FDA may soon propose regulation that could ban many/most e-cigarette products, eliminate many/most companies

[Vocalek]

A note of clarification here: While the FDA has announced their intent to regulate not only e-cigarettes but all tobacco products under the tobacco Act, this has not yet occurred. The Family Smoking Prevention and tobacco Control Act (which became Chapter IX of the Food, Drug, and Cosmetics Act) named specific products. NOT named were such products as cigars, hookahs, e-cigarettes. In order to bring these additional products in, the FDA will need to propose the regulations (which they have already announced that they plan to do, but have not done so yet). Then, there will be a period of public comment (Regulations.gov). Finally, the FDA will announce that it has published (or decided to drop) the proposed regulation.

If the FDA does announce this as their new regulation, it will be challenged in court. The FDA is authorized to enforce laws as written, not to rewrite legislation. It's called "separation of powers."

 

[Ande]

The FDA is authorized to enforce laws as written, not to rewrite legislation. It's called "separation of powers."

+1. Or more.

They seem to find ways to bend the laws, though.

Ande

 

[Luisa]

pigelty wrote



While it would be nice to have several million dollars to spend on future e-cigarette research, none of those expensive and time consuming studies (cited by pigelty) are necessary to demonstrate that e-cigarettes are far less hazardous than cigarettes. The problem is that FDA (and its contracted IOM committee) and all other e-cigarette prohibitionist have repeated that (and similar) lies (i.e. that millions of dollars of more research is needed) so many times that increasingly more e-cigarette consumers (including Cool Breeze and pigelty) appear to believe it, and are now repeating it here on ECF.

Murray Laugesen's first scientific evidence on e-cigarettes in 2007/2008 conclusively documented that e-cigarettes are exponentially less hazardous than smoking cigarettes, and dozens of subsequent studies and laboratory reports (including two done by FDA) have confirmed (without any scientific doubt) that e-cigarettes are exponentially less hazardous than cigarettes.

sqirl1 wrote



The only people who might be able to answer the first question are FDA Commissioner Margaret Hamburg, DHHS Secratery Kathleen Sabelious and perhaps some White House staff, and it appears that they've already delayed proposing the new regulation since October. My goal (which should be shared by everyone on this forum) is to convince those folks to change their mind and scrap the regulation instead of proposing it (which requires publishing in the Federal Register).

Ever since April 25 (when the FDA stated its intent to propose/approve a regulation to apply Chapter IX to e-cigs and other unregulated tobacco products), I've been working to prevent the FDA from proposing this type of regulation.

Bill,I have only one FDA lab report. I did not realize there were two. Where might I find both reports? Thanks!

 

[VapApe]

Well it didn't work out to well for them, When they tried to bend the law by seizing E liquid shipment a wile back.
Lets hope they end up with the same judges if this ends up in court.

 

[Traver]

So how would you suggest we make sure that regulations are actually in the best interest of the million or so former smokers who need these products to be kept available and effective, and to keep them available and effective for as many of the 45 million or so current smokers who might be persuaded to switch to something less hazardous?

This is the crux of our problem. What ever happened to good government?

Vocalek, I agree with almost all of the things you have said now and in the past. That doesn't mean I disagree with Uncle Willie. Nor does it mean that I am going to trust big business. Or the democrats or the tea party.

For us the only answer I can see is in numbers. The more vapors there are the more difficult it becomes for the government to go against us. Meanwhile keep up the good work you have been doing. I for one really appreciate it.

 

[sqirl1]

A note of clarification here: While the FDA has announced their intent to regulate not only e-cigarettes but all tobacco products under the Tobacco Act, this has not yet occurred. The Family Smoking Prevention and Tobacco Control Act (which became Chapter IX of the Food, Drug, and Cosmetics Act) named specific products. NOT named were such products as cigars, hookahs, e-cigarettes. In order to bring these additional products in, the FDA will need to propose the regulations (which they have already announced that they plan to do, but have not done so yet). Then, there will be a period of public comment (Regulations.gov). Finally, the FDA will announce that it has published (or decided to drop) the proposed regulation.

If the FDA does announce this as their new regulation, it will be challenged in court. The FDA is authorized to enforce laws as written, not to rewrite legislation. It's called "separation of powers."

I thought the law gave them the authority to regulate all tobacco products but they just don't have any regulations down for anything else and that the law is essentially a blank check?

 

[Uncle Willie]

Trust me, I fully understand all the pros / cons .. FDA etc etc etc .. What I don't understand is the advocacy of the continued Wild Wild West in this industry .. I'm not going to lay down my PV's and go back to analogs, and in a worst case scenario, I'd probably turn to the Black Market ..

The work many of you fine folks do as it relates to the Industry is great, and well appreciated ..

However, tell me how and when I can expect better assurance that what I puff is what it's supposed to be .. and when full disclosure will take place in ingredients .. and when nic content is within a tollerance of error range .. because, right now, none of this is happening ..

And don't lay out the same old counter point .. like, well, nothing is safe .. etc etc etc ..

If it were not for regulation, outbreaks of food poisoning and what not would sky rocket ..

I know it's an emotional issue .. but many if not all of us from my generation bought into the idea that cigarettes were OK for you .. until proven differently .. and who led the charge for truth .. ? .. Uncle Sam ..

