Deeming Regulations have been released!!!!
- Thread starter Oliver
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I've skimmed it, and yeah, I saw that part about their estimates of applications. Even if we went with their most generous estimates of 80 applications, and the 90%(HAHAHAHA) approval rate estimated from drug approval rates(instead of the 0.00001% approval rate to date for tobacco products), that would leave us with 72 products to choose from. An entire industry of tens of thousands of products, reduced to what could fit on a 4'x4' display behind the counter. That is exactly what they want.Have you filtered through this?
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf
Q&A on their reasoning for Regulation
Seems from Constant References, Mid session, they figure - Abstinence it the only acceptably way to Quit.......................Here, have a chantix
and THIS:
we're done
well, not all of us
Also, of course they don't see vaping as an acceptable way to quit, because to them it's not quitting, it's transferring use from one tobacco product to another. There are no safe tobacco products.
I think you have it in a Nutshell nic.
I don't see anyone by a Select Few getting a Discretionary Extension on their PMTA.
And you are Correct. If your PMTA is Denied, your PMTA Product has to be removed from the market Immediately.
I believe he has very little chance of winning in this year's election, but what would really be helpful, would be for him to get the % support in polls, required for inclusion in the debates. It's there, that I believe we'd get a passionate voice in favor of vaping, and exposure of the corruption behind the ANTZ/Government misinformation campaign, and the deeming regulations.
The vaping issue can be of help to the Libertarian Party, and the Libertarian Party could be of political help to vaping.
I agree this article is pretty typical of what I have found too and it is full of errors and pop drivel.
I shall await Roxanne McDonald, Body Mind Institute certified nutrition and raw food expert, latest pearls of wisdom with zero anticipation.
Roxanne’s newly published book: The Real Skinny on Gluten-Free Living: 8 Simple Steps to Break up with Gluten
Sorry folks for the wander this my last post on the subject in this thread.
Good. But first read this drivel
What is Canola oil:
source: rape | plant
Rape (Brassica napus, variety napus), also called rapeseed or colza, plant of the mustard family (Brassicaceae), grown for its seeds, which yield canola, or rapeseed, oil. Canola oil is variously used in cooking, as an ingredient in soap and margarine, and as a lamp fuel (colza oil). The esterified form of the oil is used as a lubricant for jet engines and can be made intobiodiesel. The seeds are also used as bird feed, and the seed residue after oil extraction is used for fodder. The plant can be grown as a cover crop and green manure
Health Effects:
Source: Rapeseed - Wikipedia, the free encyclopedia
Rapeseed oil is one of the oldest vegetable oils, but historically was used in limited quantities due to high levels of erucic acid, which is damaging to cardiac muscle of animals, and glucosinolates, which made it less nutritious in animal feed. Rapeseed oil can contain up to 54% erucic acid. Food-grade canola oil derived from rapeseed cultivars, also known as rapeseed 00 oil, low erucic acid rapeseed oil, LEAR oil, and rapeseed canola-equivalent oil, has been generally recognized as safe by the United States Food and Drug Administration. Canola oil is limited by government regulation to a maximum of 2% erucic acid by weight in the USA and 5% in the EU,[27]with special regulations for infant food. These low levels of erucic acid are not believed to cause harm in human neonates.
In 1981, a deadly outbreak of disease in Spain, known as toxic oil syndrome, was caused by the consumption of colza oil (a cousin of rapeseed oil procured from a similar species of rapa) for industrial use that was fraudulently sold as olive oil to be consumed in cooking, salads, and other foods. Symptoms appeared as a typical pneumonia with interstitial infiltrates on chest X-ray, complicated by pulmonary hypertension in a significant number of cases.
Rapeseed pollen contains known allergens. Whether rape pollen causes hay fever has not been well established, because rape is an insect-pollinated (entomophilous) crop, whereas hay fever is usually caused by wind-pollinated plants. The inhalation of oilseed rape dust may cause asthma in agricultural workers.
Source: http://www.hsph.harvard.edu/nutritionsource/2015/04/13/ask-the-expert-concerns-about-canola-oil/
As with many highly processed food products there are concerns about the safety of canola oil.
