you were right and I accidentally ordered the mini glass replacement instead of the micro plus so ty and I just ordered
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Thatâs cool 
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@ringling I know that alot of people are stocking up on diy things especially nicotine since you are alot closer to whats going on in your opinion is it necassary for a diy guy or gal to stock up on nicotine ??? will it become a problem getting it for. vendors via internet and do you think the cost will substantially rise
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Michelle Hughes
June 22 at 5:40pm
This is a long letter but it states in fact that DIY will not be affected by the FDA as of now. As long as you donât SELL the juice.
Dear Ms. Hughes,
Thank you for contacting the U.S. Food and Drug Administration (FDA) regarding its recently finalized rule, âDeeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Actâ (Deeming rule).
You have indicated that you are a consumer that mixes e-liquids in your home for personal use. If you are mixing these components for personal consumption only, then you are not regulated by the FDA. If you are mixing these components and then selling them to others, you would be considered both a retailer and a manufacturer. A retailer includes any person who sells tobacco products to individuals for personal consumption, and a manufacturer means any person, including any repacker and/or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished tobacco product. The new rules will have no impact on your ability to be able to purchase your components and make e-liquids for your personal use; however they are designed to ensure that whatever you choose to purchase is safe for consumption.
You may be interested to know that the FDA Center for Tobacco Products is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009. This lawâcommonly called the Tobacco Control Actâgives us broad authority to regulate the manufacturing, distribution, and marketing of tobacco products. The FDAâs mandate is to protect Americans from tobacco-related disease and death. Ultimately, we hope that regulating all tobacco products will have a positive impact on public health. That is the motivation for finalizing the rule.
We understand that consumers, manufacturers, retailers and related businesses will be impacted by this rule in some way. Given your interest in the rule, I want to share some additional information about it in case you would like to read more.
Final Rule Addresses Public Health Concerns Focusing on Youth
The Family Smoking Prevention and Tobacco Control Act (TCA), passed by Congress on a bipartisan basis and signed by the President in 2009, gave the FDA tools to protect the public from the harms of tobacco use. Since June 2009, the FDA has regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products under its tobacco control authority. The law also gave the FDA the ability, through rulemaking, to regulate additional products that meet the legal definition of a tobacco product.
This new rule brings all tobacco products under FDA oversight, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others. This historic step will help improve public health and protect future generations from the risks of tobacco use by putting additional restrictions in place that make it illegal to sell tobacco products to minors.
Before this rule, there was no federal law prohibiting stores and websites from selling e-cigarettes, hookah tobacco, and cigars to minors. The new rule aims to deter youth initiation through restricting youth access to these products by:
⢠Not allowing products to be sold to persons under the age of 18 years;
⢠Requiring age verification by photo ID;
⢠Not allowing the selling of tobacco products in vending machines (unless in an adult-only facility); and
⢠Not allowing the distribution of free samples.
The rule also serves as the foundation for future FDA actions related to tobacco, including where scientific data supports regulatory action, addressing flavors in combustible products.
Extending the FDAâs Authority is a Milestone in Public Health and Consumer Protection
Going forward, the FDA will be able to review all new tobacco products not yet on the market. The actions being taken also will help the FDA prevent misleading claims and provide consumers with better information about the risks of tobacco use. The rule also will allow the FDA to evaluate the ingredients of tobacco products, how those products are made, and their potential dangers.
The rule will subject all manufacturers, importers and/or retailers of newly-regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.
These requirements include:
¡ Registering manufacturing establishments and providing product listings to the FDA;
¡ Reporting ingredients, and harmful and potentially harmful constituents;
¡ Requiring premarket review and authorization of new tobacco products by the FDA;
¡ Placing health warnings on product packages and advertisements; and
¡ Not selling modified risk tobacco products (including those described as âlight,â âlow,â or âmildâ) unless authorized by the FDA.
Manufacturers of newly-regulated products must show that the products meet the applicable public health standard set forth in the law and receive authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.
Under staggered timelines, the FDA does not intend to enforce the premarket review requirements for up to three years while manufacturers submit â and the FDA reviews â a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise the product will be subject to enforcement.
For More Information
To assist the newly-regulated tobacco industry in complying with the requirements, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDAâs current thinking on issues specific to the newly-regulated products.
