The U.S. Food and Drug Administration (FDA) recently completed its first pre-market consultation for a human food made from cultured animal cells and issued a letter stating it had no further questions regarding the...more
On November 1, 2022, the Office of Environmental Health Hazard Assessment (OEHHA) announced that the California Office of Administrative Law (OAL) had approved its proposal to add an alternative, non-mandatory safe harbor...more
On October 6, 2022, the Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65 (Prop 65), provided notice of new changes to the proposed regulation. If adopted,...more
FDA recently released the results of its seafood survey it conducted to measure the amount of per- and polyfluoroalkyl substances (PFAS) in 81 seafood samples of clams, cod, crab, pollock, salmon, shrimp, tuna, and tilapia...more
The U.S. Food & Drug Administration (FDA) recently issued Warning Letters to five companies selling products containing delta-8 tetrahydrocannabinol (delta-8 THC) and cannabidiol (CBD). In addition to the various violations...more
Two significant decisions were recently issued regarding California’s Proposition 65 (Prop 65). First, the U.S. Court of Appeals for the Ninth Circuit reinstated a district court’s preliminary injunction halting new...more
As regulatory bodies increase their scrutiny of per- and polyfluroalkyl substances (PFAS), food companies should work closely with their suppliers and prepare for the compliance transition....more
1/6/2022
/ Biden Administration ,
CERCLA ,
Environmental Protection Agency (EPA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
Food Supply ,
PFAS ,
Popular ,
Product Packaging ,
Toxic Chemicals ,
USDA
The U.S. District Court for the Southern District of New York granted the U.S. Food and Drug Administration’s (FDA or the Agency) motion for summary judgment on September 30, 2021, against claims brought by a group of...more
California and Vermont have recently joined a growing list of states that have passed legislation banning the use of per- and polyfluoroalkyl substances (PFAS) in food packaging. Relatedly, a group of environmental, consumer,...more
6/17/2021
/ Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Supply ,
Hazardous Substances ,
PFAS ,
Product Packaging ,
Proposed Regulation ,
Public Health ,
Regulatory Agenda ,
Toxic Chemicals ,
Toxic Exposure
China recently announced two revised decrees that, once implemented, would impose substantial new requirements for food and beverage companies that export to China. These regulations are as follows: In particular, with some...more
6/15/2021
/ Beverage Manufacturers ,
China ,
Customs ,
Exports ,
Food & Drug Regulations ,
Food Manufacturers ,
Food Supply ,
Foreign Suppliers ,
Imports ,
International Trade ,
Registration Requirement ,
Regulatory Oversight ,
Regulatory Standards ,
Suppliers
We recently became aware of a 27 May 2021 opinion from the Ninth Circuit that “stayed” the preliminary injunction barring private parties from filing new lawsuits against businesses to enforce the Proposition 65 warning...more
6/8/2021
/ Beverage Manufacturers ,
Cancer ,
Food & Drug Regulations ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
Preliminary Injunctions ,
Product Labels ,
Proposition 65 ,
Stays ,
Toxic Chemicals ,
Warning Labels
On Friday, 16 April 2021, California’s Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65, proposed modified language for its new regulation on the warning...more
4/21/2021
/ Amended Regulation ,
Food Manufacturers ,
OEHHA ,
Proposition 65 ,
Public Comment ,
Regulatory Agenda ,
Regulatory Requirements ,
Supply Chain ,
Toxic Chemicals ,
Toxic Exposure ,
Warning Labels
On 14 April 2021, the U.S. Congress passed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 (S. 578), which now heads to the White House for signature. ...more
On 29 March 2021 the United States District Court for the Eastern District of California entered a significant ruling temporarily halting the filing of new lawsuits by the California Attorney General and anyone else related...more
4/2/2021
/ Beverage Manufacturers ,
Chamber of Commerce ,
Commercial Speech ,
Constitutional Challenges ,
Consumer Product Companies ,
Corporate Counsel ,
First Amendment ,
Food Labeling ,
Food Manufacturers ,
Food Safety ,
OEHHA ,
Preliminary Injunctions ,
Proposition 65 ,
Retail Market ,
Toxic Chemicals ,
Warning Labels
On 5 March 2021, the U.S. Food and Drug Administration (FDA) issued a letter to baby and toddler food manufacturers and processors covered by the preventive control provisions of the Current Good Manufacturing Practice,...more
3/9/2021
/ Baby Products ,
Children's Products ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Hazardous Substances ,
Public Health ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Requirements ,
Toxic Chemicals
The United States’ regulation of genetically engineered (GE) animals recently advanced with two new developments from the U.S. Department of Agriculture (USDA) and U.S. Food and Drug Administration (FDA). ...more
1/11/2021
/ APHIS ,
Bioengineering ,
Food and Drug Administration (FDA) ,
Food Safety ,
Food Safety and Inspection Service (FSIS) ,
Food Supply ,
Genetically Engineered Animals ,
GMO ,
Regulatory Agenda ,
Regulatory Standards ,
USDA
On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with...more
10/20/2020
/ China ,
Generic Drugs ,
Hatch-Waxman ,
Innovation ,
Intellectual Property Protection ,
Life Sciences ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
On October 10, thirteen years after China’s Measures for the Administration of Drug Recalls first took effect, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) proposed an...more
California’s Office of Environmental Health Hazard Assessment (OEHHA) is extending the public comment period for its proposal that lays out what constitutes a Proposition 65 exposure that would require warnings for listed...more
On 11 September 2020, China’s National Medical Products Administration (NMPA, formerly “China Food and Drug Administration”) published its proposed regulation on patent linkage, “Measures for the Implementation of the Early...more
On August 28, California’s Office of Environmental Health Hazard Assessment (OEHHA), the lead state agency for the assessment of health risks posed by chemical substances, released a draft report concluding its review of the...more
On August 4, 2020, the Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65 (Prop 65), proposed to adopt a new regulation that would significantly change the...more
On 6 July, China’s National People’s Congress (NPC) published additional amendments to its draft patent law, which was first released in January 2019. As we reported at that time here, the proposed Chinese Patent Law...more
We would like to bring to your attention three recent developments related to California’s Proposition 65. On July 8, the Office of Environmental Health Hazard Assessment (OEHHA) adopted three safe harbor levels or maximum...more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
2/26/2020
/ 3D Printing ,
AIDS ,
Analytics ,
Artificial Intelligence ,
Biosimilars ,
Biotechnology ,
Blockchain ,
California Consumer Privacy Act (CCPA) ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Defense (DOD) ,
Digital Health ,
Drug Distribution ,
Drug Pricing ,
EU ,
Federal Funding ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Technology ,
HIV ,
Incident Response Plans ,
Intellectual Property Protection ,
Life Sciences ,
Medical Device Data System ,
Medical Devices ,
Medical Software ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Procurement Guidelines ,
Regulatory Standards ,
Research and Development ,
Right to Try ,
Robotics ,
Supply Chain ,
Telehealth