FDA Finalizes Guidance on Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems
by Practical Law Commercial Transactions
The US Food and Drug Administration (FDA) has finalized guidance for manufacturers submitting new tobacco product applications through the premarket tobacco product application (PMTA) pathway for electronic nicotine delivery systems.
On June 11, 2019, the US Food and Drug Administration (FDA) finalized guidance, titled Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems. The guidance is intended to assist persons submitting premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) (21 U.S.C. § 387j). The non-binding recommendations included in this guidance are meant to improve the efficiency of application submission and review. The FDA, however, will still make decisions about PMTAs for ENDS based on the Food, Drug, and Cosmetic Act’s (FDCA) requirements.
The guidance explains:
- Products to which the guidance applies, including:
- e-cigarettes (eletronic devices that can be used to inhale an e-liquid);
- e-liquids (liquid nicotine that may be combined with coloring, flavoring, or other ingredients); and
- all other electronic tobacco products that are not accessories (for more information, see Legal Update, FDA Issues Sweeping Rules for E-Cigarettes).
- When a PMTA is required under the statute and regulations.
- General procedures for review of an ENDS PMTA.
- What information FDA recommends should be submitted in an ENDS PMTA to show that permitting a new tobacco product to be marketed would be appropriate for the protection of the public health.
For more information about the FDA’s regulation of e-cigarettes and other electronic nicotine delivery systems, see Practice Note, FDA Regulation of E-Cigarettes.
NEW REGULATIONS,NEW ACTIVITY
An Unsettling Precedent
What FDA deeming regulations means for retailers and categories beyond vape.
By MELISSA VONDER HAAR
For anyone in the tobacco business, 2016 will likely go down as the “Year of Deeming.” On May 5, 2016, the U.S. Food and Drug Administration (FDA) announced its long-awaited deeming rule for cigars, electronic cigarettes, vape, pipe tobacco—and more—with the first wave of the regulations going into effect on August 8, 2016.
Key requirements for manufacturers included the submission of ingredient lists, removal of modified risk descriptions and, most importantly, gaining FDA approval for products on the market after February 15, 2007, through either the substantial equivalence (SE) or pre-market tobacco applications (PMTA). Responses to the rule were mixed.
“This is something that has obviously been in the works for a while,” said Tyler Goldman, CEO for San Francisco-based vaporizer and e-cig manufacturer PAX Labs, pointing out that the final rule did not stray far from the proposed deeming regulations announced in April 2014. “I don’t think there was anything surprising.”
THE INNOVATION ISSUE
Not every electronic cigarette company believes the PMTA requirement means the end of the category. Tyler Goldman of PAX Labs, for example, describes the cost of FDA compliance as “just a cost of business,” thanks to the company’s nine-figure revenues. Goldman is, however, keeping an eye on what the regulations mean for the future of the technology-driven vaping industry. Like cell phones, the success of the category depends upon being able to improve and innovate to better meet consumer needs. “We don’t want the pace of innovation to slow down,” Goldman said. “We’re really just in version 1.0 of these products.”
As an international company, Goldman says PAX will continue to evolve its product line. “The question is whether or not we’re able to launch the next set of products in the U.S., or if we’ll have to launch in different markets,” he said.
Don Burke of MSA, however, believes that if PMTA costs don’t kill the vaping category, ending innovation could. “The deeming regulations inhibit further innovation in the category,” he said. “If there isn’t innovation, then this category will never develop its full potential.”
Some saw the regulations as providing much-needed clarity. “The regulations are an important first step in that they provide a procedural structure and dates in which manufacturers are to make submissions to FDA for evaluation,” said David Riser, vice president of external relations for R.J. Reynolds Tobacco Company, Winston-Salem, North Carolina.
Others were conflicted between relief that the regulations didn’t go further and fear about the long-term implications. “I was surprised there was nothing about flavors at that point,” said Anna Bettencourt, a category specialist at retailer VERC Enterprises, Duxbury, Massachusetts. “I’m glad they came out with some regulations, but I feel the costs associated with it are a little too much for smaller companies to bear.” VERC operates 23 facilities in Massachusetts and southern New Hampshire.
WHAT’S AT STAKE
These costs stem almost entirely from the PMTA requirement. It all comes down to the February 2007 grandfather date: If a predicate product was on the market by that date, a manufacturer can get FDA approval through the substantial equivalence pathway. If not, they must go through the more burdensome PMTA process.
The deeming regulations will clearly effect all the newly deemed products. But because the grandfather date predates the entire vapor category, NACS Senior Vice President of Government Relations Lyle Beckwith says electronic cigarettes have the most to lose. “In essence, the [vape] category will all but go away,” he said.
“It increases the cost of doing business for all companies that are regulated,” Joe Teller, category management director at Richmond, Virginia-based Swedish Match, said of the PMTA process. “Only the big companies can handle it.”
Don Burke, senior vice president of Pittsburgh-based Management Science Associates (MSA), said the FDA may have even factored this net vape ban into its decision on flavors. “It’s believed there was no need for FDA to do a flavor ban with this round of regulations because, in effect, the [vape] category was going away,” Burke said.
Even if e-vapor accounts for just 3% of total nicotine volume in the United States according to MSA data, the precedent is cause for alarm. “If an agency can regulate an entire category out of existence with no scientific basis, that’s the genie out of the bottle,” Beckwith said. “What’s next, soda?”
THE COST OF COMPLIANCE
The FDA estimates the PMTA process will cost manufacturers between $117,000 and $466,000 per application (with each product SKU requiring its own application). By comparison, it puts a price tag of $3,500 to $22,700 for SE.
