{"id":2400,"date":"2025-01-13T23:06:57","date_gmt":"2025-01-13T22:06:57","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?p=2400"},"modified":"2025-02-26T11:01:32","modified_gmt":"2025-02-26T10:01:32","slug":"regulation-of-products-based-on-valerian-root","status":"publish","type":"post","link":"https:\/\/www.pharmanager-development.com\/en\/regulation-of-products-based-on-valerian-root\/","title":{"rendered":"Regulation of products based on valerian root"},"content":{"rendered":"\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h2 class=\"wp-block-heading\" style=\"font-size:25px\"><strong><strong><strong><strong><strong><strong><strong>Dietary supplement or medicine? The case of valerian-based products<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h2>\n\n\n\n<p style=\"font-size:20px\"><strong><strong><strong>Indication and active substance<\/strong><\/strong><\/strong><\/p>\n\n\n\n<p style=\"font-size:18px\">\ud83d\udccc Indication: sleep<br>\ud83d\udccc Active substance: valerian root extract<\/p>\n\n\n\n<p style=\"font-size:20px\"><strong><strong><strong>Regulatory regime<\/strong><\/strong><\/strong><\/p>\n\n\n\n<p style=\"font-size:18px\">A product based on valerian can be marketed under two distinct statuses:<br>\u2714\ufe0f dietary supplement, under certain conditions<br>\u2714\ufe0f herbal-based medicine, if the composition and claims go beyond the scope of dietary supplements<\/p>\n\n\n\n<p style=\"font-size:20px\"><strong><strong><strong>Risk of reclassification as a medicine<\/strong><\/strong><\/strong><\/p>\n\n\n\n<p style=\"font-size:18px\">A product containing between 400 and 600 mg of ethanol extract of valerian root with an extraction ratio of 4\/1 is likely to be reclassified as a medicine by function.<\/p>\n\n\n\n<p style=\"font-size:18px\"><strong>Why?<\/strong><\/p>\n\n\n\n<p style=\"font-size:18px\">\u2714\ufe0f Valerian has a monograph in well-established medical use, validated by the European Medicines Agency (EMA).<br>\u2714\ufe0f A high dosage and a particular extraction method can shift the product&#8217;s status to medicine.<\/p>\n\n\n\n<p style=\"font-size:20px\"><strong><strong><strong>Solution to avoid reclassification<\/strong><\/strong><\/strong><\/p>\n\n\n\n<p style=\"font-size:18px\">\u2714\ufe0f Adapt the composition and dosage to remain within the scope of dietary supplements.<br>\u2714\ufe0f Avoid any therapeutic claims that could suggest an effect comparable to a medicine.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"font-size:30px\"><strong>Conclusion<\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">Valerian-based products are subject to strict regulations. It is essential to clearly define the formulation and claims to avoid reclassification as a medicine and ensure compliant market release.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Dietary supplement or medicine? The case of valerian-based products Indication and active substance \ud83d\udccc Indication: sleep\ud83d\udccc Active substance: valerian root extract Regulatory regime A product based on valerian can be marketed under two distinct statuses:\u2714\ufe0f dietary supplement, under certain conditions\u2714\ufe0f herbal-based medicine, if the composition and claims go beyond the scope of dietary supplements Risk [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1959,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[281,61,75],"tags":[],"class_list":["post-2400","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-herbal-medicinal-product","category-medicament-a-base-de-plantes","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Regulation of products based on valerian root - 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