PurSleep- Cosmetic or Drug? Safe or Not?

[christinequilts]

I didn't want my post getting lost on the other PurSleep thread & myriad of other PurSleep threads. I would really like some answers to my questions. It sure doesn't seem to be a cosmetic to me, according to the information from the FDA below. Where are all its defenders who kept telling Snoredog it was perfectly safe to use and to just order it & try it?

Moved from the Since Starting PurSleep oils thread

I'll be the first to admit I don't always agree with Snoredog, especially some of his view on centrals, but I think he is right to question this- we all should be.

I notice the web sites says it okay to use with all CPAP, autoPAP, BiPAP, BiLevel, etc, so it will work with my VPAP Adapt ASV, correct? What about exposure to the eyes if someone uses a Total Face Mask? That's fine too? I didn't see anything in the instructions about testing it out, but if it does seem to negatively affect your xPAP treatment, to discontinue its use immediately...even most cosmetic makeup products include a similar type warning. You only seem to note that if the smell doesn't agree with you, to discontinue using it. So if my machine acts funny, but I like the smell, its fine to use? And you have tested with every type of machine out there, and it doesn't affect the more complex machines used to treat CSA and CSDB? And its fine for someone using a CPAP or BiPAP or autoPAP or BiPAP ST or ASV-PAP for reasons other then apnea, like COPD?

Have you done any long term studies on the effect of essential oils in a semi-closed system, applied directly to the nose & mouth- both of which are mucosal membranes? As well as eyes, in the case of Total Face Mask? What about sensitization over time?

And what about where the diffusion pad is held, that's not made of plastic is it? Anyone knows you don't allow essential oils to come in contact with plastic, as they dissolve the plastic, releasing compounds I'd rather not think about. Someone mentioned the rings on lights bulbs as being similar to PurSleep, but they are made of ceramic not only because of the heat of the light bulb, but because ceramic doesn't interact with the oils, as plastic and other man made materials can. Are your essential oils shipped in dark colored glass bottles? And stored in the same at all times, while in your care?

I'm sure you are also not using any of the essential oils that are warned against for someone with seizure disorders, high blood pressure or kidney disorders, right? And all of them are safe during pregnancy? Just because a substance is listed on GRAS, doesn't mean its safe to use however you want, in whatever quantity you want. Many items that are GRAS in small amounts would not be in larger amounts.

Do you include instructions for how to flush the skin, should someone accidentally get essential oil on their fingers while putting onto the diffusion pad, since direct skin contact should be avoided with pure essential oils, as they are so strong. It seems it would too easy to get a drop on your finger while setting up and then transfer it to your face and eyes as you put your mask on, but I'm sure you've considered that.

And I'm sure your labels list not only the common name, but the full Latin name of each essential oil used, including country of origin when necessary, as German chamomile is different then Roman Chamomile, for example. And I'm a little confused, first everything I read says everything is 100% pure, unadulterated essential oils, then your Creme says it has alcohol in it...that's pretty important for me, considering its usually corn based alcohol and I'm highly allergic to corn and corn derivatives.


And I'm still a little confused on if your product is a cosmetic or drug. It sure seems like you are making a lot of drug claims of improving sleep, treating claustrophobia, improving xPAP compliance and such. Is it cleansing, beautifying, promoting attractiveness or altering appearance? Will my nose be cleaner in the morning? Will I be more beautiful & attractive? Will my nose look smaller?- I hope not, I already have a fairly small nose...but I really don't want it to look bigger either. So which is it?

"The Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)].

http://www.cfsan.fda.gov/~dms/cos-218.html

And is it you're a cosmetic because you say are? Gee, can I be 110 pounds and 21 again just because I say I am too? It seems the FDA's definitions are a little more specific then you'd like, darn pesky regulation....Let's see what they have to say (emphasis added mine):

How is a product's intended use established?
Intended use may be established in a number of ways. Among them are:
* Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells.
* Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.
* Ingredients that may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principle also holds true for essential oils in fragrance products. A fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use.

http://www.cfsan.fda.gov/~dms/cos-218.html


I think I'll pass on the PurSleep and breath my boring, unadulterated air for now and enjoy my essential oils in other, more conventional ways.