Now we want to advocate the PV with a very short history .. and we justify that by stating "I feel so much better" or "Nic is actually good for you" .. Meet the new Boss, Same as the Old Boss ..

 

[Vocalek]

I thought the law gave them the authority to regulate all tobacco products but they just don't have any regulations down for anything else and that the law is essentially a blank check?

That's debatable. It will be up to the legal experts to sort it all out.

Read The Bill: H.R. 1256 [111th] - GovTrack.us

‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.

‘(a) In General- Tobacco products, including modified risk tobacco products for which an order has been issued in accordance with section 911, shall be regulated by the Secretary under this chapter and shall not be subject to the provisions of chapter V.

‘(b) Applicability- This chapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this chapter.

‘(c) Scope-

‘(1) IN GENERAL- Nothing in this chapter, or any policy issued or regulation promulgated thereunder, or in sections 101(a), 102, or 103 of title I, title II, or title III of the Family Smoking Prevention and Tobacco Control Act, shall be construed to affect, expand, or limit the Secretary’s authority over (including the authority to determine whether products may be regulated), or the regulation of, products under this Act that are not tobacco products under chapter V or any other chapter.

‘(2) LIMITATION OF AUTHORITY-

‘(A) IN GENERAL- The provisions of this chapter shall not apply to tobacco leaf that is not in the possession of a manufacturer of tobacco products, or to the producers of tobacco leaf, including tobacco growers, tobacco warehouses, and tobacco grower cooperatives, nor shall any employee of the Food and Drug Administration have any authority to enter onto a farm owned by a producer of tobacco leaf without the written consent of such producer.

‘(B) EXCEPTION- Notwithstanding subparagraph (A), if a producer of tobacco leaf is also a tobacco product manufacturer or controlled by a tobacco product manufacturer, the producer shall be subject to this chapter in the producer’s capacity as a manufacturer. The exception in this subparagraph shall not apply to a producer of tobacco leaf who grows tobacco under a contract with a tobacco product manufacturer and who is not otherwise engaged in the manufacturing process.

‘(C) RULE OF CONSTRUCTION- Nothing in this chapter shall be construed to grant the Secretary authority to promulgate regulations on any matter that involves the production of tobacco leaf or a producer thereof, other than activities by a manufacturer affecting production.

‘(d) Rulemaking Procedures- Each rulemaking under this chapter shall be in accordance with chapter 5 of title 5, United States Code. This subsection shall not be construed to affect the rulemaking provisions of section 102(a) of the Family Smoking Prevention and Tobacco Control Act.

Read The Bill: H.R. 1256 [111th] - GovTrack.us

If the law was meant to apply to all tobacco products, why were some specifically named? Cigars have been around longer than most of the named products. Why were cigars not mentioned?

Here is the portion that Judge Leon referenced when recommending that FDA regulate e-cigs under the tobacco act.

SEC. 101. AMENDMENT OF FEDERAL FOOD, DRUG, AND COSMETIC ACT.

(a) Definition of Tobacco Products- Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:

‘(rr)(1) The term ‘tobacco product’ means 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).

‘(2) The term ‘tobacco product’ does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 503(g).

Read The Bill: H.R. 1256 [111th] - GovTrack.us

Under the Tobacco Act, FDA may now regulate tobacco products, which the Act defines as "any product made or derived from tobacco that is intended for human consumption," 21 U.S.C. § 321(rr)(l), but it cannot regulate those products as it would a drug or device under the FDCA, id. § 387a(a).5 There being no dispute that the nicotine in plaintiffs' electronic cigarettes is naturally distilled from actual tobacco and is intended for human consumption (FDA Supp. Br. [#41] at 5 n.3), plaintiffs assert that their electronic cigarettes qualify as a tobacco product and are therefore exempt from regulation as a drug-device combination.

http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf

So it was one of the plaintiffs that asserted that their products are a tobacco product. Judge Leon took that argument and explored it, finding wording in the Tobacco Act to support the plaintiff's assertion.

 

[Ruppy]

Trust me, I fully understand all the pros / cons .. FDA etc etc etc .. What I don't understand is the advocacy of the continued Wild Wild West in this industry .. I'm not going to lay down my PV's and go back to analogs, and in a worst case scenario, I'd probably turn to the Black Market ..

The work many of you fine folks do as it relates to the Industry is great, and well appreciated ..

However, tell me how and when I can expect better assurance that what I puff is what it's supposed to be .. and when full disclosure will take place in ingredients .. and when nic content is within a tollerance of error range .. because, right now, none of this is happening ..

And don't lay out the same old counter point .. like, well, nothing is safe .. etc etc etc ..

If it were not for regulation, outbreaks of food poisoning and what not would sky rocket ..

I know it's an emotional issue .. but many if not all of us from my generation bought into the idea that cigarettes were OK for you .. until proven differently .. and who led the charge for truth .. ? .. Uncle Sam ..

Now we want to advocate the PV with a very short history .. and we justify that by stating "I feel so much better" or "Nic is actually good for you" .. Meet the new Boss, Same as the Old Boss ..

