18i3_FDA Multi-Tasking
Where decisions are made: FDA headquarters
By Murdoch McBride
Food and Drug Administration (FDA) resources must be spread thin, considering all that the agency is managing in terms of tobacco products.
This spring the American tobacco industry was already keenly focused on FDA market application review of IQOS, the heat-not-burn product from Philip Morris International (PMI). The drill was familiar, with all the dense application verbiage, scientific data, and corporate anticipation that comprises a major tobacco product marketing application. And the stakes with IQOS are notably high because the product that PMI seeks to market via a licensing deal with Altria in the United States may help revolutionize not only PMI’s business but also the industry at large since other companies also continue to evolve and move away from traditional cigarettes.
In early April, during the initial research for this story, FDA spokesperson Michael Felberbaum was asked whether it would be correct to assume that PMI’s IQOS was currently the key topic for FDA in terms of the public’s interest in tobacco issues. “I think it’s fair to say that is accurate,” Felberbaum said, “based on all the attention and the calls I have been receiving from the media.”
Certainly, that was accurate, at the time. But within several days, things changed in the FDA orbit and the media spotlight went from PMI’s IQOS to a letter signed by several members of Congress demanding that the agency take steps to address Juul, which is considered the most popular vaping product on the market. Recently, the success of Juul has led to juuling (verb) for the discreet, undetectable, and often clandestine use of Juul by teens, even in their classrooms. Juul resembles a sleek USB and can be charged on a laptop. It also comes in many flavors and packs a high-nicotine punch, so kids have taken to it in a big way. Many are juuling in school–and at especially high rates in the New York City area. The device looks so much like a USB that it often fools teachers. Even this writer, who should have known better having interviewed Juul creators James Monsees and Adam Bowen, mistook his son’s Juul device for a USB and sent the entire family a group text in case someone was missing valuable digital information. So much for the intellectual capacity of the average tobacco writer.
The alarming rate of juuling among New York City school kids–reportedly as high as 20%–precipitated Senator Chuck Schumer (D-NY) weighing in several months ago with an October 2017 letter to FDA. Schumer’s campaign against indoctrinating youth to tobacco products is well established. His website also covers the usual bases, outlining how FDA’s tobacco control authority does not cover e-cigarettes as they “are not yet regulated by FDA.” He has urged the agency to step into the debate over flavors and bemoans the fact that flavored e-cigarettes can remain on the market “until at least 2022” because of FDA’s delayed “enforcement of a finalized rule that would allow the agency to exercise its authority to regulate e-cigarettes under the Family Smoking Prevention and Tobacco Control Act of 2009.” Schumer notes that “the rule would have included an age restriction of 18, and prohibit vending machines sales and free samples. In addition, the rule requires manufacturers to list product ingredients [and] tobacco products containing nicotine to carry an addicting warning label and [that] new or changed tobacco products be approved by FDA before going to market.”
More recently, a highly publicized Congressional group letter to FDA was released in April that led to warnings to retailers and other enforcement actions.
FDA’s website now leads off with a statement by Commissioner Scott Gottlieb, M.D. that reports compelling action steps taken both as part of the agency’s own anti-youth smoking agenda and in response to the April 2018 Congressional letter:
“• FDA cites 40 retailers for violations related to youth sales of Juul e-cigarettes.
• Agency announces a new blitz of retail establishments targeting youth sale violation.
• Agency takes new action to examine youth appeal of Juul.
• Agency takes steps to foreclose online sales of Juul to minors.
• These are the first steps in a new effort aimed at stopping youth use of e-cigarettes”
Also on FDA’s site, Gottlieb fleshed out agency priorities. “Protecting our nation’s youth from the dangers of tobacco products is among the most important responsibilities of the US Food and Drug Administration–and it’s an obligation I take personally. We recognize that if FDA is to end the tragic cycle of successive generations of nicotine and tobacco addiction, we must take every opportunity to disrupt that process where it starts: youth access to and use of tobacco products. That’s why, as part of our comprehensive plan announced in July, we’re pursuing a policy to prevent future generations from becoming addicted in the first place by rendering cigarettes minimally or non-addictive. A key part of that plan was establishing the foundational framework for regulating non-combustible tobacco products for adults, like e-cigarettes.”
On April 30, at Washington, D.C.’s Marriott Georgetown, many of the most informed and motivated parties both in (and surrounding) the e-cig industry gathered for the E-Cigarette Summit, an all-day series of trenchant presentations on tobacco science, vaping issues and general topics that were sometimes controversial but primarily supportive of the continuum of risk and/or the manufacturing and distribution of reduced harm products. In a keynote address, Mitch Zeller, director, FDA Center for Tobacco Products spoke about recognizing a crossroads that exists between health reduction and the e-cig debate, saying that the agency is using the “tools of regulation to greater impact” as it works toward creating a world where “cigarettes no longer exist or sustain addiction…but where adults can find alternatives.”
Also in early May, Senator Schumer again wrote to Gottlieb saying that, “while cigarette smoking among high school students is at a record low–only 8% as of 2016–this accomplishment is at risk due to the rise of non-cigarette tobacco products, particularly e-cigarettes and the JUUL vaping device. E-cigarette use among middle and high school students more than tripled between 2011 and 2016, and e-cigarette companies are raking in record profits.” Schumer’s letter went on to say, “As a leading child psychiatrist at NYU Medical Center said, ‘Who over 25 is looking for crème brûlée as part of a smoking experience?’ I appreciate and applaud the May 1, 2018 announcement in which FDA and FTC issued 13 warning letters to manufacturers, distributors, and retailers for selling e-liquids with advertising that made them appear similar to food products–such as candy, cookies, or juice boxes–that are targeted at children. Some of the products that received warning letters include Vape Heads Sour Smurf Sauce, V’Nilla Cookies & Milk, Golden Oreo, Whip’d Strawberry, and Twirly Pop, which quite literally is shipped along with a Unicorn lollipop…While this latest FDA action is a positive step in the right direction, more must be done.”
While Juul currently takes a great deal of attention off other products due to its popularity and the whole juuling trend, other products are moving through their respective pipelines. Analysts have been bullish about IQOS and the product’s prospects for FDA approval and its release in the American marketplace, which could take place perhaps this fall. This speculation is not surprising given the positive scientific data available on IQOS and the international response to the product thus far.