How are dietary supplements produced and tested?

Dietary supplements are treated by law as food, but users perceive them as closer to drugs. They look the same and are sold mainly in pharmacies, not grocery stores (with exceptions). However, the requirements regarding production and control standards of medicines and dietary supplements differ significantly.

Izabela Wawrzyniak, operational director of Eubioco, told NikeLIVE on Instagram what it looks like from the inside. It is one of the largest Polish contract manufacturers of medicinal products and dietary supplements, which has been producing products to the highest pharmaceutical GMP standard for over 30 years. You can listen and watch live at this link .

It is often said that dietary supplements are inferior to medicines in quality and that they can be produced even in a garage because no one checks it. Is this really the case?

Izabela Wawrzyniak: Maybe not in the garage, but for the production of dietary supplements only the minimum requirements must be met. Let me start by saying that we have 2 different regulations when it comes to drugs and supplements. Medicines are supervised by the Chief Pharmaceutical Inspectorate , while dietary supplements are supervised by the Chief Sanitary Inspectorate . The legal acts and requirements for these two different forms are completely different. Medicines must be registered with the Office for Registration of Medicinal Products and to do this, a lot of work must be done, documents confirming the effectiveness of the medicine must be presented, evaluations of the suppliers of the ingredients of the entire formulation must be presented, a number of quality tests must be presented , and it must be shown that the place where the medicinal product is manufactured has a certificate of compliance with GMP . This is a necessary legal requirement to guarantee the quality of products throughout their shelf life. In the case of medicines, attention must be paid to the preparation stage of the production process to ensure the quality of the final product. However, when it comes to supplements, the regulator does not require the same set as for drugs. It really requires minimal things, i.e. the supplement is allowed on the market on the basis of reporting the declared product composition to the Chief Sanitary Inspectorate (GIS). This should not relieve producers of dietary supplements from responsibility for the final composition of the product. Because if they take care of the ingredients at the preparation stage, like for medicines, the more high-quality product we will have. By voluntarily choosing a high drug standard (GMP) , the manufacturer simply cares about quality.

Do many producers of dietary supplements available on the Polish market decide to produce their product in accordance with the rules applicable to medicines?

I regret to say that there are still not many manufacturers who produce supplements to the highest GMP standard. Probably because there is no obligation to certify supplement manufacturers , it is voluntary. And as we know, quality costs money. For now, the market looks like this, with many manufacturers wanting to compete on price . This year, the Supreme Audit Office published a report that, among other things, presents how GIS verifies dietary supplements first introduced to the market. The results presented in the report are chilling. It turns out that only 5% of over 62,000 dietary supplements introduced to the market in the last 3 years have been verified. This shows that the remainder did not even pass this first verification.

So we don't know what's inside these supplements?

We do not know. And this shows how much we depend on the honesty of dietary supplement producers, and that there is a high probability that we will come across a low-quality product on the market.

And why does this situation occur? GIS doesn't have enough power to check this?

The last 3 years have certainly been difficult. The pandemic period has imposed a lot of responsibilities on the Sanitary and Epidemiological Station, which certainly prevents it from exercising the kind of supercontrol it should have. The Sanitary and Epidemiological Station will certainly improve this control in the future, but for now we have it as we have it. You need to be aware of this situation.

You mentioned that producers prefer to compete on price. Indeed, we can find supplements on the market that cost a few zlotys, but they are also really expensive. Does this mean their quality is better?

Unfortunately not. A high price does not automatically mean that the product is of high quality. The cost of a supplement consists, to put it simply, of the cost of capsule or tablet ingredients, production cost and packaging cost. For many manufacturers, up to 80% of the product cost can be devoted to packaging to create the appropriate marketing effect, to break through the competition, to create the impression of "premium". So we often have a high price, which is driven by the price of the packaging. And this means that only 20% is devoted to what is most important in the supplement, i.e. what should draw our attention first and foremost, what can improve our well-being. And the packaging is not the most important thing. Honest producers pay attention to what's inside , set high standards for themselves, care about product quality and decide to produce in accordance with GMP drug principles.

Nikalab dietary supplements are manufactured according to such GMP principles. Could you explain to us more specifically what this standard is in practice?

GMP is an abbreviation for Good Manufacturing Practice . It applies in many areas. However, when it comes to medicines, these requirements are regulated by the Regulation of the Minister of Health. This is a legal act that every drug manufacturer must comply with. To meet GMP standards, a drug production plant must have a pharmaceutical quality system and a GMP certificate issued by the Chief Pharmaceutical Inspector. To obtain such a certificate, the manufacturer must maintain the highest standards of supervision over rooms, devices, microbiological cleanliness of the entire space, supervision over production, storage, staff competences, and, of course, research and product quality . In the GMP standard, in accordance with the requirements, all stages are subject to mandatory control, inspection and documentation. And the supplement manufacturer can only voluntarily choose this standard, because the law only requires general hygiene of the process. GMP means super control over super production conditions.

Let's assume that the supplement has been manufactured. One in the GMP standard, the other in the minimum hygienic standard required by law. What other tests must both of these supplements undergo before they go on sale?

There can be a big difference here. Let's imagine a supplement that was not manufactured in accordance with drug principles. Mandatory tests for it include microbiological purity and heavy metal content , as well as several others depending on the composition of production. This is the absolute minimum. And you don't need anything more. The manufacturer only submits the composition declaration to the GIS. In the case of supplements, the Sanitary Inspectorate sometimes randomly takes samples from the market to check whether, for example, the vitamin D content inside such a capsule is consistent with the declaration. However, if it turns out that the vitamin D content is too little, less than the manufacturer declares, there is no obligation for the product to be withdrawn from sale because it is still considered safe for health. And the fact that it does not contain the same content as on the label does not matter. The manufacturer is obliged to withdraw a dietary supplement only if it turns out that its composition poses a threat to life or health, i.e. if it contains, for example, any microbiological contaminants, heavy metals or ethylene oxide in a random sample. But the manufacturer does not have to test this for each series. It also has to check the product's stability during the shelf life, i.e. whether the product's composition is still consistent with the declared one.

But if we take medications, do we have to perform such a test?

It is mandatory for medications. Similarly, with medications, it is necessary to test each batch. In the case of supplements , not every series undergoes these additional tests . For example, if it turns out that there is a medicinal product on the market that does not meet the declared content, the manufacturer is obliged to withdraw such product. In the case of supplements, there is again the voluntary nature of an honest manufacturer who can withdraw a product. So the difference in quality control is dramatic. GMP guarantees us much higher quality if the supplement manufacturer decides to voluntarily submit to these requirements.

What about the so-called research? independent laboratories? Some supplement manufacturers like to boast that they have them.

If a supplement manufacturer boasts that it tests in an independent laboratory, this tells us that the manufacturer does not have its own laboratory and sends product samples outside. What I would check and what I would recommend everyone to check is whether the laboratory is accredited and certified. But these are still those minimal “samplings” I mentioned earlier. We are not sure that all product batches have the same composition as the samples sent to the laboratory. Drug manufacturers have laboratories and quality control within their facility and this is certified quality control, in accordance with GMP . This guarantees better quality, requires testing of all product series at all stages and guarantees the reliability of the results. Only a certified laboratory provides reliable results. It's independent - we don't know, it still has to be accredited or certified, and at least meet some standard. In addition, the GMP laboratory also has staff who track the requirements for drugs or supplements that change and implement them. An independent laboratory has no such obligation.