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Showing posts with label Holistic And Healthy Lifestyle. Show all posts
Showing posts with label Holistic And Healthy Lifestyle. Show all posts
Giving Advice On Healing Properties Of Essential Oils
The enjoyment of essential oils is certainly not lost on me and I use them in my body care formulas and LOVE them for the soothing aroma they offer me over synthetic fragrance. I also am aware of the history of EO's and how wonderful they can be for many health benefits, but sharing that info under the context of medicinal qualities or healing benefits would be tantamount to providing a drug or practicing medicine without a license....and that is a scary thing.
Unfortunately, this is EXACTLY what is occurring with MLM reps of two companies that are rapidly growing in popularity which are dōTERRA and Young Living. To some degree these companies have developed quite the cult following which can be dangerous to the average consumer. If they are taking their healing and medical rhetoric to the point of an infallible belief because one may not be knowledgeable about essential oils, this is where harm can be done to the populace. If one wishes to self diagnose, then great....but to offer diagnosis to another person simply based on the fact that a company is headed up or founded by a doctor, does not allow or provide the credentials for someone to spread the information as scientifically or medically sound.
One lady in particular and my good friend, Kayla Fioravanti, has spent many years formulating and using essential oils and has now written a book on the subject and her research is exemplary. It is however this very knowledge she shared, courageously I might add, that set off a firestorm of the most hateful and mean spirited comments after she wrote the article which I decided to share below. It was clear that many of them are in this cult like following of being duped by these companies and clearly accepted their marketing materials at face value.... which in a sense has become all about the money rather than the scientific reality of these essential oils. These sales people have zero training in safe use of these oils, let alone having the education it requires to understand the possibility of drug interaction with others the person might be taking at the time of use. They are merely trained in how to sell these products and recruit more sales staff to grow these two company's bottom line.
Fortunately, as of Sept. 22nd, 2014, Kayla's attempts to protect and inform the public are now vindicated for all to see. Thankfully, the FDA finally stepped in and issued Violation Letters to both dōTERRA and Young Living in order to prevent harm to the public. This is serious stuff once they become involved. It was clear that the proponents of these companies have been misguided and are breaking the law as is represented in the comment wars in the link above. Now the founders of these companies have to answer to the scrutiny of the FDA, especially since they advise people to ingest these essential oils. Not a wise thing to do at all and frankly I don't understand this concept. Holistic healing is awesome, but without the science to prove it or under the care of a practicing physician, this is ill advised by many EO experts. What I do find interesting however, is since publishing this latest update involving the FDA, it is nothing but crickets from her critics. Truth and science rule the day, EVERY TIME!
If you know anyone or you yourself are using these oils in some type of medicinal way as promoted by these MLM companies, please share this vital information so as to keep yourself and others from possible harm of using essential oils in such a way as they are being promoted that goes outside the boundaries of safe use. Kayla's article will shed much light on this issue and I hope you find it helpful.
Warnings dōTERRA And Young Living Won’t Tell You - author Kayla Fioravanti
The dangerous practices of consuming essential oils and applying them undiluted on the skin have gone viral on the internet, chat rooms and via sale representatives of many dōTERRA and Young Living MLM representatives. Beware of anyone who tells you to ingest essential oils either by putting a few drops in your water or putting them into a capsule. The only cases of death, organ failure and hospitalization in the history of aromatherapy have been caused by ingesting essential oils. It is THAT dangerous.
Another dangerous practice many dōTERRA and Young Living representatives teach is to apply essential oils undiluted directly on your skin. Please don’t.
I am so passionate about the safe use of essential ones that I dedicated an entire chapter to it in my book The Art, Science and Business of Aromatherapy. I decided to share a section Chapter 10 in response to the overwhelming number of people I am hearing from who are being taught to ingest essential oils and use them undiluted. Please share with your friends and family. Keep aromatherapy safe.
My Top 12 Aromatherapy Safety Rules from Chapter 10
History and safety testing have given us useful aromatherapy data. For review of this chapter, please study the following twelve rules that I think are the most important when it comes to using essential oils safely.
Rule #1
Never consume essential oils. Even if you read a book by an aromatherapist from a country that uses essential oils internally, they should never be consumed. The practice of consuming essential oils is dangerous and was designed to be done under the care of an aromatherapist trained in that form of therapy. In addition, studies have shown that topical aromatherapy is more effective than internal aromatherapy methods.
Rule #2
Always dilute your essential oils before applying them to the skin. There are a very small handful of exceptions to this rule including lavender and tea tree which can be occasionally applied neat, or directly, to the skin. In different aromatherapy books there may be recommendations of essential oils over 3% in massage oils but it simply isn’t necessary. Less is more in the world of essential oils. There is no need to overdose and it is always better to be safe than sorry.
Essential oils are incredibly potent and need to be dispersed into a carrier before applying them to the skin. You wouldn’t wrap your body in 30 lbs. of plant material so don’t apply that much or more directly onto your skin.
Typically, essential oils are diluted into products at 1 to 3% – sometimes less and sometimes more, but that is the general rule of thumb. Some essential oils have an intense aroma and price tag combination that allows for their use as low as 0.1% Take jasmine, blue chamomile and neroli for example.
Raindrop therapy is a good example of how undiluted and too high of concentrations of essential oils can be dangerous. This method of applying essential oils is the practice of dripping pure undiluted essential oils directly onto the skin which has many adverse effects. People have had burns, skin irritation, and intense detoxification effects that could have been avoided if this dangerous practice was no longer taught. The human body does not need to detoxify at such a rapid rate, and the skin should not come in direct contact with undiluted essential oils. Please report injuries at the Atlantic Institute.
