Earlier this month, the US regulatory agency sent a letter to Jaba Labs regarding the product claims that appeared on its Stemcellfacecream and Synovialabs websites.
According to the letter, 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’.
This is due to the fact that the claims suggest the products are intended to affect the structure and function of the human body, the letter continues.
Some of the claims highlighted by the letter include:
- “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....”
- “This incredible PhytoCellTec apple stem cell cream emulsion is the first product to harness the regenerative potential of your own facial stem cells to renew skin …. It will actually ‘rejuvenate’ your skin by ‘awakening’ your body’s own reservoir of undifferentiated stem-cells.”
According to the FDA, the company is required to ensure that its products and labeling are in compliance with the laws and regulations of the FDA and is advised to take prompt action. No one was available for comment at Jaba Labs at the time of publication.
Cosmetics, according to the FDA’s definition, are for cleansing, beautifying, promoting attractiveness or altering the appearance. But if a product is intended to affect the structure or any function of the body then it becomes a drug.
Many industry insiders have suggested that this definition may need to be updated as it was constructed when cosmetics were very different and may not have kept up with what the science has made possible.
Anti-aging creams that were once expected to simply smooth over and fill in the wrinkles, now regularly promise to regenerate, synthesise and repair – claims that very obviously rely on their ability to affect the structure of the body.