Fiona: Okay. So, we are gonna be talking labels today, which is always fun to talk about. The recent labeling legislation is Therapeutic Goods Order No. 92, otherwise known as TGO 92. It did come into force a few years ago, but it has had an update in the last 12 or 18 months, just to kind of, you know, clarify a few things, fix up a little bit of some of the things in there that were causing a little bit of confusion, and kind of clarifying everything. So, yeah, look, we can talk about, you know, label warnings, allergens, etc., because, you know, it doesn’t matter, I don’t think, how long TGO 92 has been in play now. We’re still getting the same questions over and over again about the same kinds of things. So, it does cause a lot of confusion out there. So, if we can clear any of that up today, then that’s why we’re here, talking labels.

Andrew: Yeah. Beautiful. Yeah. So, well, okay. So, let’s go on to what have been the most common questions.

Fiona: Okay, most common questions we get are around the allergens, particularly sulfites and phenylalanine are the two big ones. And I think, largely, they come about because of the difference in TGO 92 legislation for listed medicine labeling, and I think we’re so used to seeing those allergens being listed on foods. And the difference between the food labeling laws and TGO 92, particularly around those types of allergens, is quite different. So, where as you’d expect to see, or not see, a sulfites warning on a food label, you will probably see it on a listed medicine or a registered medicine label. And that tends to be causing a little bit of confusion.

Andrew: Yeah. Okay. So, if we’re talking… TGA is based around safety, particularly for complementary medicines.

Fiona: Exactly. Yeah. Yeah.

Andrew: So, that being the case, is FSANZ not the same?

Fiona: Is it FSANZ you meant? Sorry, Andrew? FSANZ?

Andrew: Yeah.

Fiona: Not all the time. A lot of the time, with allergens, FSANZ will have a cut-off limit. So, for instance, with sulfites, I think it’s 10 parts per million or 20 parts per million or something like that. So, if you’ve got more than that in your product, you need to declare it on the label. Whereas with TGO 92, you have to declare the presence of sulfites no matter how much. It could even be trace, minute, miniscule amounts, that probably won’t have a biological effect, but you still need to make sure they’re on the label, and it, like you said, it comes back to a safety concern amongst the TGA. So, they’re a lot more tighter on medicines with stuff like that than FSANZ are.

Andrew: Okay. So, I have to ask, is this only pursuant to complementary medicines, or is this pursuant to pharmaceutical medicines as well?

Fiona: Pharmaceutical medicines as well. The TGO 92, or the labeling orders, pertain…or TGO 92 pertains to listed medicines. There is another TGO that pertains to registered medicines, but as far as I believe, the allergen declarations are the same.

Andrew: Okay. All right. So, what about with regards to, you spoke about foods, and one of the things that some people worry about is they go, “Oh, phenylal…” this is the public, “Phenylalanine equals artificial sweeteners.” And I have to go, “No, no. If it’s a protein powder.” Phenylalanine is an amino acid that you’ll find in protein powders, like whey and pea and things like that.

Fiona: Yeah, exactly.

Andrew: So, are they required to list this as phenylalanine being a component of the protein powder always?

Fiona: Yeah. So, the sports food industry that uses phenylalanine as an amino acid in whey protein powders or in other types of sports supplements, they’ll need to put, like, the warning on there about PKU, and, you know, “this product includes phenylalanine” etc., but generally speaking, in the general food sense, when we’re taking the sports foods away from that, phenylalanine only needs to be declared on food labels if aspartame is present, or if the aspartame-acesulfame salt is present in the food as well.

That’s the food law. With listed medicines, again, we have to declare the presence of phenylalanine regardless of its source. So, if it’s part of an amino acid chelate, so, for instance, magnesium, amino acid chelates often use phenylalanine as an amino acid component of that chelate…

Andrew: Yep,

Fiona: …so will need to declare phenylalanine there. So, other times that you might need to declare phenylalanine is if you’re using a soft gel capsule that’s derived from animal proteins, like the gelatin, they will have naturally-occurring phenylalanine in there, so you’ll need to declare that as well. And, as I said, there’s no minimum amount, so whether it’s trace or whether you’ve got a lot in there, as an actual ingredient, as an amino acid, you’ll need to declare it. So, it’s a little bit different. Yeah.