[SleepGuy]

christinequilts, you're obviously concerned about the safety of the pur-sleep products, which you've never used. But you've 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 of any EO 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. I note that as to the oils, like savin, that may present risks, none are on the FDA GRAS list and none are used in pur-sleep products.

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.

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

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.

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 Vics products (much less let your children use them!)--Vics uses essential oils that have not been designated as being safe for human consumption by the FDA and actually may be harmful. 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. Of course, risks should not be evaluated in a vacuum. 650 times more people die every year in the USA from falling out of bed than from the avian flu or mad cow disease, yet how much have you worried about falling out of bed vs. the avian flu or mad cow disease? 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. I practially leap out of bed every morning, ready to take on the day. It's been a fantastic, life-changing experience for me.

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.

[SleepGuy]

I'm also happy to announce that the forum host, cpap.com, is now carrying pur-sleep products:

https://www.cpap.com/productpage-advanced.php?PNum=2470

[bookwrm63]

Congratulations, Bret! As one who has been using Pur-Sleep products from the very beginning, I couldn't be happier for you. I know it has made my cpap experience so much more enjoyable and relaxing!

By the way, my pulmonologist has not found any reason to distrust the use of Pur-Sleep in it's intended way and if it increases compliance, all the better!

Mary

[christinequilts]

If you bothered to even look at my signature, you would see I'm not on CPAP, I'm on VPAP Adapt SV, for treatment of CSA & CSDB, not OSA. Most long time posters here know how long I struggled with less then optimal treatment with BiPAP ST for 3 years, which left me with significant residual AHI still in the severe range, because that was the best the technology could offer at the time. I'm glad you've had success with your product, but have you really considered all the variables in apnea, xPAP, and sleep medicine besides CPAP + OSA?

In addition to multiple sleep disorders, I also have severe allergies, including to corn and all corn derivatives, which does make me have to question any products I would ever consider even bringing into my home. I have to make most of my personal care products and household cleaners, or rely on small, cottage industry manufacturers who use simple, pure ingredients- who I can trust with my life. Your level of avoidance of the real questions being asked would not earn you a place on that list. I use essential oils daily, in multiple ways, so it is not an issue with the type of product you sell per se, but the way you are marketing it, repeating claiming its a cosmetic, all while making numerous medical claims. I also have an issue with your diffuser itself, if the tubing adaptors/quick connectors have to have medical approval, why is your product exempt? Can you provide documentation specific to your product from the FDA that states it is exempt?

I've had to learn way more about labeling on everything from foods, cosmetics, soaps, otc medications, etc. I've made friends with a lot of small cosmetic cottage industry owners who have worked hard to establish their cosmetic and soap products, carefully adhering to FDA labeling and safety requirements, going above and beyond the requirements much of the time, not taking short cuts. I know most people are not as skeptical of companies, nor do they have to be, but aromatherapy products are not something to mess, especially when added to xPAP, and as I understand from reading your White Paper, other respiratory devices. But if someone doesn't question the safety and legitimacy of a product, the internet would be more flooded with herbs, tonics, products, and gimics making illegal claims.


I'm glad to see you agree your product is like Vicks, we agree on something. GRAS doesn't apply to Vicks because unless you are doing something wrong, you should not be ingesting Vicks Vapo products. Of course it has several non-GRAS ingredients that are not meant for oral consumption, so that that argument doesn't fly- its just more distraction from the real issues at hand, cosmetic or drug. GRAS applies to food additives, period. Are you suggesting anyone ingest your PurSleep Oils, since they are GRAS? I wouldn't think so. Something can be GRAS, it can be CODEX listed- great if you're ingesting them, but it doesn't mean anything when it comes to cosmetics or drugs.

