An interview with Katarzyna Wójcicka, chair of the Expert Council of the Polish Council for Supplements and Nutritional Foods (KRSiO), and Joanna Krakowiak, chair of the Ethics Committee of KRSiO and legal adviser in the Life Science and Regulatory Practice of Wardyński & Partners.
Why does the Polish Council for Supplements and Nutritional Foods need an Ethics Committee? Are unethical practices particularly common in this market?
Katarzyna Wójcicka: Every industry needs to have an ethics code, because unethical behaviour reflects on the entire industry. The market for food supplements is closely regulated, but to gain customers some flirt with the boundaries or sometimes cross the line. It is ethical to meet the needs of consumers, but unethical to try to create a need where there is none.
Joanna Krakowiak: The market for food supplements is highly fragmented, so the ethical standards followed by the industry vary. The role of KRSiO, and the Ethics Committee in particular, is to set high ethical standards and promote the principles of socially responsible business. Our activities primarily serve an educational purpose.
What influence can you have on the behaviour of companies that are not KRSiO members?
Katarzyna Wójcicka: Obviously an industry association is not an oversight institution. It is a voluntary association of businesses designed to help them function better on the market. But for the good of the industry, it is important for us to make non-member producers aware as well when they have crossed the bounds of good taste, e.g. in advertising. In the case of clear violations, we have issued letters and pointed out improper behaviour. Of course we have no enforcement authority, but in many instances it has sufficed. Often firms commit violations out of ignorance or because they are following poor examples from practices they see online.
Do you encounter the accusation that for example by denying producers the ability to refer to fear of illness, you are depriving them of a competitive advantage?
Katarzyna Wójcicka: Competitive advantages should be sought in quality and in good communications with consumers. In any event, our members do not advertise in this fashion. Such ethically dubious claims appear with products offered online which have never been notified to the Chief Sanitary Inspector.
Here is where we also perceive one of the main tasks of our association: to distinguish the legal market from the illegal market. A simple procedure should suffice—making consumers aware of the need to review the register of products notified to the Chief Sanitary Inspector. The register is available at the website of the inspectorate, but the current procedures do not guarantee that the consumer will find every notified product there. We are striving to ensure that every notified product is automatically included in the register and can easily be identified.
Notification alone does not guarantee that the inspectorate will not have any comments, but we would like to use this simple method for dividing the legal market from the illegal market.
What are food supplements exactly?
Joanna Krakowiak: A food supplement, as the name suggests, is intended to supplement the diet and not as treatment. It is a concentrated source of vitamins, minerals and other nutrients which exert a certain physiological effect on the human organism, but it is different from a medicinal effect. Based on this definition, in many instances it is difficult to determine whether a product is a food supplement or a non-prescription medicine. There are many “borderline” products. Every case should be evaluated individually, taking into consideration how the product affects people.
The second element of the definition concerns the manner of presentation. If the producer of a supplement ascribes medicinal functions to the product, it would be classified as a drug even if in reality it does not have such functions.
Katarzyna Wójcicka: Which does not mean that the product can be marketed as a drug, because its therapeutic action could not be demonstrated.
Joanna Krakowiak: In any event, the reality in Poland is that the average consumer does not distinguish between a food supplement and an OTC drug. So a major role of the association is to increase this awareness. An educated consumer is a huge asset for any firm. That kind of consumer knows what he or she is buying and why, and is less susceptible to empty slogans. That consumer also knows what substances are in the product and is aware that exceeding the recommended dose could be hazardous. So conducting educational initiatives reduces the regulatory risks to producers of foods, who might otherwise be held liable in the future for improper warnings concerning the possibility of exceeding the doses for vitamins, minerals and other substances from various sources.
Katarzyna Wójcicka: It should be borne in mind that foods and supplements are a special field. Through diet and supplements, we can stay healthy, but it is easy to do harm by using products of poor quality or in the wrong doses, not suited to our real needs, just as in the case of eating foods produced under improper conditions, outdated or in excessive quantities.
This is why we conduct a broad range of educational initiatives. We have started a mini social campaign on healthy, vitamin-rich eating. We published a children’s book, Maleńka nauka o zdrowiu (the Polish edition of La pequeña ciencia de la salud) by the Catalan-American cardiologist Valentín Fuster. The point is to instil in youngsters certain nutritional habits and a healthy lifestyle—to explain why one diet is healthy and another is not.
Together with the Food and Nutrition Institute, we have submitted a project to the National Centre for Research and Development called “Getting There Before the Candy Bar,” as part of the Social Innovations programme. We want to study how long it is possible to influence eating habits among children to prevent them from developing the habit of eating sweets. The point is for the child to reach for healthy, tasty snacks, like a carrot or an apple, instead of cookies or chocolates.
