Wednesday, March 5, 2014

Breast Cancer Reconstruction And Benefits Of Essential Oils


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.  

Cheers!

Protected by Copyscape Originality Check

Wednesday, February 19, 2014

Has Manuka Honey Really Been FDA Approved?


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.
Date Published: 04/22/2013

Desc:BLIS Streptococcus Salivarius M18 Freeze Dried Probiotic Powder Dietary Supplement
Notes:New Zealand
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/22/2013

Desc:BLIS Streptococcus Salivarius K12 Freeze Dried Probiotic Powder Dietary Supplement
Notes:New Zealand
61 I - - 99 Anti-Bacterial Enzyme, N.E.C.
Date Published: 04/22/2013

Desc:BLIS Streptococcus Salivarius K12 Freeze Dried Probiotic Powder Dietary Supplement
Notes:New Zealand
61 I - - 99 Anti-Bacterial Enzyme, N.E.C.
Date Published: 04/22/2013

Desc:BLIS Streptococcus Salivarius M18 Freeze Dried Probiotic Powder Dietary Supplement
Notes:New Zealand
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/22/2013

Desc:BLIS Streptococcus Salivarius K12 Freeze Dried Probiotic Powder Dietary Supplement
Notes:New Zealand
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/22/2013

Desc:BLIS Streptococcus Salivarius M18 Freeze Dried Probiotic Powder Dietary Supplement
Notes:New Zealand

Curaderm Global Ltd
Date Published : 05/20/2011

Po Box 7031 Port Vila , Vanuatu, NEW ZEALAND
62 I - - 99 Anti-Neoplastic N.E.C.
Date Published: 05/20/2011

Desc:Curaderm BEC 5 Cream
Notes:New Zealand

Ebos Group
Date Published : 04/11/2011

249-243 Bush Road, Albany , Auckland, NEW ZEALAND
62 G - - 99 Anti-Inflammatory N.E.C.
Date Published: 04/11/2011

Desc:Anti Inflammatory Herbal Releiv
Notes:New Zealand

Evergreen Life Ltd
Date Published : 01/16/2013

219 Bush Road - PH 426 , Auckland, NEW ZEALAND
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."

Comvita is a major provider of the Manuka Honey and offers skincare and cosmetic brands of their own and is also in partnership with Derma Science which holds a 7.3% stake in the Comvita company.

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.

The FDA is certainly busy and their searchable database is ever growing with many Warning Letters, including those that have already been sent out this year and it is only February.  As you can see with this link, all of this info is far from secret and is available for viewing by the general public.

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!

Cheers

Protected by Copyscape Originality Check