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Dragana Skokovic Sanji

Clinical Pharmacist at Hamilton Family Health Team specializing in evidence-based probiotics and women's health; author of the Clinical Guide to Probiotic Products.

Jun 23, 2026

16:30
And I know that a lot of probiotics companies are eyeing that label to say, "Can we change our formulation and apply for an indication through the FDA under this live biotherapeutic product category?" And so I, I have a sneaking suspicion, and I know that there are some companies racing to do this, that we're probably going to see clinical trials coming out that are-- have a goal of these probiotics, for all intents and purposes, fall under this label, label of live biotherapeutic products from the FDA, and we'll be able to give patients a much more confident answer at that point.
17:17
That is wonderful.
17:18
Just wanna- Yeah.
17:19
I wanna add something else.
17:20
You know, uh, John, you're talking about regulation in USA and, uh, um, regulation in Canada, where I am, are maybe a little bit stricter, uh, maybe more defined, but again, there's not much of the enforcing of that regulation.
17:35
Any company producing probiotic needs to file, um, all the, the information and data with the Natural Health, Health Product Directorate with Can- Health Canada, but they don't have to put a label, uh, strain on the label.
17:52
And what that ki- means in real life is, for example, I'm not going to mention any brand names, but there was a brand name, very recognizable in Canada, that up to 2010 contained a Lactobacillus rhamnosus GG, which is Well-known strain with good, uh, lots of proof of benefit.

20 MINS LATER

38:17
Dragana, do you wanna go ahead?

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