Back to the Vicks VapoRub or VapoCream, it sounds like you're saying your PurSleep Oils are the equivalent, as far as general use, safety and potential harm, correct? Both vapor or aromatherapy products, right? Good, because I do too...and so does the FDA, as Vicks VapoRub & VapoCream are classified as drugs, not cosmetics- “topical cough medicine”
Note the similarity of claims-
*Vicks- relieves your cough
*PurSleep Clear oil “ clear up mild congestion and waking up feeling particuarly invigorated.”

Notice how Vicks Vapo products have “active ingredients” listed, which had to be substantiated in medical testing to be effective, as claimed in marketing, to receive FDA approval as a drug, if it were to be introduced as a new product today.

Vicks® VapoRub® medicated vapors begin to work quickly to relieve your cough.
VapoRub is not likely to cause drowsiness or jittery side effects. Because VapoRub is a topical cough medicine, it may be appropriate for diabetics looking for an alternative to oral cough medicines that may contain sugar.

Active Ingredients (Purpose)
Camphor 4.8% (Cough suppressant and topical analgesic)
Eucalyptus oil 1.2% (Cough suppressant)
Menthol 2.6% (Cough suppressant and topical analgesic)
Inactive Ingredients
Cedarleaf oil, nutmeg oil, special petrolatum, thymol, turpentine oil

Vicks® VapoRub® Cream medicated vapors begin to work quickly to relieve your cough.
VapoRub Cream is not likely to cause drowsiness or jittery side effects.Because VapoRub Cream is a topical cough medicine.

Active Ingredients (Purpose)
Camphor 5.2% (Cough suppressant and topical analgesic)
Eucalyptus oil 1.2% (Cough suppressant)
Menthol 2.8% (Cough suppressant and topical analgesic)
Inactive Ingredients
Carbomer 954, cedarleaf oil, cetyl alcohol, cetyl palmitate, cyclomethicone copolyol, dimethicone copolyol, dimethicone, EDTA, glycerin, imidazolidinyl urea, isopropyl palmitate, methylparaben, nutmeg oil, peg-100 stearate, propylparaben, purified water, sodium hydroxide, stearic acid, stearyl alcohol, thymol, titanium dioxide, turpentine oil

You keep claiming your product is 'just a cosmetic', yet you never answered directly the questions I asked per FD&C Act, Section 201.

So once again, can you tell me how does PurSleep:

• 
  a) cleanse?
  
  b) beautify?
  
  c) promote attractiveness?
  
  d) alter appearance?

You claim over and over aromatherapy isn't considered a drug by the FDA, yet the FDA site clearly states:

What is Aromatherapy?:
While cosmetics and drugs both are under FDA's jurisdiction, the legal requirements applying to them differ. A claim that a perfume's aroma makes a person feel more attractive, in general, is a cosmetic claim not requiring FDA approval before a product is sold. But if someone tries to market a scent suggesting effectiveness as an aid in quitting smoking, as a sleeping aid, or to treat or prevent any other condition or disease, or otherwise affect the body's structure or function, such a claim may cause the product to be regulated as a drug, requiring premarket approval. The agency will make judgments on a case-by-case basis.

http://www.cfsan.fda.gov/~dms/qa-cos9.html

But then, making 'claims' is what you do:

On Products page, under Diffuser:
“Aromatics are simply the most effective way on the market to help you overcome the most common and difficult problems associated with CPAP use (feelings of claustrophobia, irritation, inability to relax, etc.).”
“And before you know it you'll be drifting off into the best sleep you've had in a long while.”

Under Library:
Introducing the In-Line Diffuser!
“While aromatics have been proven effective to address the very same kinds of psychological variables at issue in CPAP therapy (even claustrophobic feelings), until now there has not been a practical way to experience pleasant aromatics in CPAP equipment. Manufacturers uniformly recommend using only distilled water in humidification chambers and aromatic oils may cause damage if directly applied to equipment....That's why we invented the CPAP In-Line Diffusion Chamber.”

Of course xPAP manufacturers also uniformly recommend not using any non-approved accessories too, and I can't imagine any xPAP manufacturer approving an in-line diffuser for essential oils.

