The Food and Drug Administration has alerted gun giant Juul with a couple of letters calling on the company for misleading statements about its products and ongoing targeting of teens. There are demanding written answers to a boatload of relevant questions and expect Juul to respond within two weeks or risk "even more aggressive action" from regulators.
The specific allegations that the FDA disputes have to do with Juul's positioning as a smoking cessation product. Now, it may be obvious anecdotally that vaping is a good way to get rid of smoking. But unlike nicotine plastics and other products, there is not much documentation on the complete risk associated with vaping ̵
"Companies must demonstrate with scientific evidence that their specific product actually poses less risk or is less harmful," acting FDA Commissioner Ned Sharpless said in a news release. "Juul has ignored the law, and very carefully, has made some of these statements in the school of our nation's youth."
Juul was reportedly directly targeting social media channels that young people visit, and "despite commitments JUUL has made to address this epidemic, JUUL products still represent a significant proportion of the total use of ENDS products by Some of this adolescent use appears to have been a direct result of JUUL's product design and promotional activities and outreach efforts. "
In a recent congressional hearing on the risk of" electronic nicotine delivery systems "or ENDS, evidence was presented that a Juul representative told students that the company's products were "much safer than cigarettes," "completely safe," and that "the FDA was coming out and said it was 99% safer than cigarettes … pretty soon."
Representations like these seemingly made wide and wide, among students absolutely and also among Native American communities, are not the kind of statements you can just say – tobacco Violence products are regulated, mainly medical products, and the FDA is watching them closely. Claims must be documented and evaluated.
Juul seems to have gone very close to the line in its public statements, and it is likely that the company very carefully made these messages to convince people that the devices are good alternatives to smoking while not making any claims that would delay it. for FDA attention. But they seem to have crossed that line now and again, provoking exactly the kind of scrutiny they would prefer to avoid.
"We request that you provide all scientific evidence and data, including any consumer opinion studies, related to whether each statement or representation explicitly or implicitly communicates that JUUL products represent less risk, are less harmful, have reduced exposure, or are safer than other tobacco products, "the FDA told Juul.
Further, it asked Juul to explain why it uses a 5% nicotine concentration in the products, which may increase the likelihood of addiction, and why the company uses nicotine salts, a substance that reduces hardness and allows greater nicotine concentrations.
Probably regardless of the ongoing investigation of lung problems apparently caused by vaping, the FDA also requested "Aerosol particle size analysis of aerosol formed from your device," "experimental design and data on p K studies from your device, your e-liquid and burn cigarettes, "comparisons between free nicotine and nicotine salt delivery, and" How the design and performance of your device and / or e-liquid, including the level, formulation and delivery specifications of nicotine, affect lung deposition in relation to its use and the addictive potential of the product. "
In other words, tell us why you designed your product to be extra addictive and attractive to non-smokers, and whether this was in spite of knowing the substances created caused lung damage.
In a statement, Juul said it was "reviewing the letters and will cooperate fully."