Natural is not Equal to Safe - A Conversation on Nutrivigilance

Not all risks come in prescription bottles!

Tune in to IVPN Pharmacovigilance’s newest podcast episode featuring Dr. samer mohammed, Founder and CEO of VigiPulse and one of the most prominent advocates for nutrivigilance across the region.

In this episode, Câline J. Saade, also unpacks Dr. Samer’s publication titled: “The Importance of Nutrivigilance in Middle East Countries and the Necessity for Incorporation into PV Health Authorities Regulations”. 

Transcript

SPEAKER_01 0:12

Hello to everyone tuning in and welcome. This is Kaleen Saade from IVP and Pharmacovigilance. Welcoming you all to our fourth podcast episode titled Natural Does Not Equal Safe. This is going to be a conversation on Nutri Vigilance. I will be your host for today, and I'm thrilled to be joined by Dr. Samir Mohammed, who has been part of really the early building blocks of IVP and Pharmacovigilance and who is a strong advocate for Nutri Vigilance. So to start, I'll briefly introduce Dr. Samir. Dr. Samir Mohammed is a pharmacovigilance consultant and trainer and the CEO and founder of Vigipul, the first consultancy service in Iraq dedicated to pharmacovigilance. Over the years, he has represented around 20 marketing authorization holders, including both local and multinational companies, as well as approximately nine CROs. He also acts as a PV consultant for several local distributors and manufacturers. Dr. Samir has represented IDOC in the ISOP Middle East chapter since 2021 and currently serves as a scientific advisory board member within IVPN Pharmacovigilance. Academically, he holds a PhD in pharmacology and is the associate dean at the College of Pharmacy at Al Rafa Fidain University. And he has also contributed to several publications focused on PV, particularly with a focus on raising awareness and strengthening practices in the field. Dr. Samir is also an IRCA certified lead auditor in ISO 9001. Thank you very much, Doctor, for joining us today to uh share your experience and reflections on this very important topic that is really resurfacing in our times. And I'm certain that this will be a very enlightening discussion.

SPEAKER_00 2:02

Thank you, Calleen, for your uh brief introduction. Thank you for having me uh in this um important podcast. It's really my pleasure uh to participate or to be a part of this important committee, which is IVPN Pharmacovigilance Committee, and to participate with the uh with the other, with the uh the rest incredible team, uh improving the awareness of pharmacovigilance in different aspects like regulatory and like academics, like pharma industry in our region.

SPEAKER_01 2:38

Thank you, Dr. Samir, and it's really an honor to be growing this space alongside people like you and definitely the IVP and XCO. So, Dr. Samer, if we were to lay the groundwork or the foundations for this episode, how would you define NutriVigilance and why has it not evolved at the same pace as traditional PV systems?

SPEAKER_00 3:00

Okay. Um, let's first uh define what's the neutral vigilance, which could be defined as a systemic time-space monitoring, evaluation, prevention of adverse events that's related to product uh rather than medicine, like like food, dietary supplements, herbals, um, or and similar health-related products. So the core objective here, it's like that for pharmacovigenus, but with different in uh in medicine or in products here, which is the uh pharmacovigenus is the early detection, assessment, and prevention of risk and revoluse. But here we apply it on non-medicinal products rather than medicine. Regarding the second point is why neutral vigilance has not the same pace for pharmacovigilance. This is maybe attributed to several reasons. Historically, most of national and international frameworks treated these products primarily as food rather than medicine, so they were not integrated in formal pharmacovigilance system. In addition to that, regulatory standards for pre-marketing evidence, like quality and post-marketing surveillance, is uh are less stringent or maybe heterogeneous, which is one of one of the common of drawback is the here is the under-reporting for for neutrovisions or for neutracy, which is even more pronounced than that for for medicine or drugs. Because both healthcare professionals and patients uh frequently underestimate the potential for harm, which is the data regarding the neutracy. Uh, furthermore, the sector is highly fragmented, which means that there is a huge number of small and medium-sized manufacturers for neutrocycles. And there is many extensive online and cross-border trades. These all make the structured or mandatory surveillance state is harder than that uh when compared to the medicine.

SPEAKER_01 5:17

Thank you, Dr. Samir. So we can really say that the reasons behind this uncertainty are multifactorial. And as you mentioned, patients sometimes maybe underestimate or maybe don't have the optimal set of knowledge to deal with a subject such as nutrient vigilance. So this brings me to my second question. Um from the consumer perspective, we can see that many individuals tend to associate natural with being inherently safe. So, from a scientific perspective, how misleading is this assumption?