And on that note, if your customers ignore instructions from their xPAP manufacturer about accessories by using PurSleep, what is keeping those same customers from ignoring your instruction to not use other essential oils of unknown quality, or worse yet, fragrance oils and other various chemical compounds? And how is your PurSleep diffuser any different then the xPAP hose, tubing connector, etc, at that point? All medical equipment, of course.

Just a Few Drops
“You will be amazed what a difference just a few drops of our essential oils will make in your CPAP experience, substantially improving both the quality and quantity of the sleep you will achieve or we'll gladly refund your entire purchase price!”

It's That Easy!
“Just a few drops of one of our amazing all-natural aromatic blends will transform your CPAP experience...lay back, relax, and revel in the authentic aromas...And before you know it you'll be drifting off into the best sleep you've had in a long while.”

Under Essential Oils
“Clear...success in using this blend to help clear up mild congestion and waking up feeling particuarly invigorated.”

“Comfort...comforting and sleep-enhancing qualities...that is formulated to help induce and promote deep, comfortable sleep, all night long...scientifically proven to enhance deep sleep!”

“Spice...Orange essential oil has been shown to significantly reduce stress and anxiety associated with dental procedures and appears to exhibit sedative effects.”

[SleepGuy]

I believe these questions have already been addressed in sufficient detail both here and on various other threads, but I would like to offer the following:

1. Vics offers a large number of products containing essential oils of camphor, tea tree, etc. Some of them are branded and marketed as over-the-counter medications (as you quoted) and many of them are branded and marketed as "comfort" aromatherapy products. My primary point about the Vics products related solely to the questions raised about the safety of breathing essential oils all night. In that respect, the pur-sleep products are similar to Vics, though pur-sleep does not use any oils not otherwise on the GRAS list.

2. The GRAS list goes to human consumption / ingestion. Nowhere has anyone or anything suggested that the pur-sleep oils should be ingested. The point is simply that if the FDA considers these oils to be safe for eating, they are safe for other forms of consumption as well (such as dermal application and breathing).

3. The legal questions relating to "drugs" and "cosmetics" under the Food, Drug, and Cosmetics Act are not as narrow as your analysis suggests. Even SnoreDog stated on the other thread that the pur-sleep products are not treating anything:

I have worked with many Patent attorneys and directly assisted in obtaining over 100 US and Foreign patents. I am familar what intellectual property law is and we all know your device doesn't treat anything that is not what is in question.

Quoting from informal guidance documents issued by FDA is not nearly the same as quoting from and analyzing the statutory provisions and relevant caselaw. The U.S. Code Annotated, available at a local law library, contains both the statute and caselaw on hundreds of points of interpretation regarding these issues. In sum, a cosmetic includes articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance of the body. In other resources the FDA has made it clear that when essential oils are marketed for their aromatic effects, they are regulated as a cosmetic, not a drug. You obviously believe that the statements on the pur-sleep website cross the line. I think we'll just have to "agree to disagree" on that point.

I am flattered that you have shown so much interest in these products. You are obviously very concerned about safety and apparently I've not been able to answer your questions to your satisfaction. Good luck with your continuing therapy and business ventures.

[kavanaugh1950]

BRET, CONGRATULATIONS ON THE SUCCESS OF YOUR PRODUCT. I LOVE IT AND WILL CONTINUE TO ENJOY IT NIGHTLY. IT HAS GREATLY IMPROVED MY QUALITY OF SLEEP.I REALLY CAN'T UNDERSTAND THE MEANESS OF SOME WHO HAVE NEVER USED THIS WONDERFUL PRODUCT. WE ARE ALL ADULTS AND CAN MAKE OUR OWN DECISIONS. I MADE MINE AND WILL STICK WITH IT. PAT

[StillAnotherGuest]

Well, I don't see anybody being "mean", I see "spirited debate". But that's academic, these concerns will have to be addressed on their content, not their format.

