Newly proposed rules regarding nontobacco-related flavored vapor products could crush the industry.
By Timothy S. Donahue
On March 13, the U.S. Food and Drug Administration (FDA) put the vapor industry on notice. The regulatory agency released its new draft guidance for vapor products titled, “Modifications to Compliance Policy for Certain Deemed Tobacco Products (March 2019),” and it wasn’t good news.
The plan includes new restrictions on most flavored e-liquids and pods, a tighter deadline to review flavored nicotine products and the ability for the agency to pull all vapor products from the market if it deems the action is necessary to prevent the rise in youth vaping. If enacted, the new policy will likely remove some flavored vapor products from retail stores. Sales of flavored nicotine pods will be restricted to websites, vape shops and other retailers that impose strict age restrictions.
The newly proposed final guidance provides additional clarity to vape shops on their responsibilities under federal law. Any changes in the compliance policy addressed in its new draft guidance will be implemented 30 days after a final version of the guidance is issued. The rule explains that retailers can continue to assist their adult customers with electronic nicotine-delivery systems (ENDS) by demonstrating or explaining how to properly use an e-cigarette or other type of ENDS.
Sam Salaymeh, president and CEO of North America for AMV Holdings, which owns Madvapes, Alohma, Maxx and Select-A-Vapor stores, says the new FDA proposal appears to be based on the collective punishment principle—hurting good companies along with ones that violate the rules by marketing toward youth, for example.
“I would prefer reasonable regulation,” Salaymeh says. “We have a crisis that is the result of a single product. It is creating undo pressure on the good stewards of this industry. If easily concealed, high-nicotine products are the problem, then easily concealed, high-nicotine products should be the target of harsher regulations.”
One risk of the proposed FDA regulations is the growth of the black market, according to Salaymeh. He says that the push to make vapor products available only to adults over the age of 21 and limiting flavors are bad ideas.
“Closed systems are demonizing [an industry that is probably] one of the most significant public health advancements in the last two decades. Anything that impacts an adult’s accessibility to these products will have a negative impact on the public health of this country,” he says. “The mission to ban some of these products could push consumers towards an unhealthy and unsafe black market.”
AGING ISSUES
The regulatory agency has said that, when it comes to enforcement, it will prioritize vapor products offered for sale in ways that make them more accessible and appealing to minors. For over a year, vapor products have been under scrutiny as the FDA has struggled to address what it calls an “epidemic” of youth vaping, especially with popular pod systems like the Juul vapor device.
The rule states that vapor products with flavors other than tobacco, such as fruit and candy flavors, can still be sold online or at brick-and-mortar stores that use a third-party age verification system or that have age-restricted sections. Stores that allow minors to enter will be held to different standards if only tobacco, menthol and mint flavors are sold—provided those standards comply with local and national laws.
“For online sales, if the products are sold without an appropriate limit on the quantity that a customer may purchase within a given period of time, and without independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records [a company would be in violation of FDA rules],” former FDA Commissioner Scott Gottlieb wrote in a press release.
Representatives of Avail Vapor recently shared with FDA officials their customer insights, perspectives and best practices for combatting youth access. “Commissioner Gottlieb asked the industry to step up, and that’s exactly what we did,” said Maggie Gowen, Avail Vapor’s director of external relations. “In addition to current regulations, we have proactively taken additional measures to prevent youth access in-store and online.”
Among other measures, Avail Vapor increased the minimum purchase age online to 21. Its website is age-gated, and the firm conducts third-party age-verifications prior to purchase. In its stores, the company IDs all customers regardless of ages and scans all IDs prior to purchase. “We have also implemented best practices regarding marketing and advertising practices,” says Gowen.
AMV Holdings is doing its part, as well, scanning identification cards and working toward age-restricted entry, among other measures. “We don’t want issues like kids being left in cars in the heat or cold, so we may look at creating a foyer area with a waiting room,” says Salaymeh. “There are several possibilities, and we are striving to do what is best for our customers. It is great that the FDA is seeing that brick-and-mortar vape shops aren’t the root of the problem and the agency does see value in flavors helping adult smokers switch.”