Andrew: [inaudible 00:06:30] Okay. So, yeah. Just stepping back from this from a second, if the TGA is based around, certainly pursuant to complementary medicines, regarding safety, then one would guess that there’s been some issue with somebody who suffers from phenylketonuria. You mentioned PKU, its abbreviation, just before. I’ve never seen this. So, what has sparked the change in labelling? What’s the point of it? If phenylketonuria is so rare, what’s the point?

Fiona: I think one of the big, overarching things that the TGA likes to talk about is that people have information, so they’re able to make an informed decision about the medicines that they want to take. And I think also, because, you know, complementary medicines largely are available over the counter, so, you can walk into a health food store, or you can walk into a pharmacy, and just pick a product off the counter, if the TGA… I know, I’ve heard delegates from the TGA actually say this. People must be able to read all of the warnings, and they must be able to get as much information as they can about the product, because the chances are they won’t have a consultation with a health professional before they purchased that product. So, I think, overall, it’s just about making people aware of what is potentially in the product, and to be able to make an informed choice about whether that product is appropriate or safe for them to use, at the end of the day.

Andrew: Sorry for the snide comment here. It’s not directed at you, but they’re talking about purchasing product. But how many times have I served customers in the pharmacy I work in, and it’s very common for pharmacies to just simply choose themselves a generic. It’s, unless the customer directs them specifically, or the doctor directs them specifically to not use a generic, then it’s up to what’s available. There’s a drug availability issue that we won’t get into, but anyway. But I’ve spoken to quite a few customers that have had issues with either the generic, or indeed the original, the traded product, and so they’ll prefer one or the other because of the excipients in there. Sometimes, for instance, lactose. So, if the issue is because they want people to be safe because they don’t think they’re gonna be having a consult, just having a consult is not the reason that people will be educated, because often, they have the consult, and they’re still uneducated, and they have to find out the hard way, through trial and error, about…

Fiona: Yep.

Andrew: …what is indeed the excipient in that drug. And I’m talking pharmaceuticals here.

Fiona: Yeah, yeah. Yeah, yeah. And I completely agree with you.

Andrew: So there’s my snide comment for the day.

Fiona: Yeah, no. I agree. Just because you’re gonna have a consult with someone doesn’t necessarily mean you’re gonna be exposed to all of the pertinent information that you need to make a choice, but I guess it’s just the TGA being, you know, overly safe and…yeah.

Andrew: Yep. Yeah, not without Medicare consults. Not a chance.

Fiona: No.

Andrew: So, we’ve covered a few TGO 92 differences between food standards. Now, you say FSANZ.

Fiona: Yep.

Andrew: All right. I say F-SANZ. Okay.

Fiona: Yeah. Food Standards Australia New Zealand. Yeah. FSANZ. Oh, yeah.

Andrew: Tomato, to-mah-to. But are there any other differences that we need to know about with regards to labelling, particularly when it’s gonna be impactful to our patients?

Fiona: Yeah, there are. And actually, can I just say, too, just before we move on to that, that I know that there is some push to the TGA from our industry at the moment to align the sulfite and phenylalanine warnings with the way that it’s legalized around food, because, like I said, with foods, sulfites, you know, you, I think it’s 10 parts per million in foods, if the sulfite content comes in under 10 parts per million, you don’t have to declare it. And we’re trying to push the TGA to give us that kind of flexibility as well about not having to declare it on the label if it’s, you know, past a certain amount. So, watch this space. That may end up changing in the future. But some other things that sometimes cause confusion about labelling, warning legislation and allergen legislations in particular, is the soy warning that can sometimes cause a little bit of an issue.