If Some Is Good, Why Is More Better?
I'm not saying lavender isn't good for improving sleep quality (I don't know about any of the other EOs, tho), there is some data on that:

An Olfactory Stimulus Modifies Nighttime Sleep in Young Men and Women, Namni Goel, Hyungsoo Kim, Raymund P. Lao (Abstract)

Aromatherapy is an anecdotal method for modifying sleep and mood. However, whether olfactory exposure to essential oils affects night‐time objective sleep remains untested. Previous studies also demonstrate superior olfactory abilities in women. Therefore, this study investigated the effects of an olfactory stimulus on subsequent sleep and assessed gender differences in such effects. Thirty-one young healthy sleepers (16 men and 15 women, aged 18 to 30 yr, mean±SD, 20.5±2.4 yr) completed 3 consecutive overnight sessions in a sleep laboratory: one adaptation, one stimulus, and one control night (the latter 2 nights in counterbalanced order). Subjects received an intermittent presentation (first 2 min of each 10 min interval) of an olfactory (lavender oil) or a control (distilled water) stimulus between 23:10 and 23:40 h. Standard polysomnographic sleep and self-rated sleepiness and mood data were collected. Lavender increased the percentage of deep or slow-wave sleep (SWS) in men and women. All subjects reported higher vigor the morning after lavender exposure, corroborating the restorative SWS increase. Lavender also increased stage 2 (light) sleep, and decreased rapid‐eye movement (REM) sleep and the amount of time to reach wake after first falling asleep (wake after sleep onset latency) in women, with opposite effects in men. Thus, lavender serves as a mild sedative and has practical applications as a novel, nonphotic method for promoting deep sleep in young men and women and for producing gender-dependent sleep effects.

My comment is why would you even have to risk prolonged inhalation when that's not what the data shows? The data says 8 minutes, not 8 hours.

You'll have to buy a copy of that study; it's not published on the internet. I wouldn't consider it to be anecdotal. It's the first study of its kind on essential oils and sleep. It was a double-blind, placebo controlled human study in a sleep lab where sleep patterns were directly recorded. Now this study clearly was looking at the therapeutic aspects of lavender EO on sleep--it goes way beyond the subjective emotional effects.

Well, lemme check the magazine rack at work, maybe it's sittin' there. 30 bucks is a lot for an article. I will get it at some point, I'm also curious about that "opposite effects in men." They also did a gender difference study at the same time, so I'll sneak it in as a "work-related expense."

Of course everyone is free to put a drop of lavender essential oil someplace else or take a couple of snorts before bedtime.

My point exactly. And if that's a scientific study, then perhaps that's how one should go about it. If that's the data, then let's use the data.

Google "YoungLiving" and you'll find that essential oils cure STDs, cancer, bone spurs, colds, and almost anything else.

Yeah, I see what you mean. Hmmm. I also see where Amazon has a little 10 ml bottle for about 5 bucks. Maybe that's the way to go if people are a little short on coin, want to share with their non-CPAP SO, are concerned about changing the flow characteristics of the machine, ruining their mask, excess dosing, long-term side effects, developing a tolerance, etc.

Trial Size Lavender Essential Oil?

Are There Safety Issues?
If we're now talking about direct inhalation of this stuff, increasing contact time 50-fold (I'm also wondering about heating it up if you use a humidifier) then can you use the above study to syllogistically say "Aha! Scientific proof that MY device works!"? That's not what it says. It says brief lavender inhalation works (and safety is is not specifically addressed here) not continuous infusion through a positive pressure machine.

Good point about the eyes, tho, CQ.

Every Lavender Oil MSDS sheet has eye precautions there. Wonder what's gonna happen after 2000 hours of contact time if you have a leak?

Lavender Essential Oil MSDS

But hey, plenty of studies show stick it anywhere, why do you need to set it up as a Bong?
SAG

So How About the FDA
Yeah, well, I know, FDA, all that. But as a continuous, direct infusion? I think it does qualify as a treatment

The federal Food, Drug and Cosmetic Act defines a "medical device" as a device that is:

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

FDCA § 201(h), 21 U.S.C. § 321(h).

