FDA Warning Letters Week of 4/27/2020: HCT/P

FDA continues its effort to limit the sale of unauthorized electronic nicotine delivery devices by posting ten warning letters last week to firms who target teenagers and other youth.  They also continue to issue warning letters to firms that are advertising and distributing unapproved drug products for the prevention and treatment of COVID-19 infection. 

On the drug GMP side, there were two untitled letters issued: one to a cell therapy firm and one to a compounding pharmacy. The cell therapy firm distributes products made by a firm that received an untitled letter earlier in April 2020.

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HCT/P|Regenerative Solution of New Jersey aka Stem Cell Center of New Jersey (Edison, NJ)

Regenerative Solution of New Jersey (Stem Cell Center of New Jersey) received an untitled letter on April 10, 2020, based on the firm’s marketing of exosomes from Kimera Labs, Inc.  These products are among those that should be regulated as HCT/P. The firm advertises the product to treat COVID-19 virus infections as well as a variety of other illnesses and diseases including spinal cord injury, lupus, MS, and seizures to name a few.  

Kimera, who supplied the exosomes that this firm sells, previously received an untitled letter that mentioned the manufacture of these products.  


HCT/P|Infuze MD (Milpitas, CA)

Infuze MD received an untitled letter dated April 27, 2020, based on a review of their websites and other information.  The firm distributes cellular products derived from umbilical cord blood and meets the requirements to be regulated as an HCT/P product.  They do not qualify for an exception identified in 21CFR1271.15.  

This firm also identifies exosomes among their product listings although FDA notes that this untitled letter addresses only the cord blood products.  A similar situation happened to Kimera (see immediately above) in their untitled letter.

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