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	<title>Consumer Products Regulatory Consultants Archives - Focal Point</title>
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	<description>Scientific, Regulatory and New Product Consultants</description>
	<lastBuildDate>Wed, 09 Sep 2026 16:55:55 +0000</lastBuildDate>
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	<title>Consumer Products Regulatory Consultants Archives - Focal Point</title>
	<link>https://focalpointresearch.net/tag/consumer-products-regulatory-consultants/</link>
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<site xmlns="com-wordpress:feed-additions:1">126679100</site>	<item>
		<title>ICCR: E-labelling and Digital Information General Principles</title>
		<link>https://focalpointresearch.net/our-view/iccr-e-labelling-and-digital-information-general-principles/</link>
		
		<dc:creator><![CDATA[Sagarika Sharma]]></dc:creator>
		<pubDate>Wed, 09 Sep 2026 16:55:50 +0000</pubDate>
				<category><![CDATA[Our View]]></category>
		<category><![CDATA[Canadian Regulatory Consultants]]></category>
		<category><![CDATA[Consumer Products Regulatory Consultants]]></category>
		<category><![CDATA[Cosmetic Consultants]]></category>
		<category><![CDATA[Focal Point Research]]></category>
		<category><![CDATA[FPR]]></category>
		<category><![CDATA[ICCR]]></category>
		<category><![CDATA[ICCR E LABELLING]]></category>
		<category><![CDATA[North American Regulatory Consultants]]></category>
		<category><![CDATA[North American Scientific Regulatory Affairs & Quality Assurance Consulting Firm]]></category>
		<category><![CDATA[Regulatory Affairs Consultants]]></category>
		<category><![CDATA[Regulatory Consultants]]></category>
		<category><![CDATA[Scientific Regulatory & New Product Consultants]]></category>
		<guid isPermaLink="false">https://focalpointresearch.net/?p=5988</guid>

					<description><![CDATA[<p>ICCR has published a guide regarding e-labelling and digital information general principles. Through the ICCR, global regulators have established a set of general principles designed to foster globally compatible approaches to digital cosmetic labelling. The digital and physical labelling principles in the guide apply to specific product details. These include product identification, manufacturer or responsible [&#8230;]</p>
<p>The post <a href="https://focalpointresearch.net/our-view/iccr-e-labelling-and-digital-information-general-principles/">ICCR: E-labelling and Digital Information General Principles</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph">ICCR has published a <a href="https://www.iccr-cosmetics.org/topics-documents/15-e-labelling-and-digital-information">guide</a> regarding e-labelling and digital information general principles. Through the ICCR, global regulators have established a set of general principles designed to foster globally compatible approaches to digital cosmetic labelling.</p>



<p class="wp-block-paragraph">The digital and physical labelling principles in the guide apply to specific product details. These include product identification, manufacturer or responsible party contact information, product composition, weight or net content, and warning statements or safe-use instructions. The scope also covers any other use instructions and legally required statements for the specific region.</p>



<p class="wp-block-paragraph">For digital labels: Access should be provided via a single data carrier (e.g., a QR code) per product. There should be no additional text or pictograms placed next to the carrier to avoid operational complexity. Duplication of mandatory information across physical and digital formats should be minimized where permitted.</p>



<p class="wp-block-paragraph">Points to note:</p>



<ul class="wp-block-list">
<li>To ensure a seamless consumer experience, digital information must be highly accessible and transparent.</li>



<li>There should be Barrier-Free Access: Consumers must be able to access mandatory digital information quickly, without needing to register, provide personal data, or download any specialized apps.</li>



<li>Language Compliance should be maintained: Digital labels must be viewable in the languages required for physical labels in the target market.</li>



<li>There should be clear visual separation: Mandatory digital information must be visually separated from voluntary marketing or brand communications.</li>



<li>For uninterrupted viewing: Regulatory information must be prominent and cannot be obscured by promotional screens. Furthermore, consumers should not be redirected away from mandatory details prior notification.</li>



<li>Companies maintain full responsibility for their data and the technological mechanisms used to deliver it.</li>



<li>Security &amp; Privacy: Companies are required to implement cybersecurity measures to prevent data breaches. They must also protect consumer privacy and any personal data collected through the digital interface.</li>



<li></li>
</ul>
<p>The post <a href="https://focalpointresearch.net/our-view/iccr-e-labelling-and-digital-information-general-principles/">ICCR: E-labelling and Digital Information General Principles</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></content:encoded>
					
		
		
		<post-id xmlns="com-wordpress:feed-additions:1">5988</post-id>	</item>
		<item>
		<title>Upcoming Deadlines for Minnesota’s PFAS Reporting</title>
		<link>https://focalpointresearch.net/u-s-regulatory/upcoming-deadlines-for-minnesotas-pfas-reporting/</link>
		
		<dc:creator><![CDATA[Sagarika Sharma]]></dc:creator>
		<pubDate>Wed, 09 Sep 2026 16:52:44 +0000</pubDate>
				<category><![CDATA[Our View]]></category>
		<category><![CDATA[U.S. Regulatory]]></category>
		<category><![CDATA[U.S. State Updates]]></category>
		<category><![CDATA[Amara's law]]></category>
		<category><![CDATA[Canadian Regulatory Consultants]]></category>
		<category><![CDATA[Consumer Products Regulatory Consultants]]></category>
		<category><![CDATA[Cosmetic Consultants]]></category>
		<category><![CDATA[Focal Point Research]]></category>
		<category><![CDATA[FPR]]></category>
		<category><![CDATA[North American Regulatory Consultants]]></category>
		<category><![CDATA[North American Scientific Regulatory Affairs & Quality Assurance Consulting Firm]]></category>
		<category><![CDATA[Regulatory Affairs Consultants]]></category>
		<category><![CDATA[Regulatory Consultants]]></category>
		<category><![CDATA[Scientific Regulatory & New Product Consultants]]></category>
		<guid isPermaLink="false">https://focalpointresearch.net/?p=5986</guid>

					<description><![CDATA[<p>The Minnesota Pollution Control Agency is reminding manufacturers of critical impending deadlines under the state&#8217;s PFAS pollution prevention law, commonly known as Amara&#8217;s Law. Passed in May 2023, this legislation mandates that businesses must report intentionally added per- and polyfluoroalkyl substances (PFAS) in products sold within Minnesota and pay an associated fee. ​Products manufactured prior [&#8230;]</p>
<p>The post <a href="https://focalpointresearch.net/u-s-regulatory/upcoming-deadlines-for-minnesotas-pfas-reporting/">Upcoming Deadlines for Minnesota’s PFAS Reporting</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph">The Minnesota Pollution Control Agency is reminding manufacturers of critical impending deadlines under the state&#8217;s PFAS pollution prevention law, commonly known as <a href="https://www.pca.state.mn.us/get-engaged/pfas-in-products">Amara&#8217;s Law</a>.</p>



