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Understanding Australian Medicine Labelling Requirements with Fiona Wing · Wellness by Designs - Practitioner Podcast

• 0:02
  Speaker 1: Music, music, music Music Music Music, music, music, music, music, music, music, music, music, music, music, music, music, music, music, music, music, music, music.
• 0:25
  Speaker 1: This is Wellness by Designs, and I'm your host, andrew Whitfield-Cook.
• 0:28
  Speaker 1: Today we're chatting with Fiona Wing, a naturopath and regulatory manager at Designs for Health, and our topic for today is, behind the label, new regulatory changes that you need to know about.
• 0:40
  Speaker 1: Welcome to Wellness by Designs, fi.
• 0:42
  Speaker 1: How are you?
• 0:44
  Speaker 2: Good thanks, andrew.
• 0:44
  Speaker 2: How are you?
• 0:44
  Speaker 2: Good thanks Andrew.
• 0:45
  Speaker 2: How are?
• 0:46
  Speaker 1: you Really good, thank you, okay.
• 0:48
  Speaker 1: So thank you so much for your time, by the way, because I know that your job is like head down, bum up all the time.
• 0:53
  Speaker 1: What's happened, what have they done to us now?
• 0:55
  Speaker 1: Sort of thing.
• 0:56
  Speaker 1: So let's open with recent regulatory changes.
• 0:59
  Speaker 1: What's going on here?
• 1:02
  Speaker 2: Okay, so we are going to be talking labels today, which is always fun to talk about.
• 1:09
  Speaker 2: The recent labelling legislation is Therapeutic Goods Order number 92, otherwise known as TGO 92.
• 1:16
  Speaker 2: 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.
• 1:34
  Speaker 2: So, yeah, we can talk about, you know, label, warnings, allergens, etc.
• 1:39
  Speaker 2: Because you know it doesn't matter.
• 1:41
  Speaker 2: I don't think how long TGO92 has been in play now.
• 1:45
  Speaker 2: We're still getting the same questions over and over again about the same kinds of things.
• 1:50
  Speaker 2: So it does cause a lot of confusion out there.
• 1:53
  Speaker 2: So if we can clear any of that up today, then that's why we're here talking labels yeah, beautiful, yeah, so well, okay.
• 2:02
  Speaker 1: So let's go on to what have been the most common questions.
• 2:07
  Speaker 2: 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 TGO92 legislation for listed medicine labelling and I think we're so used to seeing those allergens being listed on foods and the difference between the food labelling laws and TGO92, particularly around those types of allergens, is quite different.
• 2:40
  Speaker 2: So whereas 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.
• 2:56
  Speaker 1: Yeah, okay.
• 2:57
  Speaker 1: So if we're talking, TGA is based around safety, particularly for complementary medicines, Exactly yeah.
• 3:02
  Speaker 1: So that being the case, is f-sans not the same?
• 3:08
  Speaker 2: um, is it phyzanse?
• 3:10
  Speaker 2: You?
• 3:10
  Speaker 2: You meant sorry, andrew phyzanse yeah not not all the time.
• 3:15
  Speaker 2: A lot of the time with allergens, phyzanse will have a cut-off limit.
• 3:19
  Speaker 2: So for instance, with sulfites, I think it's 10 parts per million or 20 parts per million or something like that.
• 3:25
  Speaker 2: So if you've got more than that in your product you need to declare it on the label, whereas with TGO92 you have to declare the presence of sulfites, no matter how much.
• 3:35
  Speaker 2: It could even be trace minute, minuscule amounts that probably won't have a biological effect, but you still need to make sure they're on the label.
• 3:44
  Speaker 2: And, like you said, it comes back to a safety concern amongst the TGA.
• 3:51
  Speaker 2: So they're a lot more tighter on medicines with stuff like that than Fizans are.
• 3:57
  Speaker 1: Okay.
• 3:57
  Speaker 1: So I have to ask is this only pursuant to complementary medicines, or is this pursuant to pharmaceutical medicines as well?
• 4:03
  Speaker 1: To complementary medicines, or is this pursuant to pharmaceutical medicines as well?
• 4:05
  Speaker 2: Pharmaceutical medicines as well.
• 4:07
  Speaker 2: The TGO92 or the labelling orders pertain, or TGO92 pertains to listed medicines.
• 4:16
  Speaker 2: There is another TGO that pertains to registered medicines, but as far as I believe, the allergen declarations are the same.
• 4:24
  Speaker 1: Okay, all right.
