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					<title>Health Law Advisor - Laws and Regulations Affecting Health Care and Life
Sciences - Featuring HEAL® | Epstein Becker Green</title>
					<link>https://www.healthlawadvisor.com/author/elena-m-quattrone</link>
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					<description><![CDATA[The latest updates to Health Law Advisor - Laws and Regulations Affecting Health Care and Life Sciences - Featuring HEAL®.]]></description>
					<lastBuildDate>Sun, 12 Jul 2026 23:08:25 -0700</lastBuildDate>
					
				<item>
				<title>DOJ’s Second National Health Care Fraud Takedown of the Second Trump
Administration Heavily Targets Medicaid Fraud</title>
				<link>https://www.healthlawadvisor.com/dojs-second-national-health-care-fraud-takedown-of-the-second-trump-administration-heavily-targets-medicaid-fraud</link>
<dc:creator>Sarah M. Hall, Zachary S. Taylor, Elena M. Quattrone, Daniella R. Lee,
Jeremy A. Avila</dc:creator>
<guid isPermaLink='false'>dojs-second-national-health-care-fraud-takedown-of-the-second-trump-administration-heavily-targets-medicaid-fraud</guid>

					<pubDate>Wed, 24 Jun 2026 17:45:00 -0700</pubDate>
					<description><![CDATA[<p>On June 23, 2026, the U.S. Department of Justice (&ldquo;DOJ&rdquo;) <a href="https://www.justice.gov/opa/pr/national-health-care-fraud-takedown-results-455-defendants-charged-connection-over-65">announced the results of the annual National Health Care Fraud Takedown</a> (&ldquo;2026 Takedown&rdquo;)&mdash;the first under DOJ&rsquo;s new <a href="https://www.commerciallitigationupdate.com/doj-creates-national-fraud-enforcement-division-what-it-means-for-fraud-enforcement-in-america">National Fraud Enforcement Division (&ldquo;NFED&rdquo;) announced on April 7</a>. This year, the 2026 Takedown charged 455 defendants in connection with more than $6.5 billion in alleged fraud.</p>
<p>Although much of the content of the prosecutions is the same as in past years (e.g. wound care, opioids), Medicaid fraud&mdash;long the province of state Medicaid Fraud Control Units (&ldquo;MFCUs&rdquo;)&mdash;featured prominently in the 2026 Takedown. DOJ claims to have charged the largest number of Medicaid fraud defendants and Medicaid fraud loss in DOJ history: 295 defendants and over $518 million in alleged false claims submitted to Medicaid. Per the DOJ press release, the MFCUs of all 50 states participated, the highest number ever.</p>]]></description>
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				<title>FDA Regulations to Establish Minimum CGMP Requirements for Manufacturing,
Packaging, Labeling, and Holding of Dietary Supplements</title>
				<link>https://www.healthlawadvisor.com/fda-regulations-to-establish-minimum-cgmp-requirements-for-manufacturing-packaging-labeling-and-holding-of-dietary-supplements</link>
<dc:creator>Elena M. Quattrone, Jack  Wenik</dc:creator>
<guid isPermaLink='false'>fda-regulations-to-establish-minimum-cgmp-requirements-for-manufacturing-packaging-labeling-and-holding-of-dietary-supplements</guid>

					<pubDate>Wed, 24 Jun 2026 09:00:02 -0700</pubDate>
					<description><![CDATA[<p>On June 18, 2026, the Food and Drug Administration (&ldquo;FDA&rdquo;) <a href="https://www.federalregister.gov/documents/2026/06/18/2026-12238/agency-information-collection-activities-submission-for-office-of-management-and-budget-review">announced the submission of a proposed collection of information</a> to the Office of Management and Budget (&ldquo;OMB&rdquo;) pertaining to the manufacturing, packaging, labeling, or holding of dietary supplements to ensure their quality (&ldquo;FDA Notice&rdquo;). Written comments (including recommendations) are due to OMB by July 20, 2026.</p>]]></description>
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				<title>The DOJ’s Bulk Sensitive Data Rule and Your Obligation to “Know Your
Reporting Requirements”</title>
				<link>https://www.healthlawadvisor.com/the-dojs-bulk-sensitive-data-rule-and-your-obligation-to-know-your-reporting-requirements</link>
<dc:creator>Elizabeth J. McEvoy, Elena M. Quattrone</dc:creator>
<guid isPermaLink='false'>the-dojs-bulk-sensitive-data-rule-and-your-obligation-to-know-your-reporting-requirements</guid>