The regulations placed upon food have VERY little impact upon your safety. I have worked in the food service industry for 20+ years. I work with suppliers on a daily basis. I keep up with regulation as it comes up and translates to my pocket book. The majority of FDA regulations are there more to protect liability than safety. Producers are not getting inspections because the FDA says they have to.... They get them so they dont get sued. If you ever have nothing to do.... and I really mean nothing ...... Read the FDA food code.

FYI the majority of consumer foodborne illness is from improper preparation, handling, or storage in the home or final destination retailer (IE..restaurant). The rest is generally from cross contamination in transport. Cases involving production of food products rarely come from the source. I would guess in the range of 1 in 100.

Add to this the record of FDA failures in the prescription drug market....

I dont have much faith in the FDA telling me what is or is not safe.

Ecig industry standards will come on their own once consumers demand it. If consumers shop with suppliers that give them standards, ingredients, and everything else they want other suppliers will follow to keep customers.

 

[kristin]

However, tell me how and when I can expect better assurance that what I puff is what it's supposed to be .. and when full disclosure will take place in ingredients .. and when nic content is within a tollerance of error range .. because, right now, none of this is happening ..

I truly believe that those vapers calling for no regulation (the "wild west mentality") at all and want the industry to "sort itself out" through the open market are a definite minority. Most vapers want to see the kind of standards put forth as you do - but those are basically food standards, ie., full disclosure of what we are consuming and assurance that production is sanitary and consistent.

The FDA wants to go way beyond those standards and wants e-cigarettes to be held to the same standards as pharmaceutical products. Pharmaceutical products are meant to be 100% safe (even though most are not and just get a little warning box) but e-cigarettes are meant to be smoking harm reduction - that means that they should be significantly safer than smoking, but not required to prove themselves 100% for anyone who uses them (which is what the ANTZ and FDA want.) And traditional cigarettes are not required to even meet food safety standards!

Most people would be happy to just let the FDA do their thing if they knew that the FDA did not have a vested interest in removing e-cigarettes from the market and would regulate e-cigarettes as they would any basic food item. But we know that is not its intention, so if we don't question its every move and highlight how its actions would ultimately harm smokers and e-cigarettes users by effectively removing them from the market, the average Joe would see no problem in letting the FDA do whatever it wants.

You can "expect better assurance that what I puff is what it's supposed to be .. and when full disclosure will take place in ingredients .. and when nic content is within a tollerance of error range" when the FDA declares its intention to regulate e-cigarettes that way, rather than requiring e-cigarettes to meet unrealistic and unfair standards and stop threatening e-cigarette efficacy and availability with attempts to reduce nicotine content, remove individual customizability, restrict refills and eliminate flavor choices. Those attributes are what make e-cigarettes effective for a much greater percentage of smokers and eliminating them would severely reduce effectiveness and guarantee a much higher failure in the quit smoking rate.

Once the FDA truly starts acting in the best interest of we, the consumer, then it will get our support. As it stands now, it is working for special interests, Big Pharma and its own prohibitionist standards. We cannot support that and must continue to fight for proper regulation.

So, to answer your question, these things will start happening once the FDA agrees to regulate e-cigarettes as the vast majority of consumers themselves want them regulated and not how it wants to regulate them. Of course, there would also have to be an inspection system set up to actually enforce those standards, as well.

 

[kristin]

Ecig industry standards will come on their own once consumers demand it. If consumers shop with suppliers that give them standards, ingredients, and everything else they want other suppliers will follow to keep customers.

This is true, too. Until consumers demand full disclosure of ingredients and safety practices (ie. not buying from vendors who do not provide such) the vendors are under very little pressure to do so. The law of supply and demand works. There are new vendors every day, which is increasing supply - that allows consumers to start becoming very picky in who they buy from.

I completely agree that the vendors are going to need to step up or the FDA will do it for them and they won't be happy with the regulations. As it is, the mass-market companies (who make only low nicotine, tobacco-only flavored, sealed and unrefillable cartridges) are the only ones getting the FDA's ear these days.

Unless the vendors start showing the public that they can be trusted via full disclosure and giving them what they want, the public will be more inclined to let the FDA set the regulations. If the public is happy with the industry, they will more likely to fight against stricter regulations than they want in place.

Currently, the TVECA is the only media-recognized e-cigarette industry organization and they are made up mostly of mass-market companies, so they will only fight for their business model (pre-filled, tobacco-flavored carts.) Unless the companies that sell refillable models, liquids, mods, and flavors either organize themselves and follow standards expected by the consumers or join the TVECA in order to have influence on TVECA policy to support their business model, they will find themselves soon regulated out of the market.

 

[Uncle Willie]

I use the food industry as an example only .. any Governmental agency that enforces standards, expects and demands compliance and sets minimum standards of safety, etc, could be used ...

As well, I don't buy into the whole "The FDA (or fill in the blank with whatever) is out to get us Consumers because they all work for Big Business Conspiracy" ... although I won't deny business has some sway, the record for Consumer Protection pretty much says it all .. a very long list of safety / food / transportation / import / pharma / etc list could be compiled that makes the case that, in fact, we are being watched out for .. and I'll also not deny that it can be a positive or a negative experience .. but for the most part, I believe we are better for it .. and how can that be refuted .. ??