According to TGO 92, you only need to disclose the presence of soy if you’re adding actual soybean, the Glycine max ingredient that’s sometimes in women’s health products, any time where the soy protein might be in the product, because that’s generally the TGAC, that’s generally where the allergens come from, the proteins in there. So, if soy is in a product… You know, for instance, let’s just say fish oil products, where, often, the fish oil raw material will come into the manufacturer with a tocopherol, or a mixed tocopherol ingredient, to help protect the fish oil, sometimes that tocopherol is derived from soy. In that case, you don’t necessarily need to declare it on the label, because it’s a fatty-based, or a, you know, a lipid-based form of soy, that the TGAC sees as unlikely to cause an allergy, so you don’t need to declare it there.

We have had one of our manufacturers in particular kind of call that out. They have actually seen a case of an allergy or a sensitivity flare up with a soy-derived tocopherol in a fish oil. So, whereas normally, that warning wouldn’t be mandated on a fish oil label, I know that we at DFH have put that on our label, just to let people know that, you know, it could potentially pose a problem. Very, very unlikely. But that causes a little bit of a confusion as well, because I know that some sponsors might declare it, some sponsors won’t, because it’s not a mandatory, you know, declaration.

So, yeah, it’s, you kind of sometimes, there’s a little bit of a trade-off. Do, you know, soy, do we declare the presence of soy, or do we not? We don’t have to, but do we wanna keep our products safe on the other hand? So, you know, we always kind of go down the road of let’s stay safe, and just make sure that it’s there.

Andrew: But I see incongruence in the labeling requirements with regards to sulfites versus soy, and, you know, in certain instances you have to put soy regardless of the source, like a chelate, for instance. But in other instances you don’t, so it’s like, what’s the standardization?

Fiona: Yeah, I know. It can be very confusing. I know. And sometimes I think, too, is this really relevant? Like, is the average everyday person really going to look at this label and be able to make sense of it? You know? Like, gluten is another one, I think. It, like, to me, in listed medicines, gluten doesn’t need to be declared on the label unless it’s present above 20 parts per million. I’ve seen extremely sensitive celiacs react to minuscule amounts of gluten. So, that, to me, doesn’t make sense either, you know. So, I would wanna be declaring gluten, you know, in trace amounts. So, it just doesn’t seem…

Andrew: In trace, yeah, in trade amounts.

Fiona: Yeah, it doesn’t seem…

Andrew: I see gluten… I agree with you with gluten, that gluten is a far bigger issue at smaller doses than things like, for instance, lactose.

Fiona: Yeah.

Andrew: And I’ve seen super-sensitive people with lactase. With lactse, forgive me. Forgive me. But they can be rescued, whereas gluten, it’s really hard to. You know, there’s new digestive enzymes on the market now that are specific for gluten, but be that as it may, excuse me, what about things like yeast? I commonly get asked this. “Does it contain any yeast?” And I do make the point that sometimes there is a real paranoia about certain things, that they think, they, the lay public, think that they can totally isolate themselves from naturally-occurring yeasts. And their knowledge isn’t quite there. So I commonly ask people, I say, “Take a breath in. Big breath.” I say, “You just inhaled some yeast.” Miniscule amounts, but it will contain yeast.

Fiona: But it’s there.

Andrew: So, what are we talking about here? Yeah. And really, what [crosstalk 00:15:43] they’re talking about is the end issue, which is a Candida or Candida infection. So, which is a yeast, therefore, “all yeasts are bad.” It’s not quite right.

Fiona: Yeah, yeah.

Andrew: But what are the issues with, regarding yeast? Any?

Fiona: On labels, you mean? If we’re talking labels?

Andrew: Yeah.

Fiona: So, yeast actually doesn’t have to be declared on labels.

Andrew: Gotcha.

Fiona: The presence of yeast doesn’t legally have to be declared. Even, you know, products that contain SB, the, you know, the Saccharomyces, we don’t have to declare a yeast warning on the label.

Andrew: It contains yeast, because it’s a yeast.

Fiona: Yeah, and it contains…yeah. So, yeah.