<p class="wp-block-paragraph">Passed in May 2023, this legislation mandates that businesses must report intentionally added per- and polyfluoroalkyl substances (PFAS) in products sold within Minnesota and pay an associated fee.</p>



<p class="wp-block-paragraph">​Products manufactured prior to July 1, 2023, are strictly excluded from these reporting requirements.</p>



<p class="wp-block-paragraph">Companies should be aware that after a formal review period, all submitted data will become publicly accessible, with the exception of verified trade secrets.</p>



<p class="wp-block-paragraph">​Critical 2026 Reporting Deadlines:</p>



<p class="wp-block-paragraph">​Because the initial reporting deadline is approaching rapidly, manufacturers are highly encouraged to begin their data entry and submit any necessary technical support requests immediately. Please ensure your compliance teams track the following key dates:</p>



<ul class="wp-block-list">
<li>​September 15, 2026: Initial PFAS reports are officially due.</li>



<li>​November 14, 2026: For manufacturers who previously secured a due date extension, requests for waivers must be postmarked or mailed by this date.</li>



<li>​December 14, 2026: Initial reports are due for manufacturers operating under an approved extension.</li>



<li>​February 1 (Annually): Moving forward, subsequent annual updates will be required each year on this date.</li>
</ul>



<p class="wp-block-paragraph">​</p>



<p class="wp-block-paragraph">If you have any questions regarding how this update may affect your business, do <a href="https://focalpointresearch.net/">reach out</a> to us today.</p>
<p>The post <a href="https://focalpointresearch.net/u-s-regulatory/upcoming-deadlines-for-minnesotas-pfas-reporting/">Upcoming Deadlines for Minnesota’s PFAS Reporting</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></content:encoded>
					
		
		
		<post-id xmlns="com-wordpress:feed-additions:1">5986</post-id>	</item>
		<item>
		<title>Virginia Enacts Ingredient Restrictions (HB 122)</title>
		<link>https://focalpointresearch.net/u-s-regulatory/virginia-enacts-ingredient-restrictions-hb-122/</link>
		
		<dc:creator><![CDATA[Sagarika Sharma]]></dc:creator>
		<pubDate>Wed, 09 Sep 2026 16:49:29 +0000</pubDate>
				<category><![CDATA[Cosmetics]]></category>
		<category><![CDATA[U.S. Regulatory]]></category>
		<category><![CDATA[U.S. State Updates]]></category>
		<category><![CDATA[Canadian Regulatory Consultants]]></category>
		<category><![CDATA[Consumer Products Regulatory Consultants]]></category>
		<category><![CDATA[Cosmetic Consultants]]></category>
		<category><![CDATA[Focal Point Research]]></category>
		<category><![CDATA[FPR]]></category>
		<category><![CDATA[HB 122]]></category>
		<category><![CDATA[North American Regulatory Consultants]]></category>
		<category><![CDATA[North American Scientific Regulatory Affairs & Quality Assurance Consulting Firm]]></category>
		<category><![CDATA[Regulatory Affairs Consultants]]></category>
		<category><![CDATA[Regulatory Consultants]]></category>
		<category><![CDATA[Scientific Regulatory & New Product Consultants]]></category>
		<guid isPermaLink="false">https://focalpointresearch.net/?p=5984</guid>

					<description><![CDATA[<p>On April 13, the Governor of Virginia signed House Bill 122 (HB 122) into law. This enacted legislation introduces new regulatory constraints regarding ingredient restrictions for cosmetic products within the state. ​Key Provisions of Virginia HB 122: ​To review your product formulations and ensure continuous compliance with emerging state-level legislation, please contact us.</p>
<p>The post <a href="https://focalpointresearch.net/u-s-regulatory/virginia-enacts-ingredient-restrictions-hb-122/">Virginia Enacts Ingredient Restrictions (HB 122)</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph">On April 13, the Governor of Virginia signed <a href="https://fypllyfab.cc.rs6.net/tn.jsp?f=001PBNfNXR-KTCdDkHtuPzXoVXuO4VH6597k_7e5bWfWNy6z3nFjQ35dM-Bh5dep7VrpFT9EnqGndgzyp93mj03yn01hYvjZVq7-5N7oWaHMJPaj1nPZS0A3otEFnfJ4p-B_laCO0bz6sCbxMjKwyf-Tj-WBXcJogE4LTRJCknHCO9dAKILTG6rLepzJJlvBIritwLdGGR0u5FwPWzYRDxClPaVRTD_AqdaXgYBXIwaK9AXifNo0PbDH1lX-T_xf6q5xml4vWn-Uka5mS7djz94UiSN3TP0wA2N0ga8kYeD84lj5qByYOhOddkoGcjROklrOL4x5mYnQ4w=&amp;c=3anWzeQDWLpQ8AXF0Sj9f_KDWsHG_6Ez3bby5lCWSA42yGJvGIw70A==&amp;ch=jPE5_hAlBMyFj8VeIqEetENYY1DTsWtGXUkjaex0S3FFXB6QHx-Z1Q==">House Bill 122</a> (HB 122) into law. This enacted legislation introduces new regulatory constraints regarding ingredient restrictions for cosmetic products within the state.</p>



<p class="wp-block-paragraph">​Key Provisions of Virginia HB 122:</p>



<ul class="wp-block-list">
<li>​The law strictly prohibits the use of certain <a href="https://fypllyfab.cc.rs6.net/tn.jsp?f=001PBNfNXR-KTCdDkHtuPzXoVXuO4VH6597k_7e5bWfWNy6z3nFjQ35dM-Bh5dep7VrpFT9EnqGndgzyp93mj03yn01hYvjZVq7-5N7oWaHMJPaj1nPZS0A3otEFnfJ4p-B_laCO0bz6sCbxMjKwyf-Tj-WBXcJogE4LTRJCknHCO9dAKILTG6rLepzJJlvBIritwLdGGR0u5FwPWzYRDxClPaVRTD_AqdaXgYBXIwaK9AXifNo0PbDH1lX-T_xf6q5xml4vWn-Uka5mS7djz94UiSN3TP0wA2N0ga8kYeD84lj5qByYOhOddkoGcjROklrOL4x5mYnQ4w=&amp;c=3anWzeQDWLpQ8AXF0Sj9f_KDWsHG_6Ez3bby5lCWSA42yGJvGIw70A==&amp;ch=jPE5_hAlBMyFj8VeIqEetENYY1DTsWtGXUkjaex0S3FFXB6QHx-Z1Q==">intentionally used ingredients</a>.</li>