Swedish Match, the sole company that has received approval through the PMTA pathway (for eight General Snus products), says the process is more expensive, more time-consuming and requires more resources than the FDA predicted:
- Costs: Swedish Match didn’t keep a running tally of the costs, but Teller says, “it was a lot more than the [FDA] estimate,” and resulted in a 100,000-page-plus application.
- Time:The FDA gave manufacturers two years from the August 8, 2016, implementation of the deeming rule to submit to PMTA. “If companies hadn’t already started on this process before the law was announced, who knows if there’s enough time to get it all done,” Teller warned.
- Resources: PMTA requires significantly more research, data and information than the SE pathway. “Only so many entities can do that research,” Teller said. “There’s probably been a mad scramble to find these companies.”
Submitting the application is only half the battle. Under the FDA’s timeline, the agency has one year to review the applications. After that, the products can be pulled off the market if a ruling has not been made (which the FDA is not legally required to do). In other words, a manufacturer could do everything right and still see its products taken off store shelves.
“Right now, the FDA has about 3,000 SE applications in front of them and has taken well over a year on nearly all of them, with still no response,” Burke said. “The likelihood of the FDA being able to [review the applications] in a year is very slim.”
FIGHTING BACK
One way to avoid this outcome would be to change the 2007 predicate date so vaping products are “grandfathered” in—just as most cigarettes were in the 2009 Tobacco Control Act.
Karen Nuckols, a senior communications specialist for Richmond, Virginia-based Altria Group Inc. said “not revising the predicate date would mean that newly deemed tobacco products, like e-vapor, would be treated much more harshly than cigarettes.”
WHAT ABOUT FLAVORS?
Though the FDA did not include limits on flavors in the May 2016 deeming regulations, it announced that it intended to issue a new rule that would ban flavored cigars.
“I don’t understand how you can take a perfectly legal adult product, but won’t allow a certain flavor,” said Anna Bettencourt of VERC. “It’s like saying you can only sell regular rum, nothing spiced.”
Other than menthol, NACS did not oppose the ban of flavors in cigarettes. However, Lyle Beckwith points out that retailers face a backlash when the government enacts a ban. “If we’re carrying products, it’s because our customers want them,” he said. “If those products go away, we’re the ones who are going to be blamed.”
Bettencourt has already seen what happens when these sales are removed, operating in six Massachusetts towns that have passed some form of flavor ban. VERC has “definitely had a revenue loss” at those locations. Though that loss was in part due to customers going elsewhere for flavored products, Bettencourt believes that if flavors were banned nationally, there’d still be a black market.
“It takes money away from businesses that do follow the rules and regulations,” she said.
The Cole-Bishop Amendment seeks to do just that, moving the predicate date from February 15, 2007, to August 8, 2016. This measure was introduced by the House as part of a rider in the Agricultural Appropriations Bill. Though approved by the Appropriations Committee, Cole-Bishop would still need to be approved by the Senate and signed into law by the president.
“All the products that were on the market up until the final regulations went into effect would not have to pass substantial equivalency or pre-market tobacco applications,” Beckwith said.
Though it moves the grandfather date, Cole-Bishop would, in some ways, be stricter than the deeming regulations. Nuckols said Altria supports the amendment because “it updates the predicate date and requires the agency to go further than the deeming rule on issues like underage access prevention and battery safety standards.”
NACS is also in favor of this bill, devoting resources to lobbying on Capitol Hill and fighting last year for Cole-Bishop to be included in the 2016 “omnibus” (a year-end bill that funds the government for the following year). To get retailers and vapers involved in the process, NACS also launched a social media campaign called “Stop the Vape Ban,” an online source for deeming, Cole-Bishop and getting involved.
“Moving the grandfather date doesn’t mean these products won’t be regulated,” Beckwith said of these efforts. “Vape will still be regulated and there will be a category to be regulated.”
WHAT RETAILERS CAN DO
Retailer involvement comes down to two things: staying engaged and staying educated.
Both Altria and Reynolds have encouraged retail partners to participate in the regulatory process, through resources such as the NACS Stop the Vape Ban website (stopthevapeban.com), pointing out that retail perspectives are an effective tool in influencing legislators.
Retailers should initiate an open and honest dialogue with their tobacco and e-cig suppliers. Ask them: “Are you going to be applying for substantial equivalency or new product applications?”
“Don’t hesitate to contact your elected officials and be sure they know how things might negatively affect your business,” said Riser of RJR.
There’s still more than a year before the SE application deadline (February 8, 2018), and more than a year and a half before the PMTA deadline (August 8, 2018). Between the Cole-Bishop Amendment and a number of lawsuits filed against the FDA deeming regulations, much could change between now and when the FDA starts making application rulings.
That’s where the need for awareness comes in. While NACS will advise its members on the outcome of Cole-Bishop or other lawsuits that might change the deeming rule, Beckwith urges retailers to start an open and honest dialogue with their tobacco and e-cig suppliers. “Talk with your vendors and see how they’re going to be dealing with it,” he said. “Are they going to be applying for substantial equivalency or new product applications?”
As to just how much impact deeming will have on the convenience channel, it’s simply too soon to tell. But it’s a troubling precedent to say the least.
“My concern is, moving forward, the FDA might not be reasonable,” said Bettencourt of VERC. “The regulations should be fair. I don’t think you can heavily regulate a product if you’re not aware of the potential risks…or rewards.”