• 4:25
  Speaker 1: So what about with regards to?
• 4:28
  Speaker 1: You?
• 4:28
  Speaker 1: Spoke about foods, and one of the things that some people worry about is they go oh, this is the public.
• 4:35
  Speaker 1: Phenylalanine equals artificial sweeteners and I have to go no, no, if it's a protein powder.
• 4:42
  Speaker 1: Phenylalanine is an amino acid that you'll find in protein powders like whey and pea and things like that.
• 4:48
  Speaker 1: So, are they required to list this as phenylalanine, being a component of the protein powder?
• 4:57
  Speaker 1: Always?
• 5:00
  Speaker 2: Yes.
• 5:00
  Speaker 2: So the sports food industry that uses phenylalanine as an amino acid in whey protein powders or in other types of sports supplements.
• 5:09
  Speaker 2: They'll need to put the warning on there about PK foods.
• 5:12
  Speaker 2: Away from that, phenylalanine only needs to be declared on food labels if aspartame is present or if the aspartame, a sulfame salt, is present in the food as well.
• 5:36
  Speaker 2: That's the food law.
• 5:38
  Speaker 2: With listed medicines, again, we have to declare the presence of phenylalanine regardless of its source.
• 5:45
  Speaker 2: So if it's part of an amino acid chelate.
• 5:48
  Speaker 2: So, for instance, magnesium amino acid chelates often use phenylalanine as an amino acid component of that chelate.
• 5:55
  Speaker 2: So we'll need to declare phenylalanine there.
• 5:58
  Speaker 2: Um.
• 5:59
  Speaker 2: So other times that um you might need to declare phenylalanine is if you're using a soft gel capsule that's derived from animal proteins, like the gelatin, um, they will have naturally occurring phenylalanine in there, so you'll need to declare that as well.
• 6:17
  Speaker 2: And, as I said, there's no minimum amount.
• 6:19
  Speaker 2: So whether it's trace or whether you've got a lot in there as as an actual, 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.
• 6:30
  Speaker 2: So it's a little bit different.
• 6:32
  Speaker 1: Yeah, just stepping back from this for a second.
• 6:36
  Speaker 1: 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.
• 6:51
  Speaker 1: You mentioned PKU.
• 6:52
  Speaker 1: It's an abbreviation just before.
• 6:54
  Speaker 1: I've never seen this.
• 6:56
  Speaker 1: So what has sparked the change in labelling?
• 6:59
  Speaker 1: What's the point of it If phenylketonuria is so rare?
• 7:02
  Speaker 1: What's the point of it If phenylketoneuria is so rare?
• 7:04
  Speaker 1: What's the point?
• 7:08
  Speaker 2: 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.
• 7:22
  Speaker 2: 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.
• 7:35
  Speaker 2: 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 purchase that product.
• 8:00
  Speaker 2: 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.
• 8:14
  Speaker 1: Sorry for the snide comment here.
• 8:16
  Speaker 1: It's not directed at you, but they're talking about purchasing product.
• 8:20
  Speaker 1: 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.
• 8:33
  Speaker 1: It's unless the customer directs them specifically, or the doctor directs them specifically to not use a generic.
• 8:40
  Speaker 1: Then it's up to what's available.
• 8:42
  Speaker 1: There's a drug availability issue that we won't get into, but anyway.
• 8:47
  Speaker 1: 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.
• 9:04
  Speaker 1: Because of the excipients in there, sometimes, for instance, lactose.
• 9:10
  Speaker 1: So if the issue is because they want people to be safe, because they don't think they're going to 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 what is indeed the excipient in that drug and I'm talking pharmaceuticals here.
• 9:32
  Speaker 1: Yeah, yeah, and I completely agree.
• 9:35
  Speaker 1: So there's my snide comment for the day.
• 9:36
  Speaker 2: Yeah, no, I agree.
• 9:37
  Speaker 2: Just because you're going to have a consult with someone doesn't necessarily mean you're going to be exposed to all of the pertinent information that you need to make a choice.
• 9:46
  Speaker 2: But I guess it's just the TGA being, you know, overly safe and yeah, not without Medicare consults, not a chance.
• 9:55
  Speaker 1: Um so um, we've covered a few TGO 92 differences between food standards.
• 10:01
  Speaker 1: Now you say for sans yeah all right food standards australia new zealand yeah tomato, tomato.
• 10:11
  Speaker 1: But are there any other differences that we need to know about with regards to labeling, particularly when it's going to be impactful to our patients?
