Durbin, Murkowski Urge FDA To Immediately Ban Kid-Friendly E-Cigarette Flavors, Restrict Online Sales
Following FDA declaration of youth e-cigarette use “epidemic,” Senators call for end to regulatory delays
U.S. Senators Dick Durbin (D-IL) and Lisa Murkowski (R-AK) today, in a letter to the U.S. Food and Drug Administration (FDA), urged the agency to immediately ban kid-friendly e-cigarette flavorings and restrict online sales of the addictive nicotine products. Durbin and Murkowski’s letter comes on the heels of the FDA’s announcement last month that—due to a public health “epidemic” of youth e-cigarette use—it would issue new enforcement actions on e-cigarette companies’ use of kid-appealing flavors, in order to better protect children and teens from using addictive and dangerous e-cigarettes.
“While it remains unclear whether e-cigarettes can actually help adults quit smoking cigarettes, it is abundantly clear that tobacco companies are developing and marketing e-cigarette flavors that appeal to, and addict, children. A recent search of the FDA’s own database reveals more than 1,000 results for scores of different flavored e-cigarette products—everything from mango to gummy bear; whipped cream to tutti fruitti; blue razz candy to chocolate cupcake. The e-cigarette industry’s efforts to hook kids have been overwhelmingly successful, as demonstrated by the reportedly 75 percent spike in e-cigarette use among high school students over the past year,” Durbin and Murkowski wrote. “We urge you to take the strongest action possible to protect our children from a lifetime of nicotine addiction, and to offer our continued Congressional assistance in whatever way would be helpful in your efforts.”
Last month, FDA Commissioner Gottlieb announced that his agency was taking three important steps to curb youth use of e-cigarettes, including sending letters to five leading e-cigarette manufacturers (including JUUL, which owns more than 70 percent of the market), requiring them to submit plans within 60 days detailing ways they will sharply curb sales to underage consumers. If these plans do not promise to “substantially reverse” youth use, Dr. Gottlieb announced that FDA will consider temporarily or permanently ordering the removal of flavors from the market. Durbin has repeatedly raised concerns and pressed FDA about the decision in July 2017 to delay regulation of e-cigarettes from 2018 until 2022.
FDA also announced that it was sending letters to 1,200 brick-and-mortar stores and online retailers warning them that they could face penalties for selling e-cigarettes to people under age 18, and is imposing fines (ranging from $279 to $11,182) to another 130 establishments for repeatedly selling e-cigarettes to minors.
Additionally in July, Durbin and Murkowski introduced bipartisan legislation to crack down on kid-friendly flavorings in highly-addictive e-cigarettes and cigars. The bipartisan Stopping Appealing Flavors in E-Cigarettes for Kids (SAFE Kids) Act would place strong restrictions on e-cigarette flavorings and ban cigar flavorings altogether. Most notably, the bill would:
Place Strong Restrictions on E-Cigarette Flavorings: The bill would generally restrict flavored e-cigarette products, but allow manufacturers one year to prove to the FDA that their e-cigarette flavorings meet three criteria. If companies can prove that their e-cigarette flavors meet these three criteria, they can remain on the market:
(1) Help adults quit smoking cigarettes;
(2) Do not increase youth initiation of nicotine or tobacco products; and
(3) Do not increase the risk of harm to the person using the flavor.
Ban Cigar Flavorings Altogether: Given that there is no public health benefit to smoking cigars, the bill would ban the use of all flavors in cigars within one year.
A copy of today’s letter is available here and below:
October 2, 2018
The Honorable Scott Gottlieb, M.D.
United States Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Dear Commissioner Gottlieb:
On September 12, 2018, citing “an epidemic of e-cigarette use among teenagers,” the Food and Drug Administration (FDA) announced a number of important and long-overdue actions that represent a promising step toward addressing a public health crisis that is threatening an entire generation of children. We commend you for sending warning letters and issuing civil monetary penalties to retailers who have repeatedly violated the law by selling tobacco products to minors, but we are most encouraged by FDA’s apparent willingness to finally consider prohibiting kid-friendly e-cigarette flavorings in the near term and restricting online sales. Given the e-cigarette industry’s calculated decision to target children with dangerous and addictive flavored products—and given their success in these efforts—we strongly urge FDA to take decisive action and immediately ban kid-friendly e-cigarette flavorings.