<li>​The bill has successfully passed and its status is officially updated to enacted.</li>
</ul>



<p class="wp-block-paragraph">​To review your product formulations and ensure continuous compliance with emerging state-level legislation, please <a href="https://focalpointresearch.net/">contact us</a>.</p>
<p>The post <a href="https://focalpointresearch.net/u-s-regulatory/virginia-enacts-ingredient-restrictions-hb-122/">Virginia Enacts Ingredient Restrictions (HB 122)</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></content:encoded>
					
		
		
		<post-id xmlns="com-wordpress:feed-additions:1">5984</post-id>	</item>
		<item>
		<title>Rhode Island Enacts PFAS Ban on Covered Products</title>
		<link>https://focalpointresearch.net/u-s-regulatory/rhode-island-enacts-pfas-ban-on-covered-products/</link>
		
		<dc:creator><![CDATA[Sagarika Sharma]]></dc:creator>
		<pubDate>Wed, 09 Sep 2026 16:46:34 +0000</pubDate>
				<category><![CDATA[Our View]]></category>
		<category><![CDATA[U.S. Regulatory]]></category>
		<category><![CDATA[U.S. State Updates]]></category>
		<category><![CDATA[Canadian Regulatory Consultants]]></category>
		<category><![CDATA[Consumer Products Regulatory Consultants]]></category>
		<category><![CDATA[Cosmetic Consultants]]></category>
		<category><![CDATA[Focal Point Research]]></category>
		<category><![CDATA[FPR]]></category>
		<category><![CDATA[North American Regulatory Consultants]]></category>
		<category><![CDATA[North American Scientific Regulatory Affairs & Quality Assurance Consulting Firm]]></category>
		<category><![CDATA[Regulatory Affairs Consultants]]></category>
		<category><![CDATA[Regulatory Consultants]]></category>
		<category><![CDATA[Scientific Regulatory & New Product Consultants]]></category>
		<guid isPermaLink="false">https://focalpointresearch.net/?p=5982</guid>

					<description><![CDATA[<p>On June 19, the Governor of Rhode Island officially signed House Bill 7734 (RI HB 7734) into law. This enacted legislation establishes strict new restrictions surrounding per- and polyfluoroalkyl substances (PFAS) in consumer goods. ​Key Provisions of RI HB 7734: ​Considering the upcoming deadline, contact us today to review your product formulations to ensure full [&#8230;]</p>
<p>The post <a href="https://focalpointresearch.net/u-s-regulatory/rhode-island-enacts-pfas-ban-on-covered-products/">Rhode Island Enacts PFAS Ban on Covered Products</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph">On June 19, the Governor of Rhode Island officially signed <a href="https://fypllyfab.cc.rs6.net/tn.jsp?f=001PBNfNXR-KTCdDkHtuPzXoVXuO4VH6597k_7e5bWfWNy6z3nFjQ35dM-Bh5dep7VrAbSBvLb79ZyZIiym2tI1jywOr6LoGa-fWOhU54WHT4GlAod2dhHeCSO5xris7xrZDk5sOMuG5LhhIWJ9wXE8kom_2gfoasVMFmI2e4ByQYvR2za0Qcb3VRBUrSuhEnB77gDD9HTdncJEGtYuMpy78GZTk84R7Ch5aurr-NAeAvDIpZwF0xs_UvnETQKkOK1OICxTu724a8fiw8u_uk2YNi0eNlDoPsgQpncg8NFWqskoMuhoxF36fp2bcm8lhuy_VAgL3MaywEA=&amp;c=3anWzeQDWLpQ8AXF0Sj9f_KDWsHG_6Ez3bby5lCWSA42yGJvGIw70A==&amp;ch=jPE5_hAlBMyFj8VeIqEetENYY1DTsWtGXUkjaex0S3FFXB6QHx-Z1Q==">House Bill 7734</a> (RI HB 7734) into law. This enacted legislation establishes strict new restrictions surrounding per- and polyfluoroalkyl substances (PFAS) in consumer goods.</p>



<p class="wp-block-paragraph">​Key Provisions of RI HB 7734:</p>



<ul class="wp-block-list">
<li>The law strictly prohibits the sale of covered products (including cosmetics) that contain intentionally added PFAS.</li>



<li>​This prohibition will officially take effect beginning January 1, 2027.</li>
</ul>



<p class="wp-block-paragraph">​Considering the upcoming deadline, <a href="https://focalpointresearch.net/">contact us</a> today to review your product formulations to ensure full compliance before enforcement begins.</p>



<p class="wp-block-paragraph"></p>
<p>The post <a href="https://focalpointresearch.net/u-s-regulatory/rhode-island-enacts-pfas-ban-on-covered-products/">Rhode Island Enacts PFAS Ban on Covered Products</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></content:encoded>
					
		
		
		<post-id xmlns="com-wordpress:feed-additions:1">5982</post-id>	</item>
		<item>
		<title>Maryland Enacts Ingredient Restrictions for Cosmetics and Hair Care</title>
		<link>https://focalpointresearch.net/cosmetics/maryland-enacts-ingredient-restrictions-for-cosmetics-and-hair-care/</link>
		
		<dc:creator><![CDATA[Sagarika Sharma]]></dc:creator>
		<pubDate>Wed, 09 Sep 2026 16:39:32 +0000</pubDate>
				<category><![CDATA[Cosmetics]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[U.S. Regulatory]]></category>
		<category><![CDATA[U.S. State Updates]]></category>
		<category><![CDATA[Canadian Regulatory Consultants]]></category>
		<category><![CDATA[Consumer Products Regulatory Consultants]]></category>
		<category><![CDATA[Focal Point Research]]></category>
		<category><![CDATA[FPR]]></category>
		<category><![CDATA[MD HB 1533]]></category>
		<category><![CDATA[MD SB 656]]></category>
		<category><![CDATA[North American Regulatory Consultants]]></category>
		<category><![CDATA[North American Scientific Regulatory Affairs & Quality Assurance Consulting Firm]]></category>
		<category><![CDATA[Regulatory Affairs Consultants]]></category>
		<category><![CDATA[Regulatory Consultants]]></category>
		<category><![CDATA[Scientific Regulatory & New Product Consultants]]></category>
		<guid isPermaLink="false">https://focalpointresearch.net/?p=5979</guid>

