E-Cigarette Makers Object to How FDA Will Review Flavored Vapes

The e-cigarette industry is criticizing an FDA proposal for how it will evaluate flavored vaping devices, arguing it makes it too challenging to bring more smoke-free alternatives to the market and advance a promise from President Donald Trump to save vaping.

Reynolds American Inc., Altria Group Inc., JUUL Labs Inc., and groups representing independent vaping businesses are pushing back on draft guidance from the US Food and Drug Administration that details the agency’s consideration of flavored electronic nicotine delivery systems, commonly known as e-cigarettes, seeking market authorization.

The FDA suggests that it’s still unlikely to authorize vaping devices that feature fruit and candy flavors that appeal more to youth, but would consider products with flavors such as coffee, teas, and spices that it deems appealing to adults.

While the guidance is nonbinding, any direction from the FDA is crucial as e-cigarette manufacturers have long sought an overhaul of the agency’s evaluations and pace of reviews for flavored vaping devices. But e-cigarette companies and groups say the framework proposes no substantial reform and doesn’t support Trump’s promise.

“The draft guidance basically puts in black and white the same misguided policy,” Tony Abboud, executive director of the Vapor Technology Association, said in an interview. “It is clearly the wrong direction for the FDA, as well as a failure in attempting to fulfill the president’s promise to save vaping.”

E-cigarettes have been touted for delivering nicotine with fewer harmful effects than smoking combustible cigarettes. Many flavored vaping devices with colorful names that evoke fruit and dessert have become appealing to youth, raising concerns from the FDA about authorizing the products.

The agency has received over 27 million applications seeking to market products over the past five years, but only 45 e-cigarettes have been authorized.

The latest clearance was significant as it authorized mango and blueberry flavored e-cigarettes—products with flavors other than tobacco and menthol for the first time.

Still, the industry is urging the FDA to authorize more products with clear requirements that address flavors, nicotine, ingredients and additives, product appearance, and marketing plans subject to postmarket surveillance and reporting.

FDA’s ‘Yardstick’

E-cigarette companies said the guidance does nothing to improve the agency’s Premarket Tobacco Product Application system, a process in which companies must submit an application for any new tobacco product seeking an FDA marketing order.

The applications are a massive investment in time and money, requiring hefty scientific evidence and data that demonstrates a product is appropriate for the protection of public health.

The tobacco industry has filed several lawsuits challenging marketing denial orders, alleging the FDA shifted the goal post and failed to weigh all relevant evidence in applications.

“Manufacturers invest millions of dollars and years of science—and get denied under secret criteria that apparently change at will,” Reynolds said.

“The draft guidance gives manufacturers nothing to work with,” Reynolds added. “No objective standard. No benchmarks.”

The lack of clarity also deals a blow to small and midsize businesses spending just as much to comply with the FDA’s demands, said Jim McCarthy, a spokesperson for the American Vapor Manufacturers.

“Despite this half-measure guidance, FDA’s yardstick remains entirely concealed from applicants and the public” and “created a blindfold steeplechase for American companies,” McCarthy said.

Weighing Flavors

Companies also argued that while the guidance seeks to deter youth use of e-cigarettes, it sets a high burden for authorization of fruit and candy-flavored products that the agency deems to have the potential to appeal to younger people.

The FDA signals that it expects companies to prove that the flavor provides an additional benefit for adult smokers compared to tobacco-flavored e-cigarettes.

“To be clear, youth should not be using tobacco or nicotine products,” Altria said. “However, the empirical evidence does not support FDA’s narrative that youth ENDS use risk is escalating—or that youth risk would worsen if FDA were to begin authorizing non-tobacco flavored ENDS products.”

The agency suggested that it may be open to some flavors that may have lower youth appeal, such as coffees, teas, or spices.

“I am happy that FDA is at least willing to admit that flavors are going to be a motivating factor,” Nick Green, a former smoker and tobacco harm reduction advocate, said in an interview.

However, “adults ultimately overwhelmingly prefer fruit flavors when they’re quitting, bakery flavors when they’re quitting,” Green said. “I don’t know that that’s a huge step in the correct direction.”

Shifting Risks

Anti-tobacco groups are also skeptical of the guidance, arguing the FDA’s risk assessment of flavors doesn’t recognize that youth preferences have shifted over time.

“Youth preferences are likely to continue to shift if the availability of flavored e-cigarettes changes in response to enhanced enforcement against unauthorized flavored products or authorization of other flavored products,” public health groups said.

The guidance creates the threat that the FDA will authorize particular flavors as “lower risk” based on a snapshot of flavor preferences at one point in time, only to have the authorized flavor increase in youth prevalence, the groups added.

“When it comes to flavored tobacco products, there is a robust body of science demonstrating the risks to youth,” Brian King, the FDA’s tobacco chief under the Biden administration, said in an interview. “It’s important that the agency weigh those risks.”

“What you’re seeing is more appetite by the administration to facilitate getting these flavored products on the market,” added King, who is now executive vice president of US Programs for Campaign for Tobacco-Free Kids.

Michael Bloomberg has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco. Bloomberg Law is operated by entities controlled by Michael Bloomberg.