On March 26, 2021, the FDA updated and reissued the fee rates for the newly created over-the-counter (OTC) monograph Drug User Fee program (OMFUA) for FY2021 in a Federal Register Notice (FRN) titled “Fee Rates under the...more
Cell-based or cell-cultured seafood products (seafood products grown in a bioreactor from tissue specimens from fish / seafood) are not yet commercially available, but the FDA is working to decide how they will be labeled. ...more
Are baby foods subject to stricter standards than adult foods? The short answer is, not really. The U.S. Food and Drug Administration (FDA) has specific guidelines for baby formulas, labeling requirements for baby and...more
While most people have probably never heard of a Food Safety Plan, these plans are critically important to manufacturers and consumers alike. A Food Safety Plan tracks the creation and packaging of the food from the...more
M-E-A-T has become a complicated word. A variety of alternative meat products are on the market or in development. Plant-based meat substitutes are already commonplace in our grocery stores and restaurants. Some of these...more
2/19/2021
/ Bioengineering ,
Comment Period ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Manufacturers ,
Food Supply ,
Life Sciences ,
Meat Processing Plants ,
Plant Based Products ,
Research and Development ,
USDA
By now, most of us have seen plant-based “meat” in supermarkets and restaurants. For one of those plant-based meat substitutes, ImpossibleTM Burger, a lawsuit is underway challenging the FDA’s approval of the compound used to...more
As we have all heard, the gastrointestinal tract (gut) is full of numerous types of bacteria. Some are helpful, some are harmful. For those of us who take probiotics and/or eat fermented foods, we know that we are working...more
Last year Bayer announced a plan to settle lawsuits alleging injury due to exposure to Roundup™. Lawsuits alleging injuries related to pesticide exposure, such as the lawsuits involving Roundup™, are not new, and they are...more
During the 2020 COVID-19 pandemic, statistics have shown a significant decline in emergency room and hospital admissions for multiple conditions, including acute coronary syndrome (ACS) (-40–50%), stroke (-30–40%), and cancer...more
Food poisoning is an experience that no one is likely to ever forget. Some of the common bacteria that cause foodborne illness include Listeria monocytogenes (L. monocytogenes), Salmonella (S. enterica), and Escherichia coli...more
Phages, formally called bacteriophages — the most abundant, ubiquitous organisms in nature — are viruses that infect, replicate in, and destroy bacteria. These viruses are species-specific, and sometimes infect only certain...more
Produce production requires lots of water — water for irrigation, water for cleaning tools and facilities, water for cleaning the produce, etc. Water used on farms can come from a variety of sources — from wells, ponds,...more
On November, 10, 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (Eli Lilly and Company, Indianapolis, IN) for the...more
As part of the Food Safety Modernization Act (FSMA), the Produce Safety Rule outlines the regulatory requirements that apply to entities that grow, harvest, pack or hold fresh produce. Depending upon the amount of their...more
10/29/2020
/ Agribusiness ,
Farms ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
FSMA ,
Produce Safety Rule ,
Recordkeeping Requirements ,
Regulatory Standards ,
Safety Precautions ,
Small Business
When you buy and eat smoked nuts and cheeses, do you have images of smoke from a wood fire wafting up from smokers as you savor those snacks? Have you ever thought about how your nuts and cheeses were smoked? Many of those...more
No painful procedure or biopsy needed. We can test our blood to diagnose and even predict cancer.
The Human Genome Project, a joint effort between the U.S. Department of Energy and the National Institutes of Health, began...more
On August 26, 2020, the U.S. Food and Drug Administration approved Foundation Medicine, Inc.’s Foundation One® Liquid CDx, a quantitative next-generation sequencing (NGS) test that can detect mutations using circulating...more
The Food and Drug Administration’s approval of Guardant Health’s Guardant360 CDx assay marks a new era for genetic mutation testing in cancer treatment. On August 7, 2020, the FDA approved the first diagnostic test that...more
A central question in every tort case is what caused the injury. The question of proximate cause does not end with the inquiry of whether it is possible for a particular product or act to cause an injury, but also whether it...more