					<description><![CDATA[<p>On April 28, the Governor of Maryland signed into law MD HB 1533 and MD SB 656, officially enacting new ingredient restrictions for cosmetic and hair care products within the state. ​Key Provisions of the Enacted Bills: ​This legislation introduces strict regulatory requirements and robust enforcement mechanisms for the personal care industry: ​These new laws [&#8230;]</p>
<p>The post <a href="https://focalpointresearch.net/cosmetics/maryland-enacts-ingredient-restrictions-for-cosmetics-and-hair-care/">Maryland Enacts Ingredient Restrictions for Cosmetics and Hair Care</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph">On April 28, the Governor of Maryland signed into law <a href="https://fypllyfab.cc.rs6.net/tn.jsp?f=001PBNfNXR-KTCdDkHtuPzXoVXuO4VH6597k_7e5bWfWNy6z3nFjQ35dM-Bh5dep7VrjaRDTUq0tT8FaD5Ktt7tiwIVepMrVIoacc12RakR2hT40YyE9k9tuhgQWBmDJvbFoe9p2eDyXRgBN4eIZiR9I945rllwW3TTtuNwNuUWJ5kPsfywcLoMptCbEQD6rRmw7XVElHI8A1nLfSa9wtm-og1JoXUxWJ4j_gLKy7IOQ4QRwXFd9gs6ORgsBedKXlAE8XLlWhesog06mMQKDfiyInM-KNyCbO5cAn-yJ79F-C37WhZ1PtvMTks9vgino2FRxS7CviDooAc=&amp;c=3anWzeQDWLpQ8AXF0Sj9f_KDWsHG_6Ez3bby5lCWSA42yGJvGIw70A==&amp;ch=jPE5_hAlBMyFj8VeIqEetENYY1DTsWtGXUkjaex0S3FFXB6QHx-Z1Q==">MD HB 1533</a> and <a href="https://fypllyfab.cc.rs6.net/tn.jsp?f=001PBNfNXR-KTCdDkHtuPzXoVXuO4VH6597k_7e5bWfWNy6z3nFjQ35dM-Bh5dep7VrCgh8SlJ4KACBOIZ8oXTqFdYAFnxsvXowMcYegMrp3Fdu0T1lwSkTJCs9MF1PYLWjs-g2t0Rh3FNns0j3PIE5RrmiJlFOAQ_ev2RPdgTw7nYEBfYooZxZIUs2SQXeEZQcVDfJ6xx8RAbzJf_9EzGdyg_rLmU9fISg8VVn98rzHIb6MbT_EOyXIVVXgZcAcaKuIu_X-RWsqaXlB9qA--dgbbLDN2I0QkQ9_iVpKn_1vQbSfFy6KS2_yQGifdR1eq6dJwzQvK3pYa0=&amp;c=3anWzeQDWLpQ8AXF0Sj9f_KDWsHG_6Ez3bby5lCWSA42yGJvGIw70A==&amp;ch=jPE5_hAlBMyFj8VeIqEetENYY1DTsWtGXUkjaex0S3FFXB6QHx-Z1Q==">MD SB 656</a>, officially enacting new ingredient restrictions for cosmetic and hair care products within the state.</p>



<p class="wp-block-paragraph">​Key Provisions of the Enacted Bills:</p>



<p class="wp-block-paragraph">​This legislation introduces strict regulatory requirements and robust enforcement mechanisms for the personal care industry:</p>



<ul class="wp-block-list">
<li>​The enacted bills prohibit the manufacture, sale, or distribution of cosmetic and hair care products in Maryland that intentionally contain lead and certain other harmful chemicals.</li>
</ul>



<ul class="wp-block-list">
<li>​The Maryland Department of Health is now authorized to actively investigate complaints and enforce compliance with the new restrictions.</li>
</ul>



<ul class="wp-block-list">
<li>​Violations of the law are considered unfair trade practices. Businesses found in violation may face significant civil damages, which can include treble and punitive damages in cases of willful non-compliance.</li>
</ul>



<p class="wp-block-paragraph">​These new laws underscore the growing trend of state-level scrutiny regarding cosmetic ingredients, emphasizing the immediate need for rigorous formula and supply chain reviews to ensure compliance in the Maryland market.</p>



<p class="wp-block-paragraph">​To get your formulas reviewed and to ensure compliance, <a href="https://focalpointresearch.net/">contact us</a> today.</p>
<p>The post <a href="https://focalpointresearch.net/cosmetics/maryland-enacts-ingredient-restrictions-for-cosmetics-and-hair-care/">Maryland Enacts Ingredient Restrictions for Cosmetics and Hair Care</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></content:encoded>
					
		
		
		<post-id xmlns="com-wordpress:feed-additions:1">5979</post-id>	</item>
		<item>
		<title>California DTSC Updates Candidate Chemicals List to Include PPD Derivatives</title>
		<link>https://focalpointresearch.net/california-cosmetic-regulations/california-dtsc-updates-candidate-chemicals-list-to-include-ppd-derivatives/</link>
		
		<dc:creator><![CDATA[Sagarika Sharma]]></dc:creator>
		<pubDate>Wed, 09 Sep 2026 16:36:51 +0000</pubDate>
				<category><![CDATA[California Cosmetic Regulations]]></category>
		<category><![CDATA[Our View]]></category>
		<category><![CDATA[U.S. Regulatory]]></category>
		<category><![CDATA[U.S. State Updates]]></category>
		<category><![CDATA[Canadian Regulatory Consultants]]></category>
		<category><![CDATA[Consumer Products Regulatory Consultants]]></category>
		<category><![CDATA[Cosmetic Consultants]]></category>
		<category><![CDATA[Focal Point Research]]></category>
		<category><![CDATA[FPR]]></category>
		<category><![CDATA[North American Regulatory Consultants]]></category>
		<category><![CDATA[North American Scientific Regulatory Affairs & Quality Assurance Consulting Firm]]></category>
		<category><![CDATA[Regulatory Affairs Consultants]]></category>
		<category><![CDATA[Regulatory Consultants]]></category>
		<category><![CDATA[Scientific Regulatory & New Product Consultants]]></category>
		<guid isPermaLink="false">https://focalpointresearch.net/?p=5977</guid>

