Posted: Sun Apr 01, 2007 9:22 am
christinequilts, you're obviously extremely concerned about the safety of the pur-sleep products. You have raised good questions that I would consider to be fair game. There has already been a great deal of discussion on the points you have raised here on different threads (particularly the "essential oils" thread) and I offer the following thoughts:
1. Essentail Oil Safety. All of the essential oils used in pur-sleep products have been designated as being "generally recognized as safe" (GRAS) for human consumption by the U.S. FDA. Consumption is general but certainly includes ingestion, direct application to the skin, and inhilation (though I would NOT recommend ingestion or direct dermal application except for lavender).
Just as there is a great deal of folklore out there about essential oils curing all kinds of diseases and conditions, there's an equal amount of folklore about essential oil safety. For example, most essential oil sellers warn against use of almost every oil by pregnant women. But the book Essential Oil Safety by Tisserand and Balacs (Churchill Livingstone 1995), the leading scholarly work on the subject states concerning Risks in Pregnancy:
"A thorough search of the literature has not revealed any cases of unwanted abortion resutling from the use of essential oils. In fact most attempts by women to use essential oils to cause abortion have proven unsuccessful."
That's not to say there are no pregnancy-related risks: "there is evidence that a few oils, including the notorious savin, are possible abortifacients. Dangers to the fetus are also a risk with some oils." Essential Oil Safety p. 3.
Drbandage, an MD, offered the following thoughts on essential oil safety and the pur-sleep products on the "essential oils" thread:
3. EO Labeling. The essential oils are listed on the label though that's not required. For aromatic products it is sufficient to list "fragrance" on the label. The latin names are not used nor is the country of origin noted--but that information could be provided should anyone ask. Creme is something of an exception. It comes labeled to me from one of the largest EO dealers in the world as an "essential oil" but, depending on the definition used, it's probably not a true EO. The vanilla is an oleoresin; ethyl (drinking) alcohol is used to extract the aromatic elements from the vanilla, which are very thick and heavy. Most of the alcohol is removed but a small amount is necessary to keep the vanilla in a liquid form. The Creme label reflects this information.
4. Aromatherapy and the FDA. The sense of smell is linked directly to the emotional centers of the brain. The "therapeutic" aspect of aromas is linked to emotion. Pleasant aromatics make us feel calm and provide comfort. In my opinion, this is not the kind of the kind of claim that the FDA regulates as a drug. This is not being marketed as a sleep aid per se. It is being marketed as a product that helps people feel calm and relaxed, which will help people sleep. There may well be other therapeutic benefits of essentail oils (as has been proven with lavender in a placebo-controlled, double-blind human study) but that's not the focus of the marketing efforts here. Perhaps the marketing descriptions could use some clarification.
In many respects, the pur-sleep products are similar to the Vics products, which are meant to be breathed all night. They are marketed and branded as providing soothing "comfort." Ironically, the Vics products include essential oils of camphor and tea tree, neither of which is on the FDA list of EOs that are safe for human consumption. The Essential Oil Safety book also cautions against camphor and tea tree--these may not be safe for human consumption at all. So if you're that worried about the pur-sleep products, please NEVER use any products by Vics--they use unapproved essential oils that may be harmful and you breathe them all night. Certainly there's no study proving that the Vics products are either effective or harmless.
5. Unadulterated Air. It's worth noting that when it comes to xPAP, there's no such thing as unadulterated air. xPAP equipment is made from hard and soft plastic parts that emit plasticizers that, apart from presenting health exposure risks, can also be extremely irritating from an aromatic standpoint.
Here's a link to one thread:
viewtopic.php?t=18021&highlight=pvc
And another thread I started on PVC exposures: viewtopic.php?t=17138&highlight=pvc
7. Risk Assessment. Before using the pur-sleep products at best I was using my cpap 4 hours a night, 5 nights a week, for 3 years. And I felt terrible. I hated cpap with a passion. The pur-sleep products help me use my cpap every night, all night. I feel better. I'm getting very satisfying sleep.
Given the known risks of untreated OSA (including death, brain damage, depression, hypertension, heart disease, diabetes, stroke, and just plain feeling like warmed-over #$@#%$, I'm extremely happy that I can make my own decisions on this subject. Your personal decision came out the other way (which seems like the very best decision for you). If your cpap therapy is already working well for you, is effective, and you're satisfied I wouldn't recommend changing a single thing. I wouldn't change one thing about my therapy right now--I couldn't be happier with it.
And thanks to the forum for helping people be able to make well-informed decisions.
1. Essentail Oil Safety. All of the essential oils used in pur-sleep products have been designated as being "generally recognized as safe" (GRAS) for human consumption by the U.S. FDA. Consumption is general but certainly includes ingestion, direct application to the skin, and inhilation (though I would NOT recommend ingestion or direct dermal application except for lavender).
