Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and treatment of diseases, conditions, and infections. Examples of LDTs are the COVID-19...more
A year ago, the FDA issued draft guidance for lead levels in baby foods. In the year since the FDA issued its draft guidance for lead levels in baby food, two states, California and Maryland, have adopted laws which require...more
1/16/2025
/ Baby Products ,
Compliance ,
Consumer Protection Laws ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Food Safety ,
Lead ,
Multidistrict Litigation ,
Product Safety Labels ,
Public Health ,
Regulatory Requirements ,
State and Local Government ,
Toxic Chemicals
The cell cultivated meat industry has had its difficulties with funding, technology and regulatory barriers and the roller coaster ride is not over. In 2021 and 2022, $1.6 billion in venture capital investments went into the...more
In this blog, we have written a number of times on the topic of cultivated, i.e., lab grown meats. Last year, the FDA gave final regulatory approval for two different companies to sell their cultivated chicken in the United...more
The practice of altering plant genetics to better suit human needs, dates back thousands of years. What was once done through selective plant breeding – as well as alterations beyond what is possible with selective breeding –...more
You have probably heard that scientists around the world are searching for sustainable, climate safe ways to keep up with the steadily increasing demand for protein sources to feed the World’s population. According to the...more
Reports of a recall of apple cinnamon fruit pouches for children have been prominent in the headlines for the last few weeks. This blog has previously covered the topics of lead in spices and the FDA’s January 2023 issuance...more
In June of this year, the USDA approved the label of “cell-cultivated chicken” to be used for the sale of laboratory grown chicken. It also issued grants of inspection to Upside Foods and Eat Just (GOOD Meat), authorizing...more
Would FDA testing of feedlots for bacteria promote safer vegetables? Would it decrease the availability of and increase price of meat? You might ask, what do feedlots have to do with vegetables? Concentrated Animal Feeding...more
The concept of artificial intelligence (AI) in drug discovery and manufacturing has been in progress for more than 10 years; however, with the current advancements in technology, medicine, and research, AI is closer than ever...more
If there is one thing that everyone can agree on, it is that health is an important factor in life. In 2021, over 3 million people died in the United States with heart disease and cancer topping the list....more
4/14/2023
/ Artificial Intelligence ,
Diagnostic Tests ,
Food and Drug Administration (FDA) ,
GAO ,
Health Care Providers ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Physicians ,
Preemption ,
Software ,
Standard of Care ,
Strict Product Liability
On March 4, 2021, we wrote about lawsuits concerning alleged high levels of heavy metals in baby foods (“Are Your Baby’s Strained Carrots Safe? Considerations for Manufacturers”). A precipitating factor was a staff report...more
3/13/2023
/ Arsenic ,
Baby Products ,
Children's Products ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Food Contamination ,
Food Manufacturers ,
Food Safety ,
Food Supply ,
Hazardous Substances ,
Lead ,
Mercury ,
Regulatory Oversight ,
Toxic Chemicals
Cultured meat and its introduction into our grocery stores and restaurants is on the horizon. The FDA has established a premarket consultation process which allows companies who would like to market cultured meat in the U.S....more
We have all heard stories of lead exposure from paint. Recently, high lead levels in dark chocolate have made headlines. But have you ever considered that lead could be lurking in your spice rack?...more
Could cultured meat be available in your U.S. grocery store in the new year? A previous article focused on the topic of “cultured meat” – meat made from the cells of animals and grown in a nutrient medium. While no cultured...more
When you go to the grocery store or farmer’s market and buy produce (I prefer the latter), do you consider how safe the produce is? If you are anything like me, perhaps you have wondered about the regulatory requirements...more
Earlier this year, a pet food company issued a recall of its products after reports of animals becoming sick, allegedly, from consuming the company’s pet food. Recalls and their role in ensuring food safety was addressed in a...more
For a variety of reasons, including celiac disease and autism diets, numerous people now follow a gluten free diet. Gluten is the term applied to a group of proteins found in grains such as wheat, rye, spelt, and barley. ...more
The trend toward state-level legalization of cannabis has led to a surge in cannabis-derived products and a continually evolving market with many types of cannabis products for people as well as their pets. Analysts predict...more
8/19/2021
/ Agribusiness ,
Animal Health ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Cannabis-Related Businesses (CRBs) ,
Controlled Substances Act ,
Department of Agriculture ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Hemp ,
Hemp Cultivation ,
Interstate Commerce ,
Marketing ,
Pets ,
Product Labels ,
Professional Associations ,
State and Local Government ,
USDA ,
Veterinarians ,
Warning Letters
On March 4, 2021, we posted “Are Your Baby’s Strained Carrots Safe? Considerations for Manufacturers.” Multiple plaintiffs had filed class action lawsuits in jurisdictions around the country alleging that baby food...more
Do you know where your last meal came from? Can you trace your vegetables to the field where they were grown? Do you know where the goat whose milk was used to make your feta lives? Why would you even want to know the...more
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