• 10:21
  Speaker 2: yeah, there are um 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 legalised around food Because, like I said, with foods, sulfites, you know you, I think it's 10 parts per million in foods.
• 10:49
  Speaker 2: If it's um, if the sulfite content comes in under 10 parts per million, you don't have to declare it um 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.
• 11:04
  Speaker 2: So watch this space.
• 11:06
  Speaker 2: That may end up changing in the future.
• 11:08
  Speaker 2: But some other things that sometimes cause confusion about label it, warning legislation and allergen legislations in particular is the SOI warning.
• 11:18
  Speaker 2: That can sometimes cause a little bit of an issue.
• 11:22
  Speaker 2: According to TGO 92, you only need to disclose the presence of soy if you're adding actual soybean, the glycine max ingredient.
• 11:35
  Speaker 2: 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.
• 11:46
  Speaker 2: So if soy is in a product.
• 11:49
  Speaker 2: 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.
• 12:04
  Speaker 2: Sometimes that tocopherol or mixed tocopherol ingredient to help protect the fish oil, sometimes that tocopherol is derived from soy.
• 12:07
  Speaker 2: In that case you don't necessarily need to declare it on the label because it's a fatty based or, you know, a lipid based form of soy that the TGA sees is unlikely to cause an allergy, so you don't need to declare it there.
• 12:21
  Speaker 2: We have had one of our manufacturers in particular kind of call that out.
• 12:28
  Speaker 2: They have actually seen a case of an allergy or a sensitivity flare up with a soy-derived tocopherol in a fish oil.
• 12:42
  Speaker 2: 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.
• 12:54
  Speaker 2: You know it could potentially pose a problem very, very unlikely.
• 12:59
  Speaker 2: But that causes a little bit of 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.
• 13:09
  Speaker 2: So yeah, you kind of.
• 13:11
  Speaker 2: Sometimes there's a little bit of a trade-off.
• 13:13
  Speaker 2: You know, soy.
• 13:15
  Speaker 2: Do we declare the presence of soy or do we not?
• 13:18
  Speaker 2: We don't have to, but do we want to keep our products safe, on the other hand.
• 13:23
  Speaker 2: So you know, we always kind of go down the road of let's stay safe and just make sure that it's there.
• 13:30
  Speaker 1: But I see incongruence in the labelling requirements with regards to sulphites versus soy.
• 13:36
  Speaker 1: 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.
• 13:48
  Speaker 2: So it's like the standardisation.
• 13:50
  Speaker 2: I know, and sometimes I think too, is this really relevant?
• 13:54
  Speaker 2: Like, is the average everyday person really going to look at this label and be able to make sense of it?
• 14:03
  Speaker 2: You know, like gluten is another one, I think.
• 14:07
  Speaker 2: To me, in enlisted medicines, gluten doesn't need to be declared on the label unless it's present above 20 parts per million.
• 14:15
  Speaker 2: I've seen extremely sensitive celiacs react to minuscule amounts of gluten, so that to me doesn't make sense either, you know.
• 14:25
  Speaker 2: So I would want to be declaring gluten in trace amounts.
• 14:31
  Speaker 1: So it just doesn't seem yeah, in trace amounts.
• 14:34
  Speaker 2: Yeah, it doesn't seem.
• 14:36
  Speaker 1: I agree with you with gluten that gluten is a far bigger issue, at smaller doses, than things like, for instance, lactose, and I've seen super sensitive people with lactase.
• 14:46
  Speaker 1: With lactose, forgive me um, um, but they can be rescued, whereas gluten it's really hard to um.
• 14:55
  Speaker 1: You know there's new uh digestive enzymes on the market now that are specific for gluten.
• 15:01
  Speaker 1: But be that as it may, excuse me, what?
• 15:05
  Speaker 1: What about things like yeast?
• 15:07
  Speaker 1: I commonly get asked this does it contain any yeast?
• 15:10
  Speaker 1: 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.
• 15:29
  Speaker 1: So I commonly ask people I say take a breath in big breath.
• 15:33
  Speaker 1: I say you just inhaled some yeast.
• 15:35
  Speaker 1: Milliskill amounts, but it will contain yeast.
• 15:38
  Speaker 1: So what are we talking about here?
• 15:40
  Speaker 1: Yeah, and really, what we're talking about is the end issue, which is a candida or candida infection, which is a yeast.
• 15:51
  Speaker 1: Therefore, quote unquote all yeasts are bad.
