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Olivia Dworkin

Olivia Dworkin minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance. With a focus on cutting-edge medical technologies and digital health products and services, Olivia regularly helps new and established companies navigate a variety of state and federal regulatory, legislative, and compliance matters throughout the total product lifecycle. She has experience counseling clients on the development, FDA regulatory classification, and commercialization of digital health tools, including clinical decision support software, mobile medical applications, general wellness products, medical device data systems, administrative support software, and products that incorporate artificial intelligence, machine learning, and other emerging technologies.

Olivia also assists clients in advocating for legislative and regulatory policies that will support innovation and the safe deployment of digital health tools, including by drafting comments on proposed legislation, frameworks, whitepapers, and guidance documents. Olivia keeps close to the evolving regulatory landscape and is a frequent contributor to Covington’s Digital Health blog. Her work also has been featured in the Journal of Robotics, Artificial Intelligence & Law, Law360, and the Michigan Journal of Law and Mobility.

Courts in the Northern District of California continue to turn away lawsuits alleging that food and beverage companies must adjust protein content claims to account for protein digestibility.  In Brown v. Nature’s Path Foods, Inc., 2022 WL 717816 (N.D. Cal. Mar. 10, 2022), Judge Gilliam observed that recent FDA guidance reaffirms that companies may

As discussed in our recent post, a court in the Northern District of California recently dismissed a complaint against Kashi involving its front-of-pack protein content claims.  See Nacarino v. Kashi Co., No. 21-CV-07036-VC, 2022 WL 390815, at *1 (N.D. Cal. Feb. 9, 2022).  That decision confirmed that food manufacturers may use the “nitrogen method” to calculate protein content claims made outside the Nutrition Facts Label and that plaintiffs’ theory that manufacturers must adjust such claims to reflect protein digestibility is preempted.  Judge Seeborg, also of the Northern District of California, followed in the footsteps of the Kashi court on February 15 by dismissing with prejudice a virtually identical case against KIND.  See Chong v. KIND LLC, No. 21-CV-04528-RS, 2022 WL 464149 (N.D. Cal. Feb. 15, 2022).Continue Reading Second Court Upholds Industry-Standard Method for Calculating Front-of-Pack Protein Content Claims

Background

Many food companies now make quantitative protein content claims on the front of pack or elsewhere on their product labels outside the Nutrition Facts Label (NFL), such as the example from a recent case below:  

FDA regulations direct manufacturers to use the “nitrogen method”—which generally calculates protein content by multiplying the nitrogen content of the food by 6.25—when calculating the amount of protein reported inside the NFL.  Companies have generally used the same method for protein claims made elsewhere on the label, i.e., outside the NFL.Continue Reading A Closer Look: Court Upholds Industry-Standard Method for Calculating Front-of-Pack Protein Content Claims