. 1, 2024, the rules by which Florida’s vaping products committee places products on the “illegal” list. The attorney general would then use those rules to put products on the list for review by the vaping committee, whose members are to be appointed by DeSantis.

The law requires the state’s Department of Legal Affairs to create and keep a directory of all single-use nicotine vapes that it considers appealing to minors. This directory must be made accessible to the public by Jan. 1, 2025, and it should be updated regularly. Once a product is added to the list, retailers and wholesalers in Florida have 60 days to sell or remove it from their inventory. Any products left in circulation will be subject to seizure and destruction.

Other states are responding to Florida’s legislative style for vaping product registration. Orlando said several state vapor associations are trying to figure out ways to tailor the Florida bill to their respective states. Due to varying administrative laws among U.S. states, Florida’s bill cannot be a “cookie-cutter” bill for different jurisdictions. Lawmakers cannot just copy language from Florida’s legislation.

“State organizations have called me to ask how it all looks and how does this work. And when I’ve explained it, our lobby team has gotten on the phone with their lobby team, and they’ve helped draft some legislation similar to [Florida’s] where the industry can continue to operate,” said Orlando. “Nothing to report yet. We will have to wait and see if other states can recreate what has happened for Florida’s vaping industry.”

Conley disagreed. While the Florida bill trumps an outright ban, politicizing vaping regulations is unnecessary. “While undoubtedly better than a full-blown ban on 98 percent-plus of the current vaping market, Florida’s bill should not be a model for other states,” said Conley. “Politicizing vaping by putting unilateral control into the hands of attorneys general does not make sense, particularly in light of the decline in youth usage we have seen since 2019 …. Adult use of vaping products has grown significantly since 2020 all while youth vaping has continued to fall. In any other reality, this would be celebrated as a significant public health victory.

“On the plus side, Florida does have strong due process rights built into its administrative law statutes, so Florida businesses and consumers will have the opportunity to weigh in on future bans and potentially bring litigation.”

Many manufacturers praised the Florida rules. Several companies said that the U.S. needs to address the flood of “illegal” vapes “entering the country from China.” Juul Labs (formerly an Altria subsidiary) stated in a release that illegal flavored disposable vaping products are produced by foreign manufacturers who “shirk U.S. laws while continuing to illegally target minors” with vape products that feature youth-appealing packaging and flavors.

“Properly constructed and effectively enforced product directory laws can be an important supplement to federal enforcement against these illegal vapor products. We remain committed to upholding and participating in a well-regulated nicotine marketplace across the United States and in Florida,” Juul Labs stated. “We have invested significantly in product development, regulatory science, manufacturing quality controls, and compliance programs.

“We believe all companies participating in the nicotine vapor market should be doing the same, to ensure that the products reaching consumers are of the highest quality and are reaching only intended users—adult smokers.”

Disciplinary Reaction

Another difference in Florida’s vaping rules is that the regulations have some teeth to combat underage retail sales. Any person who sells a nicotine product, including vapes, to someone under 21 for a third or subsequent time will face a third-degree felony charge, punishable by up to $5,000 in fines and five years in prison.

Beginning March 1, 2025, manufacturers that sell prohibited products in the state will face a $1,000 daily fine for each such product until it’s removed from the market. This stricture will also apply to retailers, wholesalers and distributors who ship products into Florida.

“That piece was in the original PMTA bill. We didn’t massage that one at all, but I think it does have a little more meat to it because there’s a third-strike rule that is substantial,” said Orlando. “Now, between you and me, I would go a little deeper than that, but they’re happy with what they wrote, so we’ll take it.”

Orlando said retailers have embraced Florida’s new rules. The options were either an outright ban on all flavored vaping products or HB 2007, which allowed for adult vapers to have access to a variety of flavors and hardware options to help a broader swath of combustible smokers make the switch to vaping.

“Once I explain to them what really happened and they understand the dynamics of it and what it takes, actually, to get something on the list and that open systems are totally excluded, they’re happy with it,” he said. “Because let’s remember, they had a choice: either be banned or be able to sell. I mean, it’s a pretty simple thing. There was no chance for a veto in this scenario.”

Research has shown that flavors play a crucial role for individuals transitioning from cigarettes to vapes. Many ex-smokers report that they were only able to quit after discovering the specific vape flavor that suited them. Additionally, several studies have shown that many adult vapers prefer flavors other than tobacco.

Regulations that specifically target THR products and raise their price or reduce their availability to adults not only threaten Americans’ health but also negatively impact state and federal budgets reliant on excise tax revenues, detrimentally impact 380,000 small businesses, encourage market consolidation in the tobacco industry and fail to target underage tobacco use, according to Citizens Against Government Waste. 

“These regulations also push consumers and sellers into the unregulated black market for tobacco, putting consumers at risk of tainted products, many of which come from China. Responsible policymakers should acknowledge the benefits of THR products in mitigating the costly health impact of combustible cigarettes,” the group stated in a release. “Yet proposals to restrict the availability of THR alternatives relative to cigarettes continue to move through state legislatures, including Virginia and South Carolina.”

Brandon Suriff, owner of Texas-based Create A Cig, said he once operated five thriving vape shops in Louisiana. However, the state’s PMTA registry forced Suriff to close two locations and lay off eight staffers. He says without action by the Louisiana lawmakers, the three remaining Create A Cig stores are struggling to survive.

“The PMTA registry, while perhaps well-intentioned, has drastically limited the vaping products we can sell, cutting our sales in half and reducing our inventory selection by 90 percent. This change not only affects our bottom line but also drives our adult customers to seek products in neighboring states or through online vendors, inadvertently fostering an illicit market,” explains Suriff. “The enforcement of this registry by the Louisiana Office of Alcohol and Tobacco Control, which has just 30 agents to oversee the entire department, has proven to be a significant challenge. This has led to uneven enforcement and placed an undue burden on legitimate businesses like ours while doing little to curb underage vaping.

“Legislators rushed into this registry without fully understanding its economic impact or its inefficacy in addressing the illicit market. It’s time for a reevaluation. Our aim has always been to offer a safer alternative to smoking, with strict measures to prevent sales to minors. If protecting our youth is the goal, there are better ways to achieve it without decimating local businesses and restricting adult consumers’ access to harm reduction products.”

Orlando said that, at the end of the day, the vaping industry needs reasonable regulations and industry players need to be responsible. He believes the Florida regulations are a step in the right direction for THR.

“Let’s get real. Let’s get accountable and start doing business like we should,” he said. “It takes people being engaged. It takes a great lobby team with a long history and be able to get those ears …. We’re lucky enough to have that. We’ve been doing this for 10 years nonstop, 365 days a year, volunteer efforts. The grassroots people help, too, because when we need them, they’re there.

“Unfortunately, we can’t give up; otherwise, we’ll wind up like them. I advocate for tobacco harm reduction and vaping products because I saw the need for these products to stay on the market. It helped me quit smoking; I opened a shop because of it. It’s worth getting engaged. It’s definitely worth staying engaged before [anti-vaping legislation such as flavor bans and registry bills] comes up, so when it does, you can work through what the real challenges are and understand the root of the situation. Then fight the good fight.”