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
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
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
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 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 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
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
We are writing this memo to bring to your attention that the Food and Drug Administration (FDA) recently published a new final guidance titled: “Preparation of Food Contact Notifications for Food Contact Substances in Contact...more
On October 9, 2018, the U.S. Food and Drug Administration (FDA) issued a final rule revoking authorization for seven synthetic flavorings and adjuvants as food additives. Notably, FDA’s rigorous scientific analysis determined...more
10/30/2018
/ Additive Manufacturing ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Food Supply ,
Proposition 65 ,
Public Health ,
Regulatory Oversight ,
Regulatory Requirements ,
Toxic Exposure
A California appeals court has reversed a trial court decision that would require businesses to post Proposition 65 cancer warnings on certain breakfast cereals for acrylamide. The court ruled that a Proposition 65 warning...more
8/6/2018
/ Appeals ,
Beverage Manufacturers ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
OEHHA ,
Preemption ,
Proposition 65 ,
Reversal ,
Toxic Chemicals ,
Warning Labels