I am not for intervention, I am for rational regulations that demand standards and compliance .. and I find it sad that the Industry as a whole is unable / unwilling to start down that road on their own .. because, a limbo situation such as it is now, is doing nothing more than inviting intervention ...

 

[FreakyStylie]

My opinion - In regards to the current pro/anti FDA theme in this thread:

• Regulation is good - it has the ability to create a larger percentage of safe and quality products.
• Reasonable taxation is good - it allows for effective regulation.
• Fear-mongering is bad - telling lies to the American people to sway public belief is nothing short of a terrorist act.
• Banning without legitimate basis is bad - there are no genuine studies to provoke any sort of aggressive move against our industry.
• The love of money is bad - there is no need to regulate and tax our industry to the point that it is no longer a viable alternative to smoking.
• San Dimas High School football rules!

In short, I am all for the fair regulation and taxation of electronic cigarettes. It can be a simple matter, and should stay a simple matter; it should not involve any sort of witch-hunt behavior or criminalization of people who use electronic cigarettes.

 

[Traver]

I use the food industry as an example only .. any Governmental agency that enforces standards, expects and demands compliance and sets minimum standards of safety, etc, could be used ...

As well, I don't buy into the whole "The FDA (or fill in the blank with whatever) is out to get us Consumers because they all work for Big Business Conspiracy" ... although I won't deny business has some sway, the record for Consumer Protection pretty much says it all .. a very long list of safety / food / transportation / import / pharma / etc list could be compiled that makes the case that, in fact, we are being watched out for .. and I'll also not deny that it can be a positive or a negative experience .. but for the most part, I believe we are better for it .. and how can that be refuted .. ??

I am not for intervention, I am for rational regulations that demand standards and compliance .. and I find it sad that the Industry as a whole is unable / unwilling to start down that road on their own .. because, a limbo situation such as it is now, is doing nothing more than inviting intervention ...

Isn't the FDA's stance on e cigs a pretty good example of the influence of money and politics. I don't the think you can say it is based on science.
At this time I can still agree that the FDA is doing more good than harm but I also see a growing influence of money. Not so much in the FDA itself but in congress and the administration and the FDA has to pay attention to the people who control it's purse strings. I would not want the FDA involved in this business until we have enough power to influence those regulations.

 

[dragonlover]

"What they should do and what they can do are two different things. There is a clause in the Tobacco Control act that states no new tobacco products can be introduced after 2007. This means that the FDA could a) claim that there were zero electronic cigarettes being sold before the cut-off, or b) select one product that was on that market then and then require a lot of proof that anything introduced after that is "substantially equivalent". If they went with Option a, all e-cigarettes would be banned. If they went with Option b, we would be left with the Ruyan R4081--an underpowered e-cig with batteries that go dead in about half a day and with tobacco flavored liquid at a maximum strength of 16 mg (1.6%)."

What effect would the "pre- 2007" rule have (if worse case scenario it came to that) on liquid nicotine sellers such as RTS who have been in business since 2006? Also an article in the New York Times reports that electronic cigarettes where first readily available in the US in 2006. Again thinking worse case scenario-are adapters for different battery/atomizers made in the US? I once had to buy a disposable ecig at one time and for some reason kept it-I just took the hard cap off and it looks like a regular cartomizer in there.

Just random thoughts

 

[prole]

Could it be argued that nicotine extracted from the tobacco plant, does not constitute a tobacco product as it found in several varieties of plants with eggplant containing the highest content after tobacco... thus a food product, that is extracted from a non-edible plant simply for cost effectiveness reasons?

http://www.ehow.com/list_7377348_plants-containing-nicotine.html

ps: wonder how long it would take to develop an eggplant strain with nicotine concentrations to make viable for the production of nicotine liquid???

 

[Ande]

It's the same catch-22 that comes up here a lot.

Nicotine IS a drug. (By most definitions.) IF it's tobacco derived, and used as tobacco is used (for pleasure), then it may very well be considered a tobacco product.

If you source the nicotine from non-tobacco sources, you're making it more likely that it will be considered a drug rather than a tobacco product. This will not help regarding regulation.

We need to understand: Our job here is to fight unreasonable regulation of these and other harm reduction alternatives.

But there is no magic loophole of "they won't be able to regulate them if we do __________."

No matter what we do, we're gonna have to fight unreasonable regulatory processes.


Best,
Ande

 

[Ruppy]

My opinion - In regards to the current pro/anti FDA theme in this thread:

• Regulation is good - it has the ability to create a larger percentage of safe and quality products.
• Reasonable taxation is good - it allows for effective regulation.
• Fear-mongering is bad - telling lies to the American people to sway public belief is nothing short of a terrorist act.
• Banning without legitimate basis is bad - there are no genuine studies to provoke any sort of aggressive move against our industry.
• The love of money is bad - there is no need to regulate and tax our industry to the point that it is no longer a viable alternative to smoking.
• San Dimas High School football rules!

In short, I am all for the fair regulation and taxation of electronic cigarettes. It can be a simple matter, and should stay a simple matter; it should not involve any sort of witch-hunt behavior or criminalization of people who use electronic cigarettes.

This is a pretty good summation. I also think its how most of us feel. Im a realist and I know we will eventually get taxed. Im honestly fine with a reasonable tax. Reasonable regulation made my a REAL legislative body is also acceptable.

