Updates on Lumina Probiotic

Since publishing my post expressing safety and efficacy concerns about Lumina Probiotic, the anti-cavity genetically modified probiotic, I've received answers to some of my concerns from Aaron Silverbook, the founder. He has also promised to connect me with people connected to Lumina who can answer the rest of my concerns. 

In the meantime, he's asked me to take down the post while Lumina people provide me with additional information.  I've agreed to do so.

I've recapped my main concerns below in italics, with Aaron's responses following.

1. Lumina's probiotic is a drug, not a cosmetic, and thus should have to go through the rigorous and extensive safety and efficacy FDA testing that drugs go through.

Aaron maintains Lumina is a cosmetic. He also clearly disagrees with me on the importance of the FDA's protocols or the rigor of FDA drug testing for products like Lumina's.

2. Lumina does not follow proper manufacturing protocols, including the legally mandated GMP protocols.

Aaron has assured me that Lumina follows all legally mandated manufacturing protocols, including GMP protocols, and maintains high production standards, including contamination testing and bimonthly sequencing. He also has informed me that they are investing significant sums and efforts in their own production facility. He's connected me with Rob Williams, their engineer.

3. Lumina's product produces a naturally-occurring antibiotic, mutacin-1140, that survives the digestive tract and has been dangerous at high doses in rat trials. This could be dangerous for humans' digestive tracts.

Aaron says he's not the right person to talk to about this, but has connected me with Justin Merritt, their scientific advisor, to answer my concerns.

4. The genetic modifications that the probiotic have gone through, although they are intended to prevent transfer of genetic material to or from the probiotic (and thus weakened efficacy or safety), are insufficient to do so.

Justin Merritt will also answer this concern.

5. Lumina's probiotic, like all probiotics, will be dangerous for infants or immunocompromised people. Infants or immunocompromised people could be exposed to this probiotic through sharing saliva with people who have used the probiotic.

Aaron says their packaging will state that immunocompromised people and infants should not take the product, and that he does not recommend it for them. He does not expect the product to be more dangerous for infants or immunocompromised people than the wildtype S. mutans people would spread through kissing anyways.

6. Lumina's probiotic was only 50% effective in reducing caries in a rat trial. This is not an impressive level of efficacy for an animal trial and does not bode well for human trials. 

Aaron maintains that 50% effectiveness at reducing caries in an animal trial is impressive. Also, as stated above, Aaron disagrees with me on the importance of large, rigorous human trials for this product (phase 3 equivalents).