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FDA Issues Warning Letters

March 8, 2017

Healthy Habits and Aegeia Skin Care make drug claims.

Two more skin care manufacturers have been cited by the US Food and Drug Administration for making drug claims about their products.

In a Dec. 16, 2016 letter to Healthy Habits CEO Matthew Martin, FDA warned that the company's website makes drug claims for Dermatox Ointment 1.7oz and DermaTox 4oz in both product descriptions, testamonials and Q&A. Some examples include:

“DermaTox® is an all-purpose skin wellness formula. Our customers tell us that they use DermaTox® daily to nourish their skin, speed healing, soothe the pain of a burn or bed sores, diminish irritation associated with eczema, psoriasis, rashes, cuts, bites, scrapes, spray on liver spots, moles, etc…”


“I use DermaTox® Ointment on these red patches that I get on my skin. It also helps me with my Diabetes related skin conditions...”


“2. I received my first order of DermaTox® and started using it. My purpose for using it was to remove the many skin tags that I have. I applied DermaTox® on my skin tags every 4-5 hours during the day for 1 week. I have continued to use it twice a day since then. I have not seen ANY change in my skin tags. I was under the impression that they would just fall off after a couple of days of using DermaTox®. What am I doing wrong? What do I need to do to get rid of them? A:…On the same day we may get a product review from someone raving about how well DermaTox® helped get rid of their skin tags and we may also receive a message saying that it did nothing…One thing that you can try is to continually soak the tag, if possible for your lifestyle, by using cotton soaked in DermaTox® held in place with a band-aid…This has worked for others as well as to heal infected cysts. Nothing on the planet helps to regenerate new cells like DermaTox®…”



More recently, in a  Feb. 17, 2017 letter to Aegeia Skin Care Founder Rebecca Sue Wachsle, FDA charged that the company made drug claims for products including Purifying Facial Cleanser, Refining Facial Toner, Nourishing Clay Mask and Silken Body Butter.


FDA took exception to claims such as "(s)timulating circulation." for the facial cleanser; "Antibacterial & antimicrobial properties..." for the facial toner; "Dead Sea Clay...stimulating vital facial circulation." for Nourishing Clay Mask.


Product claims made by Healthy Habits, Scottsdale, AZ and Aegeia Skin Care have raised eyebrows at the US Food and Drug Administration. As a result, both companies received warning letters from FDA for their new drug/cosmetics labels and marketing with drug claims. In a letter dated Dec. 16, 2016, FDA warned Healthy Habits CEO Matthew Martin that the company's website makes drug claims for its Dermatox Ointment (1.7oz) and DermaTox (4oz) products. Examples cited by FDA as drug claims include a product description: “DermaTox is an all-purpose skin wellness formula. Our customers tell us that they use DermaTox® daily to nourish their skin, speed healing, soothe the pain of a burn or bed sores, diminish irritation associated with eczema, psoriasis, rashes, cuts, bites, scrapes, spray on liver spots, moles, etc…” And testamonials such as: "I had ankle surgery not to (sic)long ago, the overall pain from the incision and the surgical repair it self (sic)was really making it difficult for me to do anything I tried your product and I was blown away! I cant (sic) believe it really works! The pain and swelling around the scar is going away! even see the scar shrinking a bit!...” In a - See more at: http://www.happi.com/contents/view_breaking-news/2017-03-08/fda-issues-more-warning-letters-40951/#sthash.i1hOoHsk.dpuf

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