Rule #3
Keep all essential oils out of the reach of children; they are notorious for putting everything in their mouths. Compared to adults, essential oils should be used in half the dosage rate for children for topical application. They are not miniature adults, and their bodies were not designed to process the same ratio of essential oils on their skin. I have safely used aromatherapy on all three of my children since 1998.
I heard of a case of a woman who read that tangerine essential oil would help with hyperactivity in children. She decided to put undiluted tangerine essential oil directly on the palms of her child’s hands. Thankfully, tangerine is a safe enough essential oil and the child suffered no serious ill effect. But she had decided to try it on a day that the child had a big test to take at school, and the high concentration of tangerine oil knocked the child out for the entire day and he slept through his test, lunch, dinner…and into the next morning.
Rule #4
Stay with the tried and true essential oils. Avoid ones that are not the common essential oils used historically in aromatherapy. Unless you understand the chemistry, it is best to stick with the commonly used essential oils. A trained aromatherapist can read the chemical composition of an essential oil profile and make an educated decision about the safety of an essential oil. But without that training you would not know whether you should avoid or use essential oils based on their chemical composition of aldehydes, esthers, ketones, phenols, and monoterpene hydrocarbons.
Rule #5
Know which essential oils to avoid or use with caution. Avoid them even if you like the way they smell or the properties that you read about them.
Essential oils to be avoided altogether include: unrectified bitter almond, basil ct. methyl chavicol, birch, boldo leaf, blue cypress, bitter fennel, bog myrtle, buchu, unrectified cade, calamint, calamus, (brown, blue or yellow) camphor, cassia, cinnamon bark, costus, davana, dog basil, elecampane, fig leaf, horseradish, jaborandi, lantana, melaleuca bracteata, mustard, mugwort, parsley seed, pennyroyal, rue, dalmatian sage, santolina, sassafras, savin, tansy, tarragon, tea absolute, thuja, tonka bean, verbena, wintergreen, wormseed, and wormwood.
Essential oils that should be used with caution or at very low dosages include: yarrow, dill, tarragon, caraway, white camphor, hyssop, spearmint, rosemary ct. verbenone, and tagette. Essential oils that should be heavily diluted due to potential skin irritation include: cassia, cinnamon leaf, cumin, lemongrass, oregano, clove stem, clove bud, clove leaf, wild thyme, and red thyme.
Rule #6
Always wear protective gear while handling essential oils. Remember that essential oils are very concentrated and should not be applied directly to the skin. If you wear gloves while handling essential oils you lessen the chance of spilling undiluted essential oils directly onto your hands. Even if it doesn’t hurt at the moment, it could hurt later. A good example is how peppermint essential oil spilled directly onto your hands might not hurt at the moment, but later when you touch your eye, it will burn like crazy.
Rule #7
Work in a well-ventilated area. Remember that essential oils can enter the body through inhalation. Some essential oils can cause euphoria, sleepiness or can be extremely stimulating. In a closed space with poor circulation the essential oils can become overwhelming.
Rule #8
Use extra caution when using essential oils on children and the elderly. The dosages should be at least half that of what you would use for a healthy adult. And essential oils are toxic to cats so never ever use essential oils on them.
Rule #9
Use common sense. Essential oils are safe when used in moderation. Many substances on earth are toxic when used in the extreme. Too much water can lead to water poisoning, and carrots, tomatoes, saffron, and mustard will all cause illness when consumed in excess.
Rule #10
To safeguard your business, do not make healing claims about your products. That would transform your cosmetic into a drug. The rules and regulations for drugs are completely different, and aromatherapy does not qualify on any monograph for approved over-the-counter drugs.
Rule #11
Always use the botanical name for essential oils when ordering. I never make an aromatherapy decision without reviewing the botanical name. The botanical name tells the genus and species of the plant and includes information about the variety, cultivar, chemotype, and hybrid when needed. Often these details are the difference between an essential oil being safe for use or not.
Rule #12
Check contraindications of an essential oil before using it. You don’t want to be making a sleepy time bath with essential oils that are contraindicated for insomnia like peppermint, basil, lemon verbena, cornmint, or rosemary.
FYI (from earlier in Chapter 10) on the Seriousness of Ingesting Essential Oils
There has never been a reported case of a woman or baby being harmed by topical or inhalation therapy used during pregnancy or labor. Aromatherapists all warn their clients away from pennyroyal essential oil due to a case in the USA in which a woman drank a large dose of pennyroyal in order to induce an abortion that proved fatal to her (Gold and Cates, 1980). One out of four cases in which pregnant women accidently drank camphor oil instead of castor oil resulted in the death of the baby (Weiss and Catalano, 1976).
Another reported case in which pennyroyal and parsley seed were taken in large doses caused hepatotoxicity which resulted in the death of the baby.
There are two other cases in which women consumed the same large doses of pennyroyal (100 to 200 times the recommended topical application) in which both the mothers and the babies survived unharmed. It is cases like this that give essential oils their warnings and contraindications.
Other Safety Topics
Chapter 10 of my book The Art, Science and Business of Aromatherapy also includes other safety topics including: essential oil testings, grades of essential oils, drug claims, essential oil adulteration, contraindications, more safety warnings, the use of essential oils during pregnancy, the history of aromatherapy warnings in pregnancy, MSDS information along with my top 12 aromatherapy warnings. You can find it in paperback and on Kindle.
What makes me qualified to teach about aromatherapy? I am a Certified and was a Registered Aromatherapist with more than a dozen years of experience. The references for this article and my book can be found here. I was certified by a school approved by the National Association of Holistic Aromatherapy and was registered by The Aromatherapy Council.
UPDATE From Kayla: Many of the comments in this article ask for proof. Others have said injury is only caused by other brands of essential oils. Please take the time to read these articles. I would like to leave comments open on my blog post, but some of have been so ugly and negative that I am having second thoughts. I have added this information below to try to answer the attacks before they come.