					<description><![CDATA[<p>On July 3, 2026, the California Department of Toxic Substances Control (DTSC) Safer Consumer Products Program finalized a regulation to add para-phenylenediamine (PPD) derivatives to its Candidate Chemicals List. This new inclusion is scheduled to go into effect on October 1, 2026. DTSC’s decision is driven by environmental and health safety evaluations regarding this class [&#8230;]</p>
<p>The post <a href="https://focalpointresearch.net/california-cosmetic-regulations/california-dtsc-updates-candidate-chemicals-list-to-include-ppd-derivatives/">California DTSC Updates Candidate Chemicals List to Include PPD Derivatives</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph">On July 3, 2026, the California Department of Toxic Substances Control (DTSC) Safer Consumer Products Program <a href="https://fypllyfab.cc.rs6.net/tn.jsp?f=001PBNfNXR-KTCdDkHtuPzXoVXuO4VH6597k_7e5bWfWNy6z3nFjQ35dM-Bh5dep7VrtTZMU7N0A8NoSjnrfzL9CJfiA0o1ztHfVpy_JQ4hrg6SjCFlwsN7fRntVyaF9pFgsjtZeoYi6qz6Uh05M0JKvwmK5Xr3hvYnz1XwkP0U_M_Xu8DsQ_8fqaXC5-wCKdnZ_pgXXc4rB5WwjlcwHLo6eXyukKNGZszBK_t3icmsL97cx3XyEMwJmomflIU9nio_&amp;c=3anWzeQDWLpQ8AXF0Sj9f_KDWsHG_6Ez3bby5lCWSA42yGJvGIw70A==&amp;ch=jPE5_hAlBMyFj8VeIqEetENYY1DTsWtGXUkjaex0S3FFXB6QHx-Z1Q==">finalized a regulation</a> to add para-phenylenediamine (PPD) derivatives to its <a href="https://fypllyfab.cc.rs6.net/tn.jsp?f=001PBNfNXR-KTCdDkHtuPzXoVXuO4VH6597k_7e5bWfWNy6z3nFjQ35dFEvufcwi-826A4UuwQU8jBvKicr8Fv7aa6h3WbtKRXaNXk0OgeuWAYLSKmymmB34kD6gA41kWohvUTKXVpjkx5WB0JOMukOB4rRgbUwjJ-y68sWSM18PkVxJUl-HBdlBeQ6HFdpB5al&amp;c=3anWzeQDWLpQ8AXF0Sj9f_KDWsHG_6Ez3bby5lCWSA42yGJvGIw70A==&amp;ch=jPE5_hAlBMyFj8VeIqEetENYY1DTsWtGXUkjaex0S3FFXB6QHx-Z1Q==">Candidate Chemicals List</a>. This new inclusion is scheduled to go into effect on October 1, 2026.</p>



<p class="wp-block-paragraph">DTSC’s decision is driven by environmental and health safety evaluations regarding this class of chemicals. The department has determined that PPD derivatives are expected to exhibit specific hazard traits, primarily dermatotoxicity and wildlife survival impairment.</p>



<p class="wp-block-paragraph">​Regulators are concerned that these derivatives may cause or contribute to adverse dermatological impacts (such as skin sensitization) as well as severe adverse aquatic impacts (such as death).</p>



<p class="wp-block-paragraph">​What This Means for Your Business:</p>



<p class="wp-block-paragraph">​It is important for manufacturers and formulators to understand the immediate impact of this update. Adding a chemical to the Candidate Chemicals List does not create any new regulatory obligations. However, this listing serves as a strong indicator that PPD derivatives are under scrutiny and may be targeted for future evaluation or product prioritization by the DTSC.</p>



<p class="wp-block-paragraph">​If you have any questions regarding this update or would like to get your formulas reviewed, our team is here to help. <a href="https://focalpointresearch.net/">Contact us</a> today.</p>
<p>The post <a href="https://focalpointresearch.net/california-cosmetic-regulations/california-dtsc-updates-candidate-chemicals-list-to-include-ppd-derivatives/">California DTSC Updates Candidate Chemicals List to Include PPD Derivatives</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></content:encoded>
					
		
		
		<post-id xmlns="com-wordpress:feed-additions:1">5977</post-id>	</item>
		<item>
		<title>FDA Update: Revised Timelines for MoCRA Implementation and Cosmetic Regulations</title>
		<link>https://focalpointresearch.net/mocra/fda-update-revised-timelines-for-mocra-implementation-and-cosmetic-regulations/</link>
		
		<dc:creator><![CDATA[Sagarika Sharma]]></dc:creator>
		<pubDate>Wed, 09 Sep 2026 16:26:38 +0000</pubDate>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[MoCRA]]></category>
		<category><![CDATA[U.S. Regulatory]]></category>
		<category><![CDATA[Canadian Regulatory Consultants]]></category>
		<category><![CDATA[Consumer Products Regulatory Consultants]]></category>
		<category><![CDATA[Cosmetic Consultants]]></category>
		<category><![CDATA[Focal Point Research]]></category>
		<category><![CDATA[FPR]]></category>
		<category><![CDATA[North American Regulatory Consultants]]></category>
		<category><![CDATA[North American Scientific Regulatory Affairs & Quality Assurance Consulting Firm]]></category>
		<category><![CDATA[Regulatory Affairs Consultants]]></category>
		<category><![CDATA[Regulatory Consultants]]></category>
		<category><![CDATA[Scientific Regulatory & New Product Consultants]]></category>
		<guid isPermaLink="false">https://focalpointresearch.net/?p=5975</guid>

