Cooley’s Highlights From ICPHSO 2025 Annual Meeting and Training Symposium – Plenary Session 2
‘Across the Recall Ecosystem: Leading Practices, Challenges & Lessons Learned’ Plenary session 2: ‘Across the Recall Ecosystem: Leading Practices, Challenges & Lessons Learned’ featured speakers from Costco, Peloton and Health Canada, and was moderated by a representative from the Retail Industry Leaders Association. The panel discussed best practices in product […]
Cooley’s Highlights From ICPHSO 2025 Annual Meeting and Training Symposium – Plenary Session 1
‘Market Surveillance and Product Recalls: Linking Policy to Action in Case of Online Sales’ Plenary session 1 featured speakers from Amazon, TIC Council Americas, UL Solutions and Anushi Amin of Cooley (UK) LLP. The panel examined how the new European Union (EU) General Product Safety Regulation (GPSR) would affect the […]
Cooley’s Highlights From ICPHSO 2025 Annual Meeting and Training Symposium
Cooley’s international products team will be attending the ICPHSO 2025 Annual Meeting and Training Symposium, “Fostering Bridges Within the Product Safety Community,” in Orlando, Florida, from February 17 – 20, 2025. We will be posting highlights from the plenary panel sessions on our Productwise blog throughout the event.
European Commission Publishes Guidance on EU Batteries Regulation Removability Requirements
New European Commission (EC) guidance on the European Union Batteries Regulation 2023/1542 has been published, which is relevant to anyone who places products containing batteries on the EU market. The new guidance sheds light on the challenging Article 11 requirement that portable batteries be ‘readily removable and replaceable by the end user at any time during the lifetime of the product’.
Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson[1] upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for a four-year, $4.7 million Medicare fraud scheme involving repeated use of surgical devices approved for one-time use.
Daniel Grooms, Andrew Goldstein, Zach Hafer, Sonia Nath, Matt Nguyen, Son Nguyen, Jim Santel
2024 – What a Year for Products Law! What’s Next in 2025?
The Cooley products team brings you a roundup of the highlights from Europe in 2024 and what to look out for in 2025.
Rod Freeman , Claire Temple , Tracey Bischofberger
The EU’s General Product Safety Regulation: New Accident Reporting Obligations
In the third in a series of blogs on the General Product Safety Regulation, the Cooley products team unpacks the new accident reporting obligations being introduced across the European Economic Area (EEA) – made up of European Union Member States, plus Iceland, Liechtenstein and Norway – and Northern Ireland.
Rod Freeman , Claire Temple , Jamie Humphreys , Tracey Bischofberger
One-Year Delay to EU’s Anti-Deforestation Law Confirmed
On 18 December 2024, the Council of the EU formally adopted the regulation delaying the application of the European Union’s Deforestation Regulation (EUDR) by 12 months. This follows the European Parliament’s formal adoption of the amending regulation on 17 December 2024. Now that the final legislative hurdles have been overcome, the amending regulation must be signed and published in the Official Journal of the European Union so that it can become law before the end of the year. This delay means that businesses now have until 30 December 2025 to ensure they have procedures in place to comply with the EUDR.
One-Year Delay to EU’s Anti-Deforestation Law Close to Approval
On 3 December 2024, provisional agreement was reached on the proposal to delay the application of the European Union’s Deforestation Regulation (EUDR) by 12 months. According to the provisional agreement, the targeted amendment will not affect the substance of the existing legislation as it was originally agreed. The EUDR only allows in-scope products and commodities that are ‘deforestation-free’ to be placed or made available on the EU market and/or exported from the EU. This includes certain products made from cattle, wood, cocoa, soy, palm oil, coffee and rubber.
EU’s General Product Safety Regulation: An Expanded Concept of Safety
In the second in a series of blogs on the European Union’s new General Product Safety Regulation, the Cooley products team takes a look at the expanded concept of safety under the new rules and why this matters.