The approval process supposedly required an impossible ask. Oddly enough, I could find no record of this impossible ask anywhere except in this company's website or on other "rationalist" websites, all of whom cite this company as the sole source.
And in fact...this impossible ask doesn't actually take into account how the FDA approval process works...or has ever worked...
It's the kind of story someone make ups when they're trying to explain why their miracle invention failed.
(And note that oral probiotics have been approved by the FDA for human use for several decades, including back when this supposed miracle bacteria was discovered. And Japan and Europe have much more lenient standards, now and then, for oral treatments and yet no attempt was made to launch the product there. And China and much of South East Asia don't even bother regulating this type of product, so why wasn't this launched in Asia? Why is the only market they're launching this product in a jurisdiction in which "biohacking" products are completely exempted from regulationo)
Nothing about this product adds up, and it bares multiple hallmarks of being a scam. (See the currently top-ranked comment on this post.)
"Dr. Hillman has been working on this therapy for 25 years and first applied to the F.D.A. for permission to begin a clinical trial in 1998. The agency, the company said, has demanded change upon change to make sure the modified bacteria would not run amok, cause undesirable changes in the mouth, or revert to a cavity-producing form. To win approval, Oragenics has agreed that the 15 volunteers in the first trial will not even have teeth -- they will have dentures."
This differs from the version I heard from Aaron in that Aaron said 100 people and NYT says 15 people, but NYT says the FDA demanded "change after change", so the 100 might be either an earlier or a later version of this.
Hopefully this changes your opinion of whether or not this is a scam, and of how much you understand about the FDA approval process.
Exaggerating details the way the linked post does is one of the major red flags of almost every scam. Especially dangerous is the way it attempts to make the regulator the enemy based on a fraudulent retelling of actual events.
The treatment was proposed to the FDA decades ago as a drug. The drug approval process yielded the impossible ask. Those same standards prevent them from seeking FDA approval now as a drug.
That this could be approved as a probiotic is a recent idea. The impossible standards are not the probiotic lenient standards.