[MauranKilom]

Regardless of all the "he said, she said", libel or not libel, email response times, GMP, threats and whatever drama:

Is there anyone who is seriously contesting the "it is intended to cure/prevent a disease, therefore it is a drug, therefore it needs FDA approval to be sold legally" line of reasoning?

More humoristically: https://xkcd.com/2475/ and https://xkcd.com/2530/

Less humoristically: https://en.wikipedia.org/wiki/Thalidomide

[Sevii]

Seems like a stretch to argue a biological organism qualifies as a drug.

[SamBam]

Except it's not at all. The FDA regulates plenty of live organisms as drugs if they're claimed to be used to treat diseases.

For example, fecal transplants are regulated by the FDA. Rebiotix Inc is developing a bacterial fecal transplant, RBX2660, and Seres Therapeutics is developing an oral version (also live bacteria) called SER-109. Both of these are being regulated by the FDA.

There are hundreds of other live biotherapeutic products (LBPs) regulated by the FDA.

[dekhn]

It's not a stretch at all.

[perlgeek]

Live-attenuated vaccines (see [1]) seem to fit that role, and have been around for ages. I'd be very surprised if they didn't count as drug.

[1] https://www.hhs.gov/immunization/basics/types/index.html