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FTC Issues Updated Health Products Claims Guidance

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On December 20, 2022, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products.

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We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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On December 20, 2022, the Federal Trade Commission (FTC) issued its <a href="https://www.ftc.gov/system/files/ftc_gov/pdf/Health-Guidance-508.pdf" target="_blank">Health Products Compliance Guidance</a> (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims for dietary supplements, foods, over-the-counter drugs, and other health-related products. The update draws on the over 200 new cases since the last guidance was published to illustrate potentially false and misleading claims and proper claim substantiation. Read the <a href="https://lifesciences.mofo.com/topics/ftc-issues-updated-health-products-claims-guidance" target="_blank">full blog post</a>.

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Julie Park is the practice group chair of Morrison Foerster’s Complex Litigation + Advisement practice group and managing partner of the San Diego office.Julie protects her clients’ products throughout the product life cycle. Drawing on her deep technical and legal experience, she counsels clients on consumer product safety regulation and pharmaceutical and medical device preemption. She manages complex and multijurisdictional litigation both in state and federal court and also guides clients through product recalls.Clients appreciate Julie’s ability to assess both the practical business implications and legal impact of a matter. They also value the way she recommends solutions that meet their objectives.Julie is committed to providing thought leadership for her clients. She is an editor of, and frequent contributor to, MoFo’s <a href="http://classdismissed.mofo.com/" target="_blank">Class Dismissed</a> blog, where she provides insights on class-action and product–related issues affecting companies in the consumer arena. She has been recognized for her writing as a top author in the JD Supra Readers’ Choice Awards, 2016–2019.Julie is also committed to pro bono service and diversity in the legal profession. While at Harvard Law School, she worked at the Harvard Legal Aid Bureau, a nonprofit law firm that provides free legal services. She has continued her pro bono work at MoFo, which has resulted in her being a regular recipient of the Wiley W. Manuel Award from the California State Bar for pro bono contributions. She co-chairs the firm’s Women’s Strategy Committee and has served on the Associates Steering Committee of Athena San Diego, an organization that promotes professional growth for women executives and rising managers in science and technology.Julie brings an industry perspective to her work with MoFo. Before going to law school, she was a medicinal chemist at Pfizer, where she researched cancer drugs.Beyond her impressive legal work, Julie has a life in the arts. She is a professional-level violinist who performs with chamber music groups in the San Diego area and has played with the Harvard-Radcliffe Orchestra, Cambridge University Chamber Orchestra, and La Jolla Symphony.

Julie Park

Chair of Complex Litigation + Advisement

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

Partner

Matt is an associate in the Litigation Department in MoFo’s San Diego office.Matt’s practice focuses on the product lifecycle, from early product development to litigation to end-of-life advisement. He counsels clients through complex consumer product safety regulatory landscapes and product recalls. Matt’s product liability litigation experience spans single-plaintiff cases, class actions, and multijurisdictional litigation for consumer products and pharmaceutical companies. He manages all phases of e-discovery, including e-discovery collection, review, and production.Before joining the firm as a summer associate, Matt interned at the Post-Conviction Justice Project, where he represented inmates at parole hearings and for related post-conviction matters. He served as a law clerk at the United States Commission on Civil Rights, where he helped prepare and write Commission reports.Matt received his J.D. from the University of Southern California Gould School of Law, where he was elected to the Order of the Coif and selected to serve on the Southern California Law Review. Matt obtained his B.A. summa cum laude in finance from University of San Diego.