					<pubDate>Thu, 30 Apr 2026 09:00:03 -0700</pubDate>
					<description><![CDATA[<p>Epstein Becker Green (&ldquo;EBG&rdquo;) has previously advised U.S. organizations that share data in bulk or otherwise grant access to U.S. sensitive data to countries of concern or covered persons to &ldquo;<a href="https://www.healthlawadvisor.com/the-dojs-bulk-sensitive-data-rule-and-your-obligation-to-know-your-data">Know Their Data</a>&rdquo; and &ldquo;<a href="https://www.healthlawadvisor.com/the-dojs-bulk-sensitive-data-rule-and-your-obligation-to-know-your-vendor">Know Their Vendors</a>.&rdquo; In this post, we discuss why U.S. organizations across all industries with cross-border operations &ndash; including health care / life sciences, finance, e-commerce, and research &ndash; must &ldquo;know their reporting requirements,&rdquo; to fully comply with the BSD Rule and its brand-new reporting obligations. &nbsp;&nbsp;</p>]]></description>
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				<title>New York’s Food Safety and Chemical Disclosure Act: A State-Level Overhaul
of GRAS Regulation</title>
				<link>https://www.healthlawadvisor.com/new-yorks-food-safety-and-chemical-disclosure-act-a-state-level-overhaul-of-gras-regulation</link>
<dc:creator>Julianna  Dzwierzynski, Elena M. Quattrone</dc:creator>
<guid isPermaLink='false'>new-yorks-food-safety-and-chemical-disclosure-act-a-state-level-overhaul-of-gras-regulation</guid>

					<pubDate>Wed, 29 Apr 2026 09:00:04 -0700</pubDate>
					<description><![CDATA[<p>New York has passed sweeping food additive legislation that, if signed by the Governor, will fundamentally reshape how food manufacturers and suppliers operate in the state. The <a href="https://www.nysenate.gov/legislation/bills/2025/S1239/amendment/F"><em>Food Safety and Chemical Disclosure Act</em> (S1239F)</a> (the &ldquo;Act&rdquo;) would establish the first state-level disclosure and database regime for substances that companies have independently determined to be &ldquo;Generally Recognized as Safe&rdquo; (&ldquo;GRAS&rdquo;). The bill represents a significant escalation in state-level food safety regulation with far-reaching consequences for food manufacturers, ingredient suppliers, and consumer products companies operating in the New York market.</p>]]></description>
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				<title>FDA Meeting Invites Stakeholders to Weigh in on Dietary Supplement
Ingredients</title>
				<link>https://www.healthlawadvisor.com/fda-meeting-invites-stakeholders-to-weigh-in-on-dietary-supplement-ingredients</link>
<dc:creator>Elena M. Quattrone, Zachary S. Taylor, James A. Boiani</dc:creator>
<guid isPermaLink='false'>fda-meeting-invites-stakeholders-to-weigh-in-on-dietary-supplement-ingredients</guid>

