Discussion in 'FDA Regulations' started by skoony, Aug 18, 2016.
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The administration could also quietly decide that enforcement will not be a priority.
The court has ruled with the FDA
Dropbox - NicopureDecision.pdf
I am not surprised. If always was a weak case. Something many perhaps do not understand is that the FDA has done nothing outside of the authority congress gave them with the tobacco control act.
Well that just sucks. Thanks for posting. Have yet to regret a penny I've spent stocking up...
Time to buy more nic base...
Well there it is. Our only hope now is congress changing the rules.
I learned long ago to avoid situations where my survival or mental well-being is dependent on specific actions by others. So while I would have been thrilled by a different outcome, and would consider it fantastic if Congress were to fix this, I've never counted on either one actually happening.
Now ROssum You Know I took my own steps to ensure my ability to continue to vape for the rest of my natural lifetime and I did it years ago.
I guess my mistake was hoping there would be anything left for those smokers who have not yet made the switch.
Disappointed, but not really surprised. Fortunately, I have learned not to rely on government to decide what's best for me...
Nope, one of the best decisions I ever made...
I went through -- not read all -- the Decision and found a few interesting things. The most interesting one is a lengthy footnote on p. 51 which states that "The legislative history reflects that Congress was well aware of the advent of e-cigarettes at the time that the TCA was passed" due to congressman Buyer and Senator Burr speaking in defense of them. I don't see how this proves that they were able to overcome superstition and political expediency and it is a clear mandate against less harmful products, and I'd still say the tobacco companies were definitely more aware of this risk to their profits, but it is definitely of note. Burr is quoted:
"There are electronic cigarettes . . . and other products that have less risk. All those products in February 2007 were not in the marketplace. They are banned. They are eliminated. What are we asking the FDA to do? We are asking them to grandfather three categories of products and let all adults who choose to use a tobacco product choose from the most risky categories ...Any claim –any claim – that [the proposed TCA] reduces the cost of health care is only because we have grandfathered in smokers who will die sooner, not that we have allowed them a pathway through this bill to ever experience not only products that are currently on the marketplace that reduce the risk from 100 percent to as little as 1 percent, but we have completely eliminated any additional innovation in product in the future . . . ."
Just wow. The problem with banning new products due or despite lower risk is compassion, but the clear problem here is between the gov't moving slow and vaping moving fast, that intent is already broken.
On p. 44, the judge states:
"It is important to note at the outset that the decision to deem e-cigarettes to be tobacco products will not ban e-cigarettes from the market. It will unquestionably subject the products to heightened regulation, but the deeming decision does not – and could not – completely ban those products from the market."
Does she have an inside source telling her this, because there is no guarantee of this in the Deeming? I have considered that the FDA knows they need to look tough if the actual plan is to grant PMTAs....
I also see that Count III of the Right to be Smoke-Free complaint is summarized as 'In its equal protection claim, RSF objected to the fact “FDA treats ENDS products the same as traditional tobacco products,” even though “ENDS present a lower (and different) risk profile than cigarettes.” ' ... I didn't find the original text but RSF has it wrong, it does not treat them the same, it treats ENDS much worse because of being new.
Looking at patents also recently, I'm seeing examples of both nicotine and non-nic products in the prior art, including priority dates to Ruyan of 2006 for a heater coil type ecig, and heat not burn using electric published in 1998 to Philip Morris including that "Preferably, a humectant, such as glycerin or propylene glycol, is added to the tobacco web 57 during processing in amounts equalling between 0.5% and 10% of humectant by the weight of the web. The humectant facilitates formation of a visible aerosol by acting as an aerosol precursor. When a smoker exhales an aerosol containing the flavored tobacco response and the humectant, the humectant condenses in the atmosphere, and the condensed humectant provides the appearance of conventional cigarette smoke."
