Significant legal changes are underway in the market of products notified to the Chief Sanitary Inspector (GIS), including the segment of dietary supplements. The draft law that will introduce them will probably come out next year, Mateusz Pazdan, President of SFD, a leading manufacturer of nutritional supplements for sportsmen and sportswomen, and Business Centre Club (BCC) expert, said in an interview with PMR.
Fees and inability to sell immediately after notification
According to the current regulations, there are no fees for notification of dietary supplements. Sales can be started immediately after notification. The entrepreneur takes full financial responsibility for the possible withdrawal of the product from the market, as well as the liability for damages to the consumer for possible damage to health.
– Due to the new regulations, as we can hear at training courses run by pharmaceutical organisations, we must be prepared for the fees and inability to sell products until the application is processed. At the moment, it can take up to several years. It may lead to the withdrawal of some products from the market and price increases due to lower competition and additional costs of introduction to the market – says Mateusz Pazdan in an interview with PMR. As the President of the SFD emphasises, the planned fee for each notified product in the amount of PLN 1,000 will significantly affect smaller and medium-sized domestic food and dietary supplement producers in particular.
In addition, according to one of the proposed changes, companies that have previously submitted GIS applications will have to pay for the pending notifications. In the case of long-term waiting time, this means several hundred thousand zlotys of fees. Adding to this the ban on trading until the acceptance of the notification, it may lead to bankruptcy of many smaller players.
GIS limits plant components and active substances
Another planned change is the creation of a catalogue of plant ingredients permitted for use in dietary supplements with their maximum content.
– This may mean that in the future we will not buy dietary supplements with valuable plant ingredients from China or India, which have a special and confirmed effect e.g. in ayurveda, dealing with physical, mental and spiritual health. It is worth mentioning here that as a concept of health and therapy ayurveda is recognised since 1979 by the WHO. Already today, there are noticeable restrictions in the marketing of dietary supplements containing such plant components as: mountain rosary, incense, ground mace or fluffy bonnet known as cat’s claw – says Mateusz Pazdan.
Amendments may also concern the setting of maximum limits for active substances in food supplements. Until now, the law did not regulate this directly, and the maximum amounts of vitamins and minerals are indicated through the agency of EFSA (European Food Safety Authority). As the President of the SFD says, a change in the GIS approach to the amount of some active substances in dietary supplements can already be observed.
For example, a greater restriction was introduced as to the amount of zinc in dietary supplements. Still at the beginning of 2018, GIS allowed 25 mg of zinc in a daily portion of dietary supplements. At the moment, the maximum approved amount of zinc is 10-15 mg. – The demand for zinc by sexually active men and athletes (who get rid of a large amount of this element with sweat) is set at up to 150 mg per day. This will make it necessary for consumers to obtain supplies in other EU countries where there is no such rationing for these products. The fact that it is possible to establish average reference values does not mean in any way that every person needs such quantities – stresses Pazdan.
GIS standards lower than EU regulations
Another example given by the BCC expert is the amount of beta alanine in dietary supplements. By the end of 2018, the acceptable daily intake level for GIS was 4 g. In 2019 it was reduced to 2.4 g in 800 mg portions. However, according to the opinion of the International Society of Sports Nutrition, a single portion of 2 to 4 g taken once before a workout is safe.
– It is also worrying that the GIS Dietary Supplements Team recently passed a resolution that the maximum amount of manganese in a daily portion of dietary supplements is 1.8 m. But the daily requirement for this mineral was set at 2 mg. in one of the regulations of the European Parliament and Council (EU) – adds Pazdan.
The grey market will not feel any change
According to the President of the SFD, the main problem lies in the segment of dietary supplements that have not been reported to the GIS. They are sold at online auctions and in many stores. The planned legal changes will not affect them in any way.
– The regulations are very much needed, but they should concern mainly misleading advertising and penalties for entrepreneurs who do not report their products to GIS, thus effectively avoiding control. Currently, the penalties for not notifying a product are so low that many “entrepreneurs” coldly calculate the potential profits with the risk of receiving a penalty – says Mateusz Pazdan.
Dietary supplements are food products
The Ministry of Health and GIS have been working on the amendment of the Food and Nutrition Safety Act of 25 August 2006 with regard to the regulation of dietary supplements for a long time. The draft amendment itself appeared already in 2017. At that time, the ministry indicated that it would increase the penalties for producers and would start to fight against misleading advertising, but the amendment never reached the Sejm.
Planned legal changes will cover all products that, under the Food and Nutrition Safety Act, must be notified to the GIS before being placed on the market. These include fortified foods, foods for specific groups (including processed cereal products and other foods for children), foods for special medical purposes, foods to replace the daily diet, weight control products and, in particular, dietary supplements.
– In my opinion, the amendment of the law in its proposed form is very beneficial for manufacturers of over-the-counter medicines. For these products, supplements, carrying prophylaxis, are becoming more and more competitive every year. In addition, supplements often contain the same active substance, only in a smaller dose and, as a result, in a lower price. Dietary supplements are not pharmaceutical products but food, and they are not directed at patients, but at healthy consumers. Pharmaceutical companies should not have the deciding vote here – concludes Mateusz Pazdan.