The FDA plans to air a television ad campaign explaining the risks of e-cigarette use in kids. If the 2019 National Youth Tobacco Survey indicates continuing high use of ENDS, the agency reserves the right to further strengthen policies and enforcement, possibly even banning all vapor products.
What’s more, the FDA expects manufacturers of all flavored ENDS (other than those with tobacco, mint and menthol flavors) that remain on the market under these new conditions to submit premarket tobacco product applications (PMTAs) to the agency by Aug. 8, 2021—one year earlier than the agency had previously proposed. In addition, the FDA has requested comments on whether to adjust the premarket review compliance date to include tobacco-, mint- and menthol-flavored products.
The FDA also requested comment on whether there are any technologies or other measures that could be useful in addressing youth access to ENDS. Gowen has asked the FDA to convene a working group comprising FDA staff and industry members to explore ways to strike a balance between providing adult smokers with options and preventing youth engagement.
After Aug. 8, 2021, the FDA plans to step up its enforcement against flavored ENDS for which the manufacturer has not submitted a PMTA. Several other developments are set to impact the vapor industry. The White House’s March 11 budget proposal includes a user fee on vapor products to fund FDA oversight, for example.
CHANGING PLACES
When Gottlieb announced his retirement in early March (also see, “FDA in Transition,” page xx), many industry representatives hoped the change of guard would result in a less heavy-handed approach to vapor regulation. Gottlieb, however, was quick to douse those expectations.
“Our pledge to reduce youth use of e-cigarettes is deeply rooted and has broad support within the Trump administration. Nobody wants to see children becoming addicted to nicotine,” Gottlieb stated prior to his departure from the FDA on April 5. “Our dedication to this effort will endure, and our commitment to advancing our comprehensive framework will continue …. We won’t tolerate a whole generation of kids becoming addicted to nicotine as a trade-off for enabling adults to have unfettered access to these same unreviewed products, and we’ll continue to put the full scope of our regulatory tools against this mounting public health crisis.”
The appointment of Ned Sharpless, director of the National Cancer Institute, as the acting head of the FDA seems to underscore that pledge. Anti-vapor groups have been quoted in news articles saying that the appointment of Sharpless should allay any concerns that Gottlieb’s departure would end the FDA’s crackdown on flavored electronic cigarettes and teen smoking.
“There will be no letup in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes,” says Alex Azar, the U.S. Secretary of Health and Human Services.
To support its public health objectives, the FDA has requested about half a billion dollars in additional funding for 2020.
“Importantly, the budget also seeks $100 million in new tobacco fees, and includes manufacturers and importers of deemed tobacco products and [especially ENDS]. E-cigarettes … represent an increasing share of the tobacco marketplace,” the FDA stated in a press release. “The new resources will support the FDA in its continued efforts to create a modern regulatory framework for the appropriate oversight of e-cigarettes and in taking continued steps to reduce youth use of all tobacco products … and aggressively confront youth use of these products to make sure children don’t become addicted to nicotine.”
Deferred Results
The U.S. Food and Drug Administration (FDA) has extended the harmful and potentially harmful constituents (HPHC) reporting compliance date. The deadline was Nov. 8, 2019.
The new deadline is six months for large manufacturers and nine months for smaller manufacturers after the FDA releases guidance for how the testing will be conducted. The agency defines “small-scale” as a company that generates less than $5 million in revenue and has fewer than than 150 employees.
Some suspect the HPHC testing was extended only because the FDA has taken an unnecessarily long amount
of time to complete a list of what constituents the vapor industry should be testing for, and few manufacturers want to pay for expensive testing that could possibly end up not meeting the standards. The FDA also waited until after many manufacturers began the testing process to extend the deadline to an unknown date.
Sam Salaymeh, president and CEO of North America for AMV Holdings, says the rules needed to be changed
because testing under the FDA’s current rules is so expensive that only companies with large cash flows and
resources could survive.
“Testing is nearly impossible under the current FDA policy,” he says. “There are no standard temperatures, coil
variations or wattage settings, for example. Where do you draw the line? We are testing different approaches, but we don’t know what the FDA wants.”
