I must have missed that part. What I read is "whether they are sold to consumers for use in ENDS, or sold for further manufacturing into another product for a consumer." (my emphasis)
But.... I haven't read the whole doc yet.
FDA TVECA post table of contents for Deeming Final Rule
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I must have missed that part. What I read is "whether they are sold to consumers for use in ENDS, or sold for further manufacturing into another product for a consumer." (my emphasis)
But.... I haven't read the whole doc yet.
Okay! I pasted it into a Word document, so I don't know how big it will be but I would love to share it.
But this is absurd. Are they seriously going to regulate cotton balls?
I'm guessing that in the police state that follows stuff like this - IF they find you use cotton balls for wicking - yes. You, more than many, should know this.
Battery and used in flash lights I don't see them going anywhere
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I do and I'm telling you, from my own bitter experience, that it will never work. People will get what they need. People are creative.
If we are forced to sneak to a back alley to get a liter of propylene glycol, so be it. 
But there's no way that the FDA can remove propylene glycol from tractor supply stores or glycerol and rayon from drugstores or batteries and wire from hardware stores... This is so stoopid that it makes me wanna cry.
This is the reply I got from my congressman:
Dear Ms. Reeves,
Thank you for writing in and sharing your concerns about the Food and Drug Administration's (FDA) proposed rule for new tobacco products and H.R. 2058, the FDA Deeming Authority Clarification Act of 2015. I appreciate the opportunity to hear from you.
In April 2014, the FDA released a draft rule that proposes stricter regulations on pipe tobacco, cigars, nicotine gels, water pipe tobacco, hookah, and e-cigarettes. The proposed rules would require manufacturers to register products and ingredients with the FDA, garner FDA approval before marketing new products, and utilize science-based evidence before making direct or implied claims of product benefits.
In the proposed rule, the FDA laid out two different paths for the consideration of new tobacco products. If a new tobacco product has the same characteristics as a tobacco product that was commercially marketed before February 7, 2007, it would not be subject to a new approval process. If the product does not have the same characteristics as a tobacco product sold by that date, the producer would have to apply with the FDA for a premarket product review of new tobacco products. This could only be avoided if the FDA finds that the products do not raise different questions of public health.
If the FDA finalizes this rule, it is anticipated that new vapor product manufacturers, including those of electronic cigarettes, would have to attempt to have their products qualified as having the same characteristics as other products (also known as "substantial equivalence"). I've heard from some folks who are concerned this would increase the regulatory burden for manufacturers of new tobacco products and limit the ability of consumers to purchase them.
In response to concerns about the impact of this proposed rule on small businesses, Rep. Tom Cole (Okla.) introduced the FDA Deeming Authority Clarification Act of 2015. This legislation would move the deeming regulation date (i.e., the date from which products would have to demonstrate substantial equivalence) from 2007 to 2015. This legislation has been referred to the House Committee on Energy and Commerce, where it is pending a hearing. Though I do not sit on this committee, if this issue does come before the full House for a vote, I will take your thoughts into account.
Dear Ms. Reeves,
Thank you for writing in and sharing your concerns about the Food and Drug Administration's (FDA) proposed rule for new tobacco products and H.R. 2058, the FDA Deeming Authority Clarification Act of 2015. I appreciate the opportunity to hear from you.
In April 2014, the FDA released a draft rule that proposes stricter regulations on pipe tobacco, cigars, nicotine gels, water pipe tobacco, hookah, and e-cigarettes. The proposed rules would require manufacturers to register products and ingredients with the FDA, garner FDA approval before marketing new products, and utilize science-based evidence before making direct or implied claims of product benefits.
In the proposed rule, the FDA laid out two different paths for the consideration of new tobacco products. If a new tobacco product has the same characteristics as a tobacco product that was commercially marketed before February 7, 2007, it would not be subject to a new approval process. If the product does not have the same characteristics as a tobacco product sold by that date, the producer would have to apply with the FDA for a premarket product review of new tobacco products. This could only be avoided if the FDA finds that the products do not raise different questions of public health.
