Cutanix goes offline, gets letter from FDA

Written by on April 27, 2007 in cutanix with 42 Comments

A few people have noticed that Cutanix seems to have vanished off the face of the internet. Their web sites at cutanix.com, tvdepot.com are offline, and their corporate web site at bioformmedical.com no longer even mentions Cutanix. Also the other regular online stores for Cutanix DRL at Amazon, DermaDoctor and Skin-Etc have no stock.

So what has happened to this much loved product ? I haven’t had official word from BioForm, but a recent letter from the FDA looks telling.

Warning Letter: FDA to BioForm Medical, Inc.

The FDA is strict about what medical claims can be made on product packaging. If a product makes claims pertaining to a certain disease it must have acceptable proof to back it up and permission to make these claims. The FDA only grants this sort of permission if the product makers sponsor a New Drug Application and it gets approved by the FDA.

I for one am certainly hoping that BioForm will be able to address the issues with the labelling and continue selling DRL.

It would seem that in order to no longer be classified as a drug, labelling will need to be severly `dumbed down’ so that no specific claims are made about the products applicability. Those who have followed the story of the FDA and Rosacea-LTD will know that it can take some time before the FDA is happy with a product’s labelling.

[update: Jan 2011] SkinMedica have announced that they are now selling Redness Relief CalmPlex which is their formulation of Cutanix DRL.

Read more about: cutanix

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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42 Reader Comments

  1. smbbarrett says:

    I am interested in the Cutanix product and have been following the issue with the FDA. Has any other product come online for sale containing the 4-ethoxybenzaldehyde ingredients? or are people obtaining this from skinactives and adding this to their favorite creams?
    smb

  2. I love this product. I have suffered from Roscea for many years. This is the ONLY product that clears my skin. Even Dermadoctor misbehaving cleanser does not do the trick.
    HELP! Get it back on line!!

  3. Hi Marie, I agree ! I am rationing my remaining tube in the hope that I can make it last. Thank goodness for tinted sunscreen is all I can say. The cetaphil moisturizer is not too bad, but not really a substitute for Cutanix.

  4. Katrin says:

    I absolutely LOVE it, and was so happy to have found it, and was set to use it as my moisturizer for the rest of my life!! I don’t know what to do now…

  5. Karen says:

    I am so disappointed. Cutanix not only helps with Rosacea, it also helps with Psoriasis, which is what I use it for. It’s even better than the $600 lotion my dermatologist prescribed. 1 tube of Cutanix lasts me 6 month give or take, depending on flare ups. I’m scraping the bottom of the last tube I have, hoping it will last longer.

  6. Rita Sue says:

    I, too, am very upset I cannot find the Cutanix. I had a CO2 laser procedure done a few years ago with terrible side effects and the only thing I have found since then that my face can tolerate is Cutanix. My face has become “allergic” to nearly all products, including sunscreen and all makeup. If anyone finds the Cutanix, I would appreciate knowing where to get it also.

  7. Tracy says:

    I’m absolutely devasated that Cutanix is off the market. I, too, had vowed to use it for life. It’s the only product that helps my face. I’m rationing my tube right now. I even bought some Donell Rosacea therapy as an interim product, and it’s awful!!! No comparison to Cutanix. I hope they bring Cutanix back soon.

  8. Diane says:

    I have been searching for the Cutanix, is there a similar product???
    Cutanix / sensitive skin gives relief to facial skin problems. It is a very good product.
    I would think something that works so well would continue to be manufactured.

  9. Hi Diane, sadly the only product that might come close is mixing the active ingredient yourself at SkinActives.

    http://skinactives.com/products/ethoxybenzaldehyde.htm

    davidp.

  10. southenrgulfhome says:

    Well…I was reading about the demise..of Rosacea LTD. / Cutanix. Infact. I had purchased this product and found that it didn’t help at all. Not to bash it…but it’s no different then any of the other over the counter products. And like all the other products that are out there. It was very enticing….very aggressive Heck..I believed it!! lol And when I called Boney direct. They told me..that I wasn’t using the product correctly and not following directions. I must have drank 4 gallons of water everyday!! LOL So..as I have said before. Caveat Emptor. Buyer Beware!!
    COME ONE SANSROSA!!!