First is the use of a solvent such as hexane to extract the maximum amount of oil from the seed. Hexane is a very volatile solvent (boiling point 69ºC, or 156ºF) with a very low toxicity (LD50 in rats of 49.0 milliliters per kilogram). Hexane has been used to extract oils from plant material since the 1930s, and “there is no evidence to substantiate any risk or danger to consumer health when foods containing trace residual concentrations of hexane are ingested” (1).
It has been estimated that refined vegetable oils extracted with hexane contain approximately 0.8 milligrams of residual hexane per kilogram of oil (0.8 ppm) (2). It is also estimated that the level of ingestion of hexane from all food sources is less than 2% of the daily intake from all other sources, primarily gasoline fumes. There appears to be very little reason for concern about the trace levels of hexane in canola oil.
Another concern is the report that canola oil might contain trans-fats that have been linked with significant health problems. In fact, canola oil does contain very low levels of trans-fat, as do all oils that have been deodorized. Deodorization is the final step in refining ALL vegetable oils. This process produces the bland taste that consumers want.
As a comparison, the fat of cattle and sheep, as well as the milk obtained from cows, contain about 2-5% of natural trans-fat as a percent of the total fat (3). When canola oil is deodorized it is subjected to temperatures above 200ºC (as high as 235ºC, 455°F) under vacuum for various lengths time to remove volatile components such as free fatty acids and phospholipids. During exposure to these high temperatures a small amount of the unsaturated fatty acids, especially the essential ω-6-linoleic and ω-3–linolenic acid, are transformed into trans-fatty acid isomers. Because of earlier studies showing that even quite low levels of trans isomers of ω-3–linolenic can have adverse effects of blood cholesterol fractions, the processes used for deodorization have been modified to limit the production of these compounds.
A consequence of transforming some of the natural unsaturated fatty acids to trans-fat during the deodorization step is a reduction in the content of beneficial ω-3–fatty acids.
Heating bleached canola oil at 220°C for ten hours reduces the content of linolenic acid by almost 20% (5). Keep in mind that canola oil sold in the supermarket still contains 9-11% natural ω-3–linolenic acid.
The same transformation occurs during commercial deep-fat frying operations with canola oil. Thus canola oil used to fry French fries for seven hours per day for seven days at 185°C (365°F) resulted in increasing the total trans-fatty acid content of the oil from 2.4% to 3.3% by weight of total fat (6).
Of potentially greater concern is the formation of oxidation products of polyunsaturated fatty acids during prolonged commercial deep-fat frying. But this is less of a concern for canola oil than for oils with higher levels of more readily oxidized polyunsaturated fat such corn, soybean, sunflower, and safflower oils.
Source: Canola Oil: Harmful Cooking Oil - Processed Vegetable Oil
Initially, the Canola Council of Canada had problems getting GRAS (Generally Recognized as Safe) status by the US Food and Drug Administration in order to market their oil in the US but it was finally granted in 1985. It is rumored that the Canadian government spent $50 million to obtain it. Even though canola oil now has GRAS status, no long-term studies on humans have been done, yet supporters state, “There is no credible scientific evidence showing that canola oil is harmful to humans.”
Since canola oil mimics healthy properties of other oils, including omega-3 fats (as found in fish & flax), and monounsaturated fats (as found in olive oil), proponents feel as though they had made a dream-come-true product. Canola oil eventually began to appear in the recipes of health books such as those by Andrew Weil and Barry Sears. The popularity of the Mediterranean diet and olive oil at the time was spreading and many were beginning to substitute their olive oil for canola oil. It was rumored that most major publishers would not accept cookbooks unless they included canola in the recipes.