					<pubDate>Tue, 14 Apr 2026 09:00:05 -0700</pubDate>
					<description><![CDATA[<p>On March 27, 2026, the Food and Drug Administration (&ldquo;FDA&rdquo;) held a <a href="https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/public-meeting-exploring-scope-dietary-supplement-ingredients-03272026">public meeting</a> entitled &ldquo;Exploring the Scope of Dietary Supplement Ingredients.&rdquo; Sponsored by FDA&rsquo;s Office of Dietary Supplement Programs (&ldquo;ODSP&rdquo;), the meeting was designed for agency officials and stakeholders &ldquo;to discuss the evolving landscape of dietary supplement ingredients and how recent scientific and technological advances are shaping the industry.&rdquo;</p>]]></description>
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				<title>Legislative Push for FDA Preemptive Authority Over Dietary Supplement
Regulation</title>
				<link>https://www.healthlawadvisor.com/legislative-push-for-fda-preemptive-authority-over-dietary-supplement-regulation</link>
<dc:creator>Zachary S. Taylor, Elena M. Quattrone, Julianna  Dzwierzynski</dc:creator>
<guid isPermaLink='false'>legislative-push-for-fda-preemptive-authority-over-dietary-supplement-regulation</guid>

					<pubDate>Fri, 13 Feb 2026 09:00:06 -0800</pubDate>
					<description><![CDATA[<p>A newly introduced House Bill, <a href="https://www.congress.gov/bill/119th-congress/house-bill/7366">H.R. 7366</a>, titled the <em>Dietary Supplement Regulatory Uniformity Act</em>, would amend the Federal Food, Drug, and Cosmetic Act (&ldquo;FDCA&rdquo;) to expressly clarify and affirm the Food and Drug Administration&rsquo;s (&ldquo;FDA&rdquo;) preemptive authority over dietary supplement regulation.</p>
<p>The bill would prohibit states from establishing or maintaining dietary supplement requirements that are different from or in addition to federal requirements, unless a state successfully applies for a specific exemption from FDA preemptive authority. Such exemptions would be limited to circumstances where a state requirement is more stringent than federal law or addresses a compelling local condition without placing a product out of compliance with federal standards.</p>
<p>In effect, the proposed legislation reinforces a uniform national regulatory framework for dietary supplements, while preserving a narrow pathway for state involvement under FDA oversight.</p>]]></description>
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				<title>The DOJ’s Bulk Sensitive Data Rule and Your Obligation to “Know Your
Vendor”</title>
				<link>https://www.healthlawadvisor.com/the-dojs-bulk-sensitive-data-rule-and-your-obligation-to-know-your-vendor</link>
<dc:creator>Elizabeth J. McEvoy, Elena M. Quattrone</dc:creator>
<guid isPermaLink='false'>the-dojs-bulk-sensitive-data-rule-and-your-obligation-to-know-your-vendor</guid>

					<pubDate>Wed, 07 Jan 2026 09:00:07 -0800</pubDate>
					<description><![CDATA[<p><em>This blog post is the latest installment in a series focused on the DOJ&rsquo;s Bulk Sensitive Data Rule, and is intended to help stakeholders navigate the complex rule&rsquo;s requirements and move toward full compliance. </em></p>
<p>Epstein Becker Green&rsquo;s <a href="https://www.healthlawadvisor.com/the-dojs-bulk-sensitive-data-rule-and-your-obligation-to-know-your-data">previous blog post</a> on this topic encouraged U.S. organizations across all industries with cross-border operations &ndash; including health care/life sciences, finance, e-commerce, and research &ndash; to &ldquo;know their data.&rdquo;&nbsp; In this post, we discuss why it is critical for these organizations to also &ldquo;know their vendors.&rdquo; We discuss how the BSD Rule imposes new requirements on U.S.-based companies to monitor and scrutinize vendor engagements beyond those with the six designated countries of concern.</p>]]></description>
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				<title>Courts and CMS So Far Agree: States Are Preempted from Acting on MA Plan
Marketing</title>
				<link>https://www.healthlawadvisor.com/courts-and-cms-so-far-agree-states-are-preempted-from-acting-on-ma-plan-marketing</link>
<dc:creator>Helaine I. Fingold, Elena M. Quattrone</dc:creator>
<guid isPermaLink='false'>courts-and-cms-so-far-agree-states-are-preempted-from-acting-on-ma-plan-marketing</guid>

