Food Safety in the Spotlight – FDA Watch
Wayne chats with Mason Weeda, Managing Principal at OFW Law and Chair of the firm’s FDA Food Practice, and Jessica O’Connell, Partner at Covington and Co-Chair of the firm’s Food, Drug, and Device Practice Group. You’ll hear their thoughts on FDA’s handling of the ongoing Cyclospora outbreak, other food enforcement actions and inspections, potential changes ahead to the GRAS framework, where the agency’s fight against synthetic food dyes stands, top-of-mind issues for the rest of 2026 and 2027, and much more.
Headlines
White House nominates Dr. Heidi Overton to be next FDA Commissioner
HHS plans to create two new FDA deputy commissioner positions in technology and drug areas
Pharma: FDA published 55 new and revised product-specific guidances surrounding generic drugs
Devices: FDA authorizes first wearable device in U.S. that continuously monitors glucose and ketone levels
Food: Cyclospora outbreak spreads to 20 states
Cosmetics: PCPC urges U.S. and Canadian officials to resolve escalating trade tensions
Resource Links
Pharma: FDA issues new draft guidance on assessing potency of active immunotherapy products
Devices: FDA issues discussion paper on regulation of generative AI-enabled medical devices
Food: From USA Today, federal data show food recalls not actually increasing in 2026
About Our Guests
Mason Weeda
Mason Weeda advises businesses on the laws and regulations governing the manufacture, marketing, promotion, importation, and distribution of FDA-regulated products. His practice focuses on helping domestic and international companies navigate FDA regulatory compliance, enforcement risk, and transactional matters across the product lifecycle.
Mason also assists manufacturers, trade associations, and commodity groups operating in FDA-regulated industries by providing strategic policy counsel and engages directly with FDA on FDA policy developments and enforcement matters, and related federal requirements.
Mason routinely provides advice surrounding FDA-regulated products, including:
- FDA product applications and approvals
- FDA facility registration
- FDA and USDA enforcement and administrative matters (warning letters, complaints for injunctive relief and consent decrees, citizen petitions, and trade complaints)
- Promotion and advertising compliance
- Compliance with Federal Anti-Kickback Statute, Sunshine Act, CAN-SPAM, HIPAA, and other laws that may apply to advertising and promotion of FDA-regulated products
- Legislative and regulatory policy strategy, including comments on relevant rule making and agency guidance
- Class Action litigation defense involving alleged misleading product claims or product contamination under state consumer protection laws.
- Import and export requirements (import alerts, holds, detentions, refusals, and other Customs and Border Protection requirements)
- Labeling, formulation, and ingredients (food additives and GRAS petitions)
- Food Safety Modernization Act
- False Claims Act defense
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.
FDA Watch Podcast 