December 5, 2022
Dear Ann Simoneau, J.D.:
Please see Cali Steam LLC’s response to the warning letter received on November 10, 2022.
The referenced warning letter stated the following:
“FDA received your Premarket Tobacco Product Application (PMTA) assigned STN PM0001175 on September 7, 2020. However, FDA issued a negative action for PMTA STN PM0001175 in the form of a Refuse to File determination on August 9, 2021, which covers 33 products.”
We have no receipt of this determination.
We weren’t aware that we didn’t meet the threshold determination of whether the application contains sufficient information to permit a substantive review, nor that the FDA refused to review our PMTA due to the criteria in § 1114.27(b)(1).
As a small business, we were in verbal correspondence with FDA officials. We were pending a request for samples related to our application for further evaluation of our overall application.
Furthermore, in response to the section titled “New Tobacco Products Without Required Marketing Authorization are Adulterated and Misbranded” on the website https://calisteam.com, we have confirmed the inability of United States customers to purchase products that were not properly listed within our PMTA application.
Additionally, we are currently in the process of preparing our annual updates to the tobacco registration and product listing (TRLM) by December 31st, 2022.
Lastly, due to the pandemic and ongoing economic conditions we are nearing bankruptcy and by threatening our company you will be responsible for for us closing our doors permanently in the 1st quarter of 2023. We have business loans that need to be paid off with not only the SBA (Small Business Association) but also a private loan company amounting over $175,000. We are barely able to make our payments as of now and if you cut our website off then you will collapse our foundation and you will be responsible for adding additional debt to the United States whopping 31 Trillion dollar debt crisis and displacing more Americans. What are you going to do? Are you coming for our petty $4,000-$5000 monthly revenue that allows us to barely scrape by? We are not big fish, if that's what you are looking for. We have had a 90% decrease in revenue within the last 2 years but still continue to serve our handful of longtime customers because they enjoy our products, it makes us happy to continue to serve them.
Big tobacco has gained full control again and you have successfully wiped out most small businesses, you goddamn power hungry greedy pigs.
You are displaying an ABUSE OF POWER. We took all the necessary steps and worked our butts off day in and day out to stay in compliance and suffered quite a lot due to your absurd, grating, totalitarian dictatorial requests. There was absolutely nothing democratic with your approach in how you designed the PMTA.
We have already made the hard decisions to let go of all of our temporary workers due to the lack of sales, limits on shipping options and absurd increased tax rates that are designed to cripple small businesses. You have designed the PMTA to wipe out everyone except for Big Tobacco and other multi-million dollar companies, because those were the very companies that lined your pockets to do so. We all know that is how the FDA makes their decisions. You are all bought. The government is doing a GREAT job at decimating and violently displacing us hard working middle class folks. Meanwhile, you approve of poisonous fast food chains such as McDonalds and poisonous energy drink companies that have slowly killed millions of people….but not before generating billions of dollars of revenue annually for Big Pharma. Now that is pure evil. Bravo, bravissimo!
Now why dontcha pat yourselves on the back, you are really doing it well!
It doesn't get any more diabolical than that.
Throughout the last 6 years have had many customers who have written to us expressing their gratitude, who have completely quit smoking and eventually quit vaping because we are able to provide a better alternative (our vape products) that are far less addictive, which helps people reduce their nicotine intake. Additionally, our customers choose to vape instead of smoking stinky, extremely toxic shit cigarettes, because overall they feel a lot better. It's that damn simple!
Unfortunately we were not born into the 1%. We were born into “The System” that was designed to keep us SLAVES, so that during this little blip of time in existence, YOU get to enjoy life on this planet to the fullest, while the rest of US live a life of struggles and suffering. Luckily this stay is only a blip of time. But remember this, your energy/soul has to go somewhere for eternity. Laugh about it now, and you shall pay later.
It is all very sickening, shame on you! I know we are on the right side of history and we are doing the right thing. WE are the salt of the earth, remember that.
We submitted our annual registration so per Section 905(i)(3) of the FD&C Act, we should be up to date. Our website is being updated by next week as well.
Cali Steam LLC