• 15:53
  Speaker 1: It's not quite right, but what are the issues regarding yeast Annie?
• 15:59
  Speaker 2: On labels.
• 16:00
  Speaker 2: You mean, if we're talking labels, so yeast actually doesn't have to be declared on labels.
• 16:05
  Speaker 2: The presence of yeast doesn't legally have to be declared.
• 16:08
  Speaker 2: Um, uh, even you know products that contain sb, that you know the saccharomyces.
• 16:15
  Speaker 2: We don't have to declare a yeast it contains it because it's a yeast.
• 16:20
  Speaker 2: Yeah, so yeah, yeast is another one that I 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 labelling, allergens and things like that.
• 16:38
  Speaker 2: So, yeah, yeah.
• 16:40
  Speaker 1: Okay.
• 16:40
  Speaker 1: So if we're talking about phenylalanine, for instance, and we're talking about PKU the issue with eschylfame and aspartame what about other sweeteners, for instance like sucralose?
• 16:51
  Speaker 1: Are there any changes in labelling requirements regarding any or all of these sweeteners?
• 16:58
  Speaker 2: 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 two grams per serve or two grams per daily recommended dose.
• 17:16
  Speaker 2: So yeah, but that's it.
• 17:19
  Speaker 2: Other sweeteners, yeah, you don't.
• 17:22
  Speaker 2: You don't have to um declare the presence of unless, like I said, unless it's the aspartame you do.
• 17:28
  Speaker 2: Sorry, aspartame, if you're using that, you have to declare it um other than that it's sugars and sugar alcohols.
• 17:35
  Speaker 2: Um, and yes, sorry, sucralose is sorry, figure me, sucralose is Sorry.
• 17:40
  Speaker 1: Forgive me, sucralose is.
• 17:42
  Speaker 2: Is declarable as a separate allergen, so you do have to declare that, yeah.
• 17:48
  Speaker 1: Gotcha, okay, thank you for clearing that one up.
• 17:51
  Speaker 1: Okay, so what about warnings that we have to now put on labels?
• 17:57
  Speaker 1: Are there any changes with those?
• 17:58
  Speaker 1: We've seen, for instance, instance, a decrease in the dose of b6 available 250, 150.
• 18:05
  Speaker 1: Um, yeah, we've seen, I mean, I've even seen changes in.
• 18:10
  Speaker 1: This is so funny to me the highest evidence-based herbal product for irritable bowel syndrome now no longer has caledonia in it and I'm like, oh for goodness sake, but anyway.
• 18:21
  Speaker 1: Um, yeah, and it's in drop dosages, but it's there's been allegedly some liver damage.
• 18:28
  Speaker 1: I question some of this.
• 18:29
  Speaker 1: So let's go into these warnings that we have to, or maybe choose to, put on labels yeah, okay.
• 18:37
  Speaker 2: So again, this is the tga being uber safe, um and and putting you know warnings on labels for things that they do see come up as adverse events relatively regularly.
• 18:52
  Speaker 2: I know the B6 in particular um, 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 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.
• 19:20
  Speaker 2: B6 is always in there as an adverse event.
• 19:25
  Speaker 2: That happens, whether it's from people who are sensitive to it.
• 19:30
  Speaker 2: Maybe there's some, you know, genetic issues around B6 metabolism in some people.
• 19:35
  Speaker 2: I think a lot of the time it's because people are taking multiple products with B6 and not really aware of.
• 19:43
  Speaker 2: You know that higher doses can kind of cause things like you know the neuropathies, the flushing, et cetera, et cetera.
• 19:51
  Speaker 2: So B6 is one that, like I said, it comes up every week.
• 19:57
  Speaker 2: So I think the TGA really didn't have much of a choice.
• 20:01
  Speaker 2: They they kind of had to do something there.
• 20:04
  Speaker 2: I did kind of push when that was in um uh, when that was kind of coming, because we knew that was coming before it actually came, and we did kind of push for um practitioner only products to be exempt from that warning.
• 20:20
  Speaker 2: However, that one didn't go through, so it's just a blanket warning now on all listed products.
• 20:26
  Speaker 2: So that's one of them.
• 20:29
  Speaker 2: And, like I said, the B6 adverse event does come up quite regularly.
• 20:33
  Speaker 2: We are seeing at the moment some talk about curcumin and withania causing some liver injuries.
• 20:41
  Speaker 2: 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.
• 20:55
  Speaker 2: So when they talk about, you know, we've had 20 reports of turmeric causing, you know, liver damage.