:RANT:
The FDA has no legal right to make or alter a law. They are only granted the ability to enforce them. Making the proposed moves being debated is questionable at best. Interpretation will have to be left to the lawyers in the end I suppose.

Quite frankly the moves against vapers, SOPA and the changes to the NDAA have me extremely biased these days. I am tired of my government imposing themselves into everything.......
:/RANT:

 

[kristin]

As well, I don't buy into the whole "The FDA (or fill in the blank with whatever) is out to get us Consumers because they all work for Big Business Conspiracy" ... although I won't deny business has some sway

"As currently configured, the FDA is not able to adequately protect the American public. It's more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent. Unfortunately, that is the way the FDA is currently structured. Within the Center for Drug Evaluation and Research about 80 percent of the resources are geared towards the approval of new drugs and 20 percent is for everything else. Drug safety is about five percent. The “gorilla in the living room” is new drugs and approval. Congress has not only created that structure, they have also worsened that structure through the PDUFA, the Prescription Drug User Fee Act, by which drug companies pay money to the FDA so they will review and approve its drug. So you have that conflict as well."
- Dr. David Graham, senior drug safety researcher at the FDA

The FDA Exposed: An Interview With Dr. David Graham, the Vioxx Whistleblower

"They're serving industry rather than the public. In fact, when a former office director for the Office of Drug Safety criticized me and tried to get me to change a report I'd written on another drug -- Arava -- he said to me and to a colleague who was a coauthor on this report that "industry is our client."

I begged to differ with him. I said, "No, industry is not the client, it's the American people, the people who pay our taxes. That's who we're here to serve." He said, "No! Industry is our client." I ended the conversation by saying, "Well, industry may be your client, but it will never be my client." - Dr. David Graham

http://www.naturalhealthweb.com/articles/Mercola9.html

"It eventually came to light that the US Food and Drug Administration (FDA) had pressured the Texas medical board to revoke Dr. Burzynski's medical license—despite the fact that no laws were broken, and his treatment was proven safe and effective.

But WHY?

It's been stated many times that a crime can be solved simply by following the money, and this case is no exception. The FDA and the pharmaceutical industry had realized that if Dr. Burzynski's discovery—which he owned the patent for—received a fair review, chemotherapy and radiation would rapidly dwindle into obscurity, effectively crippling the industry. Not only that, but if antineoplastons were approved, billions of dollars of cancer research funds would get funneled over to one single scientist who had exclusive patent rights...

Dr. Richard Crout, Director of the FDA Bureau of Drugs, once wrote in a 1982 newsletter:
"I never have and never will approve a new drug to an individual, but only to a large pharmaceutical firm with unlimited finances."

It became clear that ever since 1977, when Dr. Burzynski first tried to get antineoplastons approved, the FDA had begun scheming to eliminate the threat he and his discovery posed to the entire cancer industry..."
- Burzynski: The Movie

(The case of Dr. Burzynski's innovation is such a close parallel to what is happening with e-cigarettes and smokeless tobacco vs. FDA/Big Pharma that everyone on this forum should watch it. It's jaw-droppingly shocking and eerily familiar. Not only did they try to ban his treatment and throw him in jail, they blatantly tried to steal his patent!)

 

[rothenbj]

(The case of Dr. Burzynski's innovation is such a close parallel to what is happening with e-cigarettes and smokeless tobacco vs. FDA/Big Pharma that everyone on this forum should watch it. It's jaw-droppingly shocking and eerily familiar. Not only did they try to ban his treatment and throw him in jail, they tried to steal his patent!)

Kristin, funny you should bring this up because as I was reading through this thread, I wanted to post to share an email I received on this very subject. A We the People petition was submitted about the FDA stonewalling antineoplaston approval. It was discussed in other threads, but the similarities to the handling of E Cigs begs me to post the email here.

As our petition was handled, the response came from the FDA AND WAS AS TYPICAL! This email is addressing that response point by point-

December 20, 2011

Dear Burzynski Movie subscribers,

I have received a lot of emails expressing confusion about the White House’s “response” to our petition. I thought I’d outline their underhanded strategy for you in this email. This entire email will also be posted as permanent record on the film’s website here.

My petition to the White House [1] was presented as this:

“Antineoplastons are gene-targeted cancer medications that have completed Phase 2 FDA clinical trials in 2009, with permission granted to enter the final Phase of FDA testing. These medicines are the first in medical history to cure inoperable childhood brainstem glioma with a 27.5%-50% cure rate, among other cures. Other gene-targeted cancer medications have been given accelerated FDA-approval without demonstrating a single cure. Antineoplastons, proven to be non-toxic, remain unapproved for public use. For the sake of public health, the results from Phase 2 clinical trials of Antineoplastons need to be publicly acknowledged by the FDA and audited by Congress. These medicines have been in FDA clinical testing since 1995—it's time for the general public to have access to them.”