Just as there is a great deal of folklore out there about essential oils curing all kinds of diseases and conditions, there's an equal amount of folklore about essential oil safety. For example, most essential oil sellers warn against use of almost every oil by pregnant women. But the book Essential Oil Safety by Tisserand and Balacs (Churchill Livingstone 1995), the leading scholarly work on the subject states concerning Risks in Pregnancy:
"A thorough search of the literature has not revealed any cases of unwanted abortion resutling from the use of essential oils. In fact most attempts by women to use essential oils to cause abortion have proven unsuccessful."
That's not to say there are no pregnancy-related risks: "there is evidence that a few oils, including the notorious savin, are possible abortifacients. Dangers to the fetus are also a risk with some oils." Essential Oil Safety p. 3.
Drbandage, an MD, offered the following thoughts on essential oil safety and the pur-sleep products on the "essential oils" thread:
Several have posted on this thread that they have presented this idea to their doctors, including a lung doctor, and none of them expressed safety concerns with it.
2. EO Reactions to Plastics. Since you've not seen the pur-sleep products this is a fair question. Non-reactivity was an important design consideration. The bottom part of the diffuser, including the bracket, is made from high-quality HDPE plastic that is completely non-reactive to essential oils.I've spoken to a few myself, including an ENT and a pulmonologist. At any rate, I've yet to meet a medical professional who has expressed any concern at all. I suspect most would share this opinion, but I haven't actually asked most, so who knows. Docs don't agree 100% on anything, as we all are aware, but on some things you certainly can get a consensus. I think this would likely be one of those things, from the things I know about the medical mind, and the reactions that I've seen thus far.
It doesn't "prove" anything of course, but we can say is that the amounts ingested are not on a grand scale, even if used eight hours every day. Yes, that name (oil) is a bit unfortunate, as it may (and has) mislead some who may not appreciate what is happening on the molecular level.
An oil "essentially" can be any of numerous mineral, animal, vegetable, and synthetic substances that are generally slippery, combustible, viscous, liquid at room temperature, soluble in various organic solvents (such as ether), but not in water. Oil and water don't mix, literally. Oil is referred to as hydrophobic, because it separates from water. SG's potion meets some criteria for being called an oil, but that isn't necessarily a bad thing. Many substances that the body needs fit that same criteria.
Now, where did I put my Cod Liver oil?
All liquids evaportate. Airborne molecules (including H20) are simply wayward formerly liquid borne molecules that have flown the coop. And, the fact that molecules in a liquid can actually fly the coop is a good thing. (Consider why we have that liquid water sitting in direct contact with the air in the humidifier reservoir.) The way that happens is that (at differing rates, depending on the liquid and the temperature), the molecules in the liquid are always in motion, and some get going so darn fast that they actually launch themselves free of their liquid neighbors and take a quick spin into the gas that is their neighbor, i.e. the atmosphere. Most will never return to their liquid buddies , as they just get carried off into the great wide beyond, floating away as airborne molecules, like Dorothy and Toto leaving Kansas, bound for Oz.
Fast forward to the inhalation stage.
Bottom line is that we are inhaling air all day long with all sorts of nasty airborne molecules in it, as well as chunkier stuff like pollens and pollutants. Most airborne molecules are absorbed by tissue in the nasal cavity, pharynx, and trachea long before they even get to the lungs.
And if they do make it to the lungs, they get absorbed there, or rolled up by cilia and stuck into mucus. That in turn is "moved" out of the lungs and leaves the body as mucus (a.k.a. snot), either through spitting it out or swallowing it and pooping it out. Yuck. Gross.
The nose allows you to make scents of what's going on in the world around you.
Up on the roof of the nasal cavity is the olfactory epithelium. The olfactory epithelium contains special receptors that are sensitive to odor molecules that travel through the air. There are literally millions of these receptors in your nasal passages, and there are literally thousands of different types of odor receptors, each with the ability to sense certain odor molecules. An odor molecule potentially can stimulate several different kinds of receptors. The brain then interprets the unique combination of receptors to recognize any one of about 10,000 different smells. (often less in husbands and boyfriends . . . )
When the smell receptors are stimulated, signals travel along the olfactory nerve to the olfactory bulb in the brain, just above the nasal cavity. Signals then are "scent" from the olfactory bulb to other parts of the brain to be interpreted as a smell you may recognize on a conscious level, and then you decide what you want to do about that odor, e.g. seek the source, flee, or tolerate it. Additionally, the brain may recognize these molecules on a subconsious level, in which case the brain makes up it's own mind (if you know what I mean) about what it wants to do about the stimulation.
