Key Issues Shaping Cosmetics and Personal Care Oversight – FDA Watch
Wayne chats with Rachel Raphael, Partner at Morgan Lewis, and Ronie Schmelz, Partner at K&L Gates. You’ll hear their thoughts on what’s happening at FDA in cosmetics and personal care products; how companies should navigate ingredient concerns amid federal inaction, aggressive state laws, and stricter foreign regimes; the state of regulation surrounding labeling and advertising and promotion; what industry should be keeping an eye on heading into 2026; and much more.
Headlines
Tensions reported between FDA Commissioner Dr. Marty Makary and HHS Secretary Robert F. Kennedy Jr.
Pharma: From the Guardian, finding CDER Director replacement left FDA in state of “turmoil” and “tensions”
Devices: From the Economic Times, European medical device manufacturers feeling U.S. tariff squeeze
Food: RFK Jr. calls for greater food allergy research at Food Allergy Fund Leadership Forum
Resource Links
Pharma: FDA’s new plausible mechanism pathway
Devices: Bipartisan Policy Center’s AI 101: AI-Enabled Medical Devices fact sheet
Food: Infant formula products linked to infant botulism outbreak
Cosmetics: PCPC’s “Buy No Lie” campaign
About Our Guests
Rachel Raphael
Rachel Raphael is a litigator and risk management counselor who represents clients in all tiers of the supply and distribution chain and across various industries ranging from automotive manufacturing to personal care and cosmetics. Rachel defends clients against claims of unfair and deceptive business practices, breach of contract, fraud, negligence, false advertising, and breach of warranty in complex product liability and consumer class action litigation throughout the United States. She regularly advises clients on issues arising throughout the product lifecycle, whether they are exploring new ventures, negotiating with contracting partners, analyzing marketing and advertising claims, dealing with customer complaints, or executing product recalls.
Rachel serves as trusted counsel on a wide range of legal issues with a particular focus on consumer protection and product safety. She represents clients not only in consumer-driven lawsuits but also in response to inquiries and enforcement actions by state attorneys general, the Consumer Product Safety Commission (CPSC), the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and the National Highway Traffic Safety Administration (NHTSA), among other regulators across the globe. Rachel also works closely with clients to identify and analyze product risks, comply with regulatory requirements, and resolve product-related challenges.
Rachel also frequently writes and speaks on issues affecting the beauty, health, and wellness industry and the correlation between product recalls and class action lawsuits.
As part of her active pro bono practice, Rachel represents asylum applicants and individuals seeking citizenship. She has also defended clients in criminal proceedings and represented federal inmates before the US Parole Commission.
Prior to joining Morgan Lewis, Rachel was a partner at another international law firm.
Ronie Schmelz
Ronie Schmelz is a partner in K&L Gates’ Commercial Disputes practice.
Ronie spent the first part of her career at an international law firm defending clients in complex litigation, including consumer class actions and disputes involving reinsurance, general commercial, real estate, and healthcare related matters.
She now spends a significant amount of her time counseling clients on litigation-avoidance strategies so they can confidently focus on building and operating their businesses in a way that reduces the risk of regulatory oversight and consumer challenges. These strategies include implementing best practices for complying with regulations and standards enforced by FDA, the Federal Trade Commission, other federal and state regulatory agencies, as well as the National Advertising Division, and ways to reduce exposure to consumer class actions. Ronie advises clients on a myriad of issues—including contract and intellectual property matters, privacy, automatic renewal and loyalty programs, implementation of recall procedures, Prop 65, responding to FDA Warning Letters, Notices of Action, and MedWatch Adverse Event Reports—and she continues to defend clients in nationwide consumer class actions and complex commercial litigation matters.
FDA Watch Podcast 