FDA Declares War on Vaping Epidemic and Expands Its Investigation of Illegal Marketing to Kids

by Sokolove Law

November has been a landmark month for e-cigarettes, as long-awaited changes are coming to the way e-cigarettes – and their flavors – are marketed, regulated, and sold in the United States. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has outlined the agency’s plan for the restriction of e-cigarette flavor sales in a detailed letter.

In response, the nation’s leading e-cigarette company Juul – worth an estimated $15 Billion – limited retail sales of its flavor pods and closed several social media accounts. Juul’s actions may seem good on the surface but are perceived by many to be nothing more than clever public-relations stunts.

Others see the FDA’s e-cigarette announcement as a move that is too little, too late; with millions of teenagers already “hooked” on e-cigarettes, the proposed restrictions to e-cigarette sales and marketing does little, as much of the “marketing” is now done by the teenage e-cigarette users themselves, many of whom might introduce the product(s) to their underage peers.

The FDA vs. E-Cigarettes, a Timeline

The past several months have seen much FDA-related news concerning the marketing, selling, and use of e-cigarettes, most of which has been centered around underage use.
Here’s a re-cap of the tactical FDA maneuvers leading up to Scott Gottlieb’s most-recent announcement:

  • September 12: The FDA sends letters to 5 major e-cigarette companies, asking for detailed plans from each company describing how they will reduce underage access to their products. In addition, over 1,300 retailers were issued warning letters.
  • October 2: The FDA conducts a surprise raid on Juul headquarters in San Francisco, and carts away thousands of documents to help determine whether or not the company was intentionally marketing their products to minors.
  • October 12: The FDA expands their inquiry, sending letters to 21 e-cigarette manufacturers, requesting internal documents and information that would help the agency “examine whether the products were being illegally marketed.”
  • November 5: FDA Commissioner Gottlieb announces a public hearing on e-cigarettes and teen use that will take place in December; the hearing will focus on teen nicotine addiction, and “the potential role of drug therapies to support the cessation [of nicotine use] among youth.”
  • November 15: The FDA moves to restrict sales of flavored e-cigarette products in an official press announcement from the commissioner.

Juul and Others Act Quickly, but Has the Damage Already Been Done?

In response to Gottlieb and the FDA, Juul vowed to stop a majority of brick-and-mortar sales of its flavor pods while also more rigorously restricting product sales online to adults aged 21-years-old and older. Its online flavor sales will be less accessible by minors through a more robust age-verification process. In addition, Juul shut down some of its social media accounts, which were used to promote their brand and products.

Several studies have shown that when underage youth start using e-cigarettes, it is only a matter of time before they switch to traditional tobacco cigarettes. Combine this fact with the Centers for Disease Control and Prevention’s (CDC) new data showing a 78 percent increase in vaping by high schools students (with 3.6 million high- and middle-school students now using e-cigarettes), and it’s clear why many are declaring the trend “an epidemic.”

With e-cigarettes acting as a gateway to traditional combustion cigarettes, it’s no wonder so many organizations from the American Academy of Family Physicians (AAFP) to the Campaign for Tobacco-Free Kids to the National Association for the Advancement of Colored People (NAACP) have come out in support the heavy restriction of flavored e-cigarettes.

That said, many organizations are seeing the FDA’s movement to restrict e-cigarette sales as too late or not comprehensive enough. According a report by the U.S. Surgeon General, e-cigarettes have seen enormous boosts in sales from a whopping 900 percent increase in e-cigarette use among high school students between the years 2011 and 2015.

In a statement emailed to CNN, President of the American Academy of Pediatrics (AAP) Dr. Colleen Kraft said,

“Not only are we seeing a staggering increase in the number of high schoolers who use e-cigarettes, we’re seeing that more and more of them have moved beyond experimentation and are using e-cigarettes almost daily. Kraft continued, “Even with new sales restrictions, teens will still find ways to purchase flavored e-cigarettes.”

Tobacco-Free Kids President Matthew L. Myers believes “the FDA still needs to go further.” For several years, Myers has continued to urge the FDA to ban all flavored vaping products, especially those products that have not been measured or studied intensively by the FDA. The rationale, according to Myers, is proactive and would stop the FDA from “dealing with [the companies] after they have become popular with kids, as in the case of Juul.”

Under the stipulations of Gottlieb’s proposal, he hopes “that within the next 90 days, manufacturers will choose to remove flavored [e-cigarette] products from stores where kids can access them and from online sites that do not have sufficiently robust age-verification procedures.”

Menthol Cigarettes Also to Be Banned – Eventually

The other, not-to-be-dismissed part of Commissioner Gottlieb’s announcement regards the use of menthol in cigarettes. Menthol cigarettes are disproportionately used by youths, too, according to new data. Gottlieb said,

“More than half (54 percent) of youth smokers ages 12-17 use menthol cigarettes, compared to less than one-third of smokers ages 35 and older. We will advance a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars.”

Menthol, which has long been a staple in the cigarette industry, is also considered a flavor by many health advocates and organizations. Like other flavored cigarettes and e-cigarette cartridges/pods, menthol too will be subject to proposed regulatory action. Gottlieb wrote,

“I’m deeply concerned about the availability of menthol-flavored cigarettes. I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes. Moreover, I believe that menthol products disproportionately and adversely affect underserved communities.”

The NAACP has long been advocating for a ban on or heavy restriction on menthol cigarettes, which it believes have been historically, unfairly, and disproportionately marketed to African-Americans. The organization also released its own public statement, supporting the FDA’s plan to eventually ban menthol cigarettes.

What’s Next in the Story of the FDA vs. E-Cigarettes?

For now, Gottlieb’s proposals are just that: proposals. Before actual regulatory action takes place, and before any new rules are created and enforced, they must first be fully researched, developed, and then published. The FDA’s first move, at the direction of Gottlieb, is to have the FDA’s Center for Tobacco Products (CTP) revisit compliance policies for all flavored e-cigarette products. Upon finishing their review of the policies, the CTP will then publish a list of rules it considers to be “best-practices” for online sales of e-cigarettes and related products.

In the short-term future, makers of e-cigarettes and related products will also have to complete new Premarket Tobacco Product Applications (PMTAs) that are more comprehensively written and reviewed for accurate data and science. The PMTAs will then be subject to approval.

So, while the regulation measures – for now – seem stymied in technical paperwork, the public can be hopeful that change is coming to the startling trend of nicotine use among minors. Limiting the sales of e-cigarettes and prioritizing the health of our nation’s youth has been a long-term goal of the FDA, since the start of its Comprehensive Plan for Tobacco and Nicotine Regulation campaign.

“I will not allow a generation of children to become addicted to nicotine through e-cigarettes,” Gottlieb said in his statement. “We won’t let this pool of kids, a pool of future potential smokers, of future disease and death, to continue to build. We’ll take whatever action is necessary to stop these trends from continuing.”

FDA Declares War on Vaping Epidemic and Expands Its Investigation of Illegal Marketing to Kids was last modified: November 21st, 2018 by Sokolove Law