• 21:03
  Speaker 2: If they actually put that in a timeframe, you'd see that.
• 21:07
  Speaker 2: That's, you know.
• 21:09
  Speaker 2: Whilst yes, it probably is, one a year is about all we're getting.
• 21:14
  Speaker 2: And when you kind of compare that to I'm going to have a bit of a dig now at the TGA and pharmaceutical medicine when you compare that to paracetamol.
• 21:27
  Speaker 2: compare it to paracetamol and you know.
• 21:30
  Speaker 2: When you see the way the warning is worded on paracetamol boxes as well, it's not highlighted nearly as much as I believe it should be.
• 21:42
  Speaker 2: 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.
• 21:58
  Speaker 2: 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.
• 22:09
  Speaker 2: So, yeah, yeah, that's my point.
• 22:13
  Speaker 1: I found the narrative regarding the curcumin issue not just ill-worded, it was incorrect.
• 22:23
  Speaker 1: I looked up that issue.
• 22:26
  Speaker 1: There was a man who died and they said that it was due to the highly absorbable curcumins.
• 22:34
  Speaker 1: When I looked up the case, I thought it strange that the use of indecid indomethazine forgive me, indomethazine, the concurrent use of indomethazine, 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.
• 23:03
  Speaker 1: And yet if you look up indomethazine although rare, same with curcumin it is.
• 23:12
  Speaker 1: There has been cases noted of acute liver failure.
• 23:17
  Speaker 1: So why then does the DAEN not say that indomethacin is suspect, just as it is suspecting curcumin?
• 23:26
  Speaker 1: That I suspect there's.
• 23:28
  Speaker 1: That word suspect is a narrative, not truth.
• 23:31
  Speaker 2: Potentially, yeah, it could have been the reporter.
• 23:35
  Speaker 2: So the reporter may have been a GP or you know, some kind of pharmaceutical specialist.
• 23:44
  Speaker 2: 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.
• 24:01
  Speaker 2: So the TGA does have all of that information at the end of the day.
• 24:06
  Speaker 2: 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.
• 24:20
  Speaker 2: So yeah, it's the same.
• 24:30
  Speaker 2: Andrew, you'd know the story about kava as well.
• 24:31
  Speaker 2: Oh, I've got a story about kava, yeah, well, it's the same kind of thing.
• 24:33
  Speaker 2: Those adverse events were all associated with, you know, people who had pre-existing liver disease or were on other medications that caused liver injury, or were taking other drugs and alcohol at the same time.
• 24:44
  Speaker 2: There is very, very rarely an adverse event that happens to the liver if someone is just taking cover.
• 24:53
  Speaker 1: Yeah, unless they really really sleep.
• 24:55
  Speaker 1: At end of the year, Tell me a story about it.
• 24:58
  Speaker 1: Well, look, I had a case in point here.
• 24:59
  Speaker 1: A friend who's a very well-accomplished nurse specialist was using Carver.
• 25:06
  Speaker 1: In fact she started using Carver upon my questioning her why she wasn't, and she said oh, it's strange, I've never really looked into Carver.
• 25:15
  Speaker 1: 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.
• 25:23
  Speaker 1: And I said, oh, back, let's investigate this.
• 25:26
  Speaker 1: And then her clinical mind kicked in and the funny thing is that she trained with a lot of these doctors who were now psychiatrists and things.
• 25:33
  Speaker 1: One of these was a psychiatrist and reported 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.
• 25:50
  Speaker 2: So I was like come on you know yeah.
• 25:53
  Speaker 2: Sometimes.
• 25:53
  Speaker 2: Yeah, you've really got to 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.
• 26:08
  Speaker 2: Is it a root extract or is it a leaf extract?
• 26:10
  Speaker 2: Is it standardisation?
• 26:11
  Speaker 2: We're trying to really drill down into what's causing that and it's the same kind of thing.
• 26:20
  Speaker 2: I think that with withaniaemia there seems to be two kinds of adverse events.
• 26:23
  Speaker 2: One is just like a gastrointestinal event causing nausea, maybe a bit of diarrhoea, maybe some vomiting in the worst cases, and then there's the liver stuff happening separately.
• 26:33
  Speaker 2: The liver, like turmeric, is happening probably once a year, once every 18 months, something like that.
• 26:41
  Speaker 2: So it's a very rare an adverse event.
• 26:45
  Speaker 2: The gastrointestinal symptoms seem to be a lot more common with withania.
• 26:49
  Speaker 2: You know that, nausea, etc.