The White House itself did not respond to the petition, they instead asked the FDA to respond. Not only that, the FDA did not address or respond to the petition itself at all. The entire point of petitioning the White House was to petition the White House. If we wanted to petition the FDA, we would have done that (we didn't do that because we understand that the FDA is a part of the problem). I specifically asked within the petition: "For the sake of public health, the results from Phase 2 clinical trials of Antineoplastons need to be publicly acknowledged by the FDA and audited by Congress." I worded this very specifically to have the results publicly acknowledged. It makes sense for the FDA to not want this data publicly acknowledged by Congress, because if they did this—the American public and the rest of the world would be furious to find out that nothing is being done about a cancer treatment that has been consistently curing certain types of cancer within Phase 2 FDA clinical trials that have verifiably never before been cured before in the history of medicine.

FDA (Janet Woodcock) petition response Part 1: Thank you for your petition asking the Obama Administration to accelerate the approval of antineoplastons for the treatment of cancer.

My response: Thanks, but no thanks Ms. Woodcock, you failed to address anything that the petition was related to and why it was drafted in the first place. For the sake of this petition response, and it’s purpose, I will be addressing only “childhood diffuse intrinsic brainstem glioma”, as the petition itself stated, in regards to the accelerated approval of antineoplastons.

FDA petition (Janet Woodcock) response Part 2: As you know, cancer treatments go through a careful research process to prove that they are safe and effective. The National Cancer Institute (NCI) has recommended that controlled clinical studies be conducted in order to assess the safety and efficacy of the therapy. To date no randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals nor have all of the trials needed to approve antineoplastons as a treatment for cancer been conducted.

My response: This is where the FDA uses complicated language to try to fool the uneducated citizen. Ms. Woodcock states, “To date no randomized, controlled trials showing the effectiveness of antineoplastons have been published in peer-reviewed scientific journals nor have all of the trials needed to approve antineoplastons as a treatment for cancer been conducted.” To the average citizen not familiar with the drug approval process in the USA, Woodcock tries to make it sound as if antineoplastons have never undergone any clinical trials, and if a substance has not undergone any clinical trials, there can't be anything in the peer-reviewed literature showing their safety or effectiveness.

For those that do not understand, a “randomized, controlled clinical trial” is what “Phase 3 trials” are. They are called “randomized” because the patents are sadly placed “randomly” into one of two groups of patients in this clinical trial. The first group consists of the “standard of care group”. In this case, the “standard of care” group for this type of brainstem glioma is “radiation only” (since there has not been any medicines to show enough safety and efficacy to ever be approved for brainstem glioma in children—nor has any substance in history ever shown enough safety and efficacy to have ever been granted randomized trials in medical history for this type of tumor—the only “standard of care” available for it is “radiation”). The second group is the “new medicine on trial”. The FDA then compares the results of the “new medicine group” to the existing “standard of care” group. If the “new medicine group” fares better than the “standard of care” group, and also shows less side effects, then the FDA will then grant that new medicine approval for market. [2]

So, to say “no randomized trials have been conducted” makes the reader believe that the FDA has not overseen any testing whatsoever regarding this therapy. This is entirely untrue. The FDA has supervised and authorized Phase 2 trials of antineoplastons for nearly two decades, and they have since granted permission for “randomized controlled clinical trials” of antineoplastons in 2009 for childhood diffuse intrinsic brainstem glioma. > [23] <- Don't miss reviewing this source

The FDA knows this, and this was not what the purpose of the petition was about. It’s purpose was to tell the FDA that we want the results of the Phase 2 clinical trials audited by Congress and to then share with the world the results from the Phase 2 clinical trials, which show that antineoplastons are the first substances in history to have ever cured this type of tumor—ever—with a minimum 30% overall cure rate.

It’s not like this information is secret, you can see from the following sources for yourself the results from antineoplastons’ Phase 2 trials for this cancer type—we just want these results publicly acknowledged by Congress and announced for the world to know and understand:

2007 [3]: http://www.cancer-therapy.org/CT/v5/B/PDF/42._Burzynski,_379-390.pdf
2006 [4]: Targeted therapy with antineoplastons A10... [Integr Cancer Ther. 2006] - PubMed - NCBI
2003 [5]: Phase II study of antineoplaston A10 and AS2-1 in ... [Drugs R D. 2003] - PubMed - NCBI

It is also public record that no other treatment in history has ever cured this type of cancer:

2008 [6]: Treatment of children with diffuse intr... [Pediatr Blood Cancer. 2008] - PubMed - NCBI
2005 [7]: Role of temozolomide after radiotherapy for newly dia... [Cancer. 2005] - PubMed - NCBI

Another element that the FDA does not want the public to know is this: Since antineoplastons were granted “randomized trials using antineoplastons for brainstem glioma” in 2009, the FDA is forcing these children to also undergo radiation in addition to antineoplastons in these new "randomized trials" within the "new medicine group", which means all of these children will be deaf, have their pituitary glands destroyed (which will stunt their growth permanently), and will also likely make them a non-functioning bed-ridden vegetable. Another thing the FDA would not like you to know is this: No hospital in the USA is allowing these Phase 3 antineoplaston "randomized" trials to be conducted, because they know they will never accrue a single patient due to radiation being forced into the "new medicine group". [23] What parent would put their child through that? Would you? [24] The FDA knew exactly what they were doing when they were forced to grant antineoplastons their first “randomized controlled trial”—the FDA knows that forcing the kids to simultaneously receive radiation in addition to antineoplastons in the "new medicine group" would halt the trial from even starting at all. The FDA's mafioso tactics in this case has once again proven successful in their efforts to keep antineoplastons from reaching the market—in turn preventing the public from having full access to them.