If the FDA finalizes this rule, it is anticipated that new vapor product manufacturers, including those of electronic cigarettes, would have to attempt to have their products qualified as having the same characteristics as other products (also known as "substantial equivalence"). I've heard from some folks who are concerned this would increase the regulatory burden for manufacturers of new tobacco products and limit the ability of consumers to purchase them.
In response to concerns about the impact of this proposed rule on small businesses, Rep. Tom Cole (Okla.) introduced the FDA Deeming Authority Clarification Act of 2015. This legislation would move the deeming regulation date (i.e., the date from which products would have to demonstrate substantial equivalence) from 2007 to 2015. This legislation has been referred to the House Committee on Energy and Commerce, where it is pending a hearing. Though I do not sit on this committee, if this issue does come before the full House for a vote, I will take your thoughts into account.
I do and I'm telling you, from my own bitter experience, that it will never work. People will get what they need. People are creative.
But there's no way that the FDA can remove propylene glycol from tractor supply stores or glycerol and rayon from drugstores or batteries and wire from hardware stores... This is so stoopid that it makes me wanna cry.
I get all that - the black market is forming as we speak. But you ask if what they (authorities) would consider - not how people will have workarounds - and right now if you sold a 'regular gas can' or a full flow toilet at a garage sale and one of those 'we know what's best for you' gov't types saw it, they may very likely report to the authorities that you're selling them. And if so, they would confiscate your goods.
You can hide stuff until they find it - see: "The Lives of Others" movie. That's how bad it could get. We have people here in gov't and out - with that same mindset.
tveca.com/tveca_docs/drp_redacted.pdf
IX Regulation of Vape shops
Section 905 "Registration and Product Listing"
Section 905 and 910 "Pre Market Requirements"
These are the most troubling of the new FDA Rules that they are trying to Add but Congress collectively has not by Bill given them SPECIFICALLY the authority to do so just Generally.
House Bill HR2058 Does give them the authority to do so.
Rule of Power : Congress by way of "
H.R.1256 - Family Smoking Prevention and Tobacco Control Act
Gives the FDA Authority to Regulate Tobacco Products.
Division A: Family Smoking Prevention and Tobacco Control Act - Family Smoking Prevention and Tobacco Control Act - Title I: Authority of the Food and Drug Administration - (Sec. 101) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to provide for the regulation of tobacco products by the Secretary of Health and Human Services.
Which the Food and Drug Administration (FDA).Bill 21 USC Ch. 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT
From Title 21—FOOD AND DRUGS uses to setup regulation of such.
HR2058 is a legislative Bill that is a backdoor way to Enforce new "Vape shop rules and Pre-market requirements." by adding section 905 and 910 amendments to Bill 21 USC Ch. 9 Which only allow products before April 2011 to be "grandfathered" i.e. "simple e-cig batteries only" of which Big Tobacco Companies have already invested.
Congress by way of Bills makes Laws. The Fda is a Regulatory agency and its power is interpreted by legality.
See congress.gov/114/bills/hr2058/BILLS-114hr2058ih.pdf
(Please read it rather than the internet rhetoric commentary posted everywhere trying to prop it)
I am pro contacting your Representative or Senator or Obama whether Republican Democrat and/or Libertarian to not regulate Vaping but HR2058 is an odd Band-Aid only benefiting the enforcement of the new FDA section 905 and 910 to the Bill 21 Usc Ch.9 and only grandfathering in products 21 months after the passing of HR 1256 "Family smoking and prevention Act" on June 22 2009.
I hope everyone will be able to challenge the FDA's Rights to enforce Vaping versus a Congress Bill HR2058 Amendment to the Bill 21 USC. ch.9. stating FDA POLICY.
The HR2058 seems the wrong way by sounding the Right and Only way.
Obviously Legislation sometimes takes teams of Lawyers to Decide and challenge but in its present state, HR2058 with its simplicity could actually cause far more harm than good.
Off my soap box...
Cheers!
IX Regulation of Vape shops
Section 905 "Registration and Product Listing"
Section 905 and 910 "Pre Market Requirements"
These are the most troubling of the new FDA Rules that they are trying to Add but Congress collectively has not by Bill given them SPECIFICALLY the authority to do so just Generally.