Dealing With Breast Cancer Reconstruction Can Be Perplexing
I would like to share an interesting story with you which has a touch of humor, written by my guest today who clearly has a zest for life, and offers support and help to women also suffering the angst of breast cancer. Perhaps you or someone you know are also dealing with past or future reconstruction of their breasts as well.
The article is wonderful and I enjoyed reading it, so I very much hope that her personal experiences can assist other women going forward.
Teri Pearman, Founder of Infusion Breast Care Botanicals is also a breast cancer survivor and firmly believes in what she offers to her ladies and without a doubt has created some delightful formulas combined with aromatherapy to provide the ultimate in a calming and soothing experience. Essential oil components are fantastic for creating a sense of well being... something so many women of today can certainly appreciate and need as life takes us on different journey's. I wish everyone happiness and well being in that journey.
One Thing Your Breast Reconstruction Surgeon May Not Tell You: Objects in Overhead Compartments May Shift During Flight
I initially posted this blog entry in August 2013 and I have since learned a little more that I wanted to share. I am a couple of years out from my final breast reconstruction surgery. I had a double mastectomy with skin expanders which were replaced with silicone implants. Thanks to Infusion Breast Care Botanicals products my scars are barely visible and my breast skin is healthy. However, I do have one breast that is slightly lower than the other. Of course even my pre-cancer breast were not a perfect match so I am okay with it. And I did have to get a ruler out to prove to my husband that I was right, so it must not be that bad. By the way, this caused some laughing as I stepped in front of the TV with my ruler and chest bared to prove my point.
Laughing is good!
I did also recently learn that if your breast reconstruction included fat transferred from another part of your body, there is a chance that you may experience ” graph volume loss” which means exactly what you think it means.
Even the most experienced breast surgeons can not predict with 100% certainty the exact outcome of your breast reconstruction surgery. Unlike a master sculpture they are not dealing with marble which once completed stays the same for ever. Flesh stretches, moves and is often unpredictable. Other challenges come into play including; is your surgeon trying to match an unaffected breast, did you have radiation, were your nipples spared, are your breast large, small, etc.
Talk with your surgeon about what you can reasonably expect. He or she can help you manage your expectations early on and help you select the reconstructive surgery best for your situation and which will give you the best outcome.
After surgery It can take several weeks for inconsistencies to show themselves. It’s not uncommon for one breast to be higher (or lower depending upon your perspective). Nature herself does not create everything with complete symmetry so most “normal” breast are often different sizes, but if you did have an outcome that you are not happy with don’t be shy about expressing your concern. Many surgeons say to give your reconstructed breast three to six months to settle in. Swelling will reduce and scars will soften giving the surgeon a better idea how to correct the asymmetry and making a minor adjustment is usually an outpatient procedure.
A friend of mine was very unhappy with her lack of symmetry after her breast reconstruction surgery. Her surgeon was trying to match her reconstructed breast with her unaffected breast which I imagine is a little more tricky than when reconstructing both breast at the same time. After struggling with the emotions that came up, like “now I’m just being vain, “I’m alive so stop complaining”, “I can’t take another surgery” etc…, she finally went back to her surgeon for an adjustment. I won’t say it was minor surgery, because no surgery is minor, but comparatively speaking she was in and out of the out patient surgery fairly quickly and she is happier with her results.
If you are not happy with your outcome and your physician is not offering solutions, consult another surgeon. The 1998 Women’s Health and Cancer Rights Act (WHCRA) helps protect many women with breast cancer who choose to have their breasts reconstructed after a mastectomy. This federal law requires most group insurance plans that cover mastectomies to also cover breast reconstruction. Under the WHCRA, mastectomy benefits must cover reconstruction of the breast that was removed by mastectomy and surgery and reconstruction of the other breast to make the breasts look symmetrical or balanced after mastectomy.
Teri Pearman
Founder of Infusion Breast Care Botanicals, LLC
My sincerest thanks to Teri for pursuing her passion and exemplifying courage, and for offering some very good advice and being open about her personal experience. Sharing of information is vital and provides a sense of community where women will know they are not alone in their struggles.
Manuka Honey....Could This Be The Next Miracle Ingredient In Skincare?
As my company continues to grow, over this past year the product and ingredient sales pitches are becoming an everyday occurrence it seems. No matter the sales pitch they gave, it always appeared to be the next best thing since the Wonderbra.
One sales pitch in particular really stood out for me. I was recently contacted by a supplier of a very special type of honey that I already knew a little bit about, yet was unaware of the perceived difference from any other type of honey. It is known as Manuka Honey, and they were touting how this amazing ingredient will cure many skin ailments and that it is the only natural ingredient approved by the FDA. So it only made sense to incorporate it into my skincare formulas...right?
Well now, I have to admit I was stunned...could this be? I got a little bit excited for a split second! Has the FDA actually approved a strain of honey for curing skin wounds, ulcers, abrasions, acne, etc? If so this would truly be amazing for creating promising new innovation in the skincare market.
According to Natural News it has been done and they preface the article with the statement of the "FDA quietly acknowledges medical benefits of honey." In an Associated Press story dated December 27th 2007, it was revealed that the U.S. Food and Drug Administration had quietly approved a line of honey-based wound dressings during the fall of that year.
Unfortunately, this headline and initial introduction infers to me and perhaps others, that somehow the FDA had an epiphany and that it was done quietly as though this were some sort of covert approval not wishing to undo their perceived stance by the public in relation to natural health products. Sadly, this news source that I mostly admire for spreading the word on getting and staying healthy in a wholesome and natural way, definitely fell a tad short in clarifying specifics or to explain what "cleared for use" means, to its readership.
