Parabiotics on the US market

Hi everyone,

Usually, my home is the medical device world, but I have some kind of a borderline issue here.

This is about parabiotics. I have a new product providing its primary mode of action through heat-inactivated, sterilized, and lyophilized lactobacilli.
I was able to identify similar products in Europe that entered the market as medical devices.
The same products were either marketed in the US as medical food, or they were not marketed at all. This is not helpful, because the product in question is not for oral intake. One of the papers I identified during my research proclaimed that "dead microbes (microbes inactivated by heat, radiation, etc.) are drugs in the US. But it did not provide a source.
I could not find any guidance by the FDA regarding parabiotics (incl. many synonyms, e.g. ghost probiotics, inactivated probiotics, tyndallized probiotics).

Does anyone have experience with similar products and can provide advice on how they are regulated in the US?

What claims are you making about the product?

The product is intended to disrupt and prevent biofilm formation. There is evidence that it works, but the mode of action is not clear.

Unfortunately, the best information I can find is this draft guidance on probiotics, which I assume you've seen. It references this draft guidance on dietary supplements in saying that:

[P]roducts that may be considered to be “probiotics” may be foods, drugs, and/or biologics under the FD&C Act and/or PHSA, depending on various factors, such as the intended use of the product.

Click to expand...

Absent any other information, I would speculate that parabiotics would fall in a similar category.