Andrew: That’s a big

Fiona: So, yeah, yeast is another one that Yeah, I know some people do have issues with yeast, particularly if they have those Candida infections. But that’s something that, yeah, the TGA hasn’t really included in that safety legislation around labeling allergens and things like that, so, yeah. Interesting [crosstalk 00:16:40]

Andrew: Okay. So, what, if we’re talking about phenylalanine, for instance, and we’re talking about PKU, the issue with acesulfame and aspartame, what about other sweeteners, for instance, like sucralose? Are there any changes in labeling requirements regarding any or all of these sweeteners?

Fiona: The only sweeteners that you have to disclose the presence of are the sugar alcohols, like the mannitol or the xylitol or the sorbitols. But again, that’s only if they’re present in more than, I think it’s 2 grams per serve. or 2 grams per daily recommended dose.

Andrew: Uh-huh. Yeah.

Fiona: So, yeah. But that’s it. Other sweeteners, yeah, you don’t have to declare the presence of, unless, like I said, unless it’s the… Aspartame, you do, sorry. Aspartame, if you’re using that, you have to declare it. Other than that, it’s sugars and sugar alcohols. And yes, sorry, sucralose is sorry.

Andrew: Forgive me, sucralose is?

Fiona: Yes. Declarable, as a separate…in allergens. So, you do have to declare that, yeah.

Andrew: Gotcha. Okay. Thank you for clearing that one up. Okay. So, what about warnings that we have to now put on labels? Are there any changes with those? We’ve seen, for instance, a decrease in the dose of B6 available, 250, 100, 50.

Fiona: Yeah.

Andrew: We’ve seen… I mean, I’ve even seen changes in, this is so funny to me, the highest evidence-based herbal product for irritable bowel syndrome now no longer has Chelidonium in it. And I’m like, “Oh, for goodness’ sake.” But anyway. Yeah, and it’s in drop dosages, but it’s, there’s been allegedly some liver damage.

Fiona: Yeah.

Andrew: I question some of this. So, let’s go into these warnings that we have to, or maybe choose to put on labels.

Fiona: Yeah. Okay. So, again, this is the TGA being uber safe, and putting, you know, warnings on labels for things that they do see come up as adverse events relatively regularly. I know the B6, in particular, as part of my job as the regs manager here at DFH, I have to look after what’s called pharmacovigilance, or medicine safety. And that part of that part of that part of my role means that I need to go into the TGA’s database of adverse event notifications weekly, and just have a look at the ingredients that we use, and see if there’s any kind of common adverse events that are coming up through that week. B6 is always in there as an adverse event that happens, whether it’s from people who are sensitive to it. Maybe there’s some, you know, genetic issues around B6 metabolism in some people. I think, a lot of the time, it’s because people are taking multiple products with B6, and not really aware of, you know, that higher doses can kind of cause things like, you know, the neuropathies, the flushing etc., etc.

Andrew: Yep.

Fiona: So, B6 is one that, like I said, it comes up every week. So, I think the TGA really didn’t have much of a choice. They kind of had to do something there. I did kind of push when that was in, when that was kind of coming, because we knew that was coming before it actually came, and we did kind of push for practitioner-only products to be exempt from that warning, however, that one didn’t go through. So, it’s just a blanket warning now on all listed products. So, that’s one of them, and like I said, the B6 adverse event does come up quite regularly. We are seeing at the moment some talk about curcumin and Withania causing some liver injuries. To put that in perspective, when I look back at the database of adverse event notifications on those two products, they’re kind of causing about one event a year. So, when they talk about, you know, we’ve had 20 reports of turmeric causing, you know, liver damage, if they actually put that in a time frame, you’d see that that’s, you know, whilst yes, it probably is one a year is about all we’re getting, and when you kind of compare that to… I’m gonna have a bit of a dig now at the TGA, and pharmaceutical medicine.

Andrew: Wait for it.

Fiona: When you compare that to paracetamol… Compare it to paracetamol, and, you know, when you see the way the warning is worded on paracetamol boxes as well, it’s not highlighted nearly as much…

Andrew: No. No.

