NKFH withdraws dangerous potency enhancers from circulation

The potency-enhancing and male health-supporting preparations marketed as dietary supplements contained unlicensed active pharmaceutical ingredients – sildenafil, tadalafil – which can only be used in medicines produced and licensed under controlled conditions and on medical prescription. The presence of the indicated active ingredients in dietary supplements and food poses a serious food safety risk and is considered counterfeiting under the relevant legal regulations. During the inspection, the authority also found that the prohibited ingredients were not listed on the product labels, which constitutes misleading consumers. The products were withdrawn from circulation by the NKFH.

Laboratory tests carried out in connection with the official inspection revealed that the following three products contained active pharmaceutical ingredients that can be used in prescription medicines: The Dragon Power, RS RUI SHEN and Hurrikán. As part of the information accompanying the products, the products were typically attributed a symptomatic, healing effect (treatment of erectile dysfunction), emphasizing their natural composition (herbs, superfoods).

The active ingredients sildenafil and tadalafil belong to the group of so-called phosphodiesterase-5 (PDE-5) inhibitors, which affect the cardiovascular system, and their use can only be considered safe under medical supervision. Their combined use with other medicines – such as nitrate-containing preparations – can be particularly dangerous. The aforementioned active pharmaceutical ingredients increase blood flow, thus affecting the entire circulatory system. For this reason, not only the desired effect but also side effects may occur. Side effects may include headaches, dizziness, blurred vision, low blood pressure, and in severe cases, even life-threatening conditions may develop, especially if the consumer is unaware of the presence of the prohibited active ingredient.

It is important to emphasize that PDE-5 inhibitors do not occur naturally in plant materials. If a product claims to have a powerful effect similar to that of a medicine, there is a reasonable suspicion that it contains an illegally added active ingredient. Uncontrolled manufacturing conditions, unknown composition, and improper dosage significantly increase the risk of overdose, allergic reactions, and cardiovascular complications.

The NKFH once again draws the attention of consumers to only purchase dietary supplements from reliable, licensed sources and to avoid products offered on the Internet, social media, or other unverified channels. Products that promise unrealistically fast or extraordinary effects pose an increased risk.

The authority also recommends that consumers check before purchasing whether the selected product is included in the database of notified dietary supplements maintained by the National Center for Public Health and Pharmacy, and whether the given product is not on the list of products withdrawn from the market.

The NKFH also draws the attention of distributors that the distribution of products containing an active pharmaceutical ingredient illegally has serious legal consequences and may be considered not only a food safety violation, but also counterfeiting and a crime.

Increased testing of dietary supplements is one of the highlights of the 7-point consumer protection action plan announced last fall. The NKFH, in cooperation with its fellow authorities, carries out continuous inspections on the dietary supplement market in order to reduce abuse and prevent dangerous products from entering the country.