    Southerngulfhome

  11. Just to be clear there is no demise of Rosacea LTD, it was Cutanix who stopped sales.

    As far as Sanrosa is concerned, we have saying in the software industry something like “nothing ever works as well as the next release” – meaning that things always look promising when you don’t have it in your hand to play with. The reality when something arrives is often different to how you anticipated. So lets not diss what we currently know and understand too much until we know for sure what sansrosa is going to really give us.

    regards,
    davidp.

  12. jasper says:

    i went straight to extra-strength DRL from Cutanix. i grew to love its effect on me. however to begin with, it caused redness. i knew this was because i went straight to the high strength, so i stopped using for a week, then used minute amounts, and built up.

    Cutanix was great and now its off the market, however i reckon Cutanix should just call it a simple moisturiser, and put out lots of community-level info that it is just the same as before, without the claims. so many people know and love this product, sales would be strong.

    i refused to believe it was being taken off the market until the website didnt work any more.

    and now, the “Brolene Gel” that cured my ocular rosacea (hard to believe, i know) is off the shelves in australia. i have no idea why. ah well. forward to the future with hope and happiness in the present! 🙂

  13. SA says:

    Typical US Government bet high US politicians can still get this product…

  14. Haha SA, nice one. Aaah you are serious !? Nice theory but sounds fanciful to me.

  15. tracy says:

    maybe these products had some bad side effects or were not popular enough to be profitable?

  16. Donna says:

    Please some one let us know what still works. My dermatologist prescribed Finacea cream which does not help at all. I am also on an oral antibiotic. HELP, it keeps getting worse.

  17. TH says:

    Hi….my husband drives truck and was told by one of the guys that makes cutanix that they are reformulating the product…whether that’s true or not..I don’t know…(he came home w/ a few of the original samples for me..) I had never heard of cutanix before, and really love the cleanser and sensitive skin moisturizer…was actually online to see if it was a ‘real’ product and came across this site! … hopefully all of you will be able to enjoy their products soon!!

  18. Hi TH,

    I haven’t heard anything about Cutanix for a couple of years so now so it was quite interesting to read your comments. It would be great if it did become available again. Please do let us know if you uncover anything else. I know that many rosacea sufferers would be happy to be able to buy it again.

    davidp.

  19. surfbob says:

    I bought two 1.7 ounce tubes of cutanixextra strength with quadrinone/2%.One is full and the other is about half .I kept trying to use but never worked for me.I have rosacea and seb derm and am doing the accutane thing now.If someone is interested in these tubes you can contact me. bobseeback@aol.com

  20. diane says:

    Cutanix was/is a fantastic product for us rosacea sufferers. Why? Because it WORKS! I am sure most of you are like me and have tried hundreds of dollars worth of ‘worthless’ products and now, to have found one that actually works, our ‘Gov’ removes it from the market. Come on now, please…return this product promptly!

    If anyone finds where to purchase this…please pass the info on!

  21. TH says:

    I have a bunch of unopened small sample size (I assume) Cutanix lotions…I thought I would use them more than I am…What should I do w/ them??? Any ideas? They are .4 fl oz…for sensitive skin w/ Quadrinone (1%)…stamped on there that it is a sample. They are all sealed.

  22. Marliese says:

    TH — I’d be interested in the samples of Cutanix, if you still have them. It was the only product that worked for me, and I’ve been searching (unsuccessfully) for a replacement.

  23. TH says:

    Marliese-I have 25 of the lotions.. .4fl oz. ready to be shipped to you…how do I get your address? Seems like I am unable to click on your name to privately email you..I can ship them today if you want.

  24. diane says:

    Wanted to share the fact that I have recently tried a product from Kohls called “Bamboo Leaf Ultra Soothing Anti-Redness cream” and so far, this is the closest product to Cutanix that I have found. I see they have also added a new ‘night cream version’ to this line. If you really liked Cutanix you may want to give this product a try!

  25. Patty says:

    I got online with the intention of purchasing cutanix. I am so dissappointed that it is not available. It is the only product I have ever tried that kept my rosacia under control.

  26. Hi Patty, yes there are plenty of us still sad that Cutanix DRL is not available anymore.

  27. Donna says:

    I continue to take an antibiotic everyday and have already had problems with a resistant bacterial infection because I have been on it for so long. Cutanix was so much healthier.