While it is not always necessary to obtain FDA approval for medical devices (the agency maintains detailed regs governing the manufacture of many classes of common medical devices, like toothbrushes), it is necessary to obtain approval for "medical devices" that are not otherwise approved.

... treatment aimed at changing sleep architecture and efficiency, in my book, fits the FDA definition precisely.

Modifying a Class II Medical Device
Whether or not this "diffuser" needs FDA approval is not the issue. Once you incorporate it into an xPAP machine, then you are marketing something that modifies a Class II Medical Device. And while individually

WE ARE ALL ADULTS AND CAN MAKE OUR OWN DECISIONS.

it would be a great idea to get some science behind this. Hey, if the FDA gives this support, and all the xPAP companies say, "Great, that's a good modification to our machines", then everybody would eventually benefit. Better compliance, more effective therapy, more machine and diffuser sales.
SAG

[DreamStalker]

All are very interesting discussions here. While I am yet uncertain as to whether the Pur-Sleep products are benefiting my sleep therapy, I feel the products to be relatively safe … but what do I know, I’m no sleep specialist.

I had two more zero AHI nights this past week and had my first zero AHI night bit over a month ago shortly after beginning trial use of the diffuser (… and I’m talking about zero AHI over a period of 7 or more hours of uninterrupted sleep here). I cannot say that the EO diffuser is directly correlated to my improved AHI because I have not used it every night and I have not kept a record of which nights I have used it … perhaps I’m just getting really good at making this therapy work? However the coincidence of achieving these recent zero AHIs has given me an incentive to begin tracking my infrequent use of the Pur-Sleep products and my AHI values. Maybe a personal experiment is in order for me?

Nevertheless, back to the discussion topic … despite the concerns and the very well presented argument/debate over safety and FDA approval, I still am not convinced that Bret’s products pose a significant risk. I mean, folks here on this forum are changing their doctor’s Rx pressure settings, analyzing data with software that is not endorsed by the xPAP manufacturer, modifying mask interfaces, and hoses and using Polident and tape as part of their therapy -- none of which has proven to be 100% safe or FDA approved. So where does RG's panty hose fix fit under? ... cosmetic or drug or class II medical device?

Bottom line is that we humans will do what ever it takes to feel better and be happy. After all, what other more important reason is there to live (besides procreating the species … something I have failed miserably at)?

[christinequilts]

I REALLY CAN'T UNDERSTAND THE MEANESS OF SOME WHO HAVE NEVER USED THIS WONDERFUL PRODUCT.

Meaness? All I've asked are simple questions anyone should have asked before ever using it, as have other posters. The only 'meanness' I've seen is that SleepGuy can't seem to answer direct questions with direct answers, his condescending attitude that I shouldn't try to understand FDA regulation, and his disregard for his customers. He continually side steps the issues at hand with claims of GRAS (doesn't apply), its as safe as Vicks (a drug, not a cosmetic according to the FDA), other people market essential oils for similar purposes (two wrongs don't make a right), quotes drbandage & snoredog as his experts (okay...but what about a little thing called the FDA? are either going to help when they start asking questions?).

He even admits, per the FDA, cosmetics are

for cleansing, beautifying, promoting attractiveness, or altering the appearance of the body

but can't define how PurSleep InLine Diffuser and essential oils do any of those four things. I agree, essential oils can be marketed and sold as cosmetics, as the definition includes

skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

I have a small tool box full of essential oils I've purchased from reliable companies, which I use in combination with with other ingredients to make my own shampoo, hair colors, skin moisturizers, deoderants, etc for my own personal use.