• 26:51
  Speaker 2: But I also just on that, actually, andrew, I just also want to 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 et cetera, on social media, talking about product testing et cetera, and I just kind of wanted to mention that you know and I know, and a lot of people do know.
• 27:19
  Speaker 2: When you've got a listed medicine, if you've got the Austell 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.
• 27:30
  Speaker 2: 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.
• 27:42
  Speaker 2: If it's a listed product, it's probably more about what are we doing with that medicine.
• 27:45
  Speaker 2: And again, in the case of curcumin, that that could be.
• 27:46
  Speaker 2: You know the bioavail about what are we doing with that medicine.
• 27:48
  Speaker 2: And again, in the case of curcumin, that that could be.
• 27:51
  Speaker 2: You know the bioavailability stuff.
• 27:53
  Speaker 2: Are we making it too bioavailable?
• 27:55
  Speaker 2: Um, what are we doing with the excipient technology that we're using there?
• 27:59
  Speaker 2: What are we using?
• 28:00
  Speaker 2: You know, how is it being extracted?
• 28:01
  Speaker 2: What part of the plant is doing it?
• 28:04
  Speaker 2: It's more about that kind of stuff rather than you know, is it being tested?
• 28:08
  Speaker 2: So, um, 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 out in um prakhi land as well, um, about that kind of stuff.
• 28:23
  Speaker 2: So, yeah, I just kind of wanted.
• 28:24
  Speaker 1: I'm glad you mentioned um mentioned what form of extraction technique do we use, because that indeed was the case with kava.
• 28:31
  Speaker 1: 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 is.
• 28:49
  Speaker 1: 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 flavouring and things like that, it was chocolate, it was the only way I could cover it.
• 29:05
  Speaker 1: Yeah, that's interesting.
• 29:07
  Speaker 1: There was this.
• 29:08
  Speaker 1: There's a whole story behind this about where I used to work, but anyway, um so I used to.
• 29:14
  Speaker 1: I had a bit of a name for covering the taste of herbs and um so I used to use chocolate and there was this.
• 29:20
  Speaker 1: I remember a.
• 29:21
  Speaker 1: It was like a shot of kava, it was called race 2000 and it was just.
• 29:26
  Speaker 1: It was so popular, it was fantastic and it was a really good quality product.
• 29:31
  Speaker 1: You'd get the numbing sensation from the carvapyrines, the carvalactones.
• 29:35
  Speaker 1: Yes yes, 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.
• 29:49
  Speaker 1: The issue in Australia never occurred really because of Carver, because if you look at the product which was blamed for the fulminant liver failure in somebody when it was reported, it also contained passionflower, 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 passionflower adulteration and the swapping, whether it be mistakenly for Stephania?
• 30:31
  Speaker 1: And this is the thing that annoys the hell out of me is this narrative?
• 30:36
  Speaker 1: It is a narrative and it's like just give us the truth, mate, you know.
• 30:44
  Speaker 2: 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 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 um, things do kind of get rushed through sometimes.
• 31:08
  Speaker 2: I think maybe they feel under pressure to maybe, you know, protect consumer safety and so they'll um kind of, you know, rush things through.
• 31:17
  Speaker 2: I know, as a member of the complementary medicines um 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.
• 31:36
  Speaker 2: But yeah, I think sometimes they do feel pressure.
• 31:41
  Speaker 2: You know that pressure of that.
• 31:44
  Speaker 2: You know they've got that responsibility of keeping the public safe, so let's do something.
• 31:48
  Speaker 2: You know we need to.
• 31:50
  Speaker 1: There's another part to that statement and that is pressure from who.
• 31:53
  Speaker 1: But anyway, we won't get into that, we won't get into that topic today.
• 31:57
  Speaker 1: What about warnings that may impact labels in the future?
• 32:01
  Speaker 1: Fi, yeah, well, that's.
• 32:03
  Speaker 2: Do you see anything on the horizon?
• 32:04
  Speaker 2: Yeah, we've kind of mentioned a couple.
• 32:07
  Speaker 2: I think there is going to be a warning that we're going to need to start putting on the label for turmeric products.
• 32:13
  Speaker 2: Yeah, and I'm also 90% sure we're going to see a warning coming out on withania products as well.
• 32:21
  Speaker 2: In the next probably 6 to 12 months 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.
• 32:40
  Speaker 2: That just means that we're in a transition period.
• 32:44
  Speaker 2: It doesn't necessarily mean that this product is going to potentially cause that, but but this one won't.