First off...FDA doesn't do anything quietly and as a matter of law all things are actually quite overt in this department. This includes warnings and alerts the FDA publishes to prevent marketers making false claims on individual products, which typically are those making "medical" proclamations. The FDA website is available to all of the public to do their own checking and just about anything you need to know about a specific company can be found there, including applications for drugs or devices. The only time FDA interactions would become a news point is when they are concerned about public health or safety, otherwise it is simply published at their website.
Now Let's Get Down To The Nitty Gritty
I decided to contact the FDA to see if there is something I missed or am I just simply uniformed as to the latest and greatest in an "all healing and curative, encompassing many skin ailments" ingredient.
I contacted the FDA requesting for them to please verify the claims made by the producers and processors of Manuka Honey that "manuka honey is the only honey on the approved list" and "manuka is the only honey approved by the FDA." If you were to Google either one of these statements, the list of bloggers, health experts, retail sellers of skincare, and others are all singing the praises of the new found Manuka Honey, including the so called curative and healing effects it has and that the FDA has given it's blessing on this all natural cure.
The following is the usual typical and "matter of fact" reply I received from the FDA:
"Thank you for writing to the Division of Drug Information, Small Business Assistance, in the FDA's Center for Drug Evaluation and Research (CDER). It should be noted that Manuka Honey is not a currently FDA approved drug product. A listing of FDA approved drug products may be found in Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm A search for "Manuka Honey" did not reveal any pertinent results."
Uh Oh...Now My Research Revealed Interesting Facts
A company by the name of Derma Sciences Inc along with another company wishing similar, have been cleared to market their products as medical devices under the premise of "wound care" only. Under a medical device provision, it does not require pre-market approval. Essentially a Band-aid can be classified as a medical device.
The FDA stipulates in their letters clearing them to proceed with marketing the products, but there is no "approval" as to this device or the ingredient, Manuka Honey being used as a drug or curative. After clicking on the link above enter in Derma Sciences as applicant, hitting enter and the individual notifications appear, click on your preference and you'll see a link to "Summary", and if you read closely, their request for clearance is simply identifying how it helps in creating an environment conducive to healing and descriptions of it's intended use. But they are in no way making a medical claim to curing or direct healing in wound care which is important to clarify since they are proceeding as is required for introduction into the U.S. market. The verbiage is very precise and a Clearance of 510K is simply an approval afforded by the FDA as to a device already equivalent to being used in the market today, yet could be slightly modified.
Derma Sciences may wish to proceed with additional testing that would take it to the next level as an OTC drug or a Class III device at which point it may be reclassified as it is suggested in one of the "intended use" letters. The FDA also makes it very clear for them to follow pre-market regulations and unless and until their research yields OTC drug or device claims as proven, their labeling practices must be the same as any cosmetic or skin care product on the market by not providing a mis-branded or adulterated product. They further advise that "post market" surveillance, including but not limited to "adverse events" should be monitored and relayed to the FDA.
The point is, a 510K clearance is far and away from an actual PMA Approval which has the same criteria for any drug approval, only it becomes a Class III device that is proven to show scientifically it's medical value. The pre-market clearance of the 510K by FDA is the required prerequisite of scientific review to ensure the safety and effectiveness of Class III devices, and that is all Derma Sciences Inc has done, is begin a process which has essentially not evolved any further since 2011 that I could find.
A Pure And Simple Marketing Campaign Can Lead To Lawsuits And / Or FDA Scrutiny
There is a big problem with the public perception by way of the many naturalists and herbalists as to how they convey the information provided by Derma Sciences Inc. Based on misinterpreted verbiage of the medical approval being touted by bloggers, PR News, Financial Reporters, etc about their wound dressings and ointments using Manuka Honey, (brand name MediHoney), this has created a rampant firestorm of misinformation across the internet. Unfortunately, this can get so out of control it is nearly impossible for Derma Sciences to monitor and correct the spread of such information, including those that would unscrupulously use this information to sell something similar, as such was the case of my contact with a sales rep for the manuka honey ingredient. To date we found no evidence on Derma Sciences website stating their products are FDA approved.
Unfortunately, all the campaigning by the supporters of keeping things as natural as possible has not gone unnoticed. A competitor, Healthpoint, Ltd. has filed a lawsuit declaring that Derma Sciences Inc is asserting false claims in regard to the MediHoney brand and Manuka Honey in general, since Healthpoint, Ltd does provide an FDA approved topical wound drug treatment called SANTYL.
Healthpoint alleges in their complaint (view documents in link above) "that Leptospermum honey is also known as "Manuka Honey" and is produced by bees that feed off the manuka plant (Leptospermum scoparium) in New Zealand. (Compl. ¶ 15 n.1.) Internet advertising touts manuka honey as having "unsurpassed healing qualities" for a wide range of conditions, including stomach ulcers, sore throats and colds, skin ulcers, wounds, boils, and infections. (Id. (citing http://manukahoney.com). However, according to Healthpoint, the FDA has never approved a drug containing manuka honey for any purpose. (Id.) Instead, the FDA recently issued an import alert allowing FDA field personnel to detain shipments of certain products from New Zealand that contain manuka honey. (Compl. Ex. 1.)"
In reference to Healthpoints claims in the change of venue notice, apparently the FDA did recently issue an import alert allowing FDA field personnel to detain shipments of certain products from New Zealand that contain manuka honey. Here is the full list of all import alerts when dealing with proclamations of drug claims, making their position "loud and clear", but I'll pluck out just the ones that pertain to this particular ingredient. The first company at the top of this list has "manuka honey active" in their skincare list which in turn is implying through their descriptive it is an OTC drug and will provide some sort of cure or healing quality to the skin. And the list goes on with many exporting from New Zealand to the United States trying to promote their products with the next miracle cure for skin health based on a misconception of how our FDA works.