					<description><![CDATA[<p>On July 3, the Department of Health and Human Services (HHS) published the latest Unified Agenda and Agency Rule List. This publication offers updated insights into the FDA&#8217;s expected timeline for implementing the Modernization of Cosmetics Regulation Act (MoCRA) and other cosmetics-related rules. ​While the published dates are not legally binding, and cosmetics rulemaking has [&#8230;]</p>
<p>The post <a href="https://focalpointresearch.net/mocra/fda-update-revised-timelines-for-mocra-implementation-and-cosmetic-regulations/">FDA Update: Revised Timelines for MoCRA Implementation and Cosmetic Regulations</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph">On July 3, the Department of Health and Human Services (HHS) published the latest <a href="https://fypllyfab.cc.rs6.net/tn.jsp?f=001PBNfNXR-KTCdDkHtuPzXoVXuO4VH6597k_7e5bWfWNy6z3nFjQ35dM-Bh5dep7VrdGRQl8I--57l0Vx_pVvvMMHGijwYBqZNlkinEt7zrVt7t3Z0rOHLINodDccEOMHveSEL6WnlzuoUQ3szJHzUtDHpj0XZVyoh2LFQB9d7gZDZlid86giYfLvRONeRNqiQEv65iDHKhZSnQw7VxaYkYgGIHaENxU2NKMD4cJnhkK0=&amp;c=3anWzeQDWLpQ8AXF0Sj9f_KDWsHG_6Ez3bby5lCWSA42yGJvGIw70A==&amp;ch=jPE5_hAlBMyFj8VeIqEetENYY1DTsWtGXUkjaex0S3FFXB6QHx-Z1Q==">Unified Agenda and Agency Rule List</a>. This publication offers updated insights into the FDA&#8217;s expected timeline for implementing the Modernization of Cosmetics Regulation Act (MoCRA) and other cosmetics-related rules.</p>



<p class="wp-block-paragraph">​While the published dates are not legally binding, and cosmetics rulemaking has historically experienced further delays following the publication of these target dates, the agenda outlines the latest thinking from the HHS and FDA regarding their regulatory timelines.</p>



<p class="wp-block-paragraph">​Key Updates to Proposed Target Dates:</p>



<p class="wp-block-paragraph">​The agenda highlights new proposed dates for several critical regulatory actions:</p>



<ul class="wp-block-list">
<li>​<a href="https://fypllyfab.cc.rs6.net/tn.jsp?f=001PBNfNXR-KTCdDkHtuPzXoVXuO4VH6597k_7e5bWfWNy6z3nFjQ35dM-Bh5dep7VrdGRQl8I--57l0Vx_pVvvMMHGijwYBqZNlkinEt7zrVt7t3Z0rOHLINodDccEOMHveSEL6WnlzuoUQ3szJHzUtDHpj0XZVyoh2LFQB9d7gZDZlid86giYfLvRONeRNqiQEv65iDHKhZSnQw7VxaYkYgGIHaENxU2NKMD4cJnhkK0=&amp;c=3anWzeQDWLpQ8AXF0Sj9f_KDWsHG_6Ez3bby5lCWSA42yGJvGIw70A==&amp;ch=jPE5_hAlBMyFj8VeIqEetENYY1DTsWtGXUkjaex0S3FFXB6QHx-Z1Q==">Disclosure of Fragrance Allergens</a>: The new proposed date for the disclosure of fragrance allergens in cosmetic labeling is November 2026.</li>
</ul>



<ul class="wp-block-list">
<li>​<a href="https://fypllyfab.cc.rs6.net/tn.jsp?f=001PBNfNXR-KTCdDkHtuPzXoVXuO4VH6597k_7e5bWfWNy6z3nFjQ35dM-Bh5dep7Vr0ugvhSLe8mTm74CVWDPw8zif0sOytc9CgeO7LDl0mhaW0sOUjWRvg_Di058t3z8NE9C5hbrxLBoTL72VfPvCkqdhpRLHD0BJ4_-ha1kB8Z7Lqe0MsUq1NwfoVwp0azYMEn1CrdL8OVuG_RzRfgYa5V7VrWEzc05aFhQq0_VTHjc=&amp;c=3anWzeQDWLpQ8AXF0Sj9f_KDWsHG_6Ez3bby5lCWSA42yGJvGIw70A==&amp;ch=jPE5_hAlBMyFj8VeIqEetENYY1DTsWtGXUkjaex0S3FFXB6QHx-Z1Q==">Formaldehyde in Hair Products</a>: The new proposed date for rules addressing the use of formaldehyde and formaldehyde-releasing chemicals as an ingredient in hair smoothing products or hair straightening products is November 2026.</li>
</ul>



<ul class="wp-block-list">
<li>​<a href="https://fypllyfab.cc.rs6.net/tn.jsp?f=001PBNfNXR-KTCdDkHtuPzXoVXuO4VH6597k_7e5bWfWNy6z3nFjQ35dM-Bh5dep7VrHJtsKm3ouc_o6GFJKlm66kaKCPaOW4awWk9auRY6ntBPiYQyDwHIHfRovDWMvZ-1LLhIjIBUxQwcCbKnCpXJCpDaFB3TKtfNThLE0P1NNGIh43_71MsTvbv1YXooKaUZ8ChmmTHAnGpiGjiwjdQ74YNwsHJCLGwSneDARXMdPxM=&amp;c=3anWzeQDWLpQ8AXF0Sj9f_KDWsHG_6Ez3bby5lCWSA42yGJvGIw70A==&amp;ch=jPE5_hAlBMyFj8VeIqEetENYY1DTsWtGXUkjaex0S3FFXB6QHx-Z1Q==">Good Manufacturing Practice (GMP)</a>: The new proposed date for Good Manufacturing Practice for cosmetic product facilities is November 2027.</li>
</ul>



<ul class="wp-block-list">
<li>​<a href="https://fypllyfab.cc.rs6.net/tn.jsp?f=001PBNfNXR-KTCdDkHtuPzXoVXuO4VH6597k_7e5bWfWNy6z3nFjQ35dM-Bh5dep7VrArnEFwHsOZYeRBFspr0qPV_dnvFFqHKx4mX3wwZBzr-J1E7x5CIUVzpsG2fUdzxB-pip5gDZPNjohms5YSeHSsD0WYXABCnpjo24j84wpsr0_FiO5CAAL4mOKvZpvo7k4QZuZ7j9c8oQPiBz7Pi3qoV7d5jPkDtrFZ1Fd-NiDho=&amp;c=3anWzeQDWLpQ8AXF0Sj9f_KDWsHG_6Ez3bby5lCWSA42yGJvGIw70A==&amp;ch=jPE5_hAlBMyFj8VeIqEetENYY1DTsWtGXUkjaex0S3FFXB6QHx-Z1Q==">Asbestos Testing in Talc</a>: The new proposed date for testing methods for detecting and identifying asbestos in talc-containing cosmetic products is November 2027.</li>
</ul>