• 32:48
  Speaker 2: So, yeah, I think they're probably the two that we're looking at at the moment.
• 32:54
  Speaker 2: There is also some rumblings in the background about probiotics in pregnancy that we might just have to be aware of.
• 33:03
  Speaker 2: There was I think it was, a clinical study rather than a meta-analysis.
• 33:10
  Speaker 2: 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.
• 33:26
  Speaker 2: So there is a little bit of talk going around at the moment um about whether or not the TGA will kind of bring that to our attention and, um, maybe a label warning might appear on that, but I haven't had any confirmation on that yet.
• 33:45
  Speaker 2: That's just me kind of just thinking off the top of my head, but, um, yeah, I think just keep in mind, if that you know, if that does kind of come up, that these women were overweight to start with.
• 33:57
  Speaker 2: So the risk of hypertension was there.
• 33:59
  Speaker 2: That risk goes up when you're pregnant, as we know.
• 34:02
  Speaker 2: So is it just an association or is it a direct cause?
• 34:06
  Speaker 2: I think you can use your judgment there.
• 34:10
  Speaker 1: Yeah.
• 34:10
  Speaker 1: Yeah, that's a bit of a long bow, but it would be interesting to see clinical trials.
• 34:18
  Speaker 1: It would be interesting to see interventions and washouts with crossover.
• 34:23
  Speaker 1: Yeah, yeah.
• 34:25
  Speaker 1: What about resources for practitioners to learn about the changes?
• 34:30
  Speaker 1: Have you developed anything?
• 34:32
  Speaker 2: Yeah, we have just brought out just like a little three-page document that kind of it's like a guide, acts as a guide that goes.
• 34:40
  Speaker 2: That talks about some of the common allergens that you'll see on labels and what they mean.
• 34:46
  Speaker 2: So and we kind of go through.
• 34:48
  Speaker 2: You know, if you do see a sulphite warning on the label sorry, I'm just looking at it here, I've got it in front of me.
• 34:54
  Speaker 2: This is what it looks like.
• 34:55
  Speaker 2: It is actually on our website, in our clinic tools section of our website.
• 34:59
  Speaker 2: It kind of goes through.
• 35:01
  Speaker 2: You know, if you do see sulfites, then it might be because they could be in the soft gel.
• 35:06
  Speaker 2: Materialsites are naturally occurring in fruits and you knowa lot of complementary medicine.
• 35:13
  Speaker 2: Sponsors will use natural fruit powders to flavor their powdered products, so it could be coming from there.
• 35:18
  Speaker 2: They can also.
• 35:20
  Speaker 2: Sulfites can also be naturally occurring in mineral salts.
• 35:23
  Speaker 2: 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.
• 35:28
  Speaker 2: They can also.
• 35:28
  Speaker 2: Phenylalanine could also be used in soft gel material if it's animal derived as a natural amino acid component.
• 35:30
  Speaker 2: Um, they can also.
• 35:32
  Speaker 2: Phenylalanine is also quite high in things like spirulina, so you know it could just be a naturally occurring amino acid in there, so that the little guide that we've created kind of steps out.
• 35:42
  Speaker 2: If you see this, this could be the reason why it doesn't mean that we've actually added it.
• 35:47
  Speaker 2: Um, it just's a naturally occurring ingredient in some amino acids or something that we've used as an active ingredient.
• 35:58
  Speaker 1: So yeah, handy little guide I think the saving grace, if you like, of that issue with sweeteners is if it has phenylalanine and there is an artificial sweetener.
• 36:11
  Speaker 1: Regardless of whether it's a protein powder or whatever, the artificial sweetener Ascalfame or Aspartame must be listed anyway.
• 36:19
  Speaker 2: So there's your culprit, rather than the protein powder.
• 36:23
  Speaker 2: Yeah, yeah, exactly.
• 36:27
  Speaker 1: And what about, like you spoke about?
• 36:30
  Speaker 1: You know you're getting constant questions from customers, from naturopaths.
• 36:35
  Speaker 1: What about things like excipients?
• 36:40
  Speaker 1: Is there any change?
• 36:41
  Speaker 1: Oh, actually, forgive me, just about the probiotics.
• 36:43
  Speaker 1: I know this is slightly off topic, but we've had a huge since what?
• 36:47
  Speaker 1: 2022?
• 36:49
  Speaker 1: 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.
• 36:59
  Speaker 1: Are there changes afoot to bring that in line in labelling?