Please note that MediHoney is not on the list and this simply addresses a problem with the manuka honey ingredient medical claims associated with these products.
This list is provided for context, however you can scroll quickly past it to get to remaining facts of the article.
NEW ZEALAND
Antipodes Nature Ltd
Date Published : 12/05/2013
Po Box 888 , Wellington, NEW ZEALAND
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 12/05/2013
Desc:Grapeseed Butter Cleanser
53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C.
Date Published: 12/05/2013
Desc:Grace Gentle Cream Cleanser
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 12/05/2013
Desc:Rejoice Light Facial Day Cream
53 L - - 07 Night (Skin Care Preparations)
Date Published: 12/05/2013
Desc:Kiwi Seed Oil Eye Cream
53 L - - 07 Night (Skin Care Preparations)
Date Published: 12/05/2013
Desc:Avocado Pear Nourishing Night Cream
53 L - - 10 Wrinkle Smoothing (Skin Care Preparations)
Date Published: 12/05/2013
Desc:Ananda Antioxidant-Rich Gentle Toner
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/05/2013
Desc:Juliet Skin Brightening Gel Cleanser
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/05/2013
Desc:Divine Face Oil Organic Avocado Oil and Rosehip
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/05/2013
Desc:Joyous Protein-Rich Night Replenish
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/05/2013
Desc:Hosanna H2O Intensive Skin-Plumping Serum
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 12/05/2013
Desc:Apostle Skin-Brightening
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013
Desc:Rejoice Light Facial Day Cream
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013
Desc:Kiwi Seed Oil Eye Cream
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013
Desc:Grapeseed Butter Cleanser
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013
Desc:Hosanna H2O Intensive Skin-Plumping Serum
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013
Desc:Grace Gentle Cream Cleanser
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013
Desc:Avocado Pear Nourishing Night Cream
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013
Desc:Apostle Skin-Brightening
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013
Desc:Juliet Skin Brightening Gel Cleanser
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013
Desc:Divine Face Oil Organic Avocado Oil and Rosehip
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013
Desc:Ananda Antioxidant-Rich Gentle Toner
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 12/05/2013
Desc:Joyous Protein-Rich Night Replenish
Apis Skin Care Cream
Date Published : 09/30/2009
219 Tuam St , Christchurch, NEW ZEALAND
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/30/2009
Notes:9/12/07 The chlamydia treatment creams products is sold and promoted on the internet for the treatment of chlamydia. Based on it uses, this product is a drug. Further, CDER is not aware of any substantial scientific evidence that this producr is generally recognized as safe and effective for the conditions recommended or suggested in its labeling.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009
Notes:9/12/07 The chlamydia treatment creams products is sold and promoted on the internet for the treatment of chlamydia. Based on it uses, this product is a drug. Further, CDER is not aware of any substantial scientific evidence that this producr is generally recognized as safe and effective for the conditions recommended or suggested in its labeling.
Apis Skin Care Cream Ltd
Date Published : 09/30/2009
68 Aylesford Street, St Albans , Christchurch, NEW ZEALAND
53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)
Date Published: 09/30/2009
Notes:9/12/2007
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/30/2009
Notes:9/12/2007
Atmor New Zealand Skin Care
Date Published : 05/25/2012
41 Smales Rd , Auckland, NEW ZEALAND
36 C - - 04 Honey
Date Published: 05/25/2012
Desc:East Cape Active Manuka Honey UMF 18
Notes:New Zealand (NZ)
Atmor Sales & Marketing Ltd
Date Published : 05/25/2012
Po Box 44 , Beachlands, NEW ZEALAND
36 C - - 04 Honey
Date Published: 05/25/2012
Desc:East Cape Active Manuka Honey UMF 18
Notes:New Zealand (NZ)
Atmor Sales and Marketing
Date Published : 05/25/2012
Unit 7 41 Smales Road , East Tamaki , Auckland, Auckland NEW ZEALAND
36 C - - 04 Honey
Date Published: 05/25/2012
Desc:East Cape Active Manuka Honey UMF 18
Notes:New Zealand (NZ)
BLIS Technologies Limited
Date Published : 04/22/2013
Centre for Innovation , 87 St David Street , Dunedin, NZ-OTA NEW ZEALAND
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
53 I - - 01 Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)
Date Published: 01/16/2013
Desc:Propolis Toothpaste
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 01/16/2013
Desc:Propolis Toothpaste
GSFOODS Ltd
Date Published : 07/19/2011
6B Southern Reclamation , Havelock , Blenheim, NZ-MBH NEW ZEALAND
36 C - - 04 Honey
Date Published: 07/19/2011
Desc:Honeymark Manuka Honey Lozenges
Notes:Note; Multiple medical claims are associated with these products; New Zealand ;
