,The South African Health Products Regulatory Authority (SAHPRA) has issued a formal warning regarding health products containing zinc picolinate and/or selenium that are intended for use in children under the age of 18. The Authority has confirmed that these ingredients are not permitted in health supplements for children under existing SAHPRA guidance.
According to SAHPRA Guideline 7.04 (SAHPGL-PEM-COMP-04 v5 CM SE Health Supplements), both zinc picolinate and selenium are excluded as acceptable ingredients in complementary health supplements for paediatric use due to safety concerns.
Safety Concerns Identified
SAHPRA highlighted the following risks associated with these ingredients when used in children:
Zinc picolinate may cause adverse effects at any supplemental dose, including indigestion, diarrhoea, headache, nausea, and vomiting. Due to variable bioavailability, the risk of side effects is considered unpredictable, making it unsuitable as a source of elemental zinc supplementation for children.
Selenium supplementation poses a risk of overdose in children, given differences in dietary intake across population groups. While selenium may be required in cases of famine or dietary restriction, general supplementation presents potential toxicity concerns.
Regulatory Classification and Compliance Requirements
SAHPRA noted that several products currently on the market are promoted as immune boosters for children, with claims related to the treatment or support of conditions such as colds, flu, diarrhoea, and skin disorders. Based on these claims and ingredients, SAHPRA considers such products to meet the definition of medicines, not complementary health supplements.
As a result:
Products containing zinc picolinate and/or selenium intended for children do not qualify as Category D (complementary) medicines.
With immediate effect, these products must be registered as Category A medicines in accordance with Section 14(2) of the Medicines and Related Substances Act, 101 of 1965.
The continued sale of these products as Category D medicines is illegal.
All affected products must be withdrawn from the market within six months from the date of publication of the notice.
Guidance to Health Professionals, Distributors, and the Public
SAHPRA has requested that health professionals and distributors immediately cease the distribution, sale, and dispensing of selenium- and zinc picolinate-containing products intended for children, and remove them from all retail and storage locations.
Members of the public are advised to return affected products to their pharmacist, distributor, or supplying warehouse.
Reporting of Adverse Events
Healthcare professionals and consumers are encouraged to report any suspected adverse reactions associated with these products using the Med Safety App, supporting SAHPRAs ongoing safety monitoring activities.
SAHPRA emphasised that these measures are necessary to protect childrens health and to ensure that products on the South African market meet appropriate safety, quality, and regulatory standards.
Consumer News Region