I believe it would be reasonable for the FDA to declare e-cigs as a class to be substantially equivalent to products that did exist as of or around 2/15/07, that it would be capricious to hold them to a tight definition of SE or require individual evaluation to be kept available for sale. I believe that date is capricious and not at all arbitrary but intentional. It should class existing vapor devices and liquids as primitive ecig products and move on with evaluated vapor products and determining and improving the actual range of risk involved. Anything else is counterproductive and an example of bad government when there is actually an opportunity to do things better.
For a while now i did follow some of these rulings but took matters into wife and i own hands and have been stocked for life with nothing needed nothing to vape the rest of our lives.
If nothing becomes of the regulations that would be great for many others but where money is involved so is BG.
Thanks for pointing this out. I looked to the source of the note and it is also interesting that Sen. Burr was 'on to them' from the start. It's worth reading the whole thing....
... but some 'highlights':
"The provisions in this bill--
I might say this was slightly over 2 years ago. As I have pointed out
and talked about last week for over 5 hours on H.R. 1256, the authors
of the bill didn't even change the dates in the bill from the bill
written 2 years ago. As a matter of fact, the section by section is the
same bill written 10 years ago. So I think it is appropriate, if they
are going to use an effective date of February 2007, that I use the
comments of the FDA Commissioner at the time, who said:
"The provisions in this bill would require substantial
resources, and FDA may not be in a position to meet all of
the activities within the proposed user levels. . . . as a
consequence of this, FDA may have to divert funds from other
programs, such as addressing the safety of drugs and food, to
begin implementing this program."
"This is not Richard Burr, this is the former Commissioner of the FDA [note: this IS Sen. Burr quoting the former FDA Commissioner, also named Burr) saying we may have to divert funds from other programs, such as safety of drugs and food." ...
"Make sure when I go to the grocery store and buy food in a global marketplace,
where the melons might have come from Chile or the spinach from Mexico,
that they have the best and brightest addressing food safety.
They have already flunked that several times in the last 3 years, and
we have all dealt with the consequences of it. But think about what we
are getting ready to do. We are getting ready to make it worse." ...
"Then the industry came up with filtered cigarettes, and they reduced
the risk by 10 percent, from 100 percent to 90 percent. But when one is
looking for a way to play this, a 90-percent risk is not a good one.
"What H.R. 1256 says is: OK, we realize FDA is not the right agency,
but we are going to place it there anyway, and we are going to tell the
FDA: We want you to leave this alone; we don't want you to touch this
100-percent risk or 90-percent risk. We want to grandfather all the
products that were made before February 2007. And, oh, by the way, that
would include U.S. smokeless tobacco.
"The most risky we are grandfathering in and we say to the FDA: You
can't change it. You basically can't regulate it. You can't regulate
the 100 percent, you can't regulate the 90 percent, and you can't
regulate this small but growing U.S. smokeless market that has a risk
of 10 percent.
"One might look at the chart and say there are other things on there.
There are electronic cigarettes, tobacco-heating cigarettes, Swedish
smokeless snus. There are dissolvable and other products that have less
risk. All those products in February 2007 were not in the marketplace.
They are banned. They are eliminated."
"The authors of this bill said its purpose is to reduce the
risk of death and disease and to reduce youth smoking. I would tell you
that a caveat to that should be that we should reduce smoking. Clearly,
the Centers for Disease Control and Prevention says that if you do
nothing, it goes to this point, and the Congressional Budget Office,
after looking at the bill, suggests it is 2 percent or 4 percent higher
if, in fact, we pass the bill. Why is that? How could it possibly be
higher if you pass legislation that is supposed to fix it? Well, it is
for this reason: It is because of what H.R. 1256 does. It is not a
public health bill. It is a bill that locks in the most risky products
and grandfathers them to the Food and Drug Administration and allows no
pathway for reduced-harm products to come to market. It actually takes
some reduced-harm products that are currently on the market, that
haven't been sold since February 2007, and says, therefore, they are
Judge Jackson makes note of some of Sen Burr's 2009 statements in Footnote #26 at the bottom of Page #51.