<p class="wp-block-paragraph">​What This Means for the Industry:</p>



<p class="wp-block-paragraph">​These revised target dates indicate continued delays in the finalization of key MoCRA provisions. However, this extension provides manufacturers, brand owners, and regulatory teams with additional time to prepare. Companies should use this window to proactively review their formulations, audit their manufacturing processes, and establish the necessary supply chain transparency to ensure full readiness once the FDA finalizes and enforces these mandates.</p>



<p class="wp-block-paragraph">​If you have any questions or need assistance with MoCRA listings, label or formulation reviews, <a href="https://focalpointresearch.net/">reach out</a> today.</p>
<p>The post <a href="https://focalpointresearch.net/mocra/fda-update-revised-timelines-for-mocra-implementation-and-cosmetic-regulations/">FDA Update: Revised Timelines for MoCRA Implementation and Cosmetic Regulations</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
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		<post-id xmlns="com-wordpress:feed-additions:1">5975</post-id>	</item>
		<item>
		<title>Louisiana moves to ease cosmetic requirements for cottage businesses</title>
		<link>https://focalpointresearch.net/cosmetics/louisiana-moves-to-ease-cosmetic-requirements-for-cottage-businesses/</link>
		
		<dc:creator><![CDATA[Srishti Chaudhari]]></dc:creator>
		<pubDate>Wed, 09 Sep 2026 16:23:26 +0000</pubDate>
				<category><![CDATA[Cosmetics]]></category>
		<category><![CDATA[U.S. Regulatory]]></category>
		<category><![CDATA[U.S. State Updates]]></category>
		<category><![CDATA[Consumer Products Regulatory Consultants]]></category>
		<category><![CDATA[Focal Point Research]]></category>
		<category><![CDATA[FPR]]></category>
		<category><![CDATA[North American Regulatory Consultants]]></category>
		<category><![CDATA[North American Scientific Regulatory Affairs & Quality Assurance Consulting Firm]]></category>
		<category><![CDATA[Regulatory Affairs Consultants]]></category>
		<category><![CDATA[Regulatory Consultants]]></category>
		<category><![CDATA[Scientific Regulatory & New Product Consultants]]></category>
		<guid isPermaLink="false">https://focalpointresearch.net/?p=5973</guid>

					<description><![CDATA[<p>Louisiana is proposing changes to its cosmetic regulations that would eliminate the state product registration requirement for cosmetics and create a new exemption for qualifying cottage cosmetic facilities. Under the proposed legislation, businesses operating from a private residence with annual wholesale cosmetic sales of $100,000 or less would be exempt from state facility permits, related [&#8230;]</p>
<p>The post <a href="https://focalpointresearch.net/cosmetics/louisiana-moves-to-ease-cosmetic-requirements-for-cottage-businesses/">Louisiana moves to ease cosmetic requirements for cottage businesses</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph">Louisiana is proposing <a href="https://www.legis.la.gov/legis/ViewDocument.aspx?d=1453291">changes to its cosmetic regulations</a> that would eliminate the state product registration requirement for cosmetics and create a new exemption for qualifying cottage cosmetic facilities. Under the proposed legislation, businesses operating from a private residence with annual wholesale cosmetic sales of $100,000 or less would be exempt from state facility permits, related fees, and routine inspections. However, the exemption would not cover injectable or internal-use cosmetics, products intended to permanently alter appearance, products that regularly contact the eye&#8217;s mucous membrane, or products making drug-type claims.</p>



<p class="wp-block-paragraph">The proposal would also clarify that cosmetics sold directly to consumers are not subject to Louisiana&#8217;s facility permitting and inspection requirements. Businesses would still need to comply with applicable federal requirements under the FD&amp;C Act and MoCRA, as well as state and local tax requirements.</p>



<p class="wp-block-paragraph">If enacted, the changes could reduce regulatory and administrative requirements for small, home-based cosmetic businesses in Louisiana, while maintaining federal compliance obligations. Companies should monitor the legislation, particularly the $100,000 sakes threshold and product exclusions, when assessing eligibility for the proposed exemption.</p>



<p class="wp-block-paragraph">For more such updates, <a href="https://focalpointresearch.net/">contact us</a>.</p>
<p>The post <a href="https://focalpointresearch.net/cosmetics/louisiana-moves-to-ease-cosmetic-requirements-for-cottage-businesses/">Louisiana moves to ease cosmetic requirements for cottage businesses</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></content:encoded>
					
		
		
		<post-id xmlns="com-wordpress:feed-additions:1">5973</post-id>	</item>
		<item>
		<title>New Mexico PFAS Protection Act: Cosmetics Restrictions Begin in 2028</title>
		<link>https://focalpointresearch.net/u-s-regulatory/new-mexico-pfas-protection-act-cosmetics-restrictions-begin-in-2028/</link>
		
		<dc:creator><![CDATA[Srishti Chaudhari]]></dc:creator>
		<pubDate>Wed, 09 Sep 2026 16:05:41 +0000</pubDate>
				<category><![CDATA[U.S. Regulatory]]></category>
		<category><![CDATA[U.S. State Updates]]></category>
		<category><![CDATA[Canadian Regulatory Consultants]]></category>
		<category><![CDATA[Consumer Products Regulatory Consultants]]></category>
		<category><![CDATA[Cosmetic Consultants]]></category>
		<category><![CDATA[Focal Point Research]]></category>
		<category><![CDATA[FPR]]></category>
		<category><![CDATA[HB 212]]></category>
		<category><![CDATA[North American Regulatory Consultants]]></category>
		<category><![CDATA[North American Scientific Regulatory Affairs & Quality Assurance Consulting Firm]]></category>
		<category><![CDATA[Regulatory Affairs Consultants]]></category>
		<category><![CDATA[Regulatory Consultants]]></category>
		<category><![CDATA[Scientific Regulatory & New Product Consultants]]></category>
		<guid isPermaLink="false">https://focalpointresearch.net/?p=5970</guid>

					<description><![CDATA[<p>New Mexico&#8217;s PFAS Protection Act (HB 212) introduces a phased ban on consumer products containing intentionally added PFAS. For the cosmetics industry, restrictions on cosmetics will take effect January 1, 2028, unless an exemption or currently unavoidable use determination applies. By 2032, the ban is expected to extend to virtually all non-exempt products containing intentionally [&#8230;]</p>
<p>The post <a href="https://focalpointresearch.net/u-s-regulatory/new-mexico-pfas-protection-act-cosmetics-restrictions-begin-in-2028/">New Mexico PFAS Protection Act: Cosmetics Restrictions Begin in 2028</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph">New Mexico&#8217;s PFAS Protection Act (<a href="https://www.env.nm.gov/pfas/pfas-protection-act-hb212/">HB 212</a>) introduces a phased ban on consumer products containing intentionally added PFAS. For the cosmetics industry, restrictions on cosmetics will take effect January 1, 2028, unless an exemption or currently unavoidable use determination applies. By 2032, the ban is expected to extend to virtually all non-exempt products containing intentionally added PFAS.</p>



