Rulings, FDA Guidance May Help Food Cos. In Protein Suits

Originally published by Law360, Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein content statements violate U.S. Food and Drug Administration (FDA) regulations, and mislead consumers by overstating …›

January 19, 2022 - Consumer Products, FDA, Food Misbranding

FDA Ends Regulation of "French Dressing"

Last week the FDA announced that it would lift regulations controlling what can be called “French dressing.” The regulations—which had been in place since 1950—previously required that a product contain 35% vegetable oil and vinegar, lemon, or lime juice to be marketed as “French …›

HHS Reverses Policy Prohibiting FDA Review of Lab-Developed Tests

On November 15, 2021, the Department of Health and Human Services (HHS) announced it would reverse a policy issued in August 2020 prohibiting the Food and Drug Administration (FDA) from requiring a premarket review of laboratory developed tests (“LDTs”), including requiring Emergency Use Authorizations …›

Manuka Honey and Waterslides

This week, we take a look at a decision addressing what a “reasonable” consumer will know in purchasing a product (and distinguishing the Seventh Circuit in the process), and at another assessing the legality of Washington’s pandemic-related shutdown of a waterpark. MOORE v. TRADER JOE’S …›

FDA’s COVID-19 Product Regulation Enforcement Roadmap

Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA …›

First Decisions Limit PREP Act Immunity in Coronavirus Context

When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act …›

FDA Signals Flexibility with COVID-19 Tests

A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy. Consistent with this, FDA has taken various steps to accelerate the …›