But here’s the main problem with canola oil, and why you should think twice before using it –canola oil is highly refined. Like high fructose corn syrup that is not “corn sugar” once it is extracted and processed, canola oil also has to go through a similar regimen. The oil is removed by a combination of high temperature mechanical pressing and solvent extraction. Traces of the solvent (usually hexane) remain in the oil, even after considerable refining. Canola oil goes through the process of caustic refining, bleaching and degumming – all of which involve high temperatures or chemicals of questionable safety. And because itis high in omega-3 and 6 fatty acids, (11% and 21% respectively) which easily become rancid and foul-smelling when subjected to oxygen and high temperatures, it must be deodorized. The standard deodorization process removes a large portion of the omega-3 fatty acids by turning them into trans fatty acids. The Canadian government lists the trans content of canola at a minimal 0.2 percent, but it is speculated that they are actually much higher due to the processing. This processing is much different from that of olive oil, which most often is first cold pressed to reduce the oxidation of the oil. Harmful chemicals and fatty acid-altering processing means do not occur with olive oil as they do with canola oil.
Another major problem with canola oil is that 80% of the acres sown are genetically modified canola, and it’s not the GMO type of product that has been developed for the benefit of the species of plant, but for the benefit of the herbicide. First introduced to Canada in 1995, genetically modified canola has become a point of controversy and contentious legal battles as Monsanto’s “Roundup Ready” herbicide allows farmers to drench both their crops and crop land with the herbicide so as to be able to kill nearby weeds (and any other green thing the herbicide touches) without killing their crop. The effects of this herbicide on the environment as well as the health of individuals who consume the products have been questioned. (Read more on pesticides and herbicides here.) Superweeds have begun to develop, and much like the overuse of antibiotics, eventually a resistance to the chemical builds up, and a more powerful one must be used. Monsanto is already working on a stronger herbicide (called SmartStax) which they hope to debut soon.
So should you be using canola oil? I say, definitely not. Doing so is risky...
You'll love this one;
Source: The Great Con-ola - Weston A Price
Canola oil is a poisonous substance, an industrial oil that does not belong in the body. It contains “the infamous chemical warfare agent mustard gas,” hemagglutinins and toxic cyanide-containing glycocides; it causes mad cow disease, blindness, nervous disorders, clumping of blood cells and depression of the immune system. This is what detractors say about canola oil.
How is the consumer to sort out the conflicting claims about canola oil? Is canola oil a dream come true or a deadly poison? And why has canola captured so large a share of the oils used in processed foods?
HIDDEN HISTORY
Let’s start with some history. The time period is the mid-1980s and the food industry has a problem. In collusion with the American Heart Association, numerous government agencies and departments of nutrition at major universities, the industry had been promoting polyunsaturated oils as a heart-healthy alternative to “artery-clogging” saturated fats. Unfortunately, it had become increasingly clear that polyunsaturated oils, particularly corn oil and soybean oil, cause numerous health problems, including and especially cancer.1
The industry was in a bind. It could not continue using large amounts of liquid polyunsaturated oils and make health claims about them in the face of mounting evidence of their dangers. Nor could manufacturers return to using traditional healthy saturates–butter, lard, tallow, palm oil and coconut oil–without causing an uproar. Besides, these fats cost too much for the cut-throat profit margins in the industry.
...
Canadian researchers looked at LEAR oils again in 1997. They found that piglets fed milk replacement containing canola oil showed signs of vitamin E deficiency, even though the milk replacement contained adequate amounts of vitamin E.14 Piglets fed soybean oil-based milk replacement fortified with the same amount of vitamin E did not show an increased requirement for vitamin E. Vitamin E protects cell membranes against free radical damage and is vital to a healthy cardiovascular system. In a 1998 paper, the same research group reported that piglets fed canola oil suffered from a decrease in platelet count and an increase in platelet size.15 Bleeding time was longer in piglets fed both canola oil and rapeseed oil. These changes were mitigated by the addition of saturated fatty acids from either cocoa butter or coconut oil to the piglets’ diet. These results were confirmed in another study a year later. Canola oil was found to suppress the normal developmental increase in platelet count.16
Finally, studies carried out at the Health Research and Toxicology Research Divisions in Ottawa, Canada discovered that rats bred to have high blood pressure and proneness to stroke had shortened life-spans when fed canola oil as the sole source of fat.17 The results of a later study suggested that the culprit was the sterol compounds in the oil, which “make the cell membrane more rigid” and contribute to the shortened life-span of the animals.18
...
