{"id":2470,"date":"2025-01-08T21:34:55","date_gmt":"2025-01-08T20:34:55","guid":{"rendered":"https:\/\/www.pharmanager-development.com\/?p=2470"},"modified":"2025-02-26T11:01:49","modified_gmt":"2025-02-26T10:01:49","slug":"audit-cosmetic-positioning-avoid-risky-claims-ensure-compliance","status":"publish","type":"post","link":"https:\/\/www.pharmanager-development.com\/en\/audit-cosmetic-positioning-avoid-risky-claims-ensure-compliance\/","title":{"rendered":"Audit of cosmetic product positioning: understanding and avoiding risks"},"content":{"rendered":"\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\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>Borderline products: where is the regulatory limit?<\/strong><\/strong><\/h2>\n\n\n\n<p style=\"font-size:18px\">In the world of cosmetics, certain products lie on the boundary between multiple regulatory categories, such as\u00a0medicines, medical devices, or biocides. These so-called &#8220;borderline&#8221; products may contain claims that bring them closer to other regulatory classifications.<\/p>\n\n\n\n<p style=\"font-size:18px\">The cosmetic status is determined by three key criteria:<\/p>\n\n\n\n<p style=\"font-size:18px\">\u2714\ufe0f\u00a0The primary function of the product<br>\u2714\ufe0f\u00a0Its composition<br>\u2714\ufe0f\u00a0The claims used in communication<\/p>\n\n\n\n<p style=\"font-size:18px\">A poor positioning strategy can result in\u00a0product reclassification, leading to\u00a0stricter regulatory requirements.<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" style=\"font-size:25px\"><strong>Practical case: massage oil and regulatory positioning<\/strong><\/h2>\n\n\n\n<p style=\"font-size:20px\"><strong><strong>Issue identified: a claim beyond the scope of cosmetics<\/strong><\/strong><\/p>\n\n\n\n<p style=\"font-size:18px\">\ud83d\udd0d\u00a0<strong>Example of a problematic claim<\/strong>:<br><em>&#8220;The Draining Oil is specially designed to promote lymphatic drainage through massage, addressing feelings of fatigue and heaviness in the lower limbs.&#8221;<\/em><\/p>\n\n\n\n<div style=\"height:5px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p style=\"font-size:18px\">\ud83d\uded1&nbsp;<strong>Errors Identified<\/strong>:<\/p>\n\n\n\n<p style=\"font-size:18px\">The claim refers to\u00a0lymphatic drainage, which involves a\u00a0physiological effect.<\/p>\n\n\n\n<p style=\"font-size:18px\">It mentions an impact on\u00a0blood circulation, which falls outside the scope of a\u00a0cosmetic\u00a0product and may lead to\u00a0reclassification as a medical device.<\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p style=\"font-size:20px\"><strong>Analysis and compliance with regulatory requirements<\/strong><\/p>\n\n\n\n<p style=\"font-size:18px\">A cosmetic product must meet three fundamental regulatory criteria:<\/p>\n\n\n\n<p style=\"font-size:18px\"><strong>1\ufe0f\u20e3\u00a0Form:<\/strong> The product must be intended for application to the skin.<br><strong>2\ufe0f\u20e3\u00a0Function:<\/strong> Its purpose must be to\u00a0clean, perfume, protect, maintain, or beautify\u00a0the skin. In this case, the product claims a physiological function.<br>3\ufe0f\u20e3<strong>\u00a0Application Area: <\/strong>It must be intended for the skin, hair, nails, lips, etc.<\/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\">By mentioning lymphatic drainage and the sensation of heavy legs, the product goes beyond the cosmetic scope and risks\u00a0reclassification as a medical device\u00a0or\u00a0medicine.<\/p>\n\n\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<section id=\"block_1811a10d9d6069c88098c5c64ec6e1cb\" class=\"stafe-blocks-faq sbfaq section section_faq-block section_faq-bg-color\" style=\"background-color: #f8f9fa;\">\n    <script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"<h3 style=\\\"font-size: 20px;\\\"><span class=\\\"third-title\\\">Why can a claim lead to the reclassification of a cosmetic product?<\\\/span><\\\/h3>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p data-pm-slice=\\\"1 1 [&quot;ordered_list&quot;,{&quot;spread&quot;:false,&quot;startingNumber&quot;:1,&quot;start&quot;:653,&quot;end&quot;:1142},&quot;regular_list_item&quot;,{&quot;start&quot;:653,&quot;end&quot;:811}]\\\"><span class=\\\"fourth-title\\\">Authorities consider claims as defining the primary function of a product. If a claim exceeds the scope of maintaining or beautifying the skin (e.g., effects on blood circulation, pain relief, therapeutic properties), it may result in a change of regulatory classification (medical device, medicine, etc.).<\\\/span><\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"<h3 style=\\\"font-size: 20px;\\\"><span class=\\\"third-title\\\">How can I ensure my cosmetic product is not classified as a medicine or medical device?<\\\/span><\\\/h3>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p data-pm-slice=\\\"1 1 [&quot;ordered_list&quot;,{&quot;spread&quot;:false,&quot;startingNumber&quot;:1,&quot;start&quot;:653,&quot;end&quot;:1142},&quot;regular_list_item&quot;,{&quot;start&quot;:812,&quot;end&quot;:978}]\\\"><span class=\\\"fourth-title\\\">It is crucial to carefully draft claims and avoid suggesting curative or therapeutic effects. Use strictly cosmetic language and ensure the product meets the criteria of a cosmetic definition (form, function, application area).<\\\/span><\\\/p>\\n\"}},{\"@type\":\"Question\",\"name\":\"<h3><span class=\\\"third-title\\\">What should I do if a product has already been launched with a borderline claim?