SPEAKER_00 5:54

This is a common mistake, the assumption of natural means safe. Um scientifically it is not correct. Uh but commercially they always uh advertise that is all uh natural products are safe. Um while many potent toxins are entirely uh natural, and the body, as you know, the um does not differentiate between natural and sensitive. Uh there is many risk, it could be specified uh or depend on the dose, on pharmacokinetics, dynamics, uh, or maybe related to the individual's susceptibility, or even there is interaction between uh between food and and and even with medicine. From scientific point, we usually encounter several risk patterns, including those dependent toxicity. As you as you know, this is called type A or augmented toxicity, which depending on the dose of uh products, uh like taking high dose of fat-soluble vitamins or maybe multi-ingredient supplements. Also, there is maybe product quality issues like contamination of uh of products and a clinical significant interaction uh between medicine or products.

unknown 7:28

Dr.

SPEAKER_01 7:28

Samus, you also mentioned that uh nutraceuticals um spans really a broad scope, such as uh dietary supplements, herbals, there could be some animal-derived substances or even fortified foods. So, as a continuation to this question, how does this heterogeneous classification complicate safety monitoring and signal detection?

SPEAKER_00 7:52

This is a good point. Uh, for Mocovigen's professionals, one of the main challenges is the extreme heterogeneicity of products uh that you mentioned. So, under the umbrella of neutrocycles, we could find vitamins, minerals, herbals, uh, animal-derived products like fish oils, probiotic, functional foods. Um, each class differs in the regulatory status, in exposure patterns, in mechanism of action, in risk profile. Also, there is uh diversity that could complicate uh the pharmacovigilance functions. Uh, here a case assessment becomes more challenging than when compared to the medicine. And in addition to that, signal detection is hindered by low reporting, and there is uh one in which large background of non-specific symptoms and poly exposure to multiple products, in which the patient may combine multiple uh supplements with multiple medicine. Uh also there's cross-country differences in classification. One of the country may classify these products as food, other may classify this as traditional uh medicine, the other classified may be classified as a drug or medicine. Meaning this this same active constituent may appear in different databases. So building good neutral vigilance requires adapting several pharmacovigilance tools, terminology, like uh coding practice, causality assessment framework, in order to overcome this huge heterogeneicity.

SPEAKER_01 9:38

Absolutely. And I can imagine how tricky it gets if there's the same product category, it can vary widely in composition, it could uh vary in source, extraction method, manufacturing process. So even looking at the nitty-gritty details, it's tricky. It's difficult to attribute an adverse event to a specific ingredient or a product. So, Dr. Simon, if we move more into the regulatory scene, unlike uh pharmaceuticals, many supplements enter the market without pre-approval for uh safety or efficacy. So, what risks does this create from a public health standpoint?

SPEAKER_00 10:18

This is true. Uh, when supplements and related products uh reach the market with limited or no pre-marketing evaluation for their safety and effectiveness, the actual risk management strategy here will become purely uh depend on on parfum marketing rather than on there is no uh and maybe reactive more than proactive. And this means that first line detection of safety issues uh depend on spontaneous report from healthcare professional and and consumers in situations where the awareness uh in our region and reporting culture are still weak when compared to other countries or other regions. While the consequences here, um, which is well known to pharmacovigilance, that is delayed recognition of many adverse events uh or or signals that may arise through using of these neutrocyticals. Most of them may lead to hepatotoxicity, hypothetical events, nephrotoxicity, serious hypersensitivity, uh and other uh events might may be arised through using these neutrocyticals. So um once safety concern is recognized, the distribution channel, especially e-commerce channel and formal marketing, may make risk minimization measures and recall uh are more complex.

SPEAKER_01 11:55

Absolutely, absolutely, Dr. Samir. If we take a look at the literature, uh it also really highlights a structural concern here. So when there's the absence of strong regulatory oversight, consumers often rely on those claims or even on manufacturers' claims. Um and this brings to rise the point of potential conflicts of interest, or maybe consumers may uh depend on other independent watchdog groups for safety information. So, for you, what would an independent and credible oversight realistically look like?

SPEAKER_00 12:30

Okay, uh independent and credible oversight require that safety evaluation is not left on the commercial interest for manufacturers. In practice, we could apply here several means to enhance the neutral vigilance. Uh, let me uh uh suggest several points here. We could uh assign a clearly national or regional competent authority with mandate to collect, analyze, and act on reports uh that related to supplement on certain categories of foods with access to their toxical toxicity, clinical and epidemiological expertise. Also, we can add legal obligations on manufacturers and distributors to maintain an internal neutral vigilant system through documenting uh um any uh product complaint and uh adverse event, conducting periodic uh signal review, uh reporting serious uh or unexpected cases within different different or uh timelines. Also, in addition to that, we can uh integrate neutral vigilance into current pharmacovigilance database in current regions with appropriate coding for product type or composition and suspected uh interaction. So this that's this would um uh um ease detection of uh signal here. Also, we can add transparent risk communication like regular public uh journals or targeted safety alerts, and clear criteria for label change, warning uh or sales restriction, or even withdrawal of products from market. Furthermore, we should build a governance mechanism to manage any conflict of interest. For example, uh independent expert committees to review signals and recommended action or recommend action that's separate from bodies dominated by industry representatives.