					<pubDate>Tue, 06 Jan 2026 15:30:00 -0800</pubDate>
					<description><![CDATA[<p>Several actions have occurred since Epstein Becker &amp; Green, P.C.&rsquo;s <a href="https://www.healthlawadvisor.com/state-insurance-department-statements-scrutinize-ma-and-medsupp-unfair-trade-practices">blog post</a>, dated November 19, 2025, regarding state insurance departments scrutinizing Medicare Advantage and MedSupp Trade Practices, which warrants a brief update on this topic.</p>]]></description>
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				<title>Understanding the False Claims Act Statute of Limitations—and the Debate
Over the “Last Overt Act” Rule</title>
				<link>https://www.healthlawadvisor.com/understanding-the-false-claims-act-statute-of-limitations-and-the-debate-over-the-last-overt-act-rule</link>
<dc:creator>Bailey  Cremeans, Elena M. Quattrone, Elizabeth J. McEvoy, Sarah M. Hall</dc:creator>
<guid isPermaLink='false'>understanding-the-false-claims-act-statute-of-limitations-and-the-debate-over-the-last-overt-act-rule</guid>

					<pubDate>Tue, 16 Dec 2025 15:00:00 -0800</pubDate>
					<description><![CDATA[<p>The False Claims Act (FCA) is one of the federal government&rsquo;s most powerful tools for combatting healthcare fraud. Yet, as with any enforcement tool, its reach is constrained by a statute of limitations. The FCA statute of limitations provisions, set out in 31 U.S.C. &sect; 3731(b), are surprisingly nuanced and often depend on when the government learns of the alleged misconduct. In practice, this framework often favors the government, yet these nuances are worth unpacking, which we do below.</p>]]></description>
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				<title>Second Circuit Affirms Denial of Preliminary Injunction in Challenge To
N.Y. Law Restricting Weight Loss and Muscle Building Supplement Sales to
Minors</title>
				<link>https://www.healthlawadvisor.com/second-circuit-affirms-denial-of-preliminary-injunction-in-challenge-to-n-y-law-restricting-weight-loss-and-muscle-building-supplement-sales-to-minors</link>
<dc:creator>Jack  Wenik, Elena M. Quattrone, Lorrin M. Melanson</dc:creator>
<guid isPermaLink='false'>second-circuit-affirms-denial-of-preliminary-injunction-in-challenge-to-n-y-law-restricting-weight-loss-and-muscle-building-supplement-sales-to-minors</guid>

					<pubDate>Thu, 11 Dec 2025 16:00:00 -0800</pubDate>
					<description><![CDATA[<p>The Second Circuit dealt a blow to the dietary supplement industry last month as it affirmed a lower court&rsquo;s decision not to temporarily pause enforcement of New York&rsquo;s new restrictions on sales of certain dietary supplements to minors as legal challenges continue to proceed through the court system.</p>]]></description>
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				<title>The DOJ’s Bulk Sensitive Data Rule and Your Obligation to “Know Your Data”</title>
				<link>https://www.healthlawadvisor.com/the-dojs-bulk-sensitive-data-rule-and-your-obligation-to-know-your-data</link>
<dc:creator>Elizabeth J. McEvoy, Lisa Pierce Reisz, Elena M. Quattrone</dc:creator>
<guid isPermaLink='false'>the-dojs-bulk-sensitive-data-rule-and-your-obligation-to-know-your-data</guid>

					<pubDate>Tue, 09 Dec 2025 12:00:00 -0800</pubDate>
					<description><![CDATA[<p>As Epstein Becker &amp; Green, P.C. previously <a href="https://www.ebglaw.com/insights/publications/dojs-final-rule-on-bulk-data-transfers-a-road-map">reported</a>, the National Security Division of the U.S. Department of Justice (&ldquo;DOJ&rdquo;) issued a final rule, effective on April 8, 2025, called the Bulk Sensitive Data Rule (&ldquo;BSD Rule&rdquo;) (codified at 28 C.F.R. Part 202), which prohibits and/or restricts U.S. persons and/or companies from engaging in certain transactions involving certain categories of government-related data and sensitive personal data with covered persons or six countries of concern&ndash; China (including Hong Kong and Macau), Russia, Iran, North Korea, Cuba, and Venezuela.</p>]]></description>
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				<title>Eliminating the GRAS Pathway: An Update</title>
				<link>https://www.healthlawadvisor.com/eliminating-the-gras-pathway-an-update</link>
<dc:creator>Elena M. Quattrone, John D. Barry, Caitlin  Carlton</dc:creator>
<guid isPermaLink='false'>eliminating-the-gras-pathway-an-update</guid>

