More than a quarter million comments submitted to the Food and Drug Administration about flavored vapor products were fake, according to a watchdog group.
The public consultation period for the FDA’s notice of proposed rulemaking that seeks to evaluate the purpose of vapor product flavors closed Thursday, after a 30-day extension, with at least 255,000 fake comments from a single Internet bot, the Regulator Watch reported earlier this month.
A computer bot was launched with the intention to individually enter a mass amount of anti-vaping comments into the system, and the bot was able to generate 255,000 comments between June 8-11 before technical staff isolated four IP addresses tied to the bot.
Regulator Watch, a watchdog group that specifically focuses on vaping regulation in the U.S. and Canada, noticed the explosion of comments during the public comment period of those few days in June and reported that there was suspicious activity associated with the uptick in comments.
Fake comments were able to be identified because they used a lot of repeated phrases, like “electronic cigarettes have quickly skyrocketed in popularity among teens,” and were usually submitted anonymously, Regulator Watch’s founder and executive producer Brent Stafford said.
More than 525,104 comments were submitted overall regarding flavors for vaping and e-cigarettes.
[Related: FDA warns companies about enticing kids with e-cigarette flavors]
Although fraudulent bot submissions are not uncommon in the regulation process during public consultation periods, seeing it at this magnitude is shocking, said Vapor Technologies Association Executive Director Tony Abboud.
Stafford also said it is “highly likely that there are at least 200,000 more” fake comments on top of the 255,000 confirmed fraudulent posts, but admitted that nobody knew yet for sure how many of the more than half-million comments were fake.
A spokesperson for the FDA said the agency is aware of there being autogenerated comments, but the quantity of fake submissions does not affect the regulation process.
“The comment process is not a vote — agencies make determinations for a proposed action based on sound reasoning and scientific evidence,” FDA press officer Michael Felberbaum said when asked about the the high quantity of fake comments. “Like any FDA-related docket, the FDA will review and account for comments, data, and research submitted to this docket as it considers appropriate next steps.”
In March, the FDA asked for feedback on the topic, and although the request does not specifically mention a ban on flavors for vapor products and e-cigarettes, there could be limitations imposed depending on the feedback and evidence the FDA collects.
FDA Commissioner Scott Gottlieb said in launching the “advance notice of proposed rulemaking” that the FDA is looking into flavored tobacco products to “better understand their level of impact on youth initiation.”
However, Abboud said the issue with possible youth initiation is not in the existence of flavors, but instead in the marketing of the vapor products.
[Also read: San Francisco first city to ban e-cigarette flavors]
In VTA’s comment submission to the FDA, the leading national trade organization for vapor products in the U.S. said they have a “zero tolerance policy for Vapor Products that use … imagery or designs that intentionally mimic” products that are primarily marketed towards minors.
The FDA requested proof of data and information to support the claim that flavors help adult cigarette smokers reduce cigarette use or completely switch to a less harmful product, like e-cigarettes or other vapor products.
“The most important thing is that flavors have proven and are proving to be an important tool in helping adults who are trying to quit smoking. That is our number one public health priority,” Abboud said. “We have many tools to help us stop youth from using these products illegally. What we don’t have in this country is tools to help adults stop smoking. And all of those tools currently available, that you can get over the counter, without prescription, and without age restriction, come in all sorts of fruity flavors.”
Through its public comment request, the FDA also sought information on the role that flavored vapor products have on helping people quit smoking traditional cigarettes.