SPEAKER_01 14:39

These are very practical how tools that we can definitely implement across the region. And you actually answered my next question where I was willing to ask you if you believe that nutrient vigilance should be integrated into existing pharmacovigilance system or whether it requires a distinct regulatory framework. And your answer is quite realistic because it's really challenging within our context to build a framework from scratch and having it be accepted or validated for use. And definitely it's not a one-size-fits-all approach. Uh Dr. Samir, if I were to move more into global or regional perspectives and starting with a global viewpoint. In the United States, dietary supplements are mainly regulated after they reach the market. Um, on the other hand, in Europe as well, there isn't any single harmonized EU-wide nutrient vigilance system, and supplements can move freely across borders. So, how do these different approaches affect consumer safety? And what strengths and weaknesses of the US and European systems should countries in the MENA region consider when they're developing their own nutrient vigilance uh framework or capacity?

SPEAKER_00 15:50

Okay. Um, as regarding US and uh and Europe, there is a different model. For uh for pharmacovigilance US model, they emphasize on on uh pre-marketing environment for that supplement. Uh also rely on post-marketing controls, uh, on the manufacturing and reporting of serious adverse events. This enables the rapid marketing expansion with uh enforced with uh with uh post-marketing surveillance, uh enforced capacity and rapid regulatory response about emerging any safety issue. While in Europe there is no single harmonized EU neutral vigilance system, but there is some countries have established formal neutral vigilance schemes that attach to the food safety agencies or public health institute, they're generating structured case series, signals, and periodic report. While free movement of goods across European countries, however, means that the national system must coordinate effectively to be fully protective to all these to all these regions or these countries. As regarding the second part of the question, which is how could be reflected in the MINA region, both these models could offer several lessons from US the importance of clear definitions and applications from manufacturers and strong enforcement when safety problems arise. While from Europe, the value of dedicated neutral vigilance program within food or health agencies and the use of structured expert assessment of cases. So when designing frameworks, MINA countries also can plan these elements while taking into account local epidemiology resources constraints and even existing pharmacovigilance and food safety infrastructure.

SPEAKER_01 17:45

Thank you, Dr. Samir. And it's quite interesting how each model reflects a different type of gap, and ideally, we would want to bypass them all. So if we were to focus more on the MENA context, what do you think are the main challenges to implementation or even opportunities to build these structured systems?

SPEAKER_00 18:05

So, as you know, Middle East countries face this combination of rapid market growth and supplement on functional foods, but due to variable regulatory maturity between different co among uh different countries, and um due to significant cross-border trade, there's still several challenges like fragmented responsibility across these agencies or ministries, limited staff, um analytical capacity for non-medicinal products, and uh uh also the low awareness among clinicians, about among healthcare professionals, about need to report adverse events. At the same time, there are many opportunities, and with several MINA countries have already established pharmacovigilance centers and regional pharmacovigilance networks. This could be leveraged and expanded to include also neutracy without building a new structure. Also, the opportunities for regional harmonization initiatives, whether within Gulf countries or broader minor collaboration, this could support common reporting formats and gathering signal detection or shared regulatory responses. And also for Marcovigen's professionals and healthcare professionals, there's an opportunity to position themselves as a key actors in building these systems through education, through uh case reporting, through participation in expert committees and etc.

SPEAKER_01 19:45

These are very, very important points, uh Dr. Samir. And uh this really opens up the window to our last theme, which is the way forward. And here I'd like to ask you about your December 2025 article titled The Importance of Nutry Vigilance in Middle East Countries and the Necessity for Incorporation into PV Health Authority's regulations. Establishing structured Nutri Vigilance uh within Middle Eastern pharmacovigilance regulations is an urgent public health priority, as you stated. So if you were advising regional regulators today, and you mentioned earlier that there are multiple areas for uh opportunities and growth, but to you, what are some foundational non-negotiable steps that you would prioritize to build a sustainable system?

unknown 20:32

Yeah.

