Correct me if I am wrong but, the FDA has not only deemed vaping
as a tobacco product but, a new generation of tobacco products.
I am unaware of any distinction that would give vaping the same status
as as Grandfathered cigarettes. If anything we would be grandfathered
as new tobacco products. Even though the FDA considers us the same
as any other tobacco product there is absolutly nothing saying we should,
could or,will be treated the same.vaping is potentially even more dangerous.
(not my view point) According to some vaping is going to enslave a whole
new generation along with generations to come to the deadly nicotine
addiction. Should the the courts and Congress discard this simplistic
analysis,yes. Will they,no.
This is why I say the best we can hope for is parity. I am not saying
I am right. I am just pointing out a very real possibility of the outcome
of all this. I hoped I was wrong about my assessment about the final
deeming regs. To my disappointment I was not.
Hope springs eternal though.
Regards
Mike
For personal use, no, you're not a manufacturer. If you were to distribute what you assembled to someone else(either sold, traded, or gift) then I believe you would be considered a manufacturer.
Based on the regulatory model the FDA follows, the burden of testing is on the applicant, not the agency. This applies for all drugs, they are tested at considerable time and expense by drug companies who then present it to the FDA for approval. The only tobacco PMTA approved was for Snus, and again was all based on testing done by the manufacturer, not by the FDA.
The FDA uses this very model to partly justify the PMTA process for vaping as by their own admission, the PMTA testing performed by the manufacturers will provide them with data to determine the long term safety and risks. All such testing occurring at the companies expense. This model might work for drugs and medical devices, but is a poor fit here, where the mindset of the agency is "prove it is safe" falls on the industry, rather than the FDA having to prove it is not safe (also saves the FDA a ton of money in doing the testing themselves).
The only other area where this was addressed head by legislation on with nutritional supplements. There it specifically required the FDA prove there was a risk with a given nutritional product before it could take regulatory action. Here are some highlights from that little legislative deal that was pushed through under some questionable circumstances.
"...........However, many people felt that the FDA was too restrictive in regulating dietary supplements. As a result, Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994 which placed dietary supplements in a special category of "foods". In October 1994, President Clinton signed DSHEA into law.............
According to DSHEA, dietary supplements are not drugs. Dietary supplement ingredients that were lawfully sold prior to 1994, have been "grandfathered" into the Act, meaning that a manufacturer is not required to submit to FDA the evidence it relies upon to substantiate safety or effectiveness before or after it markets these ingredients. The rationale for this exclusion is based on a long history of safe use; hence there is no need to require additional safety data................"
from:
ISSN exercise & sport nutrition review: research & recommendations ISSN exercise & sport nutrition review: research & recommendations | Journal of the International Society of Sports Nutrition | Full Text
What was interesting was that primary sponsor of that legislation in the Senate happened to be from a state with a large supplement industry. The original vitamin story goes back to 1975 and Senator Proxmire, who wrote and sponsored what was known as the Proxmire amendment.
"Faced with what appeared to be a massive grass-roots consumer effort, the majority of Congressmen co-sponsored legislation that would virtually remove food supplements from FDA jurisdiction. U.S. Senate Bill S-2801, introduced by Senator William Proxmire and referred to as the "Vitamin Bill," became the rallying point. As it turned out, S-2801 never came to a vote by itself, but Proxmire managed to push it through the Senate by attaching it to an unrelated but popular bill. The bill's harmful effects were softened somewhat by a compromise made through the efforts of Representative Paul Rogers, but a version did pass—much to the detriment of American consumers. The so-called "Proxmire Amendment" prohibits the FDA from limiting the potency of ingredients of vitamin and mineral products that are not "inherently dangerous" and prevents the agency from ridding the marketplace of useless "dietary supplement" ingredients and irrational combinations of ingredients. It became law because the health-food industry misled many of its customers into believing that the FDA intended to greatly restrict the sale of supplement products.
Unknown to Congress and the FDA, a large percentage of those who wrote protest letters to Congress were not merely confused users of vitamin supplements. They were also sellers. Hundreds of thousands of people worked as "distributors" engaged in person-to-person sales for large companies like Shaklee, Amway and Neo-Life. I strongly suspect that these people—who took in hundreds of millions of dollars each year selling unnecessary supplements—formed the core of the letter-writing campaign."
from: How the Dietary Supplement Health and Education Act of 1994 Weakened the FDA Dietary Supplement Health and Education Act (DSHEA)
So in the absence of that type of legislation for supplements, which is pretty unlikely, the FDA consistently places the burden on the manufacturer
Lots of those eBay and even Amazon sellers are located abroad, frequently in China. US based B&M stores would have no such protection to avoid FDA governance as foreign companies and sellers have (other than foreign items being stopped by customs). They can certainly try selling on eBay and Amazon, but that will provide no protection from enforcement if they're within the US.
