US Stem Cell Inc (USRM)

[HFM2]

From the FDA's 2017 Warning Letter:

Your SVF product does not meet all of the criteria in 21 CFR 1271.10(a), and therefore does not qualify for regulation solely under section 361 of the PHS Act [42 U.S.C. 264] and the regulations in 21 CFR Part 1271. Specifically, your SVF product does not meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue, such as adipose tissue, in 21 CFR 1271.3(f)(1). Your product does not meet this criterion because your processing alters the original relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement.

In addition, your SVF product fails to meet the 21 CFR 1271.10(a) (2) criterion that the HCT/P be “intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.” As noted above, the SVF product is intended for use in the treatment of a variety of diseases or conditions. Because the SVF product is not intended to perform the same basic function or functions of adipose tissue, such as cushioning the body, using the SVF product for treatment of these diseases or conditions is not homologous use as defined in 21 CFR 1271.3(c). As a result, your SVF product does not qualify for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/us-stem-cell-clinic-llc-524470-08242017

They have beat this drum relentlessly, but I think Chamberlain nailed the weakness, and another poster here earlier provided the example of "blood cells" as an interesting parallel.