<p class="wp-block-paragraph">Medical devices are subject to exemptions where PFAS are essential to the device and their use do not pose serious harm to users. Manufacturers should assess whether their products meet the applicable exemption criteria.</p>



<p class="wp-block-paragraph">A new PFAS labeling requirement will also take effect January 1, 2027. Products containing intentionally added PFAS sold or distributed in New Mexico will be required to display a standardized PFAS symbol. The Environmental Improvement Board finalized the implementing rules in March 2026, with the Final Rule published in the New Mexico Register on May 5, 2026.</p>



<p class="wp-block-paragraph">To ensure your compliance with this new requirement, please <a href="https://focalpointresearch.net/">contact us</a>.</p>
<p>The post <a href="https://focalpointresearch.net/u-s-regulatory/new-mexico-pfas-protection-act-cosmetics-restrictions-begin-in-2028/">New Mexico PFAS Protection Act: Cosmetics Restrictions Begin in 2028</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></content:encoded>
					
		
		
		<post-id xmlns="com-wordpress:feed-additions:1">5970</post-id>	</item>
		<item>
		<title>FDA Announces FY 2027 OMUFA User Fee Rates and Streamlines Fee process</title>
		<link>https://focalpointresearch.net/fda/fda-announces-fy-2027-omufa-user-fee-rates-and-streamlines-fee-process/</link>
		
		<dc:creator><![CDATA[Srishti Chaudhari]]></dc:creator>
		<pubDate>Wed, 09 Sep 2026 15:58:36 +0000</pubDate>
				<category><![CDATA[FDA]]></category>
		<category><![CDATA[OTC Drugs]]></category>
		<category><![CDATA[U.S. Regulatory]]></category>
		<category><![CDATA[Canadian Regulatory Consultants]]></category>
		<category><![CDATA[Consumer Products Regulatory Consultants]]></category>
		<category><![CDATA[Focal Point Research]]></category>
		<category><![CDATA[North American Scientific Regulatory Affairs & Quality Assurance Consulting Firm]]></category>
		<category><![CDATA[OMUFA User fees]]></category>
		<category><![CDATA[Regulatory Affairs Consultants]]></category>
		<guid isPermaLink="false">https://focalpointresearch.net/?p=5967</guid>

					<description><![CDATA[<p>The USFDA has announced the FY 2027 user fee rates under the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA) with significant increases in facility fees compared with FY 2026. Fee FY 2026 FY 2027 Monograph Drug Facility (MDF) $19,188 $47,891 Contract Manufacturing Organization (CMO) Fee $12,792 $31,927 OMOR &#8211; Tier 1&#160; $587,529 $614,608 OMOR &#8211; [&#8230;]</p>
<p>The post <a href="https://focalpointresearch.net/fda/fda-announces-fy-2027-omufa-user-fee-rates-and-streamlines-fee-process/">FDA Announces FY 2027 OMUFA User Fee Rates and Streamlines Fee process</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p class="wp-block-paragraph">The USFDA has announced the FY 2027 user fee rates under the <a href="https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-drug-user-fee-program-omufa">Over-the-Counter Monograph Drug User Fee Amendments</a> (OMUFA) with significant increases in facility fees compared with FY 2026.</p>



<figure class="wp-block-table"><table class="has-fixed-layout"><tbody><tr><td><strong>Fee</strong></td><td class="has-text-align-center" data-align="center"><strong>FY 2026</strong></td><td class="has-text-align-center" data-align="center"><strong>FY 2027</strong></td></tr><tr><td>Monograph Drug Facility (MDF)</td><td class="has-text-align-center" data-align="center">$19,188</td><td class="has-text-align-center" data-align="center">$47,891</td></tr><tr><td>Contract Manufacturing Organization (CMO) Fee</td><td class="has-text-align-center" data-align="center">$12,792</td><td class="has-text-align-center" data-align="center">$31,927</td></tr><tr><td>OMOR &#8211; Tier 1&nbsp;</td><td class="has-text-align-center" data-align="center">$587,529</td><td class="has-text-align-center" data-align="center">$614,608</td></tr><tr><td>OMOR &#8211; Tier 2</td><td class="has-text-align-center" data-align="center">$117,505</td><td class="has-text-align-center" data-align="center">$122,921</td></tr></tbody></table></figure>



<p class="wp-block-paragraph">The FY 2027 MDF and CMO facility fees represent an increase of approximately 149% from FY 2026. FDA attributes the increase largely to a one-time downward operating reserve adjustment that reduced FY 2026 facility fees.</p>



<p class="wp-block-paragraph">A key change under OMUFA II is the consolidation of the previously separate facility and OMOR fee announcements into a single annual Federal Register notice beginning with FY 2027. This is intended to provide a more predictable and streamlined fee-setting process for FDA and industry.</p>



<p class="wp-block-paragraph">The FY 2027 facility fee will be paid in two equal installments: 50% on October 1, 2026 and the remaining 50% on February 1, 2027, subject to the statutory appropriations conditions. From FY 2028 onward, the full facility fee will generally be due October 1. OMOR fees remain payable upon submission of the OMOR.</p>



<p class="wp-block-paragraph">Companies that own qualifying OTC monograph drug facilities, including eligible CMOs, should assess their FY 2027 fee obligations and budget for the substantially higher facility fees. Companies planning to submit OMORs should also account for the increased OMOR fees. FDA&#8217;s OMUFA requirements apply independently of other FDA user fee programs such as PDUFA, GDUFA or MDUFA.</p>



<p class="wp-block-paragraph">For more such updates, <a href="https://focalpointresearch.net/">contact us</a>.</p>
<p>The post <a href="https://focalpointresearch.net/fda/fda-announces-fy-2027-omufa-user-fee-rates-and-streamlines-fee-process/">FDA Announces FY 2027 OMUFA User Fee Rates and Streamlines Fee process</a> appeared first on <a href="https://focalpointresearch.net">Focal Point</a>.</p>
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		<post-id xmlns="com-wordpress:feed-additions:1">5967</post-id>	</item>
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