Children’s supplements recalled over safety concerns

The South African Health Products Regulatory Authority (SAHPRA) has called on the public to return products containing zinc picolinate and selenium that are intended for use in children, citing safety concerns.

According to the South African Government News Agency, SAHPRA has also instructed health professionals to immediately stop the distribution, sale and dispensing of all selenium- and zinc picolinate-containing products marketed for children. Retailers have been directed to remove these products from shelves, stores and storage facilities.

SAHPRA warned that zinc picolinate, at any supplemental dose, may cause side effects such as indigestion, diarrhoea, headaches, nausea and vomiting.

The authority said the bioavailability of zinc from zinc picolinate can vary due to several factors, making the risk of side effects higher and unpredictable. As a result, it has been deemed unsuitable as a source of elemental zinc supplementation in children.

Concerns were also raised about selenium supplementation in children. SAHPRA noted that differences in daily selenium intake among population groups could pose safety risks when selenium is included in general supplements or medicines.

While selenium may be required in specific cases, such as in areas affected by famine or dietary restrictions, SAHPRA cautioned that excessive intake could lead to adverse effects, particularly when products are widely marketed to children.

The authority said the affected products are often sold as so-called “immune boosters” for children, with zinc derived from zinc picolinate and/or selenium listed as the main active ingredients. These products are commonly promoted to support the treatment of colds, flu, diarrhoea and skin-related conditions.

SAHPRA clarified that products making such claims are regarded as medicines and therefore require registration. Any medicine containing zinc picolinate or selenium intended for children does not qualify as a Category D complementary medicine, making their sale under this category unlawful.

With immediate effect, all selenium- and zinc picolinate-containing products intended for children are required to be registered as Category A medicines in terms of the Medicines and Related Substances Act, 101 of 1965. Applications must be submitted to SAHPRA for evaluation and approval.

The authority added that all Category D complementary medicines containing zinc picolinate or selenium and intended for use in children must be withdrawn from the market within six months from the date of publication of the notice.

SAHPRA has urged parents, caregivers and healthcare professionals to take note of the warning and to prioritise children’s safety when selecting supplements or medicines.