This is part of the response that I received from an on-going debate about regulating DIY by requiring all tobacco manufacturers register and why the definitions of the law are unclear.
"The law defines a manufacturer as anyone who manufactures, fabricates, assembles, labels, or processes a tobacco product. Establishments, such as vape shops, that mix and/or prepare combinations of liquid nicotine, flavors, and/or other liquids, or an establishment that creates or modifies an aerosolizing apparatus for sale to consumers would be considered a tobacco product manufacturer."
The response is clearly scripted and did NOT answer the questions presented. I'm not going to restart the debate, but there are loopholes in the text of the law that could be used against DIY manufacturers, even though the FDA has verbally stated to others prior that it will not be regulated, though they did NOT state it to me in their responses! The law is written otherwise in several areas, including the definition of a tobacco manufacturer to include ANYONE, not just an establishment.
And instead of receiving direct answers to my questions, I got the usual confusion responses that so many of us are already familiar. They're now releasing a new 'Non-binding Recommendations Draft" for review.
http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM536997.pdf
I haven't fully reviewed this draft, but based on the 2 written responses that I have received directly from the offices of compliance at the FDA, it's more of the same drivel that can only be understood by those with a law degree. Their responses could be viewed as a direct refusal to answer my questions. Big surprise there, right?
I explained the DIY conundrum in detail, which could easily lead to an open black market if word got out about the multiple loopholes and a possible collapse of the TCA as a whole, but I received no direct answers....not 1. DIY wasn't even mentioned in their responses.
Here's more of their second response, which reads as DIY could be regulated by requiring registration since manufacturing is included but marketing, sales and distribution is not a requirement to be considered a tobacco manufacturer:
"The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the Food and Drug Administration (FDA) the authority to regulate the manufacturing, marketing, sale, and distribution of tobacco products in the United States. Section 201(rr)(1) of the FD&C Act defines “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.
FDA originally regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco under its tobacco product authorities. The Deeming rule published in the Federal Register on May 10, 2016, and took effect on August 8, 2016. While FDA continues to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products, the Deeming rule extends FDA’s authority to “newly deemed” tobacco products such as electronic cigarettes, cigars, hookah, and pipe tobacco, as well as their components and parts, but not the accessories of newly deemed products.
The rule subjects 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 since 2009. Retail establishments that engage in certain activities may also be subject to certain requirements of the FD&C Act that apply to tobacco product manufacturers and to establishments that engage in the manufacture, preparation, compounding, or processing of tobacco products. These activities may also include modifying a product so that it is a “new tobacco product” subject to premarket review. As explained in the Deeming rule, the FD&C Act authorizes FDA to regulate the manufacture of new tobacco products including those manufactured at the retail level.
The foundation of the debate and a primary concern for anyone that DIY's their own gear and juice is whether or not the FDA will at some point regulate DIY by forcing every tobacco manufacturer register (which includes DIY) because that's how the law is actually written. Everything else (import, marketing, sales, distribution) falls into a tobacco manufacturer's intent prior to registration. The dangers for DIY'ers, at this point, is guaranteeing that your stuff is ONLY used by you and if someone else is caught with your stuff...regardless of how they obtained it (given away, theft, sold, disposed of, misplaced, whatever)...you could be held accountable if you're not already registered as a tobacco manufacturer. But even if you already are registered, certain regulations already prevent you from giving anything away (free samples) or distribution beyond the scope of the regulations.
The implications of the severity of legal trouble for DIY'ers is just frightening thinking about it, especially if the recipient of your stuff is a minor.
But ZERO answers from the FDA!
AGAIN....I'm not here to restart the debate, I'm only here to tell you that the FDA did not address ANY of these concerns with clear answers and completely avoided answering them! But to be real honest, I don't think that the FDA even knows what they're doing or how to regulate tobacco products??
Feel free to comment, cuz the FDA is intentionally withholding information....that much is abundantly clear! Just issuing a "we're not going to be responsible for this draft guidance in the event it doesn't fly" pretty much says it all...doesn't it?