• 37:05
  Speaker 2: There is, but it hasn't been put in yet.
• 37:08
  Speaker 2: I think that one is still.
• 37:09
  Speaker 2: The last time I looked at that, there was something like a five or six-year timeline I think that the TGA was looking at.
• 37:17
  Speaker 2: So whilst it will happen, it's still a fair way off.
• 37:22
  Speaker 2: So there's been nothing legislated at the moment.
• 37:24
  Speaker 2: I think the TGA is still kind of looking into everything.
• 37:27
  Speaker 2: But yeah, I'd say, within the next five to 10 years we'll probably be seeing that change over as well.
• 37:34
  Speaker 1: They're waiting for the fires to die down about the furor that the biochemists forgive me, the microbiologists are having around the changes of Firmicutes to Bacillota.
• 37:44
  Speaker 1: It was a huge uproar in the scientist.
• 37:47
  Speaker 1: It was a massive fee.
• 37:50
  Speaker 1: Thank you so much for taking through.
• 37:51
  Speaker 1: I'm like I'm weird.
• 37:53
  Speaker 1: I get it like I actually get intensely interested in this.
• 37:56
  Speaker 1: But I understand this is the sort of drier end of the 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.
• 38:14
  Speaker 1: You know, oh it used to be this.
• 38:16
  Speaker 1: Now it's that.
• 38:16
  Speaker 1: Has anything else changed?
• 38:17
  Speaker 1: Oh, throw your hands up in the air.
• 38:19
  Speaker 1: 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, the more we can reassure our patients that nothing is wrong with the quality of the product.
• 38:31
  Speaker 1: It's really just the the, the um, the maze which we have to uh navigate with regards to regulatory requirements, so I can't thank you enough for knowing this stuff first off.
• 38:41
  Speaker 1: But also, I mean you, you have a passion for this stuff.
• 38:44
  Speaker 1: You need a lot.
• 38:44
  Speaker 1: I do but um I do.
• 38:46
  Speaker 2: Yeah, I'm a nerd, but I think can.
• 38:50
  Speaker 2: I just add there too.
• 38:51
  Speaker 2: Andrew, just pick up on a point you made there about patients needing to know this, I think I think practitioners need to be empowered with this knowledge as well and 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.
• 39:14
  Speaker 2: 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.
• 39:23
  Speaker 2: The TGA doesn't focus education to practitioners about changes either.
• 39:28
  Speaker 2: 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 I can.
• 39:37
  Speaker 2: 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 practice, that their patients, might have.
• 39:47
  Speaker 2: You know, if they see a warning and they find it alarming, where is this warning coming from?
• 39:53
  Speaker 2: Then the practitioner is the one that gets asked that question, not us.
• 39:58
  Speaker 2: So I think it's really important for the practitioner to know about this kind of stuff as well.
• 40:03
  Speaker 1: Well, it's actually a very good point you make.
• 40:05
  Speaker 1: And as a last question, if you like, the tga is based around public safety.
• 40:11
  Speaker 1: Does the tga have a public facing page where they actually uh list changes that have happened?
• 40:18
  Speaker 1: Because, trying to navigate to the tgo 92, you have to know exactly what you're after before you navigate to it yeah, exactly, if you want to go off piste a little bit, you're done.
• 40:30
  Speaker 2: Yeah, I don't think they do it in a very user-friendly way, and I know that that's something that us at the regs committee really kind of want.
• 40:41
  Speaker 2: 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.
• 40:50
  Speaker 2: 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.
• 41:00
  Speaker 2: We've also recently seen the head of the complementary medicine section retire, so we've got a new.
• 41:08
  Speaker 2: 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 going to be quite a breath of fresh air to the complementary medicines industry, I think.
• 41:19
  Speaker 2: 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.
• 41:38
  Speaker 2: 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.
• 41:46
  Speaker 1: 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 knowledgeable, so that we can reassure our patients.
• 41:58
  Speaker 1: Thank you so much for taking us through this today, pleasure.
• 42:02
  Speaker 2: Always a pleasure to talk to you, andrew.
• 42:04
  Speaker 1: And thank you everyone for joining us today.
• 42:06
  Speaker 1: Remember you can catch up on all the show notes.
• 42:09
  Speaker 1: There are going to be heaps of show notes for this one, plus all of the other podcasts on the Designs for Health website.
• 42:15
  Speaker 1: I'm Andrew Whitfield-Cook.
• 42:16
  Speaker 1: This is Wellness by Designs Music.