Fiona: …as I believe it should be. It is there, but it’s, you know, way amongst all the other fine print. Whereas the warnings that they kind of make us put on, you know, things like, potentially, curcumin and Withania, I think they will end up getting warnings, to be honest with you, are a lot more alarming, I think, than something that really is causing damage, and really is causing, you know, risks to public safety. So, yeah. That’s my little rant.

Andrew: Yeah. I found the narrative regarding the curcumin issue not just ill-worded. It was incorrect. I looked up that issue. There was a man who died. And they said that it was due to the “highly absorbable” curcumins. When I looked up the case, I thought it strange that the use of indocide…indomethacin, forgive me, indomethacin, the concurrent use of indomethacin was never mentioned, and more so on the DAEN, that database of adverse event notifications, like, DAEN, that it wasn’t mentioned, that it wasn’t suspected.

Fiona: Yeah.

Andrew: And yet, if you look up indomethacin, although rare, same with curcumin, it is, there has been cases noted of acute liver failure. So, why then does the DAEN not say that indomethacin is suspect, just as it is suspecting curcumin? That, I suspect, there’s that word, “suspect,” is a narrative, not true.

Fiona: Yeah. Potentially, yeah. It could have been the reporter. So, the reporter may have been a GP or, you know, some kind of pharmaceutical specialist. I’m making assumptions here, obviously, but when you go in to report the adverse event, you actually nominate which medicine you think has caused it, and then you list out all the other medications that that person was taking, that you think didn’t cause it. So, the TGA does have all of that information, at the end of the day, but if the reporter. and this is the whole thing about pharmacovigilance and notifying adverse events. If the reporter thinks that it was that product that caused that event, that is what you have to report to the TGA. So, yeah. It’s the same…Andrew, you’d know the story about kava as well. You know, those…

Andrew: Oh, I’ve got a story about kava.

Fiona: Yeah. Well, it’s the same kind of thing. Those adverse events were all associated with, you know, people who had pre-existing liver disease, or were on other medications that cause liver injury, or were taking other drugs and alcohol at the same time. There is very, very rarely an adverse event that happens to the liver if someone is just taking kava.

Andrew: Yeah, unless they’re really, really stupid and abusing…

Fiona: Tell me your story now. I’m interested in what… I wanna know.

Andrew: Well, look, I had a case in point here. A friend who, a very well-accomplished nurse, specialist, was using kava. In fact, she started using kava upon my questioning her why she wasn’t. And she said “No, it’s strange. I’ve never really looked into kava.” I was going… And then, not far down the track, she phoned me up and said, “Oh, I’m never using it again. I’ve had this thing…” and I said, “Whoa, back. Let’s investigate this.” And then her clinical mind kicked in. And the funny thing is that she trained with a lot of these doctors who are now psychiatrists One of this was a psychiatrist, andreported that the kava was the issue, but not this drug that was on the TGA watch list for liver failure. Notwithstanding that when she actually saw the liver tests, they were slightly elevated, nothing to do with fulminant liver failure.” So, it was like, “come on,” you know.

Fiona: Yeah. Yeah, and sometimes, yeah, you’ve really gotta look. And I know that particularly with Withania at the moment, it’s very topical, and we are, at the Complementary Medicines Australia, really looking into what possibly could be causing it. Is it a root extract or is it a leaf extract? Is it standardization? We’re trying to really drill down into what’s causing that. And it’s the same kind of thing. I think that with Withania, there seems to be two kinds of adverse events. One is just, like, a gastrointestinal event, causing nausea, maybe a bit of diarrhea, maybe some vomiting in the worst cases. And then there’s the liver stuff happening separately. The liver, like turmeric, is happening probably once a year, once every 18 months, something like that. So, it’s a very rare adverse event. The gastrointestinal symptoms seem to be a lot more common with Withania, you know, that nausea etc.