The FDA does not at all care that the therapy has cured an upward of 30% of patients treated of this disease without the inclusion of radiation. So, in an apparent effort to thwart the success of antineoplastons in Phase 3 randomized trials, the FDA is mandating radiation into the "new medicine group", even though they know what it will do to these children, and even though they know radiation is not necessary to cure any of these kids while using antineoplastons. Their very own data shows it. They verified it. It was the FDA’s own data that proved antineoplastons to be safe and effective enough to be granted “randomized phase 3 trials”. [23]

In summary, it has been proven impossible to conduct Phase 3 randomized trials of "childhood brainstem glioma" due to the FDA forcing all kids who undergo this therapy to have their brains fried by radiation treatment at the same time. Even if 30% of the kids are cured, they will be deaf, they will be stuck in the body of whatever age they started treatment, and they will likely be an non-functioning vegetable for the rest of their life.

Does this sound like an agency that is looking out for the health and well-being of its public? Or does this sound like an agency that doesn't want to see this medicine available to the public?

This is the reason I started this petition, and no other. We want the world to know what the verified cure rate is for antineoplastons in this type of cancer, to help the world understand, and to make sure they are eventually granted accelerated approval. Accelerated approval is our only option, since "phase 3 randomized trials" are impossible to conduct due to the FDA's barbaric radiation mandate.

So, you might be asking, “what is accelerated approval?" Accelerated approval was something that Dr. David A. Kessler [8 (timecode 4:18-6:14)] started in 1996 under the idea of pushing important drugs through without them having to be subjected to “phase 3/randomized trials” in the name of “public health”. This was specifically for drugs that show promise for diseases that have no good or any existing treatments for them. What could be more fitting for this than “brainstem glioma” in children? There is no medicine on the market at all for this treatment, only radiation. The FDA doesn’t care that antineoplastons are the first to cure it. And frankly, it seems it is out of their control anyway since over 50% of their drug evaluation money comes from PhRMA thanks to the drug user fee act of 1992 [9]. If PhRMA has the ability to push unsafe and ineffective drugs through accelerated approval in the name of profit, what will stop them from preventing a competing medicine like antineoplastons from getting a fair chance in the testing process? I appears that we are witnessing exactly that—right now before our eyes—we are witnessing the "privatization" of our federal government agency: The Food & Drug Administration.


Let’s take a quick look at some of the cancer medicines recently given "accelerated approval" by the FDA:


Avastin (breast cancer) 2008: The FDA granted accelerated approval for Avastin in the treatment of advanced breast cancer in 2008. The results that allowed it to be “accelerated”: Only 11.3 months of “Progression-free survival”. [10]

The FDA took it off the market for this condition in November 2011 because it doesn’t work at all if not properly prescribed [11] (or at least for the oncological world who simply does not understand how to prescribe this gene-targeted medicine—which is pretty much all of them). But don’t feel bad for the company that owns it, they made their fortune from it already for this condition, making up for 17% of the entire company's sales. [12]

Avastin (Glioblastoma brain cancer) 2009: The FDA granted accelerated approval for this medicine for Glioblastoma. The FDA’s reasoning was “People with this type of brain cancer have had no new treatments in more than a decade”. [13] Well, what about “brainstem glioma” patients? They haven’t had a new treatment for that condition—ever. But it gets better. Only 58 patients were treated in a single Phase 2 study. The median “response duration” was a mere 3.9 months. That is a “response”, not a cure, or even any real extension of life at all. Antineoplastons have a 30% cure rate in "brainstem glioma", not a “response rate”. During this single Phase 2 arm of 58 patients that got Avastin accelerated approval for Glioblastoma—none of them were cured.

Avastin is a gene-targeted therapy, which can only target certain specific genes. Oncologists do not test the patient to even see if they have these genes. Dr. Burzynski does, as demonstrated in this short film here. [14]

Antineoplastons have an upward of a 9% cure rate for Glioblastoma. [15] [16] [17] Most of the public could care less about “response rates”—they want to see actual cures. But, if “response rates” are important, how about the total of 368 patients treated with antineoplastons in Phase 2 trials for Glioblastoma where 40.5% of them had a stable disease? [15] That is of course if we care about “response” vs. “cure”.

Temodar (Anaplastic Astrocytoma brain cancer) 1999: In 1999, the FDA granted accelerated approval for Temodar for Anaplastic Astrocytoma brain cancer. Only 12 of 54 patients “responded”, with only 9% of them being “cured” [18]. As the film shows [19], Antineoplastons have a 25% cure rate for this condition. [20] And, unlike Temodar which is a poisonous chemotherapy—the 25% of patients cured of Anaplastic Astrocytoma using Antineoplastons can actually one day have children. Like most toxic chemotherapies, Temodar impairs or destroys a person’s ability to remain fertile, among other hideous side effects. [21] Again, what about the 30% cure rate for “brainstem glioma”? Why does Temodar get favored for accelerated approval based on inferior 9% results in their Phase 2 trials?

