Is the FDA readying for a fall campaign, but with the wrong data?
This post contains many questions and we would love to have your thoughts on them. At times, when reporting on the vaping industry and FDA (Food and Drugs Administration) proposed regulations, it can feel as we have donned tin foil hats and are barking up the wrong tree.
But have we?
The FDA have asked more e-cigarette companies to come forward with their marketing information. The selected companies have until the 12th July to respond.
A theme has emerged this recently and it’s about the possible misuse of data.
The FDA according to Cstore news, have requested the following information from all:
- Documents related to product marketing to include:
- Research on the health, toxicological, behavioral or physiologic effects of the products, including youth initiation and use.
- Whether certain product design features, ingredients or specifications appeal to different age groups.
- Youth-related adverse events and consumer complaints associated with the products.
- The use of e-liquids that contain nicotine salts with corresponding high nicotine concentration.
- The small size which makes these products easily concealable.
- Product design features that are intuitive, even for novice users.
The reasoning behind this request is due to the FDA wanting the e-cigarette companies to hand over their data, so they in turn can decide upon further legislation.
However, there are several issues that need exploring here, the main one being the companies will not be able to answer the youth related questions.
The motive pushing the FDA forward is youth vaping/smoking. Companies cannot sell to minors, so the information about youth smoking is not there.
All the data will be for 18-year-olds and above.
The FDA state:
“The agency is also exploring clear and meaningful measures to make tobacco products less toxic, appealing and addictive - with an intense focus on deterring youth use. This could include measures on flavors/designs that appeal to youth, child-resistant packaging and product labeling to prevent accidental child exposure to liquid nicotine. Additionally, the agency plans to explore additional restrictions on the sale and promotion of ENDS to further reduce youth exposure and access to these products. The FDA has also expanded "The Real Cost" public education campaign with messages focused on preventing youth use of e-cigarettes and will launch a full-scale campaign this fall.” (emphasis ours)
Is the FDA going to guess about the preferred flavors of youth, and gather up the data of 18-25-year old’s preferred device and use that to legislate with? Because unless they find out from the teens that are vaping which are their preferred flavors/devices, how will they know?
The FDA is asking for research about adverse effects, toxicology, behavioral responses etc., all of which is readily accessible in the public domain. E-cigarette companies do not have the finances to fund their own trials. This raises the specter of cherry picking.
We know that the FDA favor Professor Glanzt and his research findings, even if the rest of the world doesn’t and are not afraid to highlight that some of his work has been flawed.
Which research will then be chosen?
What about adverse related incidents?
What is the definition of this, and again, will the e-cigarette companies have this information? They will have customer complaints, but surely the adverse events will be found in the local ER and in the poison center stats?
And then we get to the small size and intuitive use.
If under 18’s can’t buy online or in stores, (and one assumes that the majority of companies don’t sell to minors,) where are the kids getting hold of them?
Because the majority of vape gear is sold to bona fide adults. Adults like to have small hand-held devices too. It’s not just the teens.
And intuitive use…. Why is this even an issue? Can’t adults have something that doesn’t need an engineering degree to use?
As you can see, there are so many questions!
The FDA are requesting information that many probably won’t be able to provide.
This suggest a PR stunt to look inclusive, to look as if the FDA are in dialogue with the industry, but as we have outlined, it is anything but.
How will they use the data they do obtain if it all relates to adults and they are legislating for children?
Will they ban the most popular adult flavors? Will the smaller devices go?
Let’s make it very clear that we as a company do not believe that any minor should be vaping or smoking, but as we continually state, we cannot condemn millions of adults to miss out on a product that is keeping them away from tobacco because of some children illegally getting hold of them.
The companies will not have the information that the FDA need, because the youth do not get hold of their e-cigarettes by legitimate means.
Could this then lead to a misuse of data, because none of it from the companies will represent the youth market?
What are your thoughts? Leave them in the Comments Section below.