"The law defines a manufacturer as anyone who manufactures, fabricates, assembles, labels, or processes a tobacco product. Establishments, such as vape shops, that mix and/or prepare combinations of liquid nicotine, flavors, and/or other liquids, or an establishment that creates or modifies an aerosolizing apparatus for sale to consumers would be considered a tobacco product manufacturer."
The response is clearly scripted and did NOT answer the questions presented. I'm not going to restart the debate, but there are loopholes in the text of the law that could be used against DIY manufacturers, even though the FDA has verbally stated to others prior that it will not be regulated, though they did NOT state it to me in their responses! The law is written otherwise in several areas, including the definition of a tobacco manufacturer to include ANYONE, not just an establishment.
And instead of receiving direct answers to my questions, I got the usual confusion responses that so many of us are already familiar. They're now releasing a new 'Non-binding Recommendations Draft" for review.
http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM536997.pdf
I haven't fully reviewed this draft, but based on the 2 written responses that I have received directly from the offices of compliance at the FDA, it's more of the same drivel that can only be understood by those with a law degree. Their responses could be viewed as a direct refusal to answer my questions. Big surprise there, right?
I explained the DIY conundrum in detail, which could easily lead to an open black market if word got out about the multiple loopholes and a possible collapse of the TCA as a whole, but I received no direct answers....not 1. DIY wasn't even mentioned in their responses.
Here's more of their second response, which reads as DIY could be regulated by requiring registration since manufacturing is included but marketing, sales and distribution is not a requirement to be considered a tobacco manufacturer:
"The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the Food and Drug Administration (FDA) the authority to regulate the manufacturing, marketing, sale, and distribution of tobacco products in the United States. Section 201(rr)(1) of the FD&C Act defines “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.
FDA originally regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco under its tobacco product authorities. The Deeming rule published in the Federal Register on May 10, 2016, and took effect on August 8, 2016. While FDA continues to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products, the Deeming rule extends FDA’s authority to “newly deemed” tobacco products such as electronic cigarettes, cigars, hookah, and pipe tobacco, as well as their components and parts, but not the accessories of newly deemed products.
The rule subjects 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 since 2009. Retail establishments that engage in certain activities may also be subject to certain requirements of the FD&C Act that apply to tobacco product manufacturers and to establishments that engage in the manufacture, preparation, compounding, or processing of tobacco products. These activities may also include modifying a product so that it is a “new tobacco product” subject to premarket review. As explained in the Deeming rule, the FD&C Act authorizes FDA to regulate the manufacture of new tobacco products including those manufactured at the retail level.
- Register domestic manufacturing establishment(s) and submit product listings to FDA by June 30, 2017;
- Reporting ingredients, and harmful and potentially harmful constituents;
- Placing health warnings on product packages and advertisements; and
- Not selling modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.
The foundation of the debate and a primary concern for anyone that DIY's their own gear and juice is whether or not the FDA will at some point regulate DIY by forcing every tobacco manufacturer register (which includes DIY) because that's how the law is actually written. Everything else (import, marketing, sales, distribution) falls into a tobacco manufacturer's intent prior to registration. The dangers for DIY'ers, at this point, is guaranteeing that your stuff is ONLY used by you and if someone else is caught with your stuff...regardless of how they obtained it (given away, theft, sold, disposed of, misplaced, whatever)...you could be held accountable if you're not already registered as a tobacco manufacturer. But even if you already are registered, certain regulations already prevent you from giving anything away (free samples) or distribution beyond the scope of the regulations.
The implications of the severity of legal trouble for DIY'ers is just frightening thinking about it, especially if the recipient of your stuff is a minor.
But ZERO answers from the FDA!
AGAIN....I'm not here to restart the debate, I'm only here to tell you that the FDA did not address ANY of these concerns with clear answers and completely avoided answering them! But to be real honest, I don't think that the FDA even knows what they're doing or how to regulate tobacco products??
Feel free to comment, cuz the FDA is intentionally withholding information....that much is abundantly clear! Just issuing a "we're not going to be responsible for this draft guidance in the event it doesn't fly" pretty much says it all...doesn't it?
