Industry Parses FDA Tobacco Proposals

WASHINGTON -- After weeks of public statements, Scott Gottlieb, commissioner of the U.S. Food and Drug Administration (FDA), released an extended press statement outlining the proposals the agency will consider on a number of tobacco-related matters, including restrictions on sales of flavored electronic cigarettes and a ban on both menthol cigarettes and flavored cigars.

While a majority of the industry supports measures to prevent young people from starting to use tobacco products, manufacturers, retailers and association officials are concerned about the harmful effect the agency’s proposals will have on their businesses and if the agency’s actions will ultimately solve the issue of youth access to and use of tobacco products.

Here’s a review of what came out of Gottlieb’s Nov. 15 statement …

The FDA will advance a notice of proposed rulemaking that would seek to ban menthol in combustible tobacco products. The agency’s research suggests “menthol use is likely associated with increased smoking initiation by youth and young adults,” said Gottlieb.

“There is an existing market for menthol cigarettes today, and banning them will only shift those sales to the black market,” Lyle Beckwith, NACS senior vice president of government relations, said in a statement issued by the c-store association following the FDA’s announcement “Black-market sellers of tobacco products do not check the ages of their purchasers, do not pay taxes on their sales and sell more than just menthol cigarettes. NACS urges the FDA to implement a plan to stop the current black market and prevent a new one before prohibiting a product that we know will result in large numbers of new black-market sales.”

Gottlieb said the FDA will allow c-stores to sell flavored e-cigarettes, vaping products and other electronic nicotine delivery systems (ENDS) but only in age-restricted areas.

This move does not include tobacco retailers and vape shops that prevent entry of persons under the age of 18.

The agency will also seek to curtail the sale of flavored e-cigarettes and other ENDS products that are sold online without heightened age verification, and it will “pursue the removal from the market of those ENDS products that are marketed to children and/or appealing to youth.”

The FDA also is proposing a policy to ban flavors in cigars. “Research shows that, compared to adults (25 or older) who smoke cigars, a higher proportion of youth who smoke cigars use flavored cigars,” Gottlieb said. “This data also indicates that eliminating flavors from cigars would likely help prevent cigar initiation by young people.”

Following meetings with the FDA, Altria Group Inc., Richmond, Va., announced plans to remove its MarkTen Elite and Apex by MarkTen pod-based vaping products until they “receive a market order from the FDA or the youth issue is otherwise addressed,” the company said.

Along with the removal of those products, Altria's remaining MarkTen and Green Smoke “cig-a-like” products from subsidiary Nu Mark will only sell tobacco, menthol and mint varieties. The move will discontinue other flavors until those products receive a market order from the FDA or, again, the youth issue is otherwise addressed.

Juul Labs, San Francisco, on Nov. 13 stopped accepting retail orders for its Mango, Fruit, Creme and Cucumber Juul pods from the more than 90,000 retail stores—including convenience stores, tobacco retailers and vape shops—that sell its products. The change is a reaction to the FDA’s growing scrutiny and concerns over the appeal of flavored electronic cigarettes among young people.

Juul will make those flavors available only on Juul.com, where it is adding further age-verification measures to an online sales system that is restricted to people 21 years old and uses third-party verification.

“We want to be the off-ramp for adult smokers to switch from cigarettes, not an on-ramp for America’s youth to initiate on nicotine,” said Kevin Burns, CEO of Juul, in a message posted to the company’s website.

The targeting of convenience stores and gas stations appears to go against the agency’s legal authority, said officials with a national tobacco-retailing association. In a webinar held Nov. 8, Tom Briant, executive director of Lakeville, Minn.-based NATO, said the Family Smoking Prevention and Tobacco Control Act, which gives the FDA congressional authority over certain aspects of tobacco advertising and promotion, limits the agency in certain ways. “[It] prevents the FDA from [forcing] restrictions that would prohibit the sale in a face-to-face transaction by a specific category of tobacco outlets,” Briant said in the webinar. “The FDA could not ban the sale of tobacco product in just c-stores and only allow them in vape shops.”

Briant also noted several other concerns about potential e-cigarette restrictions or bans concerning tobacco retailers:

• During this past summer, 96.7% of the retailers passed FDA-sponsored compliance checks by not selling an e-cigarette to an underage youth.
• Retailers undertake significant efforts to train their employees how to not sell tobacco products to underage youth.
• A prohibition on the sale of flavored e-cigarettes in convenience stores is unfair and unnecessary.
• The FDA needs to address the problem of adults, also known as social sources, who legally buy and then provide tobacco products to minors. The 2016 FDA Population Assessment of Tobacco and Health study found that up to 89% of underage youth relied on social sources to obtain an e-cigarette product.
• Banning the sale of flavored e-cigarettes in convenience stores could result in adult customers purchasing and using other tobacco products that may be more harmful than electronic cigarettes.

Bonnie Herzog, managing director of consumer equity research for Wells Fargo Securities, New York, said the manufacturing community, distributors and retailers will respond vocally against the move, but “we doubt they will be able to cause the FDA to course-correct in any meaningful way.”