Let's just look at an example of how eo's are marketed legitimately, by looking at Aura Cacia's, a very well known and highly respected eo company:

Lavender
Lavender's perfectly balanced floral-herbaceous aroma provides an unmatched array of attributes - calming, relaxing, refreshing, toning and cleansing - making it the most popular oil in aromatherapy.Lavender

and even in their eo directory:

*Lavender - Lavandula angustifolia/Bulgaria, France/Flowering Top. Lavender oil is used in baths, room sprays, toilet waters, perfumes, colognes, massage oils, sachets, salves, skin lotions and oils. It has a sweet, balsamic, floral aroma which combines well with many oils including citrus, clove, patchouli, rosemary, clary sage and pine. Aromatherapy benefits: balancing, soothing, normalizing, calming, relaxing, healing. Page L of EO Directory

Notice they state its attributes as being calming, relaxing, and even healing, but they never mention it will improve your sleep or treat a medical condition, like claustrophobia. Again, the FDA states clearly that "a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use." Its not a gray area, you cannot claim aromatherapy will help sleep. Its black and white, just like a shampoo cannot claim to help prevent, treat or otherwise mention dandruff or a facial cleanser cannot claim to help prevent or treat acne without being classified as a drug. If you have either in your bathroom, go look at the label and you will see active ingredients listed and other requirements that set them apart as a drug versus a cosmetic.


And don't even get me started on the actual in-line diffuser....I've found some interesting things about that too and made some interesting phone calls, but I'll save that for later.

And as far as RG mask modification, is she manufacturing, marketing or selling anything? Or is she sharing a personal experience of what she found works for her? See the difference?

[Nenetx2004]

Oh for crying out loud in the love seat! (to quote my grandmother)

Use it, don't use it......as was stated before, we're all adults. My doctor says he sees nothing wrong with the diffuser. Whatever works to keep me compliant.

I really believe that cpap.com wouldn't agree to offer the products if there were too many questions about safety.

Anyway, just my 2 cents. Thanks Bret for making a great product and having the willingness to answer questions and delve deeper into your products and their effects.....

Jeanne

[DreamStalker]

And as far as RG mask modification, is she manufacturing, marketing or selling anything? Or is she sharing a personal experience of what she found works for her? See the difference?

Ok ... I think I understand the difference. The concern is more to do with profiting from a product that is marketed to improve upon the treatment of a health issue such as xPAP without being FDA approved ... is that correct?

True RG is not selling anything but I am aware of the sale of at least two other products marketed for the improvement of xPAP treatment and have no FDA approval that I am aware of ... PACs and hose covers ... do these fall under the same category of Pur-Sleep too then?

I believe I mentioned it on a previous post but I will state it again just for the record ... I was provided with my Pur-Sleep product free of charge in return for trialing it and providing feed back to Bret ... which I did via PM discussions (just being transparent as possible and making sure everyone is aware of my perspective). I did ask the simple questions anyone should have asked before ever using it and was satisfied with Bret's answers ... I also provided suggestions through PMs regarding testing of the fluid mechanics of the diffuser which has also been discussed by others on other threads.

Anyway, I do see that there are a few who feel the need to crusade for the safety of all PAP users ... and I think that is good thing to know that there are some out there with an interest in my health and welfare (and I mean that sincerely). Nevertheless, as has already been stated several times now, in the end we as adults do make our own decisions and must accept the responsibilty and consequences that come with those decisions.

[christinequilts]

My doctor says he sees nothing wrong with the diffuser.

Your doctor was probably under the incorrect assumption that it was a FDA approved medical device, at least according the very enlightening phone call I had with an FDA representative this morning.

[Guest]

Nope. I printed out pages from the website, brought the diffuser and the essential oils in......and gave him the web address in case he wanted to contact Bret himself.

[bookwrm63]

I do believe Christine that your questions have been answered over and over....and over and over.

You seem to be taking this very personally at this point and it appears you are now just looking for an argument. I have seen nothing condescending in Bret's replies to you. In fact, I'm surprised he continues to reply to you. You have you own ideas in your head and only your ideas and I'm sure there is nothing Bret can say or do that will change that. Why not just let it go? If someone doesn't want to use the product or doesn't like it, that's fine. That is what free will is all about.

I admire your passion but it may be put to better use on a more worthy cause.

Mary