Dick Durbin (D-IL) and 13 other US Senators are urging the U.S. Food and Drug Administration (FDA) to reconsider its decision to delay a review of vaping products, and also asking for explanations in relation to other regulatory decisions.
The Senators are voicing their concerns about vaping products that are seemingly appealing to adolescents more than others, such as JUUL and e-liquid flavours that are considered child friendly such as ‘cotton candy’ and ‘gummy bear’. According to the senators these products are “clearly being marketed to children and teens.”
The Senators’ main points
Below are the main points in the letter addressed to the FDA, which the senators demand are answered by the 20th of July:
“1) Please provide a complete list of all deemed tobacco products that were on the market prior to August 8, 2016, and, following your July 2017 announcement, are unfortunately allowed to remain on the market for several years without an FDA review.
- Has FDA made this information publicly available on its website? Will the agency consider doing so? If not, why not?
2) Given the ongoing introduction of new tobacco products to the market without FDA review, there appears to be confusion about what criteria a deemed tobacco product must meet to be considered “on the market” prior to August 8, 2016. What criteria does FDA use to determine if a product was “on the market”?
- Would a product that was distributed only via free samples before August 8, 2016, satisfy FDA’s definition of “on the market”?
- Would a tobacco product available for purchase in only a very limited number of retail outlets or for a very limited duration of time be considered “on the market”?
- Has FDA set a minimum number of sales that is necessary to demonstrate that a product was “on the market”?
3) Are there any flavored cigars, e-cigarette devices, or flavored e-liquids currently available for purchase in the U.S. that were not on the market prior to August 8, 2016, and have not gone through FDA review?
- Please provide a complete list of all deemed tobacco products that FDA has identified as being on the market in violation of existing regulations.
- Has FDA ordered the removal of any such deemed tobacco products?
4) As you know, JUUL and accompanying mango-flavored JUULpods are incredibly popular with children. According to JUUL’s own social media posts, the mango flavor did not come to market until 2017, well after the August 8, 2016, effective date of the deeming rule. Did JUUL’s mango-flavored pod go through FDA review, or is this product on the market in violation of FDA’s rules? If the former, please provide information on the timeline for JUUL’s submission and FDA’s review of application materials for the mango-flavored pod. If the latter, when will FDA order the removal of this kid-appealing flavor?
5) Does FDA have in place a process for identifying products that entered the market after August 8, 2016, without receiving a marketing order from FDA? If yes, please explain that process.
- Does FDA require all manufacturers with products on the market without a marketing order to submit information to FDA to demonstrate that their products were on the market prior to August 8, 2016?
- Has FDA ever investigated whether a product is on the market without a required marketing order? How many? What were the outcomes?
6) The compliance policy in the 2016 deeming rule permitted manufacturers to keep products on the market for an additional year after submission of an application to provide a limited amount of time for FDA to review the application. But the July 2017 suspension of product review appears to permit manufacturers to keep products on the market while FDA reviews applications, no matter how long FDA’s review may take. Is that an accurate reading of your current policy? If so, has FDA taken steps to ensure that it reviews applications in a timely way?
7) On March 21, 2018, FDA issued an Advance Notice of Proposed Rulemaking (ANPRM) regarding the regulation of flavors in tobacco products. Thankfully, as FDA acknowledged in the ANPRM, much is already known about this issue—especially regarding the popularity of these products with children.
- Has FDA ever advanced a tobacco-related ANPRM through to a final rule? If so, please identify such rules.
- FDA has already once delayed the deadline for this comment period. When does FDA plan to issue a proposed rule and final rule for the regulation of flavors in tobacco products?
It has not gone without notice that FDA has taken some modest steps to address e-cigarette use in children—including requesting detailed information from a few e-cigarette manufacturers about the marketing and development of their products; ordering the removal of certain e-cigarette flavorings that resemble foods; attempting to reduce third-party sales of these products; issuing warning letters to a couple dozen brick-and-mortar storefronts that have been selling tobacco products to children; and incorporating e-cigarettes into The Real Cost campaign.
However, the horse is already out of the barn and considerably more must be done to address this looming wave of youth tobacco addiction aided, in part, by FDA inaction. If companies want to use flavors in their tobacco products, they should be required to demonstrate to the FDA that use of flavors will benefit public health—today, not four years from now. We look forward to receiving your responses. Thank you for your immediate attention to this important issue.”
The Senators’ letter leaves out an important detail
A report released by the Centers for Disease Control and Prevention (CDC) in June 2017, clearly indicated that smoking rates amongst high school students were cut in half in only five years, between 2011 to 2016. This is the period that the senators are referring to when vaping amongst the same age group had increased from 1.5% to a peak of 16.0% in 2015.
After 2015, Vaping rates amongst teens started declining
However, the senators left out an important detail, after 2015, vaping rates started dropping. From 16.0% in 2015, vaping rates dropped to 11.3% in 2016, while smoking in that same period also dropped from 9.3% to 8.0%.
In line with the above, a report titled, QuickStats: Percentage of Adults Who Ever Used an E-cigarette and Percentage Who Currently Use E-cigarettes, by Age Group — National Health Interview Survey, United States, 2016, has indicated that vaping is actually on the decline, with 3.2% of US adults using e-cigarettes in 2016, down from 3.4% in 2015, and 3.7% in 2014.
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