But I also, just on that, actually, Andrew, I just also wanna mention that I did see, when the Withania stuff first came out a couple of months ago, I saw that there was some chat on, you know, Naturopathic Practitioner Network, etc. on social media, talking about product testing, etc. And I just kind of wanted to mention that you know, and I know, and a lot of people do know, when you’ve got a listed medicine, if you’ve got the AUST L number, every ingredient in that product is tested before it goes into the product, and then it’s tested again when the product is made. So, when you’re getting adverse events, and the TGA kind of bringing things up about, you know, herbal medicines causing adverse events, it’s not necessarily about the testing if it’s a listed product. It’s probably more about what are we doing with that medicine. And again, in the case of curcumin, that could be, you know, the bioavailability stuff. Are we making it too bioavailable? What are we doing with the excipient technology that we’re using there? What are we using…you know, how is it being extracted? What part of the plant is doing it? It’s more about that kind of stuff, rather than, you know, is it being tested. So, I just kind of wanted to make that point as well, because I think that sometimes some questions that we get here, and I know there’s a bit of chat, you know, kind of out in praccie land as well about that kind of stuff, so… Yeah, just kind of wanted to clarify that.

Andrew: I’m glad you mentioned what form of extraction technique do we use. Because that indeed was the case with kava. I am of the ilk, yes, that grey hair there, when we had fluid extracts, fluid alcohol extracts, back in the day, in the mid to late ’90s. And, you know, kava, you know, I can’t say this therefore means everybody, but I’ve never seen an issue with it, apart from the taste. And the only way that I could cover the taste of fluid extracts was indeed, it wasn’t fruit flavoring and things like that. It was chocolate. That’s the only way I could cover it. Yeah.

Fiona: Well, it’s interesting.

Andrew: There was this… Oh, there’s a whole story behind this, about where I used to work. But anyway. So, I used to, I had a bit of a name for covering the taste of herbs. And so, I used to use chocolate. And there was this, I remember a, it was like a shot of kava. It was called Race 2000. And it was just, it was so popular. It was fantastic. And it was a really good, quality product. You’d get the numbing sensation from the kava pyrones, the kavalactones.

Fiona: Yeah, yeah.

Andrew: But then this news came out that people in Germany were using acetone extracts, and that’s where they initially saw the liver injuries, indeed, deaths, I think, in Germany. The issue in Australia never occurred, really, because of kava. Because if you look at the product which was blamed for the fulminant liver failure in somebody, when it was reported, it also contained passion flower, a notoriously adulterated herb, with Stephania. It’s happened about five or six times in my history. And so, it’s like, well, why did they blame kava? Because it’s popular, rather than looking at the real issue, which is passion flower adulteration, and the swapping, whether it be mistakenly, for Stephania.

Fiona: Yeah.

Andrew: And this is the thing that annoys the hell out of me, is this narrative. It is a narrative. And it’s like, “Just give us the truth, mate.” You know?

Fiona: Yeah, yeah. Yeah, I’m with you there. And I think also, you know, I think sometimes the TGA feels under pressure to do something quickly. And so…and I know, might get into trouble for saying this, but sometimes they don’t think things through. And then they kind of have to go back, particularly with something like TGO 92, things do kind of get rushed through sometimes. I think maybe they feel under pressure to maybe, you know, protect consumer safety, and so they’ll kind of, you know, rush things through. I know, as a member of the Complementary Medicines Australia Regulatory Committee, we often kind of, particularly in cases like this curcumin, shift their focus to, “Okay, well, let’s think about this. Let’s, you know, think about extracts. Let’s think about plant parts. Let’s think about this, this, this and this.” But yeah, I think sometimes they do feel pressure, you know, that pressure of that, you know, they’ve got that responsibility of keeping the public safe, so let’s do something, you know. We need to look like we’re doing something.

Andrew: There’s another part to that statement, and that is pressure from who? But anyway, we won’t get into that.

Fiona: Yeah.

Andrew: We won’t get into that topic today.

Fiona: No. No.

Andrew: What about warnings that may impact labels in the future, Fi? Do you see anything on the horizon?

Fiona: Yeah, well, that’s…we’ve kind of… Yeah, we’ve kind of mentioned a couple. I think there is going to be a warning that we’re going to need to start putting on the label for turmeric products.

Andrew: Yeah. Yeah.

