The South African Health Products Regulatory Authority (Sahpra)\u202fhas called for all\u202fchildren\u2019s\u202fimmune boosters\u202fcontaining\u202fzinc picolinate and\u202fselenium\u202fto be\u202fwithdrawn from the market.\u202f\u202f\u00a0<\/p>\n
\u202fAccording to\u202fSahpra\u202fguidelines,\u202fneither\u202fof these ingredients\u202fis\u202fpermitted\u202fin health supplements for children.\u202f\u202f\u00a0<\/p>\n
Tammy Gopal,\u202fSahpra\u2019s\u202fchief regulatory officer, says\u202fzinc picolinate, at any supplemental dose, can cause side effects\u202fwhich include indigestion,\u202fdiarrhoea, headache,\u202fnausea\u202fand vomiting.\u202f\u202f\u00a0<\/p>\n
\u201cAs the\u202fbio-availability\u202fof Zn from Zn-picolinate is variable due to multiple factors,\u202fthe risk of side effects may be higher and unpredictable, and it is unsuitable as a source of elemental zinc supplementation in children,\u201d\u202fGopal says.\u202f\u202f\u00a0<\/p>\n
She says\u202fsupplementing children with\u202fselenium\u202fposes\u202fa safety concern\u202fdue to\u202fvarying\u202fdaily intake\u202facross\u202fpopulations.\u202f\u202f\u00a0<\/p>\n
\u201cWhile 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\u202for\u202fmedicines intended for children,\u201d Gopal says.\u202f\u202f\u00a0<\/p>\n
She adds\u202fthat\u202fsome\u202fproducts\u202fare marketed\u202fas\u202f\u2018immune boosters\u2019\u202ffor children, with\u202fzinc (from\u202fzinc picolinate) and selenium as the main ingredients.\u202f\u00a0<\/p>\n
\u201cThese products are\u202findicated\u202ffor supporting the treatment of colds, flu,\u202fdiarrhoea\u202fand skin-related conditions,\u202frendering\u202fthe products in question medicines that\u202frequire registration by\u202fSshpra.\u202fAny medicine sold that\u202fcontains\u202fzinc picolinate or\u202fselenium intended for use in children does not qualify as a\u202fCategory D (complementary) medicine.\u202fAs such, their sale as a\u202fCategory D medicine is illegal,\u201d\u202fsays\u202fGopal.\u202f\u202f\u00a0<\/p>\n
She says\u202fwith effect from the date of publication of this notice\u202f(January\u202f8)\u202fall selenium and zinc picolinate-containing products intended for use in children shall be\u00a0subject to registration as a medicine falling into Category A,\u202fas defined in Section 14(2) of the Medicines and Related Substances Act, 101 of 1965, and need to be submitted to\u202fSahpra\u202ffor registration.\u202f\u202f\u00a0<\/p>\n
\u201cThe sale of Category D (complementary) medicines containing\u202fzinc picolinate or\u202fselenium and intended for use in children must be withdrawn from the market within\u202fsix\u202fmonths\u202fof the date of this publication.\u201d\u202f\u202f\u00a0<\/p>\n
\u202fAdvice for health professionals and distributors\u202f\u00a0<\/p>\n
Gopal says\u202fSahpra\u202frequests that\u202fhealth professionals cease all distribution, selling\u202fand\u202for dispensing and remove all selenium and zinc picolinate-containing products intended for use in children from stores, storage\u202ffacilities\u202fand shelves.\u202f\u00a0<\/p>\n
\u202f\u201cMembers of the public are urged to return products\u202fcontaining\u202fzinc\u202fpicolinate and\u202fselenium when intended for use in children, to their pharmacist, supplying warehouse, or distributor.\u202fPublic and healthcare professionals are encouraged to report any side effects after using a health product by using the Med Safety App. Your report will contribute to our monitoring of these health products,\u201d\u202fsays\u202fGopal.\u202f\u202f\u00a0<\/p>\n
Zinplex\u00a0responds<\/p>\n
Health supplement company\u00a0Zinplex\u00a0has responded to Sahra\u2019s statement, claiming that the regulator is acting outside its legal mandate, saying its products \u2013 sold for over 20 years \u2013 have no reported serious adverse effects.\u00a0<\/p>\n
Zinplex<\/a>\u00a0claims\u00a0there is no published scientific evidence showing that\u00a0zinc\u00a0picolinate, when used within\u00a0appropriate\u00a0and regulated dosage levels, is unsafe for children.\u00a0\u00a0<\/p>\n \u201cWe have requested that\u00a0Sahpra\u00a0bring any such medical or scientific evidence to our attention, and they have been unable to produce any such written report whatsoever,\u201d\u00a0says\u00a0Zinplex.\u00a0<\/p>\n \u201cOur products are formulated by healthcare professionals, including pharmacists, and manufactured according to strict quality,\u00a0safety\u00a0and regulatory standards. We have not received any safety reports or evidence suggesting that our products pose a risk to children when used as directed,\u201d says\u00a0Zinplex.\u00a0<\/p>\n Breaking news at your fingertips\u2026 Follow Caxton Network News on Facebook<\/a> and join our WhatsApp channel<\/a>.<\/p>\n Nuus wat saakmaak. Volg Caxton Netwerk-nuus op Facebook<\/a> en sluit aan by ons WhatsApp-kanaal<\/a>.<\/p>\n \n\t\t\t\tAt Caxton, we employ humans to generate daily fresh news, not AI intervention. Happy reading!\n\t\t\t<\/p>\n","protected":false},"excerpt":{"rendered":"The South African Health Products Regulatory Authority (Sahpra)\u202fhas called for all\u202fchildren\u2019s\u202fimmune boosters\u202fcontaining\u202fzinc picolinate and\u202fselenium\u202fto be\u202fwithdrawn from the market.\u202f\u202f\u00a0…\n","protected":false},"author":2,"featured_media":405762,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[49,48,84,395],"class_list":{"0":"post-405761","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-nutrition","8":"tag-ca","9":"tag-canada","10":"tag-health","11":"tag-nutrition"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/405761","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/comments?post=405761"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/405761\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media\/405762"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media?parent=405761"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/categories?post=405761"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/tags?post=405761"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}