It's important to recognize that he lungs are not a closed system (e.g bottle with a cap on it) where the airborne molecules are able to return to their original liquid form. So, no fear that they may somehow "coat" the tissue. Chunky stuff, (e.g. asbestos) though, is far bigger than a molecule, and may get stuck in the lung tissue as we all know. Not good.
The body, however, absorbs airborne molecules all the live long day, and for the most part it processes them and discards them back into the blood which then is filtered by the kidneys, which in turn produces urine, and out they go. Or, they may be snatched out of the blood stream as the blood courses through the liver, our own version of a filter. The liver sends the stuff out, too.
Anyway, SleepGuy's contraption requires that we pour the liquid from the bottle, and then let it reside on the little cotton thingy. Eventually, these molecules do get airborne, and fortunately we can smell them. (SG, please consider chocolate chip cookie essence. Obviously, there is some combo of molecules that fits the bill, as I've had that particular molecular structure grace my olfactory epithelium.) Ultimately, over time, all of the molecules are going to get launched, and as that is happening, the smell eventually fades away. Time to reload. Then shampoo, rinse, repeat.
SleepGuy gets my good housekeeping seal of approval for something that certainly appears to be perfectly safe when used as described, and seems to very helpful for lots of people, if the feedback on this message board is any barometer.
Of course, some would be loathe to inhale anything other than fresh, pure air if given the choice. But then, you gotta live a little on the edge sometimes to really enjoy life. As Dirty Harry pointed out, "you gotta ask yourself, punk: do you feel lucky?"
And as far as potential toxicity, it does not concern me in the least. But, then I'm just the kinda guy that sleeps in a bed, despite the known risk of falling out and onto the floor. Of course, it's only me, and dissenters may surface.
But ignore them.
drB
3. EO Labeling. The essential oils are listed on the label though that's not required. For aromatic products it is sufficient to list "fragrance" on the label. The latin names are not used nor is the country of origin noted--but that information could be provided should anyone ask. Creme is something of an exception. It comes labeled to me from one of the largest EO dealers in the world as an "essential oil" but, depending on the definition used, it's probably not a true EO. The vanilla is an oleoresin; ethyl (drinking) alcohol is used to extract the aromatic elements from the vanilla, which are very thick and heavy. Most of the alcohol is removed but a small amount is necessary to keep the vanilla in a liquid form. The Creme label reflects this information.
4. Aromatherapy and the FDA. The sense of smell is linked directly to the emotional centers of the brain. The "therapeutic" aspect of aromas is linked to emotion. Pleasant aromatics make us feel calm and provide comfort. In my opinion, this is not the kind of the kind of claim that the FDA regulates as a drug. This is not being marketed as a sleep aid per se. It is being marketed as a product that helps people feel calm and relaxed, which will help people sleep. There may well be other therapeutic benefits of essentail oils (as has been proven with lavender in a placebo-controlled, double-blind human study) but that's not the focus of the marketing efforts here. Perhaps the marketing descriptions could use some clarification.
In many respects, the pur-sleep products are similar to the Vics products, which are meant to be breathed all night. They are marketed and branded as providing soothing "comfort." Ironically, the Vics products include essential oils of camphor and tea tree, neither of which is on the FDA list of EOs that are safe for human consumption. The Essential Oil Safety book also cautions against camphor and tea tree--these may not be safe for human consumption at all. So if you're that worried about the pur-sleep products, please NEVER use any products by Vics--they use unapproved essential oils that may be harmful and you breathe them all night. Certainly there's no study proving that the Vics products are either effective or harmless.
5. Unadulterated Air. It's worth noting that when it comes to xPAP, there's no such thing as unadulterated air. xPAP equipment is made from hard and soft plastic parts that emit plasticizers that, apart from presenting health exposure risks, can also be extremely irritating from an aromatic standpoint.
Here's a link to one thread:
viewtopic.php?t=18021&highlight=pvc
And another thread I started on PVC exposures: viewtopic.php?t=17138&highlight=pvc
7. Risk Assessment. Before using the pur-sleep products at best I was using my cpap 4 hours a night, 5 nights a week, for 3 years. And I felt terrible. I hated cpap with a passion. The pur-sleep products help me use my cpap every night, all night. I feel better. I'm getting very satisfying sleep.
Given the known risks of untreated OSA (including death, brain damage, depression, hypertension, heart disease, diabetes, stroke, and just plain feeling like warmed-over #$@#%$, I'm extremely happy that I can make my own decisions on this subject. Your personal decision came out the other way (which seems like the very best decision for you). If your cpap therapy is already working well for you, is effective, and you're satisfied I wouldn't recommend changing a single thing. I wouldn't change one thing about my therapy right now--I couldn't be happier with it.
And thanks to the forum for helping people be able to make well-informed decisions.