WASHINGTON, D.C.—Today, U.S. Sen. Sherrod Brown (D-OH) urged the Food and Drug Administration (FDA) to take immediate action against e-cigarette (e-cig) companies’ predatory efforts to market their products to young people. Brown was joined on the letter to FDA Commissioner Margaret Hamburg by U.S. Senators Barbara Boxer (D-CA), Richard Blumenthal (D-CT), Dick Durbin (D-IL), Dianne Feinstein (D-CA), Tom Harkin (D-IA), Edward J. Markey (D-MA), Jeff Merkley (D-OR), Jack Reed (D-RI), and Jay Rockefeller (D-WV), as well as U.S. Representatives Diana DeGette (CO-1), Frank Pallone Jr. (NJ-6), Henry Waxman (CA-33).
According to Pediatrics, a medical journal published by the American Academy of Pediatrics, between 2011 and 2013, the number of children aged 12 to 17 years exposed to e-cigarette marketing increased by 256 percent.
“E-cigarette companies are using the same tactics to target children that have already been banned for traditional tobacco companies,” Brown said. “The FDA has the authority to protect this vulnerable population from predatory tactics and I urge the agency to address this issue immediately.”
With the public comment period on deeming regulations to expand FDA’s regulatory authority over e-cigarettes coming to a close, the Members of Congress asked the FDA to exercise its current authority to apply the restrictions levied on traditional tobacco products to e-cigarettes. The measures requested include bans on:
- Marketing to Children – The FDA should bar e-cigarette companies, which currently use glamourous celebrities, cool cartoon, and sexy televisions and print ads, from advertising their products to children;
- The use of flavorings – The FDA should prohibit the use of fruit and candy flavors meant to attract children;
- Online sales – Due to the difficulty of accurately verifying an online buyer’s age, the FDA should prevent online sales of e-cigarettes to ensure that children do not purchase them.
Brown continues to work towards protecting children from e-cigarettes and other tobacco products. Last month, Brown introduced a plan to protect children from accidental poisonings and death from liquid nicotine. Small containers of liquid nicotine—used for electronic cigarettes—contain enough nicotine to kill four small children but liquid nicotine packages are not required to be child resistant.
Earlier this year, Brown and 10 of his Congressional colleagues released a report that shows a dramatic increase in the marketing of e-cigarettes to youth through candy and fruit flavored products, social media, and sponsorship of youth-oriented events. The report, “Gateway to Addiction? A Survey of Popular Electronic Cigarette Manufacturers and Marketing to Youth,” was compiled using responses from eight e-cigarette manufacturers and the lawmakers’ investigation of the industry through publicly available information.
In April 2014, Brown and U.S. Sen. Richard Blumenthal (D-CT) met with Commissioner Hamburg, to urge the agency to do everything in its power to expand its oversight of Big Tobacco in order to protect consumers from the dangers of e-cigarettes and ensure they aren’t being marketed to children.
Shortly after their meeting, the FDA announced that it was releasing “deeming regulations” over e-cigarettes and other tobacco products. The new regulations would ban the sale of e-cigarettes to Americans under 18, and would require that people buying them show photo identification to prove their age, measures already mandated in a number of states. However, final regulations could take a year to implement. And the FDA’s proposal still wouldn’t ban ads on the television and radio, or disallow the use of fruit flavors and other flavors that appeal to kids. Brown therefore continues to urge the Administration to strengthen and expedite its regulations over e-cigarettes and their components in order to protect children and make Ohioans healthier.
A full copy of today’s letter is below:
August 4, 2014
Margaret Hamburg, Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Commissioner Hamburg,
On April 25, 2014 – five years after enactment of the Family Smoking Prevention and Tobacco Control Act – the Food and Drug Administration (FDA) published its first proposed rule on how it plans to exercise authority to regulate e-cigarettes. We commend the FDA on many of the provisions included in these proposed rules, including prohibitions on sales to minors, prohibitions on vending machine sales and samples, and requirements to list product ingredients. However, the draft regulation fails to explicitly prohibit the marketing of these products to children, the use of flavorings, and online sales.
E-cigarettes are being aggressively marketed to children today, and, not surprisingly, the use of e-cigarettes has skyrocketed in recent years. The Centers for Disease Control and Prevention reports that, between 2011 and 2012, the percentage of middle and high school students who have tried e-cigarettes more than doubled. What’s even more troubling is that these products serve as a gateway to traditional tobacco products. A recent JAMA Pediatrics study found that middle and high-school students who used e-cigarettes were more likely to smoke traditional cigarettes and less likely to quit smoking.
It is not a coincidence that the increase in e-cigarette use by children coincides with a dramatic escalation in e-cigarette companies’ advertising efforts. According to the journal Pediatrics, exposure to e-cigarette marketing by children aged 12 to17 increased by 256 percent between 2011 and 2013, with Blu ECigs accounting for more than 80 percent of the advertising. Moreover, a Congressional investigation led by our offices, found that in just two years, from 2012 to 2013, six of the surveyed companies sponsored or provided free samples at 348 events, many of which were music festivals and motorsport events geared toward young people—including Grand Prix auto racing events.
E-cigarette companies are employing the same tactics used by big tobacco decades ago: showcasing glamorous celebrities, creating cool cartoons, and pushing their brands through sexy television and print advertisements. Congress dramatically curtailed the use of these tactics to market traditional cigarettes though the Family Smoking Prevention and Tobacco Control Act, and we urge the FDA to extend these same restrictions to e-cigarettes.
The second area of grave concern is the FDA’s failure to address flavorings in e-cigarettes. Fruit and candy based flavors are clearly meant to attract children, and we similarly urge FDA to regulate a halt to the use of such flavors. In the proposed regulation, the FDA cites evidence showing that young people are the most likely to use flavored tobacco products. That is likely why e-cigarettes and liquid nicotine manufacturers are marketing products that use popular candy and drink flavors, like those used in Jolly Rancher candies and Kool-Aid mix. Authors of a recent New England Journal of Medicine study contend that the use of these specific candy flavors exploits the association children have between these familiar flavors and the candies kids enjoy.
Finally, we are disappointed that despite the importance of preventing online sales of e-cigarettes, the proposed rule does not include such a restriction. Age verification is very difficult to perform accurately for online purchases. As a result, this loophole could undermine the FDA’s ability to keep e-cigarettes out of the hands of children.
While FDA’s proposed rule sets the stage for future regulations, strong regulatory actions on marketing to children, e-cigarette flavors, and online sales cannot wait. FDA has an existing mechanism to protect children now—without waiting years to implement new regulations to accomplish these goals. The Family Smoking Prevention and Tobacco Control Act makes marketing new tobacco products illegal without prior FDA authorization. The law also gives FDA the authority to place restrictions on the sale and marketing of newly deemed tobacco products, especially those that pose a risk to children, as a condition of FDA authorization. Instead of exercising this authority to limit children’s exposure to tobacco products, the FDA is proposing a two-year “compliance policy” that allows addictive e-cigarettes to remain on the market as manufacturers submit new product applications.
We recommend that FDA use its enforcement discretion to allow newly deemed tobacco products to remain on the market only if their manufacturers apply the restrictions imposed on traditional tobacco products to limit youth access, including a ban on flavorings, prohibition of tobacco brand-name sponsorships, and limits on advertising. Allowing e-cigarette products to remain on the market without these restrictions would amount to an abdication of FDA’s responsibility to protect our children.
We urge you to finalize this proposed regulation within a year of its release and to adopt an enforcement policy that protects our nation’s youth from predatory marketing, flavors that lure youth to toxic nicotine, and easy online access.