Afinitor (ubependymal giant cell astrocytoma (SEGA) brain tumor): In 2010, the FDA granted accelerated approval for Afinitor after a single Phase 2 study of only 28 patients. 32% of the patients experienced a 50% reduction of their tumor, none of their tumors went away completely. [22]


FDA (Janet Woodcock) response Part 3: The timely review and approval of safe and effective new treatments are central to the U.S. Food and Drug Administration's (FDA) mission to protect and promote the public health. In fact, over the past 12 months, FDA approved 35 new medicines, including three cancer drugs that were approved in less than six months. This is among the highest number of approvals in the past decade. Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin's lymphoma in 30 years; and the first new drug for lupus in 50 years. The approvals came while drug safety standards have been maintained.


My response: To say “The timely review and approval of safe and effective new treatments are central to the U.S. Food and Drug Administration's (FDA) mission to protect and promote the public health,” is simply not true based on their response to this White House petition. Perhaps that means all of the public except those children who are unlucky enough to be diagnosed with brainstem glioma. Perhaps those kids do not matter to the FDA or qualify as “the public”. Then to go on and boast about their 35 new approved cancer drugs in only 12 months, I can’t think of a bigger slap in the face to the “public health” of the American people on behalf of our newly privatized FDA.

FDA petition (Janet Woodcock) response Part 4: A report released last month by FDA, FY 2011 Innovative Drug Approvals, shows faster approval times in the United States when compared to the FDA's counterparts around the globe. Of the 35 approvals in FY 2011, 24 occurred in the United States before any other country in the world, and also before the European Union, continuing a trend of the United States leading the world in first approval of new medicines.

The Administration remains committed to the timely approval of safe and effective drugs to improve the treatment of cancer and other illnesses.

My response: If “The Administration remains committed to the timely approval of safe and effective drugs to improve the treatment of cancer and other illnesses,” then why are they ignoring—or worse—denying their own data regarding antineoplastons in the treatment of childhood diffuse intrinsic brainstem glioma? It seems the pharmaceutical grade medicines known as "antineoplastons" are disqualified from playing the FDA's approval game, even though their results are far more superior than any other cancer therapy our planet has ever seen.

Janet Woodcock is the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. You can click here to contact her yourself.

In solidarity,
Eric Merola



NOTE: This article was written by Eric Merola, the director of the documentary Burzynski: Cancer Is Serious Business. Mr. Merola and his documentary are not affiliated with the Burzynski Clinic, or The Burzynski Research Institute, Inc. Mr. Merola is an independent investigative journalist working on his own, and is not in any way supported by The Burzynski Clinic.

SOURCES:
1. https://wwws.whitehouse.gov/petitio...icly-audited-congress-gain-final-fda/M1hH28lk
2. Randomized controlled trial definition - Medical Dictionary definitions of popular medical terms easily defined on MedTerms
3. http://www.cancer-therapy.org/CT/v5...py.org/CT/v5/B/PDF/42._Burzynski,_379-390.pdf
4: Targeted therapy with antineoplastons A10... [Integr Cancer Ther. 2006] - PubMed - NCBI
5. Phase II study of antineoplaston A10 and AS2-1 in ... [Drugs R D. 2003] - PubMed - NCBI
6. Treatment of children with diffuse intr... [Pediatr Blood Cancer. 2008] - PubMed - NCBI
7. Role of temozolomide after radiotherapy for newly dia... [Cancer. 2005] - PubMed - NCBI
8. (Timecode 4:18-6:10): Burzynski | 2-DVD Set Extended Edition Montage Preview of New Material | Cancer Is Serious Business - YouTube
9. Taking back the FDA - The Boston Globe
10. FDA Grants Accelerated Approval of Avastin in Combination With Paclitaxel Chemotherapy for First-Line Treatment of Advanced HER2-Negative Breast Cancer
11. FDA Commissioner Removes Breast Cancer Indication from Avastin Label
12. Stock:Roche Pharmaceuticals (RHHBY)
13. FDA Grants Accelerated Approval of Avastin for Brain Cancer (Glioblastoma) That Has Progressed Following Prior Therapy
14. Texas Med. Bd. vs. Dr. Burzynski 4/11/12 - Gene-Targeted Cancer Therapy - YouTube
15. http://www.burzynskiclinic.com/images/Pub_SRB_2006_Targeted_Therapy_for_Brain_Tumor.pdf
16. https://www.burzynskimovie.com/index.php?option=com_content&;view=article&id=80&Itemid=37
17. https://www.burzynskimovie.com/index.php?option=com_content&;view=article&id=81&Itemid=37
18. Food and Drug Administration Drug Approval Summary: Temozolomide Plus Radiation Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme
19. https://www.burzynskimovie.com/index.php?option=com_content&;view=article&id=58&Itemid=37
20. https://www.burzynskimovie.com/imag... Anaplastic Astrocytoma - Newly Diagnosed.pdf
21. Temodar Official FDA information, side effects and uses.
22. Novartis drug Afinitor® approved by FDA as first medication for children and adults with a benign brain tumor associated with tuberous sclerosis
23. Email from the FDA verifying the permission on begin Phase 3 trials for childhood brainstem glioma
24. Childhood brainstem glioma patient Jessica Ressel interview with medical records