Melissa Runsten is a corporate counsel and a member of the Healthcare & Life Sciences Group. Ms. Runsten works with drug, device, food, cosmetic and other consumer product companies to navigate the complex FDA and FTC regulatory landscape. She provides strategic counseling and represents companies facing complex compliance and enforcement matters. Ms. Runsten also assists private equity funds, strategic acquirers, and other investors in assessing regulatory risks associated with corporate transactions.

Clients frequently tap Ms. Runsten to answer their toughest regulatory questions, drawing on her experience with key FDA policy and enforcement priorities such as medical product promotion, digital health, medical device cybersecurity, drug compounding, data integrity, clinical trials and artificial intelligence.

Ms. Runsten maintains a substantial FTC advertising practice, advising clients on the FTC’s requirements for health claims; autorenewal plans; endorsements, influencers, and product reviews; “Made in USA” claims; and environmental marketing. She represents companies under FTC investigation in responding to civil investigative demands and negotiating settlements.

Clients also look to Ms. Runsten to handle advertising disputes, including those before the National Advertising Division (NAD) of BBB National Programs and under Section 43(a) of the Lanham Act.

In addition to her FDA and FTC practice, she routinely advises clients on DEA and CPSC matters. The breadth and depth of her practice provides clients with a valuable holistic perspective as they navigate the web of regulatory requirements to bring innovative products to market and avoid compliance pitfalls. 

Ms. Runsten provides pro bono counseling to microentrepreneurs developing new FDA-regulated products and to individuals in a variety of immigration matters. She is a member of the Food and Drug Law Institute’s Update Magazine Peer Review Committee.

Ms. Runsten joined Debevoise in 2017. She received a J.D. from Stanford Law School in 2015, where she was co-president of the Stanford Public Interest Law Foundation and an online editor of the Stanford Law Review. She received a B.A. in Human Biology with distinction and Phi Beta Kappa from Stanford University in 2010.