FDA Starts scrutinizing how adipose tissue is used @ Intellicel Bio - $SVFC

Judging by a recent "warning letter" issued to the CEO of Intellicell Biosciences (OTCQB: SVFC), the FDA is getting stricter regarding the processing of adipose tissue. 

 

The letter, which was posted on the FDA website, regards Intellicell's processing of adipose tissue for use in orthopedic therapies. Intellicell is a company processing adipose tissue, claiming their “ultrasonic cavitation” technology is only minimally manipulated; hence they fall under less FDA scrutiny (ie, no FDA approval required).

It seems that the FDA is concerned about how this specific process may be changing the structural characteristics of the adipose tissue (fat) itself. It appears that regardless of the process the FDA seems to be considering the product as a drug. 

 

The letter includes the following excerpt:

"IntelliCell’s adipose derived stem cells are human cells, tissues, or cellular and tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d). However, this cellular product does not meet all of the criteria in 21 CFR 1271.10(a) and therefore is not regulated solely under section 361 of the Public Health Service Act (PHS Act) [42 U.S.C. 264] and the regulations in 21 CFR Part 1271. Specifically, your processing alters the relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement. Therefore the processing would not meet the definition of minimal manipulation for structural tissue such as adipose tissue. As a result, the IntelliCell product does not meet the criterion in 21 CFR 1271.10(a)(1)." 

See the full letter on fda.gov.