SAHPRA Orders Recall of Zinc Picolinate and Selenium Products Intended for Children

The South African Health Products Regulatory Authority (SAHPRA) has issued a strong warning to the public and healthcare professionals, calling for the immediate return and withdrawal of products containing zinc picolinate and selenium that are intended for use in children, citing significant safety concerns.

SAHPRA has further instructed health professionals, retailers and distributors to cease all distribution, selling and dispensing of these products, and to remove them from stores, storage facilities and shelves with immediate effect.

Safety concerns linked to zinc picolinate

According to the regulator, zinc picolinate, when used as a supplement at any dose, has been associated with a range of side effects, including:

• Indigestion

• Diarrhoea

• Headache

• Nausea

• Vomiting

SAHPRA warned that the bioavailability of zinc derived from zinc picolinate varies significantly, depending on multiple factors. This variability increases the likelihood that side effects may be unpredictable and potentially more severe, particularly in children.

"As the bioavailability of Zn from Zn-picolinate is variable due to multiple factors, the risk of side effects may be higher and unpredictable, and it is unsuitable as a source of elemental zinc supplementation in children," SAHPRA said.

Selenium supplementation poses overdose risks

The authority has also raised serious concerns about selenium supplementation in children, noting that daily selenium intake can differ widely between population groups. While selenium may be necessary in specific contexts, such as areas affected by famine or dietary restriction, its inclusion in general supplements poses risks.

"While selenium intake is a viable requirement for children in areas of famine or dietary restriction, the potential adverse effects of selenium overdose are of concern when provided in general supplements or medicines intended for children," SAHPRA warned.

Excessive selenium intake can lead to toxicity, making uncontrolled supplementation particularly dangerous for young children.

Products marketed as "immune boosters"

SAHPRA noted that the affected products are commonly marketed and sold as "immune boosters" for children, with zinc (derived from zinc picolinate) and/or selenium listed as the main active ingredients.

These products are often promoted for the supportive treatment of colds, flu, diarrhoea and skin-related conditions. Due to these therapeutic claims, SAHPRA has classified the products as medicines, rather than dietary or complementary supplements.

Illegal sale under complementary medicine category

The regulator made it clear that products containing zinc picolinate or selenium intended for children do not qualify as Category D (complementary) medicines.

"Any medicine sold that contains zinc picolinate or selenium intended for use in children does not qualify as a Category D (complementary) medicine. As such, their sale as a Category D medicine is illegal," SAHPRA said.

Mandatory reclassification and registration

With immediate effect from the publication date of the notice, all selenium- and zinc picolinate-containing products intended for children must be reclassified as Category A medicines, in terms of Section 14(2) of the Medicines and Related Substances Act, 101 of 1965.

Manufacturers and distributors are required to submit these products to SAHPRA for full registration as prescription or general medicines, subject to rigorous safety, quality and efficacy evaluation.

SAHPRA has further directed that all Category D complementary medicines containing zinc picolinate or selenium and intended for children must be withdrawn from the market within six months from the date of publication.

Public urged to act immediately

Parents and caregivers in possession of affected products are urged to stop using them immediately and return them to the point of purchase or follow guidance provided by retailers and healthcare professionals.

SAHPRA emphasised that the measures are aimed at protecting children from avoidable health risks, while ensuring that medicines available on the market meet the country's strict regulatory standards.