On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more
1/13/2025
/ Baby Products ,
Class Action ,
Compliance ,
Consumer Protection Laws ,
Enforcement Actions ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Safety ,
Lead ,
Liability ,
Manufacturers ,
Product Defects ,
Public Health ,
Regulatory Requirements ,
Risk Mitigation ,
Toxic Chemicals
On February 22, 2024, FDA released a final guidance detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers. The...more
The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks. These requests provide the...more
11/21/2023
/ Agricultural Sector ,
APHIS ,
Biotechnology ,
Comment Period ,
Environmental Protection Agency (EPA) ,
Federal Register ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
The Nagoya Protocol ,
USDA ,
USPTO
On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken....more
The standard for written description in the life sciences seems to have tightened lately, leading patent applicants to wonder what level of written support and working example data is necessary to support genus claims....more