{"id":272,"date":"2024-09-04T20:29:31","date_gmt":"2024-09-04T20:29:31","guid":{"rendered":"https:\/\/www.libertymanagement.us\/fda-news\/?p=272"},"modified":"2024-09-04T20:29:31","modified_gmt":"2024-09-04T20:29:31","slug":"fda-acne-regulations","status":"publish","type":"post","link":"https:\/\/www.libertymanagement.us\/fda-news\/2024\/09\/04\/fda-acne-regulations\/","title":{"rendered":"FDA ACNE REGULATIONS"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">USFDA regulates acne products and treatments under drugs,\ncosmetics, and medical devices. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/www.fdahelp.us\/fda-drug-registration.html\">Acne Drug Products<\/a><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong><a href=\"https:\/\/www.fdahelp.us\/otc-monograph.html\">OTC Monograph Compliance<\/a>:<\/strong>\n     OTC acne treatments products must comply with the FDA&#8217;s &#8221; Topical\n     Acne Drug Products for Over-the-Counter Human Use &#8221; (Monograph ID: &nbsp;M006). This monograph specifies the\n     active ingredients, dosage forms, labeling, and conditions under which\n     these products can be marketed without a prescription.<\/li><li><strong>Active\n     Ingredients:<\/strong> Commonly used active ingredients in OTC acne products\n     include benzoyl peroxide, salicylic acid, and sulfur. Each active ingredient\n     has specified concentration ranges and usage guidelines.<\/li><li><strong>Labeling\n     Requirements:<\/strong> The FDA mandates specific labeling for OTC acne\n     products, including indications for use (e.g., &#8220;for the \u201cmanagement\/treatment\n     of acne&#8221;), directions, warnings, and any potential adverse effects.<\/li><li><strong>New\n     Ingredients:<\/strong> If an acne product contains an active ingredient which is\n     not FDA\u2019s OTC monograph, then it must go through the New Drug Application\n     (NDA) process to be approved.<\/li><li><strong>cGMP\n     compliance:<\/strong> All acne products must be manufactured in compliance with\n     cGMP regulations.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/www.fdahelp.us\/establishment-registration.html\">Acne Treatment\nMedical devices<\/a><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Device\n     Classification:<\/strong> Acne treatment devices (e.g., light therapy devices)\n     are classified into Class I, Class II or PMA devices based on their risk\n     to patients. Most acne devices fall under Class II, which requires <a href=\"https:\/\/www.fdahelp.us\/premarket-submission-510k.html\">510K\n     clearance<\/a> by proving that the device is substantially equivalent to a\n     legally marketed device.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><a href=\"https:\/\/www.fdahelp.us\/fda-mocra-registration-listing-cosmetic-facility.html\">Cosmetic\nAcne Products<\/a><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>Definition:<\/strong>\n     If a product is marketed as a cosmetic (e.g., cleansers, toners, or\n     non-active ingredient-based products claiming to &#8220;reduce the\n     appearance of acne&#8221;), it is not subject to the same requirements as\n     drugs or devices. However, it must still be safe to use and properly\n     labeled.<\/li><li><strong>Label\n     Claims:<\/strong> Cosmetic products must not make drug claims on the labels.<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.fdahelp.us\/\">Liberty Management Group<\/a>, as a leading FDA regulatory consulting firm, can guide the companies to determine how the products are regulated and help them with the registration process.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sudha S<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Regulatory Consultant<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email: office@libertymanagement.us<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">www.fdahelp.us<\/p>\n","protected":false},"excerpt":{"rendered":"<p>USFDA regulates acne products and treatments under drugs, cosmetics, and medical devices. Acne Drug Products OTC Monograph Compliance: OTC acne treatments products must comply with the FDA&#8217;s &#8221; Topical Acne Drug Products for Over-the-Counter Human Use &#8221; (Monograph ID: &nbsp;M006). This monograph specifies the active ingredients, dosage forms, labeling, and conditions under which these products &hellip; <a href=\"https:\/\/www.libertymanagement.us\/fda-news\/2024\/09\/04\/fda-acne-regulations\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA ACNE REGULATIONS&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[26,27,25],"tags":[41,42,29],"class_list":["post-272","post","type-post","status-publish","format-standard","hentry","category-fda-registration-drug","category-fda-registration-medical-device","category-fda-registration-drug-medical-device","tag-fda-cosmetics-registration","tag-fda-drug-registration","tag-fda-medical-device-registration"],"_links":{"self":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/272","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/comments?post=272"}],"version-history":[{"count":1,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/272\/revisions"}],"predecessor-version":[{"id":273,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/posts\/272\/revisions\/273"}],"wp:attachment":[{"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/media?parent=272"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/categories?post=272"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.libertymanagement.us\/fda-news\/wp-json\/wp\/v2\/tags?post=272"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}