Fiona: And I’m also 90% sure we’re going to see a warning coming out on Withania products as well in the next, probably 6 to 12 month. There will be a transition period that the TGA will give us some grace on, and that could be up to two years. So, practitioners might see some products come out with those warnings earlier than others. That just means that we’re in a transition period. It doesn’t necessarily mean that this product is gonna potentially cause that, but this one won’t. So, yeah, I think they’re probably the two that we’re looking at at the moment.

There is also some rumblings in the background about probiotics in pregnancy that we might just have to be aware of. There was a, I think it was a clinical study, rather than a meta analysis. There may have been two clinical studies that were done on probiotic supplementation in pregnant women who were obese. And it ended up driving up their blood pressure. So, there is a little bit of talk going around at the moment about whether or not the TGA will kind of bring that to our attention, and maybe a label warning might appear on that, but I haven’t had any confirmation on that yet. That’s just me kind of just thinking off the top of my head. But yeah, I think, just keep in mind, if that does kind of come up, that these women were overweight to start with, so the risk of hypertension was there. That risk goes up when you’re pregnant, as we know. So, is it just an association or is it a direct cause? You know, I think you can use your judgment there.

Andrew: Yeah. Yeah. That’s a bit of a long bow, but it’d be interesting to see clinical trials. Be interesting to see interventions and washouts with crossover.

Fiona: Yeah. Yeah.

Andrew: What about resources for practitioners to learn about the changes? Have you developed anything?

Fiona: Yeah, we have just brought out, just, like, a little-three page document that kind…it’s like a guide, acts as a guide, that goes, that talks about some of the common allergens that you’ll see on labels, and what they mean. So, and we kind of go through, you know, if you do see a sulfite warning on the label… Sorry, I’m just looking at it here. I’ve got it in front of me. This is what it looks like. It is actually on our website, in our clinic tools section of our website. It kind of goes through, you know, if you do see sulfites, then it might be because they could be in the soft gel materials. Sulfites are naturally-occurring in fruits, and, you know, a lot of complementary medicine sponsors will use natural fruit powders to flavour their powdered products, so it could be coming from there. Sulfites can also be naturally-occurring in mineral salts, and then again, you know, phenylalanine could also be used in soft gel material, if it’s animal-derived, as a natural amino acid component. They can also, phenylalanine’s also quite high in things like spirulina. So, you know, it could just be a naturally-occurring amino acid in there.

Andrew: Yeah.

Fiona: So, that, the little guide that we’ve created kind of steps out, if you see this, this could be the reason why. It doesn’t mean that we’ve actually added it. It just, it, usually, it’s a natural, you know, ingredient in, naturally-occurring ingredient in some amino acids or something that we’ve used as an active ingredient. So, yeah. Handy little guide.

Andrew: Oh, yeah. Yeah. I think the saving grace, if you like, of that issue with sweeteners is, if it has phenylalanine, and there is an artificial sweetener, regardless of whether it’s a protein powder or whatever, the artificial sweetener, acesulfame or aspartame must be listed anyway.

Fiona: Yes.

Andrew: So there’s your culprit, rather than the protein powder.

Fiona: Yeah, the link would be that, yeah. Yeah. Yeah. Yeah, exactly.

Andrew: Okay. And what about, like, you spoke about, you know, you’re getting constant questions from customers, from naturopaths. What about things like excipients? Is there any change…? Oh, actually, forgive me. Just about the probiotics, I know this is slightly off-topic, but we’ve had a huge, since, what, 2022 now, there was a big name change in some of the phyla, some of the genera, with regards to lactobacilli, what they’re actually called now in the scientific literature. Are there changes afoot to bring that in line with labelling?

Fiona: There is, but it hasn’t been put in yet. I think that one is still… The last time I looked at that, there was, it’s something like a five or six-year timeline, I think, that the TGA was looking at. So, whilst it will happen, it’s still a fair way off. So, there’s been nothing legislated at the moment. I think the TGA’s still kind of looking into everything. But yeah, I’d say within the next 5 to 10 years, we’ll probably be seeing that change over as well.

