What's Next for Cosmetics and Personal Care Products? – FDA Watch
Wayne chats with Jessica O’Connell, Partner at Covington and Co-Chair of the firm’s Food, Drug, and Device Practice Group; and Rebecca Dandeker, Partner in the Food and Drug Practice at Wiley Rein. You’ll hear their thoughts on the recent leadership changes at FDA; unanswered questions for the cosmetics industry as they move into long-term compliance with FDA’s MoCRA requirements; the agency’s draft guidance on its mandatory recall authority for cosmetics; how companies should be thinking risk management amid an influx of state regulatory movement; challenges balancing science, enforcement, and industry feasibility in cosmetics; the need for greater compliance and legal functions at cosmetics companies; where cosmetics and MoCRA could be headed next; and much more.
Headlines
FDA announces major expansion of internal AI capabilities, including rollout of “Elsa 4.0”
Pharma: FDA seeks input on new efforts to expand drug repurposing
Devices: FDA adds neurosurgical patties to medical device shortage list, warns supply disruptions could impact patient care
Food: FDA launches “Know Your Nutrition” campaign during National Women’s Health Week
Cosmetics: PCPC joins coalition filing complaint challenging California’s SB 343
Resource Links
Devices: FDA finalizes recommendations for patient-matched guides used with orthopedic implants
About Our Guests
Jessica O’Connell
Jessica O’Connell co-chairs Covington’s market-leading global Food, Drug, and Device Practice Group. Drawing from nearly twenty years of experience working at FDA and in private practice, Jessica provides strategic advice to a broad range of companies and trade associations in navigating regulatory frameworks and engaging with food and drug regulatory bodies and Congress. She works closely with clients to develop product strategies that are low-risk from both a regulatory and litigation perspective while also meeting marketing goals and objectives. She also regularly counsels clients regarding potential crises, such as recalls, regulator investigations, and other unanticipated regulatory attention.
Chambers USA reports that Jessica “is enthusiastic, exceptionally smart and a talented lawyer who brings tremendous insight from being a regulator” and that she “knows how best to interact with the FDA in a productive and efficient way.”
Jessica’s practice focuses on food and beverages, dietary supplements, cosmetics, and OTC drugs. She has engaged with Congress and state legislators on cosmetic and drug legislative efforts and alternative protein and other food labeling requirements, and has represented clients in both FDA and FTC investigations, including negotiating consent decrees and responding to civil investigative demands, and actively practices before the NAD. Jessica has specific expertise regarding the regulatory framework for new and emerging food technologies, including alternative protein ingredients and products and specialized nutrition products such as infant formula and medical foods, the marketing of cosmetics and OTC drugs, including sunscreens, Proposition 65, organic labeling, the federal and state legal landscapes surrounding the development and marketing of products containing CBD, and claim substantiation requirements, as well as manufacturing and supply chain requirements under FSMA and FDA’s implementation of MoCRA.
Jessica also has an active pro bono practice, with a particular focus on issues relating to reproductive rights and health care access.
Before joining Covington, Jessica served as Associate Chief Counsel in FDA’s Office of Chief Counsel. While at FDA, Jessica counseled various components of FDA and HHS on a broad range of food, cosmetic, and drug legal issues, including FDA’s implementation of FSMA, nutrition initiatives, cosmetic oversight, and FDA’s work investigating foodborne illness outbreaks and related actions, including recalls and other enforcement activities. In addition, Jessica provided legal counsel to the agency and Department regarding FDA’s import and export activities for all FDA-regulated products.
Rebecca Dandeker
Rebecca Dandeker advises clients in the life sciences and consumer health sectors on regulatory strategy, compliance, and transactional matters involving the U.S. Food and Drug Administration (FDA), Federal Trade Commission (FTC), Drug Enforcement Administration (DEA) and other federal and state agencies. Her practice spans prescription pharmaceuticals, over-the-counter (OTC) drugs, cosmetics, dietary supplements, other consumer products, and alternative therapies. She works with a wide range of clients throughout the product life cycle, from development and approval to marketing, partnerships, and post-market compliance.
Rebecca provides strategic guidance on FDA pre-approval pathways and compliance for products that do not require formal agency clearance but remain subject to extensive regulatory oversight. Her work includes advising on clinical trials, Good Manufacturing Practices (GMP), packaging and labeling requirements, distribution and retail regulations, promotional claims, market access, adverse event reporting, and emerging obligations such as those under State laws and the federal Modernization of Cosmetics Regulation Act (MoCRA). She frequently assists clients during FDA inspections and enforcement actions, including preparing responses to Form 483s, warning letters, and import alerts. She also represents clients in administrative litigation and challenges to agency decisions under the Administrative Procedure Act.
In addition to her regulatory counseling, Rebecca supports corporate and transactional matters involving FDA-regulated products, including due diligence, risk assessments, and integration planning for mergers, acquisitions, and investments. She also serves on drug promotional review committees and provides training to legal, regulatory, and commercial teams on FDA standards, advertising compliance, and internal policy development. Her experience further includes advising on Rx-to-OTC switches, OTC monograph reform, Hatch-Waxman and biosimilar strategies, and regulatory issues involving homeopathic and alternative products.Vice President of Government Affairs for the Environmental Working Group.
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