September 20, 2019, Fda Issues Proposed Rule For Premarket Tobacco Product Applications

Trump calls for ending FDA authority for regulating tobacco

Should Congress get onboard with this?

President Trump has proposed removing the Food and Drug Administration's responsibility for tobacco regulation in his latest budget request, a task likely to be met with backlash from tobacco control advocates.

The budget request, released Monday, calls for creating an entirely new agency nested under the Department of Health and Human Services to regulate tobacco products, including e-cigarettes.

Dimitris Agrafiotis (Vaping Greek) -- "double sided...at least we have some laws in place to protect us now. an independent body would have more power so depends on who is running it and the administration if it is good or bad... could be very bad."


Thoughts?  

I've seen a few awesome article links posted that show the truth to this THC/VIT E Outbreak. Please post them here if you have them.

We all need as much positivity as possible while all this mudslinging bollocks is going on

@Katya You are up - post your lil butt off

The emotional and irrational hysteria in the US about the “vaping-related” (or cannabis-related?) lung disease that goes far beyond confirmation bias - Thursday, 05 September 2019
By Dr Farsalinos

The Rest of the Story: Tobacco and Alcohol News Analysis and Commentary - Thursday, September 05, 2019
By Michael Siegel

The US and UK see vaping very differently. Here's why
By Katie Hunt, CNN
Updated at 1937 GMT (0337 HKT) September 17, 2019  

Vaping companies are required by the FDA to provide a Premarket Tobacco Product Application (PMTA), which will include scientific data to show a product is appropriate for public consumption. Manufacturers have until Sept. 9 to submit their application, failing which their products will be pulled from the market. Once an application is submitted, companies can keep selling their products for a year from the date of deadline, without official approval, or until a negative action is taken by the FDA.

It seems juul has applied, any other brands？  

Alright, so I was reading over a house bill that just passed here in Hawaii "with amendments"

Not exactly sure what the amendments are, so this could be irrelevant, but the concept still holds true.

The legislature imposes an 80% tax on "Tobacco Products" which they have conveniently bundled electronic cigarettes into.

So, what would stop a vape shop from selling all 0 nic juices, and adding nicotine as a separate purchase. For example, I buy a 30mL bottle of juice with zero nic, and then I buy enough nicotine concentrate to bump it up to say 6mg/ml

They sell me the juice for $15 (Hypothetical here) and sell me the nicotine for $1.00

So all that would get taxed is the nicotine because that's the only "Tobacco Product" (by their definition). So we only pay 80 cents in taxes rather than $12.80

If I ran a vape shop, this is what I'd be doing to prevent my customers from taking their business out of state, or worse going back to stinky sticks...

As far as I know, they would be hard pressed to define any of the electronic equipment as tobacco products, or juice without nicotine.

Is selling the nicotine as a separate purchase a viable strategy for defeating these ridiculous laws that are being proposed all over the country?  

"In a letter sent to the FDA on June 7, the Small Business Administration (SBA) Office of Advocacy asked the regulators to seek a court order extending for an additional year the current moratorium on enforcement actions against small vape manufacturers who submitted Premarket Tobacco Applications (PMTAs) before last year’s Sept. 9 deadline."

"The SBA letter doesn’t mean the FDA will ask Judge Grimm to extend the enforcement grace period, but it is an encouraging development."

See whole article he
SBA Urges Another Year of Sales for PMTA-Submitted Products - Vaping360  

And so it begins......

WASHINGTON — The Trump administration said Wednesday it plans to ban the sale of non-tobacco-flavored electronic cigarettes amid a vaping crisis.

“The Trump Administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities,” Health and Human Services Secretary Alex Azar said in a statement. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”

Michigan became the first state to prohibit sales of most flavored e-cigarettes last week in a bold move to curb the underage vaping epidemic. The ban, which will take effect in a few weeks, will cover both online and in-store sales of all e-cigarette flavors except tobacco.

Trump administration plans to ban sale of flavored electronic cigarettes  

Vaping is too enjoyable and comforting that I can stay in my room for 2 hours scrolling my phone and not go out.Part of my problem is that I am a closet vaper,so I am planning to use nicotine gum when I am out with my family as I am shy to let them see i vape and also they always brainwashed me to quit vaping,that’s why I Vape alone in my room.Today is my first day trying out nicotine gum,4mg and I can sit with my family even though I don’t talk(that’s another story cause of my MI) but at least I am presence.Anyway,does any of you vapers use smokeless tobacco/nicotinic product?  

Copied from another group.
With permission

I am the owner of Sapphyre Nicotine. I have been in the e-cig and vape business since 2009. This post is a little long but hopefully it is informative for some.