62 U - - 99 Anti-Tussive/Cold N.E.C.
Date Published: 07/19/2011
Desc:Honeymark Manuka Honey Lozenges
Notes:Note; Multiple medical claims are associated with these products; New Zealand
Honey Valley New Zealand Limited
Date Published : 07/19/2011
P.O. Box 2155 , 15 Treneglos Street , Washdyke Timaru, NEW ZEALAND
36 C - - 04 Honey
Date Published: 07/19/2011
Desc:Manuka Honey
Notes:Note; Multiple medical claims are associated with these products; AKA 100% Pure New Zealand Honey Limited; New Zealand
Natural Solutions
Date Published : 05/25/2012
4464 Te Araroa Road , Te Araroa, Waikato NEW ZEALAND
36 C - - 04 Honey
Date Published: 05/25/2012
Desc:East Cape Active Manuka Honey UMF 18
Notes:New Zealand (NZ)
Pearson & Craig Cosmetics
Date Published : 03/01/2012
Unit 7 / 41 Smales Road , The Orchard East Tamaki , Auckland, NEW ZEALAND
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/01/2012
Desc:Placenta Serum
Notes:New Zealand
53 L - - 06 Moisturizing (Skin Care Preparations)
Date Published: 03/01/2012
Desc:Placenta Creme
Notes:New Zealand
Healthpoint continues to assert: "MEDIHONEY's labeling lists no active ingredient or enzyme content. According to the Complaint, MEDIHONEY dressings are "unclassified" medical devices subject only to the premarket notification requirements of Section 510(k) of the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 360(k) (stating that MEDIHONEY products have been evaluated by the FDA "as devices subject to the regulatory requirements of Section 510(k)" and have been "cleared by the FDA for assisting in wound healing and debridement"). Moreover, Healthpoint alleges that MEDIHONEY was cleared for sale in the United States based on a determination that the products are substantially equivalent to legally marketed predicate devices marketed prior to May 28, 1976, that provide moisture to a wound. Healthpoint claims that MEDIHONEY "does not debride wounds" and that the FDA has not approved MEDIHONEY as either a drug or a medical device."
That is why it was essential for me to further clarify all aspects of this ingredient and product by providing a direct link to their application and response letters from the FDA, including the response I received to my inquiry. Accepting things at face value doesn't always provide the facts accurately.
FDA Is Adjusting How They Perceive An Association With An OTC Drug Claim
Now aside from legal issues between Healthpoint and Derma Sciences, it appears it is citing "unfair competition" and alleges that the science does not support the claims, which as we all know this will be settled, but for now we will have a "let's wait and see" on that particular issue as I am very interested in the outcome.
UPDATE: In an email from Derma Sciences to us, they state the lawsuit has been settled as of last year, and we requested the results as to the outcome of the settlement.
In their response dated 6/25/2014, Barry Wolfenson, Group President stated, "The results of the settlement were, of course, confidential." He went on to further explain, "In this current lawsuit re: Medihoney, Healthpoint tried to say that our reps went into hospitals and positioned Medihoney as a drug, the same thing as Santyl, and that we were misleading those customers. Here's the problem with that statement: Medihoney is honey. It is not a drug, synthesized in some lab. You can take a tube of 100% Medihoney and use it in your toast and tea. It would be very expensive to do so, but it is honey as the bees made it (and then subsequently sterilized). No clinician in their right mind would think, after looking/smelling/tasting our product, that it was the same thing as Santyl. Medihoney is not a drug. It is a 510K cleared for use as a medical device. Santyl is a drug that is an enzymatic debrider which helps to remove necrotic tissue by using enzymes supplied within the drug to break down collagen. Using a different method of action, Medihoney promotes autolytic debridement, which uses the body's own enzymes to break down collagen. It is up for the clinician to decide which product they want to use on their patients when necrotic tissue is present. Those clinicians can choose a drug, or a device. It is their choice. Within this previous paragraph, you have the essence of how this frivolous lawsuit was settled."
We are unable to verify the information due to confidentiality reasons, but as far as we are concerned it appears this issue is resolved and we appreciate the updated information from Derma Sciences.
However, the overall Manuka Honey industry is not without some problems and for some time now since according to the New Zealand Herald, "some importers and manufacturers using Manuka Honey learned that the ingredient shows adulteration with added sugars and not being pure Manuka. Comvita, a major exporter of Manuka honey, declined to comment when asked if any of its products had been stopped at overseas after failing the sugar test. Comvita CEO Brett Hewlett said it wasn't a major issue and all of the company's honey was routinely checked as part of its quality control system."
Now when it comes to claims as put forth by many drug, vitamin and skincare companies that purport all natural herbs or essential oils with healing capabilities, the FDA is getting savvy in dealing with those that will make these claims and others that will use the FDA to appear as though they have passed their scrutiny with an application to proceed with marketing. It can in many ways be perceived by those that don't comprehend how all this works with the FDA, that a "clearance to proceed to market" is the same as an "FDA approval" whereby making this is an endorsement of their products. FDA does not endorse any personal care products!
As our technology grows, the FDA is appearing to be more determined than ever to pay attention to the internet and website marketing including search terms that utilize a medical condition to bring up a certain product on the site. This then conveys to the FDA that the companies website is attempting to make a purported claim through a search term connection with the product associated with the affliction. A warning letter went out just a little over a year ago for exactly that against a vitamin company using medical afflictions as a search term for their products. This article articulates it quite well and shows the FDA is not happy with websites using certain words in "search terms" like "cancer" to elicit a sale or to promote a purported claim. It appears "meta" description tags making medical claims will also be scrutinized, so companies need to be careful there as well as we grow into this new millennium.
Whenever I am contacted by an ingredient or product supplier making all their fancy claims as to an ingredient profile, it is always fun to dig deeper and get at the crux of things, and then I am more than happy to share what my research revealed in reality to their purported claims. Unfortunately what typically happens...yes that's right...CRICKETS...and to no surprise they vanish, never to be heard from again. This only goes to show them that there is not a "sucker" born every minute and that some in our industry refuse to accept things at face value and debunk sales pitches and marketing hype, especially when they overreach with "medical" claims.
However, what can be revealed at times are the very "positive" aspects of my research and due diligence, and I can take great pleasure in sharing that side of the equation as well. Not everything is negative in regard to Manuka Honey, in fact far from it.
Promising Research When It Comes To Manuka Honey Wound Dressings
Despite all the overblown claims as to FDA approval put out by many, there are great things being discovered within the medical community when used as a wound dressing and other related medical research.
NCBI published an abstract compiling the research studies performed using wound dressings containing Manuka Honey and they have proclaimed some very positive aspects of this type of dressing. Other types of dressing or cures could not work due to compromised immune systems and other medical injury that was difficult to heal, so this seems to appear quite promising in this field.