House Bill HR2058 Does give them the authority to do so.
Rule of Power : Congress by way of "
H.R.1256 - Family Smoking Prevention and Tobacco Control Act
Gives the FDA Authority to Regulate Tobacco Products.
Division A: Family Smoking Prevention and Tobacco Control Act - Family Smoking Prevention and Tobacco Control Act - Title I: Authority of the Food and Drug Administration - (Sec. 101) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to provide for the regulation of tobacco products by the Secretary of Health and Human Services.
Which the Food and Drug Administration (FDA).Bill 21 USC Ch. 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT
From Title 21—FOOD AND DRUGS uses to setup regulation of such.
HR2058 is a legislative Bill that is a backdoor way to Enforce new "Vape shop rules and Pre-market requirements." by adding section 905 and 910 amendments to Bill 21 USC Ch. 9 Which only allow products before April 2011 to be "grandfathered" i.e. "simple e-cig batteries only" of which Big Tobacco Companies have already invested.
Congress by way of Bills makes Laws. The Fda is a Regulatory agency and its power is interpreted by legality.
See congress.gov/114/bills/hr2058/BILLS-114hr2058ih.pdf
(Please read it rather than the internet rhetoric commentary posted everywhere trying to prop it)
I am pro contacting your Representative or Senator or Obama whether Republican Democrat and/or Libertarian to not regulate Vaping but HR2058 is an odd Band-Aid only benefiting the enforcement of the new FDA section 905 and 910 to the Bill 21 Usc Ch.9 and only grandfathering in products 21 months after the passing of HR 1256 "Family smoking and prevention Act" on June 22 2009.
I hope everyone will be able to challenge the FDA's Rights to enforce Vaping versus a Congress Bill HR2058 Amendment to the Bill 21 USC. ch.9. stating FDA POLICY.
The HR2058 seems the wrong way by sounding the Right and Only way.
Obviously Legislation sometimes takes teams of Lawyers to Decide and challenge but in its present state, HR2058 with its simplicity could actually cause far more harm than good.
Off my soap box...
Cheers!
Might want to Double Check that Math.
I get that too. But so much of what we're using in vaping is borrowed from other, "legitimate," sources and has other applications, that I just don't see how those products can be banned.
We still can vote.
Some will be banned others will be 'watched' and if used in ecigs - confiscated.
So can others. And so did '30's Germany.
That refers to you buying a component or part (battery, coil, etc..) or another company buying it for use in their product (i.e. non removable battery, coil that comes with clearo)
But the intro sections on definitions starts off with - if a product is sold specifically for or reasonably intended for use with. So buying batteries at a vape shop is intended to use with a tobacco product. Buying a battery at Radio Shack isn't. Just like the bit on flavors. Capella will stop marketing their flavors for use with e-liquid and just stick with GRAS for food consumption. So if Bull City Flavors wants to sell them as is, they're fine. But if BC Vapes is gonna sell those same flavors with the intention of their use being e-liquid, then they would have to comply with the regs, including scientific test results for flavor inhalation (as opposed to ingestion).
I can't imagine them being able to regulate everything they want to. Wouldn't it then be on the states individually to enforce the law? I just think the whole thing is ridiculous, and I really hope the powers that be are listening closely to us right now. This is in now way fair or just, either to us or to the businesses we rely on for our products!I get that too. But so much of what we're using in vaping is borrowed from other, "legitimate," sources and has other applications, that I just don't see how those products can be banned.
We still can vote.
that's why those will be fine - ED and Bulk Apothecary will still be around, selling them as before, just removing the ecig info. Flavors too (and cotton, kanthal, etc...)