					<pubDate>Mon, 08 Dec 2025 16:00:00 -0800</pubDate>
					<description><![CDATA[<p>Legislation introduced in the U.S. Senate in November, informally called the <a href="https://www.marshall.senate.gov/wp-content/uploads/KEN25597.pdf">&ldquo;Better FDA Act of 2025,&rdquo;</a> is perhaps a bit misleading. While it involves the Food and Drug Administration (&ldquo;FDA&rdquo;), the full title of S. 3122&mdash;introduced on November 6&mdash;is actually &ldquo;The Better Food Disclosure Act of 2025,&rdquo; designed to amend the federal Food, Drug, and Cosmetic Act (&ldquo;FDCA&rdquo;) regarding food substances generally recognized as safe (&ldquo;GRAS&rdquo;).</p>]]></description>
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				<title>FDA Proposal Would Extend Food Traceability Rule’s Compliance Deadline to
July 2028</title>
				<link>https://www.healthlawadvisor.com/fda-proposal-would-extend-food-traceability-rules-compliance-deadline-to-july-2028</link>
<dc:creator>Elena M. Quattrone, Megan  Robertson, James A. Boiani, Lorrin M. Melanson</dc:creator>
<guid isPermaLink='false'>fda-proposal-would-extend-food-traceability-rules-compliance-deadline-to-july-2028</guid>

					<pubDate>Wed, 03 Dec 2025 14:00:00 -0800</pubDate>
					<description><![CDATA[<p>The federal government is back in business, and those who may be scrambling to comply with the January 20, 2026, deadline for the Food and Drug Administration&rsquo;s (&ldquo;FDA&rdquo; or the &ldquo;Agency&rdquo;) <a href="https://www.federalregister.gov/documents/2022/11/21/2022-24417/requirements-for-additional-traceability-records-for-certain-foods">&nbsp;Food Traceability Rule</a> (&ldquo;FTR&rdquo; or &ldquo;Final Rule&rdquo;) will be pleased with the likely possibility of a generous extension from the agency&mdash;to July 20, 2028.</p>]]></description>
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				<title>State Insurance Department Statements Scrutinize MA and MedSupp Unfair
Trade Practices</title>
				<link>https://www.healthlawadvisor.com/state-insurance-department-statements-scrutinize-ma-and-medsupp-unfair-trade-practices</link>
<dc:creator>Matthew P. Sprankle, Elena M. Quattrone, Helaine I. Fingold</dc:creator>
<guid isPermaLink='false'>state-insurance-department-statements-scrutinize-ma-and-medsupp-unfair-trade-practices</guid>

