Podcast - Made in the USA Claims
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More CBD Certainty: Clearing Confusion over Hemp in New York State
Lowndes Client Corner Podcast Episode 5 - Winter Park Distilling Company Brews One-Of-A-Kind Facility in Winter Park
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
In 1997, following consumer research and public comments, the FTC published an Enforcement Policy Statement on U.S. Origin Claims to guide marketers and manufacturers that want to make an unqualified Made in USA claim under...more
The Packaging and Packaging Waste Regulation (Regulation (EU) 2025/40), the European Union’s new regulation concerning the packaging of products placed on the European market (PPWR), came into force on 11 February 2025....more
On May 27, 2025, the Food and Drug Administration (FDA) released a new draft guidance, “Replacing Color Additives in Approved or Marketed Drug Products” (Guidance), that outlines regulatory expectations for manufacturers and...more
This week I had the pleasure of speaking with Lioba Oerter, Director of Expert Services, 3E Expert Service Processing Centre (ESPC), and Karin F. Baron, Director of Hazard Communication and International Registration Strategy...more
The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based milk, e.g. oat milk). FDA is...more
Short-form warnings for products that may expose consumers to chemicals on California’s Prop 65 list must now include at least one chemical name to qualify for Prop 65’s “safe harbor” protections—with one caveat. Businesses...more
The U.S. Food and Drug Administration (FDA) recently published draft guidance on the Labeling of Plant-Based Alternatives to Animal-Derived Foods (Draft Guidance). The Draft Guidance recommends best practices for naming...more
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug products by allowing the approval of a nonprescription drug product with an “Additional Condition...more
Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market. ...more
Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more