They do make it clear from the onset;"Medihoney™ has been one of the first medically certified honeys licensed as a medical product for professional wound care in Europe and Australia. Our experience with medical honey in wound care refers only to this product. In this review, we put our clinical experience into a broader perspective to comment on the use of medical honey in wound care. More prospective randomized studies on a wider range of types of wounds are needed to confirm the safety and efficacy of medical honey in wound care. Nonetheless, the current evidence confirming the antibacterial properties and additional beneficial effects of medical honey on wound healing should encourage other wound care professionals to use CE-certified honey dressings with standardized antibacterial activity, such as Medihoney™ products, as an alternative treatment approach in wounds of different natures."
Although things are looking "sweet" for this ingredient, no pun intended, don't head over to your local grocery store or natural coop and purchase some sort of raw honey for that puncture wound or open sore you might have at the moment. This is not the same thing and can actually contribute to complications with an open wound, so precaution is important.
Manuka Honey, otherwise known as MediHoney in this report is specially grown for it's reported properties but as they clarify in the NCBI article it is not an antiseptic and requires it be irradiated; Clostridium botulinum spores pervade our environment, existing in the soil, air, dust and raw agricultural products.
In deep wound cavities the possibility exists of an anaerobic environment, where the spores could proliferate and produce botulinum toxin. Negative effects such as paralysis and cardiac arrhythmia have been described related to systemic effects of the toxin. To eliminate botulism spores with heat, honey must be heated to 120°C (248°F) for 10 min, which results in adverse changes to some of honeys’ beneficial properties. Since spores have occasionally been found in honey, each batch of Medihoney™ is gamma irradiated to inactivate spores such as those from Clostridium spp. This does not have a detrimental impact on the antibacterial activity of honey. On the other hand, irradiating honey is only a safety measure on the side of caution since we could not detect a single case report in the literature of C. botulinum wound infection related to the use of non-irradiated honey in wound care.
Personally I prefer holistic and natural care in all aspects of my life when it is practical. I also do believe that this Manuka Honey has some excellent promise in the category for assisting with wound healing in a very painless and wonderful way. However to reiterate, this article is not about disproving that a promising ingredient cannot have medicinal qualities, but to clear up the fallacy that this ingredient is somehow FDA approved because it is NOT.
In the video below, Professor in Bio Sciences, Peter Molan, director of the honey research unit of Waikato University, Hamilton N.Z. explains in part how to identify the real McCoy versus those that try to sell on the coattails of this promising wound dressing. Upon conclusion of this video, you can continue to view other videos providing more interesting answers to Manuka Honey Questions. Enjoy! If viewing this in RSS feed or email please Click Here for original article and scroll down to the video section.
At the risk of being redundant, but it seems it bears repeating: to clarify to those that do their homework on this ingredient only to find all the baseless promises and claims of such a miracle honey throughout the internet in regard to using it for skincare or anti-aging.... they cannot take something that even may become medically FDA approved in the future or is currently medically certified in other countries and extrapolate it to now doing some sort of comparable miracle just because a skincare manufacturer or supplier incorporates it into their own products. Without their own FDA approved testing model showing results of intended use and compliance to OTC drugs with regulation in regard to proper labeling and manufacturing, they cannot ever make any related claim...period!
In A Final Note In Regard To Any Honey
"Real" Manuka Honey is only described in the evidence above and in the video as having anything remotely promising in regard to open wound care where the skins surface is compromised, yet notates that other natural honeys do have antibacterial properties. This is why in large part Medical Estheticians treating those with acne prefer it in some spa treatments. It is not only Manuka Honey, but other natural honey continues to be revered by many throughout the healthcare and skincare world according to this NCBI abstract, and these types will present with the hydrogen peroxide effect. It releases the hydrogen peroxide slowly and this peroxide behaves similarly to the popular anti-acne medication, benzoyl peroxide by breaking down bacterial cell walls. Another basis for gently treating acne with honey is it starves microbes of moisture by drawing excess moisture to itself through osmosis. It reduces the pH of the skin surface on which it is applied since Honey has a pH between 3.2 and 4.5. The natural acidity can be enough to kill off most microbes.
Honey is not a stand alone cure for any skin treatment and as with all things it can still pose an allergy risk to some. But if your skin loves honey then it can be used in conjunction with other acne treatments for an overall care of acneic skin types. It is certainly worth a try when other things have failed. However, when applied to otherwise intact skin the purported benefits are lost. But I'll say this, you will enjoy a lovely, natural humectant and moisturizing quality on the skin and this will leave your face wonderfully soft and can assist with improving and maintaining the health of the skin surface.
I do luvz my honey in a facial mask and my antioxidant Green Tea! I think I'll go now and relax with a little of both after such an arduous research task to understanding more in the matter of Manuka Honey!
Not Considered An Autoimmune Disease, But Certainly Acts Like One
Anyone who suffers from an autoimmune disease, definitely knows it is not in their head, but a real condition they feel throughout their entire body. It can be debilitating and insidious creating frustration when trying to get a diagnosis from the medical community.
According to the American Autoimmune Related Diseases Association, over 25 million Americans suffer some type of an autoimmune disease, yet I feel the number is much higher since there are some that are not considered autoimmune diseases, such as Chronic Fatigue Syndrome and Fibromyalgia.
I personally, would beg to differ as someone who experienced the debilitating results firsthand of such a disease (syndrome), and I am sure other women suffering would also argue this point. Women especially are plagued with these since the onset is closely related to their childbearing years. Men, children and the elderly can also suffer, but the ratios are higher among women.
As a person who suffered and was finally diagnosed with chronic fatigue syndrome in my early 30's after having 2 children myself, it was then I could perhaps do something to fight my way back to recovery. What is also interesting, it seems that having a seasonal flu can be the catalyst that triggers the onset of CFS.
