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American Botanical Council: Exploring and preventing safety risks in herbal supplements
22 Aug 2024 | American Botanical Council
We sit down with Stefan Gafner, Ph.D., chief science officer at the American Botanical Council, to discuss companies’ and consumers’ safe and responsible use of botanical supplements and herbal medicines. Although he tells us that the risks associated with such products are low, they are not zero. More serious adverse events include liver toxicity and potential issues in more vulnerable subpopulations. Gafner explains that the botanical industry aims to minimize these risks by examining data on an ingredient’s history of safe use and performing additional testing if there are indications of potential safety issues or if limited data is available.
This is Yolande van Gaal.
I'm a senior journalist at Nutrition Insights, and today I'm joined by Stefan Gaffner, who's the Chief Science Officer at the American Botanical Council.
Thank you for joining us today.
And I wanted to just straight away, ask the first question, which is, what are some of the main consumer safety concerns regarding botanical supplement use?
Because I know you've done a lot of research, in this area, and what would you say about the validity of those concerns?
First of all, Joanna, thank you very much for inviting me to comment and giving us an opportunity to say a few words.
Safety has been on the mind of many people and I thought about an answer for the question.
I go back to my classes in Phytochemistry, as a pharmacy undergraduate where we learned that the herbal medicines are Usually, the effects are quite mild, may take a little bit longer.
But also the risk of adverse events.
Is really low and having said that, what we most often see as adverse events are really mild gastrointestinal complaints, allergic reactions, skin eruptions, for example, or nervous complaints like stress or anxiety that are linked to the botanical product that people use.
Your question is, what are the Biggest safety concerns, I would think for more serious adverse events, and, I would say that's probably liver toxicity overall.
And also if you look at population.
People are mainly concerned about adverse events in babies and young children, pregnant women, obviously, again, that they could harm the future baby.
And so these are the concerns as a pharmacist that I am most often confronted with.
Are these concerns valid?
As I said before, the risk is really low, but it's not non-existent.
So there are some sensitive populations.
There are some botanicals that may have a higher risk of, adverse events, and every now and then we do see a serious adverse event.
So we certainly have to make sure or do a good job in trying to reduce the risk in as much as possible.
And I was also wondering, can you tell us a little bit how the industry itself, so the botanical industry, how do they minimize those risks that you highlight?
Sure.
First, I think the industry, if they do a safety assessment, they would go to the literature and see if for the ingredient they are considering putting in a product, if there are any signals of toxicity.
If it has a long history of safe use.
And they use an ingredient that has a similar use as the traditional use, then I think that's probably fine.
If there are some signals, then industry will do.
In silica, in vivo, in vitro assessment, and possibly human clinical studies to figure that out.
I think that would be the way to go.
So I also wanted to highlight here the efforts by an industry trade organization, the American Herbal Products Association.
They have produced the botanical safety handbook, which has a lot, a lot of good information about the The potential risk when using botanicals.
So that's another effort by the industry, but in general, it's, done by research, as I said, if there is a lot of data on traditional use, the additional tests may be less, thorough than if you have a new extract where there's not much known about where you have to do all the In vitro, in vivo and human clinical studies to prove that the ingredient is safe.
OK, that's very clear.
And in terms of the American Botanical Council that you work at, so, what is the role of that organization in addressing botanical safety concerns?
So we're an educational organization that promotes the safe and responsible use of herbal medicines.
With regards to safety, we have a number of articles in our flagship journal Herbalgram that address the safety concerns of a number of botanicals.
If there are specific questions, we usually collaborate or we pull in experts in safety, for example, that's one thing we've done, on a recent study on, that came out in JAMA Network Open where we, contacted a number of experts to, comment on, the study and Additionally, I have been involved personally almost since its inception in an organization or in an initiative called the Botanical Safety Consortium, which is a public-private partnership that looks at the Available tools in silicon and in vitro tools to assess the safety of botanicals, and I've been particularly involved in the two working groups.
One is on neurotoxicity and the other is on thermal safety.
So that's, I think, a very interesting approach and Research initiative that I think we'll hear quite a bit more in the future.
Interesting to to hear that, yeah, and you already mentioned this, this research in the JAMA network Open, that looked at percentages or estimated percentages of US adults that use 6 botanicals that were linked to case reports of liver injury or he hepatotoxicity.
Which you already said in the beginning was an important risk, safety risk for botanicals.
They highlighted six botanicals, turmeric, ashwaganda, black cohosh, garcinia, green tea, and red yeast rice.
What would you say are the known liver injury risks for those botanicals?
First, I think we need to distinguish, particularly for green tea and turmeric, the use as a beverage in the case of green tea or as a spice in the case of turmeric, which both of which have a really long standing.
Use history and, both, in both cases, I think the risk of adverse events is extremely low.
And, so this is a different, Kind of use and if you use a highly concentrated, let's say epigallo catechin galate, which is one of the constituents of green tea, or curcumin, which is a constituent in turmeric.
If you have an 80%, 90% purified curcumin extract, that's not the same as using turmeric as a spice.
If we look at the popularity of these ingredients, and again, I think all of them are fairly popular, but certainly green tea and turmeric are highly popular and the number of cases of liver injury is, is really, really very small in relationship to the.
Number or dosages that are used every day.
Again, having said that, the risk is not zero, and I do believe that, especially in People with a genetic predisposition, liver injury is a small risk, and I think it's important that the We are aware of that.
People are aware of that, that if they notice a change in their.
Digestion in their liver, if they have pain or something that would suggest the liver injury that they would also consider that one of these Dietary supplements could be the source of it and then talk to it with a health professional or stop using it.
Yeah, yeah, yeah, very clear.
And in addition to that, what other things do you think consumers can do to ensure that they use botanical supplements in a safe way?
There are a number of things.
First and foremost is to Get your supplement or buy a supplement from a reputable brand, so you have some insurance that, or you have good insurance that what's written on the label is actually what's in the supplement, and I say that because some of the adverse events that we have seen that were linked to dietary supplements were due to, adulteration, so that unfortunately happens.
Also, what I would suggest is that people follow the dosage regimen.
One thing that can help is, for example, if you take the supplement with a meal, often that reduces the risk of adverse events rather than taking it on an empty stomach.
And as I said before, if you have any doubts that you may be subject to adverse events or if you know that you have a Condition that may lead to an adverse event when using a supplement, it certainly, Important to be cautious and maybe talk to a health professional or in certain cases also just not use the supplement.
OK, thank you so much for this insights, Stefan.
Really useful.
