For more information:
¡ Final Rule: https://federalregister.gov/a/2016-10685
¡ Deeming â Extending Authorities to All Tobacco Products, Including E-Cigarettes, Cigars, and Hookah: http://www.fda.gov/âŚ/Labeling/RulesRegulationâŚ/ucm388395.htm
¡ FDA takes significant steps to protect Americans from dangers of tobacco through new regulation: http://www.fda.gov/âŚ/NewsrâŚ/PressAnnouncements/UCM499234.htm
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much appreciated
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Donât thank me⌠@authormichellehughes did all the labor for this reply from the FDA. [but, youâre welcome, eh? ]
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I see @ozo has beat me to the punch. Thatâs OK cause the info was needed. I have said I didnât think we would not be able to buy Nicotine in the past and according to the FDA answer to this letter, that seems to hold true, BUT, consider this. Just because it is legal to buy Nicotine does not mean that the US and State governments wonât start adding extra fees and Sin Taxes, and a host of other costs. Maybe even try something like the 1998 MSA lawsuit against the Tobacco Companies claiming extra Healthcare Losses. Now that they regulate and designate it as a tobacco product, anything is possible. After all, if they call call a mod a tobacco product, or 0mg Ejuice a tobacco product IF used in a Ecigarette, whatâs to stop them from changing their view today to some different interpretation tomorrow. In the short term I suspect the price to start going up eventually, in the long term, well, better keep you Eyes, and your Ears OPEN. Personally Iâll be buying a couple Liters before August 8âŚ
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thatâs my thoughts as well , ive got 250ml 100mg vg base and two 250ml 100mg pg base ill be buying a 250ml 100mg vg or pg base with each flavor order and I typically order flavors twice a month thank you for your opinion âŚ
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THIS IS NOT A PHOTO FROM OZOâŚ
THIS IS NOT A POLITICAL MEMEâŚ
THIS IS JUST A PIECE OF AMERICAN HISTORY.
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I was surprised to get an answer Ozo LOL but at least it clarifies that for NOW they arenât interested in us.
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I, too, was surprised they responded in such length to youâŚand skeptical me is curious about that.
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Manufacturers of newly-regulated products must show that the products meet the applicable public health standard set forth in the law and receive authorization from the FDA, unless the product was on the market as of Feb. 15, 2007.
Is it just me not reading this correctly or what? How did they get a product date of Feb 2007 when the FDA only received the power to control tobacco products in June 2009?
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No, you read it right.
They want to cover any vaping devicesâŚ
Not sure if any of it is legal for them to do [especially the retro date] but what do they care?
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@ringling you said a clean room is required , would a lab box work ? I only ask because I have a friend who just started making juice and thinks he wants to start a business selling his ejuice lol I told him about what you said and this was solution to the clean room whats your thought??? btw he is far from making a juice worth much but heâs one of those guys who knows it all
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I doubt the box will âpassâ for themâŚbut much worse, he would have to fulfill ALL of the other requirements.
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thats what I thought heâs now reading into it lol ty
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Key words ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
[flipside is they are just creating another black market]
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From what Iâm told a clean room is the type of lab where there is the double door entry (Not sure the purpose) but really the lab doesnât matter. Ask your friend if he has over a Million Dollars per every flavor, per every nicotine value, to pay the FDA to most likely not approve the juice BECAUSE THEY DON"T WANT US IN BUSINESS. Perhaps your friend doesnât know it all. If he really did know it all then it is doubtful he would even consider starting a ejuice business at this time, or ever if the regs remain the same. He might have a easier time getting away with collecting rain waterâŚ
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Yeah, depending on what USA state he lives inâŚ
As far as a âcleanroomâ , it will also depend on which âlevelâ they [Deemingly] require, but here are the basics:
A cleanroom or clean room is an environment, typically used in manufacturing, including of pharmaceutical products or scientific research, with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. More accurately, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size. To give perspective, the ambient air outside in a typical urban environment contains 35,000,000 particles per cubic meter in the size range 0.5 Îźm and larger in diameter, corresponding to an ISO 9 cleanroom, while an ISO 1 cleanroom allows no particles in that size range and only 12 particles per cubic meter of 0.3 Îźm and smaller.
Edit: And that includes where all ingredients are storedâŚso ask him if it all will fit in his âboxâ.
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