					<pubDate>Wed, 19 Nov 2025 09:00:14 -0800</pubDate>
					<description><![CDATA[<p>Practices related to enrollment in Medicare Advantage plans continue to draw scrutiny from government regulators. Over the last few weeks, and simultaneous with Medicare&rsquo;s Annual Open Enrollment Period, six states issued statements regarding recent Medicare Advantage and MedSupp (or &ldquo;Medigap&rdquo;) carrier actions related to enrollment and marketing accessibility.&nbsp; Specifically, regulators from state insurance departments in the states of <a href="https://insurance.delaware.gov/wp-content/uploads/sites/15/2025/10/DF-No-162-and-PA-No-39.pdf">Delaware</a>, <a href="https://doi.idaho.gov/wp-content/uploads/ID/B25-06.pdf">Idaho</a>, <a href="https://csimt.gov/wp-content/uploads/2025/11/2025-11-06-Advisory-Memorandum-Unfair-Trade-Practices.pdf">Montana</a>, <a href="https://mm.nh.gov/files/uploads/nhid/documents/20251106-ins-25-082-ab-medicare-conduct.pdf">New Hampshire</a>, <a href="https://www.insurance.nd.gov/sites/www/files/documents/Bulletins/2025/Bulletin%202025-2%20Medicare_%20Med%20Advt_%20Med%20Supp%20Enrollment%20Practices.pdf">North Dakota</a> and <a href="https://www.oid.ok.gov/wp-content/uploads/2025/11/2025-11-07-25-1084-BUL-TPT-Formatted-Bulletin-HC-Unfair-Trade-Fraud51.pdf">Oklahoma</a>, have indicated that the following acts, if taken by MA and MedSupp carriers, are considered unfair and deceptive under state law:</p>]]></description>
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				<title>DOJ Subpoena Seeks Health Information of Hospital Patients Receiving
Gender-Affirming Care: Will Judge Grant Motion to Quash?</title>
				<link>https://www.healthlawadvisor.com/doj-subpoena-seeks-health-information-of-hospital-patients-receiving-gender-affirming-care-will-judge-grant-motion-to-quash</link>
<dc:creator>Eric J. Neiman, Elena M. Quattrone</dc:creator>
<guid isPermaLink='false'>doj-subpoena-seeks-health-information-of-hospital-patients-receiving-gender-affirming-care-will-judge-grant-motion-to-quash</guid>

					<pubDate>Fri, 14 Nov 2025 11:01:00 -0800</pubDate>
					<description><![CDATA[<p>On June 12, 2025, the Children&rsquo;s Hospital of Philadelphia (&ldquo;CHOP&rdquo;) received a subpoena issued by the Department of Justice (&ldquo;DOJ&rdquo;) requesting highly sensitive patient health and procedure information related to gender-affirming care. These subpoenas, <a href="https://www.justice.gov/opa/pr/department-justice-subpoenas-doctors-and-clinics-involved-performing-transgender-medical">issued to multiple hospitals, doctors, and clinics,</a> were directly related to the Trump Administration&rsquo;s January 28, 2025, Executive Order entitled, <a href="https://www.federalregister.gov/documents/2025/02/03/2025-02194/protecting-children-from-chemical-and-surgical-mutilation">&ldquo;Protecting Children from Chemical and Surgical Mutilation&rdquo; (&ldquo;EO 14187&rdquo;).</a> &nbsp;The subpoena to CHOP has resulted in recent court activity over its purpose and enforceability.&nbsp;</p>]]></description>
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				<title>EDPA Ramps Up Its White-Collar Enforcement Framework</title>
				<link>https://www.healthlawadvisor.com/edpa-ramps-up-its-white-collar-enforcement-framework</link>
<dc:creator>Daniella R. Lee, Elena M. Quattrone, Jack E. Fernandez</dc:creator>
<guid isPermaLink='false'>edpa-ramps-up-its-white-collar-enforcement-framework</guid>

					<pubDate>Tue, 21 Oct 2025 14:38:00 -0700</pubDate>
					<description><![CDATA[<p>In September 2025, the U.S. Attorneys&rsquo; Office for the Eastern District of Pennsylvania (EDPA) announced that it would be implementing a <a href="https://www.justice.gov/usao-edpa/white-collar-justice-program#:~:text=The%20program%20promotes%20a%20culture,corruption%2C%20and%20abuse%20of%20power.">White-Collar Justice Program</a> to strengthen its white- collar enforcement framework. Among other things, the program will &ldquo;empower Assistant United States Attorneys to aggressively pursue complex investigations and significant new matters on their own initiative.&rdquo;</p>
<p>This announcement demonstrates another step in federal districts ramping up their white-collar enforcement efforts while encouraging robust procedures for compliance and self-disclosure. This is a trend several years in the making: in September 2022, <a href="https://www.justice.gov/d9/pages/attachments/2022/09/15/2022.09.15_ccag_memo.pdf">then-Deputy Attorney General Lisa Monaco directed U.S. attorneys</a> and others within the DOJ to review their policies on corporate voluntary self-disclosure, and to draft and share a formal written policy to incentivize such self-disclosure, if one was lacking.</p>]]></description>
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				<title>A Step Closer to the Proposed End of the Self-Affirmed GRAS Pathway</title>
				<link>https://www.healthlawadvisor.com/a-step-closer-to-the-proposed-end-of-the-self-affirmed-gras-pathway</link>
<dc:creator>Elena M. Quattrone, John D. Barry</dc:creator>
<guid isPermaLink='false'>a-step-closer-to-the-proposed-end-of-the-self-affirmed-gras-pathway</guid>

