The letter apparently said that the StemCellin Intensive Emulsion, StemCellin Deep Wrinkle Serum, and Faitoz-25 are ‘promoted for uses that cause these products to be drugs under the section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act’. The FDA made the decision to send the letter after seeing numerous claims on the website that made them raise their eyebrows such as:
- “Lose your wrinkles! without painful injections”
- “Hyaluronic acid [an ingredient of Faitoz-25] helps reduce spider veins….”
- “Argireline mimics the actions of Botulinum by … relaxing muscle contractions....”
The issue is simple, according to the FDA, cosmetics are for cleansing, beautifying, promoting attractiveness or altering the appearance. Once you move past that and start marketing something as being able to change the structure of the body or function of the body, you're now in drug territory and the product must be labeled as so.
Critics say that the FDA may have prehistoric guidelines because cosmetics today are a much broader field. They can not only beautify from the outside, but also from the inside. Manufacturers that once created creams to only mask the appearance of wrinkles now claim that they can repair skin and help reduce wrinkles.
But this company (Jaba Labs) as a whole may be misleading. When visiting the "clinical trials" section of the StemCellFaceCream site, you will find only one trial. Even worse, we don't know who conducted the trial and there seems to be no reason to believe that this trial was made up. A few pictures are posted of wrinkles reducing but that can easily be done with photoshop. Perhaps the biggest issue is that they boast about their use of apple stem cells. While there have been some advocates for the ingredient, there is still little known about apple stem cells.
To sum up: The FDA might want to reevaluate how they judge cosmetics, websites like StemCellFaceCream might want to reevaluate how they market their cosmetics, and the mystery of the apple stem cell continues to live on.