These studies all point in the same direction–that canola oil is definitely not healthy for the cardiovascular system. Like rapeseed oil, its predecessor, canola oil is associated with fibrotic lesions of the heart. It also causes vitamin E deficiency, undesirable changes in the blood platelets and shortened life-span in stroke-prone rats when it was the only oil in the animals’ diet. Furthermore, it seems to ...... growth, which is why the FDA does not allow the use of canola oil in infant formula.19 When saturated fats are added to the diet, the undesirable effects of canola oil are mitigated.
ETC.
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Sure, I can find articles that conclude that canola oil is safe
but I can find articles that support all kinds of weird stuff as being safe also.
Money talks...
Regardless of the veracity of the above information or lack thereof
I prefer to play it safe and not use canola oil, after all it isn't custard
But by all means feel free to eat as much of it as you want
Regards,
Hazy
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My guess is that after some stuff gets authorized some similar stuff/juice might get exempted. But you might ask a lawyer...I'm just an old vaper LOLCan anyone Shed light on this Statement?
I have said this before, and I know people think it is Crazy.
But after the current FDA gets what it thinks the e-Cigarette market should look like, I believe that the FDA as well as the CDC and NIH, will do a 180. And start Allowing the Positive Study Data to be Mainstream.
Of course, by then, the e-Cigarette market will be a Shell of what it is Today.
So maybe the Hope lies in a New HHS Secretary as well as a New FDA Commissionaire?
Can anyone Shed light on this Statement?
Without knowing more about the Quote you Quoted, I believe they are referring to Significant Equivalence (SE).
Once my VUSE is PMTA ok-ed, My VUSE II would be easier to bring to market via SE. As long as my VUSE isn't too much different from my VUSE.
Can anyone Shed light on this Statement?
BTW - This is why the FDA will Fight Tooth and Nail against moving the Predicate Date up farther than Feb 15th, 2007.
Because they see it as Opening the Door to a Less Regulated Market.
Can anyone Shed light on this Statement?
BTW2 - here is a pretty good Article which explains some of the In's n Out's of the PMTA vs SE pathways.
The Grandfather Date – What are FDA’s Alternatives? | VAPE Magazine
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf
FDA already has a New term for Us in case they ever loose the Addictive Debate.
So now we all are Habitual users. Isn't that a Roll-over from the DRUG side? I'd class that as Abusive and Degrading.
FDA already has a New term for Us in case they ever loose the Addictive Debate.
So now we all are Habitual users. Isn't that a Roll-over from the DRUG side? I'd class that as Abusive and Degrading.
I saw that too, and I have no idea. It would seem to imply there is a predicate e-liquid, since I don't think you can do SE or SE Exemption from something that was approved via PMTA, or do I have that wrong?Can anyone Shed light on this Statement?
As I understand it. There is Not Problem statuarally(sp?) in doing a SE to a PMTA-ed product.
I'll believe that when I see it, which I hope is never, because I still have hope that this whole mess will be thrown out. It's not a very big hope, but I'm a romantic at heart.
Most experts (on our side) seem to agree that there's no such thing as SE as a viable option. Smoke and mirrors.
Well, everything I've ever seen refers to it being Substantially Equivalent to a predicate product. I've wondered about it before, and no one seemed to have an answer.
ETA: statutorily?
I agree with most of what you wrote above, but the three parts I bolded promt me to reply in disagreement.
"effects every aspect of ones life in a very negative way"
Not every aspect, and not always negatively - in fact, sometimes positively, sometimes both positively and negatively.
"brain scans of people with and without it clearly show it"
While great strides have been made, many researchers overrate their understanding of such brain scan evidence.
" If somebody wants to argue about it contact me via PM not in this thread."
I consider it much more constructive use of my time and effort to respond in the thread, than by PM.
I think they have chosen the exact opposite of your strategy !
Not Now. Not with a Feb 15th, 2007 Predicate Date.
But 2 years from now there will be Successfully PMTA-ed products. And that is when SE will become Meaningful to a degree.
But remember. It's still that same Old BS. Just a smaller Turd with the FDA not saying what it takes to do a Successful SE.
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