					<pubDate>Thu, 25 Sep 2025 12:40:00 -0700</pubDate>
					<description><![CDATA[<p>As EBG previously <a href="https://www.healthlawadvisor.com/the-end-of-the-self-affirmed-gras-pathway">reported</a>, on March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (&ldquo;HHS&rdquo;), announced that the U.S. Food and Drug Administration (the &ldquo;FDA&rdquo;) is exploring rulemaking to eliminate the pathway allowing entities to self-affirm that food ingredients are Generally Recognized as Safe (&ldquo;GRAS&rdquo;). Earlier this month, on September 4, 2025, the Trump administration&rsquo;s <a href="https://www.reginfo.gov/public/do/eAgendaMain">Spring 2025 Unified Regulatory Agenda</a> (&ldquo;Agenda&rdquo;) was published, providing insight into the upcoming regulatory priorities of administrative agencies, including the FDA. In keeping with Secretary Kennedy&rsquo;s prior statements, the Agenda disclosed an impending Notice of Proposed Rulemaking (&ldquo;NPRM&rdquo;) from the FDA regarding GRAS. <a href="https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&amp;RIN=0910-AJ02">Unified Agenda Entry RIN 0910-AJ02</a>, which describes the NPRM to be published in October, states that the proposed regulations would &ldquo;require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS.&rdquo; This proposed rule, if it goes into effect, will amend the GRAS regulations in 21 CFR parts 170 and 570 and effectively eliminate the self-affirmation pathway &ndash; meaning that entities would now be legally obligated to notify the FDA before designating food ingredients as GRAS.</p>]]></description>
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				<title>New Jersey General Assembly Passes Legislation Prohibiting Sale of Diet
Pills, Weight Loss/Muscle Building Supplements to Minors</title>
				<link>https://www.healthlawadvisor.com/new-jersey-general-assembly-passes-legislation-prohibiting-sale-of-diet-pills-weight-loss-muscle-building-supplements-to-minors</link>
<dc:creator>Elena M. Quattrone, Zachary S. Taylor</dc:creator>
<guid isPermaLink='false'>new-jersey-general-assembly-passes-legislation-prohibiting-sale-of-diet-pills-weight-loss-muscle-building-supplements-to-minors</guid>

					<pubDate>Tue, 26 Nov 2024 11:30:00 -0800</pubDate>
					<description><![CDATA[<p>As the dietary supplement industry continues to draw attention from Congress, state attorneys general, and class action lawyers, now comes another state law prohibiting the sale of over-the-counter (&ldquo;OTC&rdquo;) dietary supplements that target weight loss and muscle building to minors &ndash; this time, in New Jersey.</p>
<p>On October 28, 2024, by a majority vote of 56 to 17, with four abstentions, the New Jersey General Assembly passed <a href="https://www.njleg.state.nj.us/bill-search/2024/A1848">Assembly Bill No. 1848</a>, which, if it goes into effect, will prohibit the sale or delivery of OTC diet pills, weight loss, and muscle building supplements to minors, unless the minor is accompanied by a parent or guardian. Bill No 1848 is an exemplar of efforts intended to combat the misuse and abuse of these products and the potential causal relationship between these dietary supplements and eating disorders. Violators, including employees of retail establishments, may face a civil penalty of not more than $750.</p>]]></description>
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				<title>Litigation Update: Prisoner Release Due to COVID-19 Risk - Federal Courts
Set Out Preconditions</title>
				<link>https://www.healthlawadvisor.com/litigation-update-prisoner-release-due-to-covid-19-risk-federal-courts-set-out-preconditions</link>
<dc:creator>Elena M. Quattrone</dc:creator>
<guid isPermaLink='false'>litigation-update-prisoner-release-due-to-covid-19-risk-federal-courts-set-out-preconditions</guid>