What It Was Like
When It began it was just a feeling of being tired mostly, until it gained momentum within my body. It then turned into a frightening experience for me and my husband.
I continued to suffer as it progressed from a low grade fever, to loss of appetite, weight loss, paleness to the extreme, hypersomnia, memory loss, fuzzy cognitive thinking, increased muscle fatigue and soreness. At one point it got so bad I slept all day, everyday to the point my hubby could barely raise my awareness. He had to take and retrieve the kids from school and prepare all the meals. After about a month of no improvement, my hubby truly believed I was dying and frankly so did I.
It resonated finally that this was more than just the flu and we began our search in finding doctors who were familiar with autoimmune disorders....remembering now, this was still an area of few identifiable incidences since it was only 1990. We found an endocrinologist through my primary care physician since she knew I was definitely suffering from something, yet blood tests did little to tell us anything except for white cell count and by process of elimination of other diseases.
Once Diagnosed I Had To Find My Own Cure
The endocrinologist provided the summary of my symptoms and what they were related to and he could only give me it seemed, simple instructions about diet, exercise and rest. He also advised that once I get over this I can continue to have flares of the condition if I ever overdo or have stress in my life....they related CFS to a type of offshoot from Epstein Barr Syndrome which was likened to a type of virus. Essentially making CFS a long running virus instead of being a true autoimmune disease.
Basically, CFS seems to remain within our bodies similar to herpes and will rear its head if I am foolish enough to participate in life causing another recurrence. I had two small children, a husband and a life to pursue of great things out in the future. So I was on my own since my appetite was nil and physical activity was impossible in my current state. But as always....there is a light at the end of this very dark tunnel.
An Angel Walks Into My Life
I fortunately met a registered nurse through the process of diagnosis that believed in homeopathy and nutritional healing and was the beginning of my journey that brings me full circle of the philosophy I encourage today with Sterling Minerals and ONATI Skin Care.
She introduced me to a program that I am normally quite skeptical about, but in my condition I was desperate to try anything. That is when she introduced me to SHAKLEE products.
Now allow me to preface this with I am not an independent distributor for Shaklee, nor am I getting any type of residual income as some type of affiliate. I am totally a BELIEVER giving you testimony about my own personal experience and recovery through the use of Shaklee products. My nurse did not try to sell me everything under the sun or get me to sign up, she really believed in these products as a nurse and saw my misery only to reach out to me and provide some relief.
A lot of doctors belittle homeopathy, yet they couldn't offer me a thing except rest and eat a proper diet....and since I was a hypersomniac and couldn't eat, then I was destined to suffer until whenever?
My Healing Begins And Ends Happily
My nurse kept it very simple. The core products I used were Shaklee protein powders and I took their vitamin B complex since back then we were on a limited budget so these were the premiere formulas to give me the best advantage. But the generosity of my nurse was beyond her showing the path, she provided bulk discounts to me so I could continue to regain my strength. It was after about 2 weeks of religiously taking my prescribed regimen that I found new energy and was well on my way to recovery. My muscles stopped hurting and my fatigue faded over time. It only continued to improve over the next several months.
Although I don't feel I was completely cured for about the next 10 years, since on occasion if I had periods of high stress infused into my life, I would have mild bouts of my chronic fatigue syndrome that would lay me out for a couple of days. But with Shaklee I bounced back much faster and had fewer bouts over time.
I eventually had no more attacks, so at which point I felt cured of my CFS, finally. It has been more than 15 years now since I have had any bouts of fatigue so like my doctors told me, CFS will suddenly leave my body as quick as it invaded. But through my research, some have it the rest of their life, but most seem to recover after a period of 10 yrs of problems. Fortunately, I fell into the latter category.
Why I Share This Story
I have been healthy for the most part for quite some time now, except for the oddball affliction that would co-habitate my body ....you know... menopause, blood clot in lung, parvo virus and such, and it can get only get weirder when it comes to my life.
I lost all contact with my nurse as we moved into another city, and since time healed all, I no longer felt the need to continue using my Shaklee products, however that was also a different time with fewer health products offered. Yet, I still felt it was important to tell this story since I am meeting women through my current business suffering from a variety of autoimmune diseases who are frustrated and lonely in their pain. And as is the case with some autoimmune diseases, they effect skin health as well and our products can help them with this.
As we expand and reach out to so many women through Sterling Minerals it just so happens I have met another angel in the belief of healing and staying healthy, naturally.
Allow Me To Introduce To You
Rosemary Carinci of Bella Minerali who joined the Sterling Minerals family and is one of our resellers in the New York area of our mineral makeup products. But her love of health doesn't stop at being skin deep. She believes in the whole package from the inside out. She too knows the benefits of the Shaklee products and is an independent distributor.
Rosemary can help any woman or man that is suffering similar circumstances. It is clear that Shaklee has far improved beyond the basics of simple nutrition since my days of healing, just browsing the many incredible diverse products they offer today. It is also about the bio-availability of ingredients which Shaklee seemed to had mastered ahead of its time and continues today. So who better to walk you through all of their wonderful, expanded nutritional product line than Rosemary herself.
You can find Rosemary at this SHAKLEE web address and contact her for assistance on your road to regaining a healthy body the natural and simple way. Besides all of that, Rosemary is just GOOD people!
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The dangerous practices of consuming essential oils and applying them undiluted on the skin have gone viral on the internet, chat rooms and via sale representatives of many dōTERRA and Young Living MLM representatives. Beware of anyone who tells you to ingest essential oils either by putting a few drops in your water or putting them into a capsule. The only cases of death, organ failure and hospitalization in the history of aromatherapy have been caused by ingesting essential oils. It is THAT dangerous.
