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HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

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On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to...

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On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore rulemaking to close what Kennedy calls a “loophole” regarding disclosures for food ingredients. Specifically, Secretary Kennedy’s statements targeted the “self-affirmation” marketing pathway in the Substances Generally Recognized as Safe (GRAS) Final Rule that allows manufacturers to introduce new food additives without any premarket submission to FDA.Read the <a href="https://lifesciences.mofo.com/topics/hhs-secretary-to-fda-consider-elimination-of-gras-self-affirmation-pathway" target="_blank">full blog post</a>.

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

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Claudia is renowned for her experience in advising clients on advertising and marketing compliance, including managing pre-litigation risk regarding advertising claims. She represents clients in consumer class action cases and complex litigation, including unfair business competition, false advertising, and product liability. She regularly handles matters before the National Advertising Division (NAD) and competitive advertising disputes. Claudia represents clients across a broad range of industries, from food and beverage to technology.Claudia is a leading partner in MoFo’s Food & Agriculture group. Ranked Band 1 in Chambers Agribusiness, this cross-disciplinary group has helped shape the industry for more than two decades. From disruptive new food startups to Fortune 50 companies, Claudia provides food and agriculture clients with holistic, innovative strategies that addresses their most pressing legal challenges and mission critical transactions.Claudia is also a longtime leader in MoFo’s pro bono program. She has represented asylum seekers and others in immigration proceedings, including traveling to El Paso, Texas, to work with families separated and detained at the border. She has also worked on matters relating to reproductive rights, gun violence prevention, and criminal justice reform.Claudia previously served as a Lawyer Representative for the Northern District of California and is a board member of the Bar Association of San Francisco, Diversity and Justice Committee, San Francisco Law Library, and Bay Area Legal Aid. She is also a member of the San Francisco Raza and the Hispanic Bar Association. She received her J.D. degree in 2004 from Berkeley Law (Boalt Hall School of Law).

Claudia Vetesi

Partner

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.As the lead of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA).</li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

Brigid Bondoc

Alex Schroth is an associate in the Litigation Department of Morrison Foerster’s San Diego office.Alex’s practice focuses on products liability and general litigation. Alex also has experience advising clients on FDA regulatory compliance. Additionally, he regularly assists clients in complex litigation.Before joining Morrison Foerster, Alex was a summer associate at the firm. He also served as a law clerk to the California Attorney General’s Office in the Business Litigation Division, and United States Attorney’s Office for the Southern District of California.Alex received his J.D. from the University of California, Berkeley, School of Law. While in law school, he was an executive editor for the California Law Review. Alex received his B.A. cum laude in political science, pre-law, with a minor in philosophy, from California Polytechnic State University.