It's liquid nic that's the big issue. As well as hardware that isn't a cigalike
Page 7, Lines 253 ~ 281
2. ENDS Retailers Who Mix or Prepare Their Own E-Liqlljd.~ or Create or
Modify Acrosoiidng Apparatus ji-om VariOliS Componerus
An ENDS retail establishment that mixes and/or prepares combinations of liquid nicotine,
flavors, and/or other liquids for direct sale to consumers for use in ENDS or creates or modifies
aerosolizing apparatus for direct sale to consumers for use in ENDS (sometimes known as a vape
shop) meets the defmition of .. tobacco product manufacturer" in section 900(20)6 of the FD&C
Act (21 U.S.c. 387(20» and the combinations il mixes and/or prepares are "new tobacco
products" within the meaning of section 91 O(a)( 1). Section 91 O(a)(1 ) defi.nes a '"' new tobacco
product" as "any tobacco product (including those products in test markets) that was not
commercially marketed in the United States as of February 1 S, 2007," or '"any modification
(including a change in design, any component. any pan. or any conslituent. including a smoke
constituent. or in the conlent. delivery or fonn of nicotine, or any other additive or ingredient) of
a tobacco product where the modified product was commercially marketed in the Uni ted States
after February 15, 2007." Therefore. those establishments engaged in mixing and/or preparing
combinations of liquid nicotine, flavors, and/or other liquids or creating or modifying
aerosolizing apparatus for direcl saJe to consumers for use in ENDS are tobacco product
manufacture rs and, consequentl y, are subject to all of the requirements applicable to
manufacturers.
C. How Will FDA Review an ENDS PMTA '!
FDA will review an ENDS PMTA consistent with the requirements of section 910(c) of the
FD&C Act. Under section 91O(c)( J )(A), FDA must act on a PMTA "as promptly as possible, bUI
in no event later than 180 days after the receipt of an application." A PMTA must include all
information specified in 910(b)(1) upon submission and FDA may refuse to file incomplete
applications. However, FDA may request additional information about your PMTA as necessary.
FDA may also want to inspect your manufacturing, clinical research, or nonclinical research sites
to support its review of your PMTA.
---
Note: Sorry if some words are Wacked. The OCR Software I used on the Original PDF isn't the Greatest.
2. ENDS Retailers Who Mix or Prepare Their Own E-Liqlljd.~ or Create or
Modify Acrosoiidng Apparatus ji-om VariOliS Componerus
An ENDS retail establishment that mixes and/or prepares combinations of liquid nicotine,
flavors, and/or other liquids for direct sale to consumers for use in ENDS or creates or modifies
aerosolizing apparatus for direct sale to consumers for use in ENDS (sometimes known as a vape
shop) meets the defmition of .. tobacco product manufacturer" in section 900(20)6 of the FD&C
Act (21 U.S.c. 387(20» and the combinations il mixes and/or prepares are "new tobacco
products" within the meaning of section 91 O(a)( 1). Section 91 O(a)(1 ) defi.nes a '"' new tobacco
product" as "any tobacco product (including those products in test markets) that was not
commercially marketed in the United States as of February 1 S, 2007," or '"any modification
(including a change in design, any component. any pan. or any conslituent. including a smoke
constituent. or in the conlent. delivery or fonn of nicotine, or any other additive or ingredient) of
a tobacco product where the modified product was commercially marketed in the Uni ted States
after February 15, 2007." Therefore. those establishments engaged in mixing and/or preparing
combinations of liquid nicotine, flavors, and/or other liquids or creating or modifying
aerosolizing apparatus for direcl saJe to consumers for use in ENDS are tobacco product
manufacture rs and, consequentl y, are subject to all of the requirements applicable to
manufacturers.
C. How Will FDA Review an ENDS PMTA '!
FDA will review an ENDS PMTA consistent with the requirements of section 910(c) of the
FD&C Act. Under section 91O(c)( J )(A), FDA must act on a PMTA "as promptly as possible, bUI
in no event later than 180 days after the receipt of an application." A PMTA must include all
information specified in 910(b)(1) upon submission and FDA may refuse to file incomplete
applications. However, FDA may request additional information about your PMTA as necessary.
FDA may also want to inspect your manufacturing, clinical research, or nonclinical research sites
to support its review of your PMTA.
---
Note: Sorry if some words are Wacked. The OCR Software I used on the Original PDF isn't the Greatest.
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