<\\\/span><\\\/h3>\\n\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"<p data-pm-slice=\\\"1 1 [&quot;ordered_list&quot;,{&quot;spread&quot;:false,&quot;startingNumber&quot;:1,&quot;start&quot;:653,&quot;end&quot;:1142},&quot;regular_list_item&quot;,{&quot;start&quot;:979,&quot;end&quot;:1142}]\\\"><span class=\\\"fourth-title\\\">You can revise the communication materials to align the claims with regulations. A positioning audit can be conducted to identify the necessary adjustments and ensure the product&#8217;s compliance.<\\\/span><\\\/p>\\n\"}}]}<\/script>\n    <div class=\"faq-block_container\">\n        <div class=\"container\">\n                            <div class=\"faq_title\">\n                    <h2 style=\"text-align: center; font-size: 30px;\">Mastering the regulation of your cosmetic products<\/h2>\n                <\/div>\n            \n                            <div class=\"faq_accordion\">\n                                            <div class=\"faq_item\">\n                            <span class=\"accordion-title\">\n                                <h3 style=\"font-size: 20px;\"><span class=\"third-title\">Why can a claim lead to the reclassification of a cosmetic product?<\/span><\/h3>\n                                <span class=\"btn btn-brown\">\n                                    <span class=\"icon icon-keyboard_arrow_down\"><\/span>\n                                <\/span>\n                            <\/span>\n                            <div class=\"accordion-content\">\n                                <p data-pm-slice=\"1 1 [&quot;ordered_list&quot;,{&quot;spread&quot;:false,&quot;startingNumber&quot;:1,&quot;start&quot;:653,&quot;end&quot;:1142},&quot;regular_list_item&quot;,{&quot;start&quot;:653,&quot;end&quot;:811}]\"><span class=\"fourth-title\">Authorities consider claims as defining the primary function of a product. If a claim exceeds the scope of maintaining or beautifying the skin (e.g., effects on blood circulation, pain relief, therapeutic properties), it may result in a change of regulatory classification (medical device, medicine, etc.).<\/span><\/p>\n                            <\/div>\n                        <\/div>\n                                            <div class=\"faq_item\">\n                            <span class=\"accordion-title\">\n                                <h3 style=\"font-size: 20px;\"><span class=\"third-title\">How can I ensure my cosmetic product is not classified as a medicine or medical device?<\/span><\/h3>\n                                <span class=\"btn btn-brown\">\n                                    <span class=\"icon icon-keyboard_arrow_down\"><\/span>\n                                <\/span>\n                            <\/span>\n                            <div class=\"accordion-content\">\n                                <p data-pm-slice=\"1 1 [&quot;ordered_list&quot;,{&quot;spread&quot;:false,&quot;startingNumber&quot;:1,&quot;start&quot;:653,&quot;end&quot;:1142},&quot;regular_list_item&quot;,{&quot;start&quot;:812,&quot;end&quot;:978}]\"><span class=\"fourth-title\">It is crucial to carefully draft claims and avoid suggesting curative or therapeutic effects. Use strictly cosmetic language and ensure the product meets the criteria of a cosmetic definition (form, function, application area).<\/span><\/p>\n                            <\/div>\n                        <\/div>\n                                            <div class=\"faq_item\">\n                            <span class=\"accordion-title\">\n                                <h3><span class=\"third-title\">What should I do if a product has already been launched with a borderline claim?<\/span><\/h3>\n                                <span class=\"btn btn-brown\">\n                                    <span class=\"icon icon-keyboard_arrow_down\"><\/span>\n                                <\/span>\n                            <\/span>\n                            <div class=\"accordion-content\">\n                                <p data-pm-slice=\"1 1 [&quot;ordered_list&quot;,{&quot;spread&quot;:false,&quot;startingNumber&quot;:1,&quot;start&quot;:653,&quot;end&quot;:1142},&quot;regular_list_item&quot;,{&quot;start&quot;:979,&quot;end&quot;:1142}]\"><span class=\"fourth-title\">You can revise the communication materials to align the claims with regulations. A positioning audit can be conducted to identify the necessary adjustments and ensure the product&#8217;s compliance.<\/span><\/p>\n                            <\/div>\n                        <\/div>\n                                    <\/div>\n                                <\/div>\n    <\/div>\n<\/section>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Borderline products: where is the regulatory limit? In the world of cosmetics, certain products lie on the boundary between multiple regulatory categories, such as\u00a0medicines, medical devices, or biocides. These so-called &#8220;borderline&#8221; products may contain claims that bring them closer to other regulatory classifications. The cosmetic status is determined by three key criteria: \u2714\ufe0f\u00a0The primary function [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":1787,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[278,75,1],"tags":[],"class_list":["post-2470","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-cosmetics","category-news","category-non-classifiee"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Cosmetic Positioning Audit<\/title>\n<meta name=\"description\" content=\"Learn how to secure the regulatory positioning of your cosmetic products by avoiding risky claims.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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