That would only occur if either H.R. 2058 or Cole-Bishop passes, providing current products on the market with the same grandfathered protection as was extended to cigarettes on the market pre 2007. A bit of a more level playing field.
I think we are being treated worse then smokers...especially here in Indiana. Worry about the states that's where the hammer is truly coming down..FDA has nothing on what the states are doing to vapers.
Yes, it happened. I clicked on the link that was provided and it took me to the live feed on YT.
I wish I could like this post more than just once.
RTS?Just saw a couple post's in RTS's forum, things are not going well, thanks to the deeming regs. Thanks FDA.
Nicopure's briefs are first class, IMO. Have you read them? What is the basis for your criticism?
RTS vapes. First place I got my DIY stuff, as they had nic, flavors, and glassware....total order was about $75 and I've never looked back. Sadly, a lot of their customers are vape shops and vape shops are gonna get slaughtered by the regs...
???Just saw a couple post's in RTS's forum, things are not going well, thanks to the deeming regs. Thanks FDA.
In the case of the RYO machines in the tobacco shops for the customers use I can see how there could be a legal "implied" intent to skirt the regulations even if the customer is using the machine himself. I don't remember all the specific legal jargon from back in the days that I took business law but I think "implied intent" would apply in that case. Something like if a vape shop were to have a separate counter in their store where "after" customers purchased their vape stuff they could go and have a store employee assemble their tanks and mods and build a coil for them and then the customer could fill their tank with free juice. Yea, all those things would happen AFTER the purchase BUT it certainly is implied that as long as you purchase your stuff at the store you can walk over to the after purchase counter and have it all done for you and get free juice.
It's a very different case when that elderly lady purchases her AIO, takes it home and returns later saying she cant get the top off and comes back to ask for help and the employee takes the top off for her and fills her tank for her.
I believe the court would see those two different scenarios very differently and I think the FDA knows that and would also see them differently.
I don't see a problem with a vape shop providing a tool to a customer that ask for one after purchasing juice so they can fill their tank with that juice before they leave the store. Just probably not a special second "after" purchase counter supplying everything a customer could need.
Hardball: The Vapor Industry's Legal Response to the FDA - Vaping360
I have felt for awhile that the FDA was taking a lets just get rid of this whole vaping thing and give the crumbs to BT/BP legal approach and frankly not taking the push back that might come as very serious.
"We'll just deem it tobacco and be done with this."
A very arrogant approach and I hope their counter defense shows the legal weakness of their lack of forethought and legitimate research.
I have felt for awhile that the FDA was taking a lets just get rid of this whole vaping thing and give the crumbs to BT/BP legal approach and frankly not taking the push back that might come as very serious.
"We'll just deem it tobacco and be done with this."
A very arrogant approach and I hope their counter defense shows the legal weakness of their lack of forethought and legitimate research.
In a recent FDA webinar, it was explicitly stated, they have no jurisdiction unless a sale was made and they do NOT consider a gift to be a sale.
At the state level, things may be different. The new tax law in PA redefined sale to include gifts. So, technically you are an unlicensed manufacturer or retailer. But, it is criminal only if you profit from the sale.
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So vendors can "gift" us samples? What is the distinction between a gift and a free product, is it the retailer/manufacturer status of the person giving the item?
Did they do any definition of trades or secondary sellers(used items)? Durable tobacco products is a fairly new thing(since they didn't regulate pipes before).
It has to be their status, but that was not addressed. Also, a sample can be written off as an expense. A gift can not.
They did address a secondary market in the webinar. You would have to be a retailer and you couldn't sell it anyway since it is considered an adulterated product. No legal resale. Even repair seems to be forbidden if you make a profit.
That is fan-freaking-tastic.
Arrogant is exactly right. And vindictive. Ever since they were told they couldn't regulate e-cigarettes as drug delivery devices they've been planning a strategy which will allow them to do exactly what they wanted to do all along: regulate e-cigarettes as drug delivery devices. That's essentially what the deeming does, completely ignoring the fact that they are recreational devices and aren't used or intended for the treatment of illness or disease.
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