When it comes to kids’ supplements, parents are often expected to just trust the label. However, products that contain Selenium and Zinc Picolinate for children in South Africa have sparked serious questions about regulation and safety. Behind the marketing claims are policies, warnings and industry responses that can be hard to decode. This is the clarity parents need, without the confusion or the fear.
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Attention has been drawn to selenium and zinc picolinate-containing products intended for children following a regulatory communication issued by the South African Health Products Regulatory Authority (SAHPRA). The notice focused on the classification, safety considerations and regulatory status of these ingredients when used in products marketed for individuals under the age of 18.
After SAHPRA’s announcement, pharmaceutical and supplement manufacturers operating in the children’s health sector issued formal communications addressing the notice and outlining their respective positions. This article presents the details of those communications, explaining the regulatory context and the responses from affected companies in a clear and accessible format.
SAHPRA Guidance on Selenium and Zinc Picolinate in Children’s Products
SAHPRA released an official media statement on 8 January 2026, warning about products on the South African market that contain zinc picolinate and or selenium when intended for use in children. According to SAHPRA, both ingredients are listed in its guidance documentation as not permitted in health supplements designed for individuals under the age of 18.
SAHPRA’s guidance is based on its mandate to regulate health products in South Africa in terms of safety, efficacy and quality. The authority indicated that the presence of zinc picolinate and selenium in children’s products raises specific safety and regulatory concerns that require additional oversight.
Zinc Picolinate and SAHPRA’s Safety Considerations
SAHPRA stated that zinc picolinate, when used as a source of zinc supplementation, can cause side effects at any supplemental dose. These side effects include indigestion, diarrhoea, nausea, vomiting and headaches. The authority further noted that the bioavailability of zinc from zinc picolinate varies due to multiple factors, which may result in unpredictable absorption levels in children.
Based on this variability, SAHPRA concluded that zinc picolinate is unsuitable as a source of elemental zinc supplementation for children. The concern raised was not limited to zinc supplementation in general but focused specifically on the use of zinc picolinate as the zinc source in products intended for paediatric use.
Selenium and Population Intake Concerns
In its media release, SAHPRA acknowledged that selenium is an essential trace element and that supplementation may be necessary in specific contexts, such as in populations experiencing famine or severe dietary restriction. However, SAHPRA expressed concern about the use of selenium in general children’s supplements due to variations in dietary selenium intake between different population groups.
The authority highlighted that excessive selenium intake can lead to toxicity and that providing selenium through supplements intended for widespread use in children may increase the risk of overdose. SAHPRA indicated that these concerns are particularly relevant when selenium is included in immune boosters or similar products marketed for routine use.
Regulatory Classification and Market Requirements
SAHPRA further stated that products marketed as immune boosters for children, particularly those claiming to support the treatment of colds, flu, diarrhoea or skin conditions, may meet the definition of medicines rather than complementary health supplements.
According to the authority, any medicine containing zinc picolinate or selenium intended for use in children does not qualify as a Category D complementary medicine. Instead, such products must be classified as Category A medicines and submitted for registration in terms of the Medicines and Related Substances Act, 101 of 1965.
SAHPRA instructed that all Category D products containing zinc picolinate or selenium intended for children be withdrawn from the market within six months of the publication date of the notice. Healthcare professionals were requested to cease distribution, and members of the public were encouraged to return affected products to suppliers or pharmacies.
Read the SAHPRA press release here.
House of Zinplex Response to the Regulatory Notice
House of Zinplex issued a detailed client and consumer letter on 9 January 2026, responding to the SAHPRA media release and outlining the company’s position regarding zinc picolinate and selenium.
Position on Zinc Picolinate
House of Zinplex stated that, to its knowledge, there is no published scientific evidence demonstrating that zinc picolinate is unsafe for children when used within appropriate and regulated dosage levels. The company indicated that it had requested supporting scientific or medical documentation from SAHPRA but had not received such evidence at the time of issuing the letter.
The company noted that its products containing zinc picolinate have been on the market for over two decades without reported serious health-related risks. It further stated that zinc picolinate is accepted as a source of zinc supplementation for children in several other countries.
House of Zinplex emphasised that the side effects listed by SAHPRA are consistent with zinc supplementation generally and are not specific to zinc picolinate. The company also stated that it has previously submitted scientific data to SAHPRA addressing concerns about zinc picolinate bioavailability.
Perspective on Selenium Supplementation
Regarding selenium, House of Zinplex acknowledged that excessive selenium intake can result in toxicity. The company highlighted that selenium status varies between individuals based on factors such as diet, food sourcing, lifestyle, underlying health conditions and the use of other health products or medicines.
House of Zinplex stated that the selenium content in its products is below published tolerable upper intake levels for the relevant age groups. According to the company, when used as directed, its products alone cannot cause selenium toxicity and the risk of overdose arises from combined selenium intake from multiple sources.
The company advised that parents and caregivers consult healthcare professionals to assess individual selenium requirements and overall intake, particularly when multiple supplements or dietary sources are involved.
Engagement With Regulatory Authorities
House of Zinplex stated that its products are formulated by healthcare professionals, including pharmacists and manufactured according to established quality and regulatory standards. The company reported that it has not received safety reports indicating risk to children when products are used as directed.
The letter indicated that House of Zinplex was surprised by the issuance of the SAHPRA media release and noted that the six-month withdrawal period suggested an absence of immediate safety urgency. The company confirmed its intention to engage further with SAHPRA to address the regulatory concerns raised and to provide updates as discussions progress.
Read the Zinplex press release here.
Regulatory Context and Ongoing Developments
The January 2026 communications highlight differing roles and responsibilities within the South African health product landscape. SAHPRA’s position reflects its regulatory mandate to apply precautionary principles and enforce compliance with ingredient and classification guidelines.
Industry responses reflect efforts to clarify product formulations, confirm compliance or engage with regulators regarding scientific and regulatory interpretations. These exchanges form part of the broader regulatory process governing medicines and complementary health products in South Africa.
Parents, healthcare professionals and distributors are encouraged to remain informed about regulatory updates and to consult qualified healthcare practitioners when making decisions regarding children’s supplements and medicines.
References
South African Health Products Regulatory Authority (SAHPRA)
Media Release: Warning on Selenium and Zinc Picolinate-Containing Products for Children
https://www.sahpra.org.za/news-and-updates/warning-selenium-and-zinc-picolinate-containing-products-for-children/
House of Zinplex
Client and Consumer Letter on Zinc Picolinate and Selenium
https://www.zinplex.co.za
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