Currently, a manufacturer of vapor products can choose to perform many tests, guessing what the FDA will require. Ultimately, manufacturers are expecting to be asked to supplement their applications with more testing data for the FDA. However, this still leaves many questions. The FDA has stated its intent to clarify the rules.
“In the deeming final rule, FDA stated its intention to issue guidance regarding HPHC reporting, and later a testing and reporting regulation, with enough time for manufacturers to report given the initial three-year compliance period (originally Aug. 8, 2019) …,” said FDA press officer Michael Felberbaum. “This additional time also will allow FDA to develop an appropriate policy for HPHC testing and reporting by deemed tobacco product manufacturers to account for the different types of deemed products.”
Many vapor industry representatives want to know why it is so difficult for the FDA to give the industry a list of what to test for. “How can this take as long? Why is the science agency FDA lacking scientific guidance on its [HPHC] testing list?” asked one manufacturer who requested not to be named. “Since the development of these products has been unchanged for greater than two years, the data from these products is not changing. If the products aren’t changing, why has the FDA not yet given manufacturers a complete list of things to test for? What is the FDA’s role in helping the industry to conform to their regulations?”
When asked by Vapor Voice for a response to these questions, the FDA reiterated that it is working on clearer guidelines for HPHC compliance. The agency did not explain what its role in helping companies conform is or why the process is taking so long. – T.S.D.
Retail Clarity
There isn’t much new to this one. The U.S. Food and Drug Administration (FDA) released its final guidance that interprets rules for vape shops. In the report, titled, “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops,” the regulatory agency has clarified several actions for vape shop owners.
For example, under the Food, Drug, and Cosmetic Act, a tobacco product in package form is misbranded if its label “does not include an accurate statement of the percentage of tobacco used in the product that is foreign-grown and domestic-grown,” according to the FDA. However, the FDA states that it does not intend to enforce the rule for tobacco-derived liquid nicotine or e-liquids made or derived from tobacco on labeling.
Additionally, for products that do not yet have marketing authorization orders, a vape shop’s modifying a product would generally result in a new tobacco product, for which the vape shop is required to seek premarket tobacco product authorization (PMTA). The FDA does not intend to enforce these requirements either if the vape shop modifies a product consistent within specifications provided by the original manufacturer.
The FDA states that a vape shop cannot assemble a custom final product from components or parts sold individually or from multiple pre-built kits, however, Maggie Gowen, director of marketing at Avail Vapor, says that items such as different tanks and coils can be sold for hardware, but the vape shop cannot assemble them in-store for the customer.
However, the FDA states that a vape shop can assemble a final product from the components that are packaged together in a pre-built ENDS kit or from parts sold individually that are also available packaged together. A vape shop can also explain how to charge a battery or fill a tank, as well as demonstrate how to turn on a device.
“This guidance is just more concise than the previous guidance on the subject,” says Gowen. “We turned some
of these rules into a positive educational experience at the store level because our customers walk out more confident having assembled their device on their own for the first time. They also are more likely to have continued success outside the store having already assembled it on their own.”
Refilling open systems is also allowed if the vape shop does not make any further modifications to the product or any modifications to the e-liquid. However, a closed system cannot be refilled, and an atomizer may not be repaired or modified by the vape shop without violating FDA rules. The shop can replace the coils with identical coils from the same manufacturer.
As expected, the FDA has reiterated its stance that vape shops will not be allowed to produce and fill e-liquids in-store without being considered a manufacturer and submitting a PMTA. Sam Salaymeh, president and CEO of North America of AMV Holdings, said that many of his stores add nicotine to some e-liquids in-store, but all his stores are registered as manufacturers with the FDA.
“We will go through the PMTA process for all of our flavors, including those produced in-store,” he says. “It’s a single PMTA per SKU regardless of [the] number of locations it’s sold. We are dedicated to helping smokers switch; 69.3 percent of smokers that enter our stores have stopped smoking completely, and are nonsmokers after 12 months. We will continue to do whatever we can to help end the death and disease cause by combustible cigarettes.” -T.S.D.