Andrew: Yeah. They’re waiting for the fires to die down about the furore that the biochemists…the, forgive me, the microbiologists are having around the changes of Firmicutes to Bacillota. There’s a huge uproar in the scientists… There’s a massive…

Fi, thank you so much for taking it through. And, like, I’m weird. I get it. Like, I actually get intensely interested in this. But I understand this is the sort of drier end of the stick with regards to clinical practice, but it’s so important for us to know about it, particularly when our patients don’t know why these changes are happening, and don’t know why label changes are happening.

Fiona: Yeah.

Andrew: You know, “Oh, it used to be this. Now it’s that. Has anything else changed? Oh, I’ll throw the hands up in the air.”

Fiona: Yeah.

Andrew: And the more that we can be forewarned about this, and knowledgeable about these changes, the more we can reassure our patients that nothing is wrong with the quality of the product. It’s really just the maze which we have to navigate with regards to regulatory requirements.

Fiona: Yeah, exactly.

Andrew: So, I can’t thank you enough for knowing this stuff, first up, but also, I mean, you have a passion for this stuff. You need a life [crosstalk 00:38:45] But…

Fiona: I do. I do, yeah. I’m a big nerd. But I think, too, can I just add there, too, Andrew, just pick up on a point you made there about patients needing to know this. I think practitioners need to be empowered with this knowledge as well, and I’m happy to be here, to be, you know, that bearer of knowledge for practitioners, because, often, the TGA will just let us sponsors know about the changes, without necessarily educating the public about them. So, and I know that practitioners are that middleman between us and the patient. And practitioners, you know, get lost in all of this as well. The TGA doesn’t focus education to practitioners about changes either. So, like I said, I’m happy to be, you know, the…not that I’m the all-knowing person or anything like that. But whatever, you know, knowledge we can provide at DFH, like things like this, just little handouts and guides that can help practitioners to kind of answer some of those questions that their patients might have, you know, if they see a warning, and they find it alarming. You know, where is this warning coming from? Then, you know, the practitioner is the one that gets asked that question, not us. So, I think it’s really important for the practitioner to know about this kind of stuff as well.

Andrew: Well, it’s actually a very good point you make, and as a last question, if you like, the TGA is based around public safety. Does the TGA have a public-facing page where they actually list changes that have happened? When trying to navigate to the TGO 92, you have to know exactly what you’re after before you can navigate to it.

Fiona: Yeah, exactly. Not…

Andrew: But if you wanted to go off-piste a little bit, you’re done.

Fiona: Yeah. I don’t think they do it in a very user-friendly way. And I know that that’s something that…

Andrew: Not at all.

Fiona: No. That us at the regs committee really kind of… We had a big, kind of, face-to-face meeting, about a month or so ago, about where we’d like to see the TGA kind of focusing. Now that we’ve got a new CEO there, John Skerritt has retired, we have a new guy that’s come into the fold. Dr. Lawler, I think his name is. We’ve also recently seen the head of the complementary medicine section retire. So, we’ve got a new… They haven’t actually announced who it is yet, but the person that we think it is is going to be a very, it’s like it’s going to be quite a breath of fresh air to the complementary medicines industry, I think. So, we kind of had a bit of a meeting as to where we’d like the TGO to focus on priorities when it comes to complementary medicines. And one of those priorities that we think is public education, because we don’t think they do enough of it. So, hopefully, we can get that point across to them, and that, you know, those kinds of education pages become a lot more user-friendly.

Andrew: Well, Fi, I can’t thank you enough for being that halfway person between what’s happened and educating the practitioners, so that, again, we can be forewarned and really knowledgeable, so that we can reassure our patients. Thank you so much for taking us through this today.

Fiona: Very important. Pleasure. Always a pleasure to talk to you, Andrew.

Andrew: And thank you, everyone, for joining us today. Remember, you can catch up on all the show notes. There will be heaps of show notes for this one, plus all of the other podcasts on the Designs for Health website. I’m Andrew Whitfield-Cook. This is “Wellness by Designs.”