In 2009 the FDA started seizing shipments of electronic cigarettes under the claim that they were drug delivery devices and therefore need to pass FDA approval prior to being marketed and sold in the USA. The industry was just starting out and this was a big blow. Shipments of product were not allowed to enter the USA. Credit card companies were not allowing ecig companies to work with them. It was not looking good for ecigs. A company called Smoking Everywhere sued the FDA and made the argument that ecigs should be regulated as a tobacco product since they contained nicotine which is derived from Tobacco. Njoy joined the litigation and eventually took over when Smoking Everywhere went out of business. In 2010 Njoy won the litigation and ecigs ended up being regulated as tobacco products. This was the best outcome of two evils. The FDA appealed the decision and lost that as well. That’s when the ecig industry really started taking off. Bigger players got into the market and eventually RJR, Altria/Philip Morris, BAT and other big tobacco companies came out with ecig products. They quickly became the dominant sellers in c-stores. The tobacco companies were happy selling tobacco and menthol flavors only. That’s what they knew and that’s what they were good at.

A few years later eliquids and open systems started getting popular. These products were not very popular in c-stores. That is when vape stores started opening up. They were mainly concentrating on open system (eliquids, mods and great tasting flavors). For a short time c-stores tried to sell eliquids, but they didn’t have the know how or the time to educate customers. C-stores were good at selling closed systems and vape stores were good at open systems.

To the uninformed public we are all lumped in as one industry --- electronic cigarettes.

In reality there are 2 different industries that are somewhat related.

A) The ecig/closed system industry: In the USA as of Sep 2019 is a $6.4 billion industry. It is controlled mostly by big tobacco companies. Juul (Altria/PM), Blu (Imperial Tobacco), Vuse (British Tobacco, formerly RJR), Njoy (only independent supplier), Logic (Japan International). 75% of ecigs are sold in C-Stores, drug stores and food stores. As a comparison, regular cigarette sales in the USA are around $80 billion dollars and about 75% comes from c-stores.

While ecigs sales increased at a 40% year over year rate, regular cigarette sales dropped by 7% year over year. That is a large number that is troubling to big tobacco.

The closed system industry sells primarily tobacco and menthol/mint flavors. If flavors were banned it would not impact the industry very much. The companies selling closed systems are not going to join our fight to save flavors. They have no monetary incentive to do so. In addition all of these companies are going to apply for PMTA. They are not going to sue the FDA and risk getting PMTA approval unless it greatly impacts their business.

The vapor/open system industry: In the USA as of sep 2019 is a $2.6 billion industry. It is NOT controlled by a few large companies. There are a lot of hardware and ejuice suppliers. It is mostly sold at adult only vape stores. $1.7 Billion sold at vape stores, $350 million in c-stores and $550 million online. Lots of suppliers, distributors, small businesses are part of this industry. They mostly sell flavored eliquid as opposed to tobacco and menthol flavors.

Having been involved with both the ecig business and the vape business, I can say that they are completely different. The vape industry is getting punished for crimes committed by the ecig industry. Unfortunately we are being lumped in as one. We are the easier one to target. We need to do a much better job getting this message out.

I would also like to make a point regarding zero nicotine flavors being regulated by the FDA. The reason our industry is regulated by the FDA as a tobacco product is because the eliquid contains nicotine. This is the only reason the FDA has authority over these products. Because zero nicotine ejuice does not contain nicotine, it is no longer a tobacco product. While the FDA is going to try and enforce regulation of zero nicotine ejuice as a tobacco product by using the “intent to use” rationale, that argument is simply not valid. The FDA will also not be able to regulate zero nicotine ejuice as a drug/drug device combination either. Ejuice with no nicotine does not cause a change in the body and therefore will not be classified as a drug. This is only my educated opinion. I am not an attorney and am not making any legal claims.

I hope this was somewhat informative to people that have not been involved with ecigs and vapes as long as I have. Feel free to add, correct if you have information that I missed.

Feel free to share  

Trump Administration Weighs Ban on Flavored E-Cigarettes

Sitting in the Oval Office with Alex M. Azar II, the secretary of Health and Human Services, and Dr. Ned Sharpless, the acting Food and Drug Administration commissioner, President Trump acknowledged that there was a vaping problem, and said, “We’re going to have to do something about it.”

Mr. Azar said that the F.D.A. would outline a plan within the coming weeks for removing most flavored e-cigarettes that are not tobacco products from the market.

Pressure also began to mount as Michael R. Bloomberg, the former mayor of New York, decided to step in by announcing a $160 million push to ban flavored e-cigarettes. Long an opponent of traditional smoking, the former mayor said his organization, Bloomberg Philanthropies, would seek prohibitions of flavored e-cigarettes in at least 20 cities and states.




From left, Dr. Norman Sharpless, the acting F.D.A. commissioner, Melania Trump, President Trump and Alex M. Azar II, the health and human services secretary, discussing flavored e-cigarettes in the Oval Office on Wednesday.  

Hey everyone! I've been casually vaping off and on for two years now, but I finally took the plunge and started vaping exclusively. I am almost 4 days tobacco free! It's the longest I've been without tobacco in 7 years!!! It's been a lot easier than I thought it would be.

Something that keeps me going is to think about the horrible realities of being a tobacco user.

What are the things about tobacco you are glad to have behind you? The smell? The taste? The money? What did you hate most about smoking?

I could really use the little reminders throughout the day.