FDA WARNING_LETTER - Thomas E. Young, LLC - January 10, 2012

This FDA Warning Letter, dated April 20, 2012 (CBER-12-05), was issued to Thomas E. Young, MD, Owner and Medical Director of Young Medical Spa, following inspections between December 2011 and January 2012 at their Lansdale and Center Valley, PA locations. The firm recovers and processes adipose tissue (lipoaspirate) for autologous use, specifically extracting "regenerative and stem cells" for injections like Natural Breast Augmentation.

The FDA determined that this processed adipose tissue is a Human Cells, Tissues, or Cellular and Tissue-Based Product (HCT/P) that does not meet the criteria for regulation solely under Section 361 of the PHS Act and 21 CFR Part 1271. This is because the processing "alters the relevant characteristics" of the tissue, failing the "minimal manipulation" definition (21 CFR 1271.10(a)(1)). Additionally, some uses, such as breast augmentation, do not meet the "homologous use" definition (21 CFR 1271.3(c)). Consequently, the product is classified as a drug under the FD&C Act and a biological product under the PHS Act, requiring an approved biologics license application (BLA) or an investigational new drug (IND) application, neither of which is in effect.

The letter