SPEAKER_00 20:33

Uh from my point of view, I would recommend uh phase system building approach. Uh that's I prefer to uncurb this neutracy in existing pharmacovigilance. Um, and with some uh steps we could add to this system, like clarify the scope and definition through defining uh which category fall under neutro vigilance. Uh we should focus on on dietary supplements, herbals, and etc., and specify how they interface with existing uh drug and food law. Uh, also they could establish legal and institutional mandates to amend pharmacovigilance andor uh food safety regulations to give designed uh authority a clear mandate for receiving and assessing the reports on these products and to set reporting obligations on manufacturers and healthcare professionals and even consumers. We could also expand the Canon Pharmacovigilance database and reporting tool to capture also the neutral vigilance relevant field. Also, we could train pharmacovigilance staff in issues that are specific to supplement in addition to that of medicine. Also, they should give some propriety or high priority to high risk product categories, especially these. That is related to weight loss supplements, like sexual performance and bodybuilding products, or these products that injected with high or or taken with high dose, or this product that's marketed for children, for pregnant women, and etc. Also, there is another recommendation is to develop standard operation operating procedure or guidance about how to take uh the safety event, how to coding, how to causality assessment, how to detect signals, and etc. Uh final recommendation is to embed the regional collaboration, as I said before, to share the data, the safety signal, with neighboring countries or within the same region, to recognize that there is a specific event with this product, and uh there is uh especially those uh covered with with e-commerce, that's not confined by borders. All these steps don't require immediate or large-scale investment, but they set foundation for sustainable, scalable, uh neutral vigilance function.

SPEAKER_01 23:18

I wholeheartedly agree, Dr. Samir. And on the other hand, if we were to take the perspective of healthcare professionals that are practicing or even consumers from the other end, what advice would you share with them?

SPEAKER_00 23:32

Okay, uh, we have here uh several advice to uh specialize to uh to each point you you mentioned. So, my advice to manufacturer or MAH uh we should treat post-marketing safety surveillance as a core component of product uh stewardship and plant protection. Uh, this is could be through implementing the internal neutral vigilance process through their system collection and evaluation of any product campaign or suspected adverse event, periodic signal review and promoting reporting of series of unexpected cases. Also through ensuring uh effective quality system in their institution and align promotional materials and labeling with evidence under regulatory requirements, including uh appropriate warning and contraindications. So, this is my advice to MIH and manufacturer. As regarding to healthcare professionals, is uh through uh I my advice to them is to uh include the question about supplement herbal when taking medication history of patients when there is any adverse event report. When you face a clinical event, especially those with hepatic uh dysfunction or renal dysfunction, CNS event, we should consider also supplement and food in addition to that of medicine. In addition to that, uh they also should engage in patient uh education, emphasizing on appropriate indications and duration of use and the risk of polypharmacy that includes multiple supplements. So, also my advice to consumers uh I encourage uh patients to disclose all products that are taking, whether they are uh prescription or through or uh uh over-the-counter products, uh, herbal products, and etc., to allow comprehensive benefit risk assessment. In addition to that, self-medication with multiple supplements, especially in the presence of chronic disease, should be discussed with healthcare professionals before using early reporting of unexpected symptoms allow clinician and pharmacoviginal systems to protect not only the individual patient but also the wider population.

SPEAKER_01 26:06

So um, based on our conversation, we can really say that improving safety in this space is multifaceted. It really requires shared responsibility across all stakeholders, from government to MAH to HCPs and patients, and definitely communication, having communication at the core. And um definitely it being a proactive approach rather than a reactive approach. Um, Dr. Samid, are there any other further observations that you would like to share before we wrap up this great episode?

SPEAKER_00 26:41

I really um thank you for uh um for having me today. Uh um I really thought that I covered all the aspects from uh from uh from my point of view regarding uh the neutral vigilance. Uh I also um as you say before, I um uh uh uh published an article or manuscript about this uh detailing uh uh uh or could all details of uh how to um uh put the neutrovigilance or incorporate it within the pharmacovigilance. Um as I mentioned before, it's already present in several countries nowadays in the MINA region. I talked with many uh healthcare professionals in different countries, uh in Gulf Country, in Egypt, they already incorporate the pharma uh uh neutracy within the pharmacovigilance system without uh specifying the these regulations for uh neutracy and the other for medicine. So the difference as I said before, um some countries is consider uh the food with this food agents food with food agencies, like it uh trade ministries, uh, in our situation in our in my country, uh this is not responsible, and the health authority is not responsible for for food or food products. So the the problem is here. So in this case, they should uh improve or should uh build uh a new system or a new monitoring system uh just for neurocyticals here.

SPEAKER_01 28:33

Absolutely, Dr. Samaj. Uh there are quite uh vast areas of improvement here. Uh but as you mentioned, uh surrounding countries can definitely share their best practices with us and carrying these best practices forward instead of replicating uh potential mistakes that may arise. And again, I want to thank you very much for your observations and for this wonderful exchange. Uh, uh I'm upset that that this episode is ending, but it was truly a pleasure hosting you and uh to our listeners. We really hope you enjoyed this episode as much as we did. And we will be linking Dr. Samir's NutriVigilance article in the podcast episode description if you'd like to read it. Um and definitely stay tuned for our next episodes. And as always, you can reach out to us whenever to share your thoughts and feedback through all IDP and PV platforms. Thank you very much, and we'll talk soon.