Are you worried that you might raise a generation that eats such a balanced diet they will not need food supplements?
Katarzyna Wójcicka: That’s a tempting vision, but entirely utopian. In today’s world it is impossible that there would suddenly come a time when we don’t need to supplement our diets with nutrients which we are not getting in our meals. Then a concentrated source of this ingredient in the form of a food supplement, when well chosen, can be beneficial.
What regulatory issues are particularly difficult for the industry?
Katarzyna Wójcicka: The main problem for companies is functioning on the market alongside products that are not registered or controlled. The state should implement instruments to better protect the legal market. This is important not only for producers, but also for consumers, because their safety is at stake.
The second thing is the lack of administrative procedures in explanatory proceedings. The result is that even though the product is present on the market, the proceedings can stretch out for years.
Joanna Krakowiak: This concerns the model adopted in Poland for implementation of the Food Supplements Directive. In Poland, introduction of a food supplement onto the market requires notification of the Chief Sanitary Inspector. As part of the notification procedure, it is possible to launch explanatory proceedings when there are doubts concerning the classification of a product. This could be an issue of the boundary between foods and medicines, or between a food supplement and a food for a special medical purpose. In such a case, the inspectorate will demand that the notifying producer submit an opinion showing that the notified product truly fulfils the declared characteristics. Explanatory proceedings are supposed to be completed within two months, but this does not count the time necessary to obtain an opinion, and thus producers sometimes have to wait for years for a final ruling.
In addition, the procedure involves a reversed burden of proof. In the standard situation the authority should at least substantiate its doubts with respect to the classification indicated by the producer, that is, formulate an allegation that the classification is erroneous. But here the inspectorate does not formulate such an allegation, but only requires the producer to present the relevant opinion at its own cost. In addition, the opinion of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is binding. Ascribing preclusive effect to an opinion regardless of its true weight is an oddity in Polish law.
But if a producer seeks to verify the correctness of the actions by the inspectorate, it may introduce the product onto the market and see whether the local sanitary inspector suspends sale of the product. There is a right to appeal against the decision on temporary suspension of sale of the product to the province sanitary inspector, and after that to the administrative courts. This can be an expensive solution, but if the problem is uncertainty whether a product can be marketed, it may be worth taking a calculated risk.
An example is Ginkgo biloba, a plant substance. There were doubts whether it could be used as an ingredient in a food supplement or only a medicine. This issue is resolved in various ways in different countries. In Poland the issue was decided through the administrative courts. Sales of a product containing this substance were suspended and through the system of appeals the case reached the administrative court. The court reviewed the actions of the sanitary inspectorate and issued a precedent-setting ruling, thanks to which Poland is now perceived as country favourable to ginkgo.
What actions is the Ethics Committee taking at the moment?
Joanna Krakowiak: We are conducting a review of the Ethics Code from 2006 to see if it meets the current challenges, particularly concerning online advertising and the most common mistakes made by producers. Often a manufacturer will advertise its product as “the only one on the market” or “the best on the market,” or as “tested” without specifying whether it means consumer testing or clinical testing. We want to identify current issues in marketing communications and address them in the Ethics Code, so that producers have practical guidelines on when specific claims are permissible and when they are not.
While this area is largely covered by legal regulations, the role of an industry association and an industry code is to supplement the existing regulations and provide interpretative guidelines for market practices. This can provide very practical tools that may be used for example when interpreting the regulations in litigation between competitors or disputes between producers and consumers. The courts may also resort to “soft law,” including industry ethics codes, as guidelines when interpreting generally applicable regulations.
What is the future for the food supplements and nutrients industry?
Joanna Krakowiak: The prospects are very promising. It is estimated that the value of the food supplements market will grow in value worldwide by 4–5% per year, and in Poland even 7–9%.
Katarzyna Wójcicka: In terms of the types of products, the absolute future is personalised food supplements. Because they are designed to complement our diets, each of us needs to strike a slightly different balance. Everyone has his or her own favourite dishes and certain items they won’t eat, which means that they get too much of certain nutritional elements and not enough of others.
Joanna Krakowiak: A food supplement may be adjusted to suit one’s genotype, or specific bacterial flora. The most studies in this area are being conducted now in the United States. Based on testing, it is possible to blend a product to suit the specific consumer. But this brings us to another difficult area, involving cooperation between the food industry and medicine, especially through healthcare professionals.
Katarzyna Wójcicka: Particularly in Poland, doctors are not prepared for preventive medicine, to tell patients what they should eat and what they should supplement to stay healthy. Their attitude is geared toward patients, not consumers, but prevention is cheaper than treatment.
Interview conducted by Justyna Zandberg-Malec