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

About the Author

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

Follow Rosacea Support

Subscribe via RSS Feed Connect on Pinterest Connect on Google Plus

42 Reader Comments

  1. Karla says:

    Make your own:

    http://www.skinactives.com/search.php?mode=search&page=1

    mix at .25% solution (1 drop per 1oz cream or liquid) = Cutanix cleanser….go higher carefully….too high % will cause stinging or irritation….

Leave your comment here

 

 

Top

Subscribe to Rosacea News

Enter your email address to receive the latest news about rosacea in your inbox.