As we have discussed with you many times, the fruit, candy, and other kid-friendly liquid nicotine flavorings—that FDA has knowingly allowed to proliferate on the market for years without regulation—have been driving this youth e-cigarette epidemic from day one. This has been proven time and again and affirmed in the U.S. Surgeon General’s Report on E-Cigarette Use Among Youth and Young Adults, by the Centers for Disease Control and Prevention, and even by the FDA itself—acknowledging that 81 percent of kids who ever use a tobacco products start with a flavored product, including 81 percent who have ever tried e-cigarettes and 65 percent who have ever tried cigars.
While it remains unclear whether e-cigarettes can actually help adults quit smoking cigarettes, it is abundantly clear that tobacco companies are developing and marketing e-cigarette flavors that appeal to, and addict, children. A recent search of the FDA’s own database reveals more than 1,000 results for scores of different flavored e-cigarette products—everything from mango to gummy bear; whipped cream to tutti fruitti; blue razz candy to chocolate cupcake. The e-cigarette industry’s efforts to hook kids have been overwhelmingly successful, as demonstrated by the reportedly 75 percent spike in e-cigarette use among high school students over the past year. Even prior to this spike, more than two million middle- and high-school students were using e-cigarettes, making them the most popular form of tobacco use among children.
Given the unparalleled scope of this youth tobacco epidemic, we introduced S. 3319, the Stopping Appealing Flavors in E-Cigarettes for Kids Act (or SAFE Kids Act). This bipartisan legislation would immediately ban the use of flavorings in cigars and would give tobacco companies one year to prove that their e-cigarette flavorings actually help adults quit smoking cigarettes, do not cause children to start smoking, and do not harm the user. Anything short of strong and decisive regulation of e-cigarette flavorings would not be in the best interest of our nation’s children.
Last month, FDA sent letters to the five e-cigarette manufacturers that currently represent more than 95 of the e-cigarette market (JUUL, Vuse, MarkTen, blu e-cigs, and Logic), giving them 60 days to provide “robust plans” demonstrating how they will “convincingly address the widespread use of their e-cigarette products by children.” While we are very encouraged by FDA’s attention to this issue, we remain deeply skeptical that e-cigarette companies will adequately police themselves in a way that benefits the public health. After all, manufacturers have failed to adequately respond to longstanding concerns that flavors were making their products appealing to youth and continue to assert that they do not market their products to kids. As you yourself stated, these companies have treated youth use of their products as a “public relations challenge rather than seriously considering their legal obligations, the public health mandate, and the existential threat to these products.” There is simply no reason to believe that e-cigarette companies will put children’s health ahead of their bottom line—not today, not 60 days from now, not ten years from now. This request has been made to cigarette companies for decades and with e-cigarette companies before. Their response has always been more rhetoric but no meaningful change.
Further, while focusing on the five manufacturers with the largest market share is logical, it will not solve the problem. Just as a host of other manufacturers jumped in to copy JUUL’s success, nothing would prevent other manufacturers from using kid-friendly flavors and marketing practices that appeal to youth. Other manufacturers also claim they do not market to kids even while their practices have contributed to the current problem. Voluntary action by manufacturers is no substitute for industry-wide action by FDA. It is critical that FDA step in and use the authority that Congress gave it to protect kids and the public health.
Under current law, FDA has a number of existing authorities at its disposal to get kid-friendly e-cigarette and cigar flavorings out of the hands of America’s children. For example, as you have threatened, FDA could reverse the decision it made last year to delay a product review of e-cigarettes and cigars that were on the market on August 8, 2016. Because of this delay, thousands of flavored tobacco products are on the market today without a scientific review by FDA of their health risks and appeal to youth. Further, we do not see any evidence that FDA has enforced the current requirements that prohibit manufacturers from introducing products that were not “commercially marketed” prior to August 8, 2016, or that were modified after that date, without first undergoing a review and receiving authorization from FDA. For certain, products that now deliver nicotine using nicotine salts modelled after JUUL fit that definition. FDA should also quickly promulgate regulations to more aggressively restrict online sales of e-cigarettes and cigars to youth instead of relying on enforcement actions against individual retailers and could take other steps to keep these products out of the hands of young people.
We urge you to take the strongest action possible to protect our children from a lifetime of nicotine addiction, and to offer our continued Congressional assistance in whatever way would be helpful in your efforts. Thank you.