States across the country are commencing their legislative sessions, and public health advocates have seen a resulting wave of so-called “registry” bills that have been predominantly supported by the tobacco industry. These laws seek to establish or amend product registries or directories that purport to regulate retail sales of e-cigarette and other nicotine products. Generally speaking, these laws limit the products being marketed to only those that the FDA has approved for sale—or, more accurately, to only those products that the FDA has not definitively prohibited for sale. Public health advocates should carefully consider the public health implications of these proposed laws and critically evaluate whose interests they advance.
The Regulatory Background
At first blush, these bills seem to close a loophole leveraged by e-cigarette manufacturers and distributors. Before manufacturers can sell new tobacco products, including e-cigarettes, they must submit a Premarket Tobacco Product Application (PMTA) to the U.S. Food & Drug Administration (FDA). The FDA can then either grant their application, at which point they can sell their products indefinitely, or the FDA can deny their application, at which point they must cease selling them altogether. Unfortunately, because of the lengthy time it is taking the FDA to process applications, or because of legal challenges to denial orders, some manufacturers and distributers take the liberty of keeping their products in the marketplace until they receive a final answer from the FDA or the courts, all the while risking enforcement action because they are selling without authorization.
To date, the FDA has authorized only 23 e-cigarette products and related devices, all of them tobacco-flavored. It has also issued thousands of denials. Manufacturers can and do challenge those denials in court, of course, and use a variety of legal maneuvers to delay agency action. Most e-cigarette applications fall into the limbo of having received neither a marketing granted order (MGO) nor a marketing denial order (MDO); without the former, the products cannot be legally sold in the U.S.
Unfortunately, the FDA has not aggressively pursued enforcement actions against manufacturers who either never submitted a PMTA for their products or who did but persist in selling products that have not been approved by the FDA. Thousands of e-cigarette products—including flavored products popular among youth—fall into this category and are being sold without proper FDA authorization. The tobacco-industry-backed registry laws are supposedly intended to fill the enforcement void left by FDA inaction.
The Registry Approach to Unauthorized E-Cigarettes
But what exactly are these registries? How do they work? Why is the tobacco industry lobbying for the passage of these bills? And can registries help states effectively regulate these products in the absence of marketing authorizations issued by the FDA?
While the specific language of e-cigarette registry bills (and those already passed into law) varies across states*, the laws typically create a state-managed public registry for e-cigarette products. To register with the state, a manufacturer must provide proof of an FDA-issued MGO, proof of a pending PMTA that remains under FDA review, or, in some states, proof that the manufacturer’s product has received an MDO issued by the FDA, but that the order was stayed by either the FDA or a federal court. Only those products that have been appropriately entered into the registry can then be sold in the enacting state.
On its face, these registries would appear to significantly limit the number of e-cigarettes that can be sold in a state because they should prohibit the sale of products that never submitted a PMTA. That would certainly be a victory in itself, but even if the registries completely weed out e-cigarettes that never applied through the PMTA process or that have received MDOs, tens of thousands of products can still qualify for most registries because of the FDA backlog.
Even as a means of identifying only those products with pending applications before the FDA, this system is not foolproof. Concerningly, as part of this registration process, some laws allow for self-certification by the manufacturer that its products meet one of the above criteria, including that a product received an FDA marketing authorization order or “other authorization.” What “other authorization” means, though, is unclear and potentially creates a loophole for manufacturers to get their products into the marketplace even if they are not authorized by the FDA.
And of the states that do not use this vague term but rather simply require documentation that a PMTA was previously submitted to the FDA, it remains uncertain how state agencies can verify that a PMTA application is still pending. While the FDA publishes a list of companies who received MDOs for their products, it warns the public that the list is not comprehensive. The FDA also does not publish a list of applicants because of commercial data and privacy concerns.
Thus, while these laws give the appearance of creating an easily enforced, straightforward regulatory regime, the reality is different. Most of these registries also allow for enforcement in the form of fines or other civil penalties against noncomplying manufacturers, distributors, or retailers that sell e-cigarettes and other nicotine products that are not included in a state’s registry. But there are thousands of unauthorized products for sale, and none of these registry bills seem to account for the large amount of funding that would be required to cull through the high volume of products to identify, track, and then enforce against all unregistered products being sold in the state.
Further, even setting aside such practical concerns, registry laws fall short of protecting youth from accessing e-cigarettes, especially products that contain flavors. Thus, even if rigidly enforced, such laws wouldn’t necessarily reduce e-cigarette use among vulnerable populations.
To be sure, these laws do have some potential advantages. Even if, in practice, they authorize thousands of e-cigarettes to be sold within a state, they may still succeed in weeding out many thousands of other products, especially disposable e-cigarettes made by foreign manufacturers that never went through the PMTA process. And that marginal benefit may help explain why these laws are being pushed by familiar industry players like Altria and Juul, who have engaged in the PMTA process for their products. As written, many of these laws would keep their products on the shelves (because they submitted PMTAs), while banning those made by foreign competitors (because they did not). These tobacco insiders have profit-driven incentives behind their advocacy: the registry laws keep competitors out of the marketplace without creating meaningful restraints on their ability to sell their own products.
Perhaps most importantly for industry-advocates of these laws, registries may distract from more meaningful regulations. Strong tobacco retail licensure laws, either at the state or local level, have proven time and time again that regular inspections, compliance checks, licensure fees, zoning, density caps, and prohibitions on price promotions and discounts (to name just a few) are all effective measures to protect against youth access to and use of e-cigarettes.
Public health advocates have not yet reached consensus on the ultimate utility of e-cigarette registry bills. Because a slew of bills are cropping up in states this year, each piece of legislation needs to be carefully analyzed to identify areas that fall short of protecting public health.
Indeed, registry laws can operate as an effective regulation if they are designed correctly. The City of San Francisco has already established a public health-initiated registry ordinance that prohibits the sale of e-cigarette products that do not have marketing orders issued by the FDA, with violations resulting in possible rescission of a retailer’s tobacco sales license. By restricting sales of these products only to those already authorized by the FDA—the 23 tobacco-flavored e-cigarette products—San Francisco’s registry works in tandem with the FDA’s PMTA process and federal law by requiring that all new e-cigarette products have marketing authorization prior to their introduction into the marketplace. This more public-health oriented and straightforward form of regulation is preferable to expending state or municipal resources on regulating thousands of products with pending and unverifiable FDA authorization statuses.
For many in the public health community, it will be a better use of already scarce resources to develop and enforce robust tobacco retail sales laws that serve to protect youth and public health overall. For others, the registry law under consideration in their state might be the only type of regulation that will succeed given their political climate. At the end of the day, public health advocates weighing in on these laws should reflect on who is advocating for the law and why, and should consider realistic alternatives.
*In 2024 alone, registry bills have been introduced in Florida (SB 1006) and (HB 1007); Hawaii (SB 3385) and (HB 2794); Indiana (SB227); Missouri (HB2211); New Hampshire; Utah (SB 133); Vermont (H.729); Virginia (SB550); Washington (SB6118); and Wisconsin. Registry bills have already passed in Alabama, Louisiana, and Oklahoma. And in the following states, registry bills were filed in previous years but did not pass into law: Georgia, Mississippi, South Carolina, Tennessee, and West Virginia.
Marisa Katz and Tom Pryor, Staff Attorneys
February 1, 2024