sanews - 1 month ago

Safety concerns on children’s products with zinc picolinate The South African Health Products Regulatory Authority (SAHPRA) has called on the public to return products containing zinc picolinate and selenium, amid safety concerns related to children. Furthermore, health professionals are requested to cease all distribution, selling, and/or dispensing, and remove all selenium and zinc picolinate-containing products intended for use in children from stores, storage facilities and shelves. According to SAHPRA, zinc picolinate, at any supplemental dose, can cause side effects that include indigestion, diarrhoea, headache, nausea and vomiting. “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. “Selenium, when supplemented to children, represents a safety concern, considering the potential differences in selenium daily intake between different population groups. “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/medicines intended for children,” the authority warned. The products are marketed and sold, among others, as “immune boosters” for children, with the main active ingredients being zinc (when derived from zinc picolinate) and/or selenium. These products are indicated for supporting the treatment of colds, flu, diarrhoea, and skin-related conditions, rendering the products in question medicines that require registration by SAHPRA. “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. “Therefore, with effect from the date of publication of this notice, all selenium and zinc picolinate-containing products intended for use in children shall be subject to registration as a medicine falling into Category A, as defined in Section 14(2) of the Medicines and Related Substances Act, 101 of 1965, and need to be submitted to SAHPRA for registration. “The sale of Category D (complementary) medicines containing Zinc picolinate or Selenium and intended for use in children must be withdrawn from the market within six (6) months of the date of this publication,” the authority said. - SAnews.gov.za nosihle Mon, 01/12/2026 - 11:53 3 views

Latest News

Hashtags:   

Safety

 | 

concerns

 | 

children

 | 

products

 | 

picolinate

 | 

Sources