					<pubDate>Fri, 17 Apr 2020 09:00:19 -0700</pubDate>
					<description><![CDATA[<p>Our colleagues<strong> Eric Moran </strong>and&nbsp;<strong>Elena M. Quattrone,</strong>&nbsp;attorneys at Epstein Becker Green, co-authored an article in&nbsp;<em>The New York Law Journal,&nbsp;</em>titled&nbsp;<a href="https://www.law.com/newyorklawjournal/2020/04/15/federal-courts-set-out-preconditions-for-prisoner-release-because-of-covid-19-risk/">&ldquo;Federal Courts Set Out Preconditions for Prisoner Release Because of COVID-19 Risk&rdquo; (registration required).</a></p> <p>Following is an excerpt:</p> <p style="padding-left: 40px">As the COVID-19 pandemic continues its spread throughout the nation, federal prisons are experiencing an unprecedented crisis due to its inability to implement social distancing, resulting in exponential increases in COVID-19 cases among inmates and prison staff. On April 14, the&nbsp;... </p>]]></description>
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				<title>First Federal COVID-19-Related Enforcement Action Filed as DOJ and FBI
Commit to Preventing Fraud in the Nation’s Response to the COVID-19
Pandemic</title>
				<link>https://www.healthlawadvisor.com/first-federal-covid-19-related-enforcement-action-filed-as-doj-and-fbi-commit-to-preventing-fraud-in-the-nations-response-to-the-covid-19-pandemic</link>
<dc:creator>Melissa L. Jampol, Elena M. Quattrone</dc:creator>
<guid isPermaLink='false'>first-federal-covid-19-related-enforcement-action-filed-as-doj-and-fbi-commit-to-preventing-fraud-in-the-nations-response-to-the-covid-19-pandemic</guid>

					<pubDate>Mon, 23 Mar 2020 09:00:20 -0700</pubDate>
					<description><![CDATA[<p>After U.S. Attorney General, William P. Barr<a href="#_ftn1" name="_ftnref1">[1]</a> and the Federal Bureau of Investigation issued warnings this week regarding potential fraudulent schemes that are being perpetrated in the nation’s response to the COVID-19 pandemic, on Sunday, March 22, 2020, the U.S. Department of Justice (DOJ) filed its first enforcement action to shut down COVID-19-related fraud.  DOJ attorneys moved in federal court in Austin, Texas for a temporary restraining order against operators of a website, coronavirustestingkit.com, alleged to have engaged in a wire fraud scheme by offering consumers access to “free” World Health Organization (WHO) vaccine kits in exchange for a shipping charge, which required consumers to enter credit card information on the website.<a href="#_ftn2" name="_ftnref2">[2]</a> The website stated that the kits “only” required water to administer the vaccine and provided testimonials from “recent users.” The government alleged that claims made on the website are false, as the WHO is not offering free vaccine kits and there is not yet a scientifically proven vaccine, and that the intent of the website is to gain access to consumer credit card information.</p>
<p>On March 16, 2020, U.S. Attorney General Barr directed in a memorandum to U.S. Attorneys that “[e]very U.S. Attorney's Office is thus hereby directed to prioritize the detection, investigation, and prosecution of all criminal conduct” related to the COVID-19 outbreak.<a href="#_ftn3" name="_ftnref3">[3]</a> Attorney General Barr advised, “the pandemic is dangerous enough without wrongdoers seeking to profit from public panic,” and therefore, such criminal conduct will not be tolerated.</p>]]></description>
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