  28. MommaRox says:

    Hi – just found Clinician’s Complex line has a new anti-redness serum that is formulated like the old Cutanix with the 4-ethoxybenzaldehyde ingredient. Seems to be working really well!

  29. Thanks for the tip – there have been so few recommendations for something to replace Cutanix that it is nice to see that there might be another alternative.

  30. Tom says:

    I just placed an order for the new anti-redness serum. I like how the name is serum instead of lotion or cream – sounds more upscale. 🙂 You gotta love marketing.

    And speaking of upscale, I paid about $50 for it on Amazon. Boy, my wife is gonna give me a dressing down but she doesn’t understand the constant discomfort I am in. Which is why I am willing to try the serum – I don’t normally lend any credence to over-the-counter “Aesthetics”-type concoctions but the active ingredient seems to have some real medical benefit.

    I will keep you fine folks posted.

  31. Tom says:

    My “serum” arrived today. I opened the shoe box-sized Priority Mail box and pulled out this tiny pump filled with a whopping .5 oz of clear fluid! I expected more for $50. On the plus side, the item arrived quickly and well packed. If this stuff works it will be worth the price.

  32. Donna says:

    Thanks Tom,
    Do update us.
    Donna

  33. dee says:

    A friend of mine who works for cutanix gave me a bunch of product to try and see if I liked it. I tried an I do like! I went online to see what the reviews for this stuff was like and found this site. I had a very hard time finding soaps that dident irritate my skin so I know its frustrating when something finally works and you can’t find that product again. So if anyone is looking for the soaps or creams I can get most of them very likely.

  34. Donna says:

    Hey Tom,
    How about a review of the new Serum?
    My antibiotic, Oracea 40mg on an empty stomach, daily, is keeping the bumps under control but the redness is still a big problem.

  35. amy says:

    dee- if you have extra cutanix product, i’d love some too. please email me at amyelliott {at} hotmail.com
    thanks. 🙂

  36. skincarejunkie says:

    Bioform was sold to Merz Aesthetics.
    In that sale Cutanix was sold to SkinMedica.
    They will launch the product this Jan so stay tunned!

  37. I have tried to contact `skincarekunkie’ for more information, but so far I haven’t gotten a reply. Please feel free to contact me at david@rosacea-support.org if you have more information.

    davidp.

  38. Melissa Warland says:

    Hi guys,

    I suffer horrible rosacea & the only thing that stops it dead in it’s tracks is using ‘Diprosone Lotion 30ml’
    Betamethasone.

    It is not meant for use on the face but I have been using it for 6 years. I use it at twice per week just 1 drop on my red flareups. It literally clears your skin with 1 day.

    The Dr will give it to you if you tell them you want to use it on your scalp for ‘Psoriasis’ flare ups. (Red flaking sore scalp)

    For anyone who is desperate to be rid of this terrible skin disease it might be your savior like it has been mine.

    I only use it out of desperation. I just thought I’d share the information, as it may help you like it has helped me.

  39. skincarejunkie says:

    The Press Release is out!
    SkinMedica purchased Cutanix last year from Bioform Medical and will re-launch the new product this January!!
    I will email David the Allure Magazine article or go to http://www.Allure.com and see the heading “The Best New Anti-aging Products: Allure Predicts What You’ll Want in 2011”
    SkinMedica Redness Relief CalmPlex:
    A study found that smoothing SkinMedica Redness Relief CalmPlex ($80, available in January) on flushed skin twice a day will help calm inflammation within a week and continue to improve it for the next 12. It’s revolutionary because while many products cover redness, few fix the underlying problem or ease the itchy, prickling feeling—and even fewer address the problem so quickly. This cream has a compound that suppresses inflammation, and also contains soothing ingredients, including niacinamide, squalene, and jojoba, that help maintain the skin’s moisture barrier and reduce the chance of future flare-ups.

    Please go to http://www.skinmedica.com to locate a physician near you and request to be put on the waiting list for this product.

  40. Donna says:

    Hey gang,

    Cutanix was just re-launched by SkinMedica and is called Redness Relief Calmplex! i am so excited it is back on the market.

    i found it at my doctor’s office but you can also find it at http://www.skinmedica.com. you can call your local dermatology office as well to see if they have it yet. it just came back out a few weeks ago!

    hurray for us!
    donna

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