The South African Health Products Regulatory Authority (SAHPRA) has issued a public warning over supplements containing zinc picolinate and selenium that are being marketed for use in children.

In a statement released on 8 January, SAHPRA said both ingredients are not permitted in health supplements for children under the age of 18, and that products currently on the market containing these substances pose potential safety risks.

According to the regulator, zinc picolinate can cause side effects including indigestion, diarrhoea, headaches, nausea and vomiting. SAHPRA added that the bioavailability of zinc from zinc picolinate is variable and unpredictable, increasing the risk of adverse reactions in children.

Selenium supplementation in children also raises safety concerns, particularly due to the risk of overdose and differences in daily dietary intake among population groups.

SAHPRA noted that many of the affected products are marketed as “immune boosters” for children (like Zinplex) and are promoted for conditions such as colds, flu, diarrhoea and skin problems.

The authority said this classifies them as medicines requiring formal registration, rather than complementary health products.

As a result, any product containing zinc picolinate or selenium intended for use in children will now be required to be registered as a Category A medicine in terms of the Medicines and Related Substances Act. Products currently sold as Category D complementary medicines must be withdrawn from the market within six months.

Health professionals and distributors have been instructed to stop selling, dispensing and distributing these products and to remove them from shelves and storage facilities. Members of the public are urged to return any such products to their pharmacy, supplier or distributor.

SAHPRA has also encouraged parents and healthcare professionals to report any side effects linked to these products using the Med Safety App.