In the last few months, several state lawmakers have introduced PMTA registry bills to tackle the sale of e-cigarettes. PMTA registries are designed to safeguard citizens against illegal, unauthorized tobacco products. If the bill passes, state lawmakers will create a registry that lists all FDA-approved e-liquids and e-cigarettes, and an independent state agency will oversee the registry.
Oklahoma and Louisiana already have PMTA registries, and many more states are following suit. Currently, 25 U.S. states have introduced PMTA registry bills, including Georgia, Indiana, New York, South Carolina, and Vermont. Each state has different rules for PMTA registries, but the general idea remains the same.
Under the current system, manufacturers must submit a Premarket Tobacco Product Application (PMTA) to the FDA before they can sell tobacco products, including e-cigarettes. If the FDA grants the application, the manufacturer can sell its products indefinitely. If the FDA denies the application, the manufacturer has to stop selling its products indefinitely.
The FDA seems unequipped to handle the growing number of PMTAs and, as a result, many manufacturers take advantage of what they see as a legislative loophole. Instead of waiting for a response from the FDA, manufacturers continue to sell e-cigarette products illegally.
The proposed PMTA registry bills intend to solve this problem. To register with the state and sell tobacco products, vape manufacturers must provide an FDA-issued Market Granted Order (MGO) or proof of a pending PMTA that remains under FDA review. Manufacturers that cannot provide either of these proofs cannot sell their products in that state.
PMTA registry bills put the onus on states, rather than the FDA, which might alleviate the strain on the administration. That being said, the requirements to be approved by the registry have raised eyebrows.
Under the proposed guidelines, manufacturers only have to show proof that tobacco products are under FDA review. Manufacturers who already sell e-cigarettes without the approval of the FDA can simply apply for a PMTA, show proof to the PMTA registry, and continue selling e-cigarettes as normal. We have to question the logic of making this loophole legal.
The rapid introduction of PMTA registry bills is alarming. When we dug a little deeper into this story, we heard whispers that Big Tobacco is the driving force behind the introduction of PMTA registry bills. The registries will eliminate a lot of the e-cigarettes on the market, but will also support a few popular brands that have already received FDA approval.
Small businesses, retailers, and vape brands fear the PMTA registry spells disaster for their livelihoods. Following the introduction of House Bill 635 in Louisiana, the Louisiana Convenience and Vape Association (LACVA) has fought for (and been granted) a temporary injunction against the registry1Louisiana Convenience and Vape Association [LACVA]. https://www.lacva.org/. Who is to say that this won’t happen in the other 25 states that are debating PMTA registry bills?
There are also growing concerns that PMTA registries are equivalent to an outright ban on e-cigarettes, which, as studies have shown, result in adults returning to traditional cigarettes2A. Friedman, A. C. Liber, A. Crippen, and M. Pesko, “E-cigarette Flavor Restrictions’ Effects on Tobacco Product Sales,” Social Science Research Network, Sep. 26, 2023. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4586701 for their nicotine fix.
The Consumer Advocates for Smoke-free Alternatives Association (CASAA) has issued a call to action for states debating PMTA registries. For the latest news, visit the state locator3“Vaping Laws & Regulations by State – State Locator,” CASAA. https://casaa.org/get-involved/state-locator/.
