We still cannot use exosomes legally in the USA....FDA hasn't approved them for anything!

Does an FDA study approval (an Investigational New Drug Study) mean that a company can sell this drug to the public?
NO, not even close.
Several people have messaged me about exosomes (again) because there are apparently still companies marketing these unproven product and unapproved products to the general public!
Hypothetically speaking, If a USA company had a FDA approved IND to study exosomes for a kidney or heart or pulmonary condition (like post COVID)....can they now resume selling exosomes for general use?

I mean we are still nowhere near FDA approval of exosomes even for the condition for which the IND was granted. The answer in my opinion is clearly no. (DYOR..ask your own attorney).
The process from IND to drug approval is not guaranteed...it takes a successful study showing that the drug does in fact work and is safe for the proposed indication.
Exosomes still cannot be sold and used in humans in the USA for any indication because they are drugs (per FDA) and have no FDA approval. The approved IND does not change that. There are still some big big hurdles.
Anyone selling or using exosomes in humans in the USA right now needs to close their barn door or be on the lookout for the next FDA Warning Letter.

The alternative?  We continue to use Platelet Rich Plasma and other regenerative medicine techniques that are in fact FDA compliant!  We won't inject our patients with unapproved and unproven drugs!