"26 The legislative history reflects that Congress was well aware of the advent of e-cigarettes at the time that the TCA was passed. Defs.’ Cross-Mem. at 28 & n.9, citing 155 Cong. Rec. H6626 (June 12, 2009) (statement of Rep. Buyer) (“n the marketplace right now, there are many different types of products . . . [Y]ou have an electronic cigarette, whereby it’s a nicotine delivery device.”), and 155 Cong. Rec. H4367 (Apr. 1, 2009) (statement of Rep. Buyer) (expressing concern that “these new innovative types of nicotine delivery devices could not make their access to the market.”); 155 Cong. Rec. S6010 (June 3, 2009) (statement of Sen. Burr) (“Then we have a new category called electronic cigarettes . . . It actually runs off a battery. It extracts the nicotine and delivers it into the system in a totally different way than the tobacco-headed cigarette.”). Indeed, Senator Burr seemed to propose that all electronic cigarettes should be “grandfathered” in to the SE pathway. 155 Cong. Rec. S6335–36 (June 9, 2009) (statement of Sen. Burr) (“There are electronic cigarettes . . . and other products that have less risk. All those products in February 2007 were not in the marketplace. They are banned. They are eliminated. What are we asking the FDA to do? We are asking them to grandfather three categories of products and let all adults who choose to use a tobacco product choose from the most risky categories . . . Any claim – any claim – that [the proposed TCA] reduces the cost of health care is only because we have grandfathered in smokers who will die sooner, not that we have allowed them a pathway through this bill to ever experience not only products that are currently on the marketplace that reduce the risk from 100 percent to as little as 1 percent, but we have completely eliminated any additional innovation in product in the future . . . .”). The fact that Congress passed the TCA in its current form notwithstanding the concerns raised by Congressman Buyer and Senator Burr provides further support for the conclusion that the Secretary’s decision to deem e-cigarettes to be tobacco products, and therefore subject to premarket review, is reasonable and fully consistent with the intent of the statute."
We should be fighting to have that statute amended to actually encourage the introduction of reduced harm products, with minimally intrusive obstacles.
There also should be Organized Pressure on Mr. Price to make reasonable definitions of what a Tobacco Component, Part, and Accessary are when it comes to e-Cigarettes/e-Liquids.
From Page #11...
"Congress then amended the definitions section of the Federal Food, Drug, and Cosmetic Act to define the term “tobacco product.” TCA § 101. For purposes of the TCA, a “tobacco product” is:
any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).
21 U.S.C. 321(rr)(1). Neither the TCA nor the FDCA further defines the terms “component,” “part,” or “accessory.”
It's been a while since I read the whole thing, but my recollection is that the Deeming Reg doesn't either.
I believe this is Current Guidance which was issued by the FDA under the previous FDA Director.
"Component or part means any software or assembly of materials intended or reasonably expected: (1) to alter or affect the tobacco product’s performance, composition, constituents, or characteristics; or (2) to be used with or for the human consumption of a tobacco product. Component or part excludes anything that is an accessory of a tobacco product (parts 1100, 1140, 1143)."
"Accessory means any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following:
(1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or
(2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but
(i) Solely controls moisture and/or temperature of a stored tobacco product; or
(ii) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product (parts 1100, 1140, 1143 (21 CFR parts 1100, 1140, 1143)). "
Now, as I Understand it, the current HHS Secretary could instruct the current FDA Director to revise this guidance.
ETA: Or... The current HHS Secretary could have a Different Opinion on what "Reasonably Expected" means than what the previous HHS Secretary might have had.
So they've defined these terms in the "guidance", but not in the actual regulations. In other words, these definitions were not subject to the public scrutiny and comment period that apply to regulations.
Yet somehow, we're willing to accept this as legitimate?
Actually, the Text in the guidance is pulled Directly from the "Final Rule".
It's hard to read the PDF from the Federal Register. But a PDF search of "Component" jumps you to 28975 where Component, Part, and Accessory are referenced.
Where the Ambiguity will/does arise is how one Applies the phrase "Reasonably Expected".
And that Application of a Reasonable Expectation will be, as I understand it, up to Price to decide.
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