After more than a year of waiting for the U.S. Food and Drug Administration (FDA) to issue a policy on flavored cartridge-based e-cigarettes, the agency published final guidance last month banning most flavored cartridge-based e-cigarettes, except for tobacco and menthol flavors, from the market. The guidance permits the sale of e-liquid flavors used in open vaping systems and in disposable, single-use vape products.
The new FDA policy comes as the Trump Administration tries to strike a balance between cracking down on youth vaping and allowing certain tobacco and menthol flavored products to stay on the market for adult smokers trying to quit.
Original FDA Proposal
In the fall of 2018, former FDA Commissioner Scott Gottlieb announced that he would prohibit convenience stores from selling fruity flavored e-cigarettes. His policy was formally proposed by the FDA in March when the agency issued proposed guidance that would allow adult-only stores, such as vape shops and tobacco outlets, to sell the products while prohibiting them in convenience stores. NACS has been a vocal advocate for the even treatment of retailers selling tobacco products and strongly opposed these initial efforts by the FDA.
Final Guidance
Unlike the initial FDA proposal, the final guidance recognized those concerns and contains no language that discriminates between the type of retail outlet. Instead, the final guidance focuses on which products can and cannot be sold, rather than the locations in which those products are sold.
“Given the urgent need to address the dramatic rise in youth use, this Final Guidance prioritizes enforcement with respect to any flavored, cartridge-based ENDS products (other than a tobacco and menthol-flavored ENDS product) without regard to the location or method of sale,” the FDA stated.
The FDA’s final guidance states that retailers will have until February 6, 2020, to sell-through current flavored cartridge-based products (such as JUUL, NJOY and Vuse) before they must be removed from stores.
The guidance also says that manufacturers must take steps to try to prevent minors from purchasing their products. These steps may include manufacturers requiring retailers to use certain age verification systems and/or manufacturers conducting stings of retailers and imposing fines on retailers for violations.
Premarket Tobacco Product Applications
All manufacturers of deemed tobacco products (including all e-cigarettes, flavored cigars, smokeless tobacco and hookah products) that were not on the market as of February 15, 2007, must submit Premarket Tobacco Product Applications by May 12, 2020. Premarket approval applications also are required for vape shops or other retailers that mix their own vape juice because they are, in those cases, manufacturing the product.
Manufacturers of e-cigarettes that are not affected by the guidance, such as tobacco and menthol flavored cartridge-based products and open vaping systems, must submit Premarket Tobacco Product Applications by May 12 to remain on the market. However, the FDA has determined that these products are allowed to stay on the market for up to 12 months while the agency considers those applications. Following that time period, the products can only be sold if the FDA approves the applications.
While most flavored cartridge-based products are being pulled from the market in early February, it should be noted, however, that there is a pathway for them to come back onto the market if the FDA approves the manufacturers’ Premarket Tobacco Product Applications that are due by May 12.
Tobacco 21 Surprise
On December 20, 2019, President Donald Trump signed into law legislation raising the federal minimum age to purchase all tobacco products from 18 to 21 years old. The law wasn't expected to take effect until 2020, but the U.S. Food and Drug Administration (FDA) posted a three-sentence notice on its website afterward, saying the law was effective immediately. The FDA’s overnight transition left retailers around the country confused.
The law gives FDA 180 days to finalize the tobacco 21 rule and requires that it take effect no later than 90 days after being finalized. While the law contemplates a regulation to provide retailers with clear direction on the new rules (including a requirement to verify the age of any purchaser younger than 30), the law does not require a delay of the age 21 requirement.
FDA posted a notice on its Center for Tobacco Products website stating that it views the 21-purchase-age requirement as effective immediately—even though the agency will not write implementing regulations for months.
NACS organized a joint retail association letter to the FDA explaining the complexities of the transition for retailers who must retrain employees, update signage, reprogram POS systems and inform customers. In the letter, the organizations point out that because the transition happened without a public awareness campaign, retail associates were the first to inform customers that the age had changed, leading to angry confrontations in some cases. The letter asked the agency to clarify that it will not enforce the new federal age until the agency issues implementing regulations in 2020. At press time, the FDA had not clarified its enforcement stance.
NACS is urging all retailers to take the steps necessary to come into compliance. While there are unanswered questions about when the FDA plans to enforce this requirement and whether the agency can legally enforce it before updating its regulations, retailers should be aware that the FDA views any sale to a person under 21 as a violation of the new law.
We Card has updated signage and resources available to retailers at www.wecard.org. Retailers can download three print and display in-store signs. There also are links to We Card’s smartphone app (Age Checker) and a free 10-minute training booster course to help retail employees adjust to the T-21 law. In addition, the We Card NOW website provides a digital We Card eCalendar and an age calculation tool.