1: What happened with the FDA testing?

In the original FAQ, I wrote:

Professor Hillman started a company “Oragenics” and applied for FDA approval. The FDA demanded a study of 100 subjects, all of whom had to be “age 18-30, with removable dentures, living alone and far from school zones”. Hillman wasn’t sure there even were 100 young people with dentures, but the FDA wouldn’t budge from requiring this impossible trial. Hillman gave up and switched to other projects.

I got this information from (company CEO) Aaron, who says he got it from (original inventor) Jeffrey Hillman.

Commenters (and Kevin Drum) searched publicly-available archives and found a slightly different story, with three trials:

1. A Phase 1 trial, scheduled April 2005, on 26 people, age <55, with dentures. The company couldn’t find enough people who met enrollment criteria, so they renegotiated with the FDA and switched to (2).

2. A second attempt at Phase 1 trial, scheduled October 2007, on 10 people, age 18-30, no dentures necessary, done in a hospital setting. This trial succeeded, escalating the process to (3)

3. A Phase 1b trial, scheduled January 2011. Nobody can find any details on this one, but Oragenics says it never took place because of “the very restrictive study enrollment criteria required by the FDA”.

Some people have tried to argue that someone must be lying, because I wrote about a 100 person trial age 18-30 with dentures, and this doesn’t match either of the two trials we know about.

I think two more likely explanations are:

• This is Trial 3, the one we know nothing about

• Or someone in the Dr. Hillman → Aaron → me chain mixed up details of the three trials into a mishmash with some characteristics of each.

https://www.astralcodexten.com/p/updates-on-lumina-probiotic

I don't think they're seeking FDA approval anymore.

They’ve opened pre-orders in the US, shipping in June, which seems to suggest they got FDA approval, though more likely as a probiotic instead of a drug.

@agucova not sure how this resolves if it was approved as a probiotic. @strutheo, thoughts?

@agucova link? i

@agucova if it is already approved as a probiotic then this wouldnt resolve , ill keep it for teeth decay related stuff

@strutheo https://x.com/lanternbioworks/status/1777843986193056022?s=61

@agucova this doesnt indicate they are fda approved, where do they say it?

@strutheo they don’t, but if they’re selling in the US I’m guessing they either got explicit approval or they ‘self-certified’ as a probiotic and expect the FDA to agree

@agucova yea that wouldnt count then

(someone else's hand)

@strutheo Is that yours?

@TimothyJohnson5c16 no just some image i found! should i try it?

@strutheo Scott Alexander posted about it a few months ago, and it sounds intriguing: https://open.substack.com/pub/astralcodexten/p/defying-cavity-lantern-bioworks-faq