May 31, 2020

The Niche

Knoepfler lab stem cell blog

FDA Warning Letter

2 min read

The FDA has issued a warning letter to Cell Vitals, a company that manufactures and sells stem cell facial creams. Cell Vitals is apparently owned by Irene Hardy according to the letter and the business has an address in Irvine, CA. A screenshot from their website is shown below. The stem cell creams sold by Cell Vitals are called “ReLuma Advanced Stem Cell Facial Moisturizer”, “ReLuma Skin Illuminating Stem Cell Anti-Aging Cleanser”, and “ReLuma Stem Cell Eye Cream”. The creams, listed on the skin care webpage of the company, …Read More

7 min read

It’s been a seemingly rather quiet year on the regulatory front in the US when it comes to direct-to-consumer stem cell interventions even as the number of dubious stem cell clinics continues to skyrocket. I requested an interview with the FDA to cover the key pressing issues in this arena. I want to thank the FDA for taking the time to do this interview. Below are their answers covering regulation of SVF, homologous use, FDA action/inaction on dubious stem cell clinics, Right To Try …Read More