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On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease....more
The U.S. Food and Drug Administration’s (FDA) March 2025 publication of its new “Chemical Contaminants Transparency Tool” spotlighted a lesser-known aspect of FDA’s regulation of pesticide residues on food: action levels....more
In the past couple of weeks, I have been contacted by a few major news outlets about the legality of “THC beverages“. While it sounds like you can only find these products in a state-licensed cannabis dispensary, reporters...more
With the memorandum of understanding between the Food and Drug Administration (FDA) and the Association of Animal Feed Control Officials (AAFCO) set to expire, the FDA is proposing an alternative path to market for the...more
Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more
Hemp and marijuana both come from the cannabis sativa plant but as a result of the Agriculture Improvement Act of 2018 (the “2018 Farm Bill”), cannabis sativa with a THC content of less than 0.3% was removed from the federal...more
The U.S. Food and Drug Administration (FDA) has issued a report on its recent investigation into a Fall 2020 outbreak associated with leafy greens and announced its next steps to address the safety of leafy greens. ...more
The United States Department of Agriculture's Food Safety and Inspection Service (FSIS) has issued an instruction to field personnel, FSIS Notice 49-20, to begin implementing the agency’s new Adulterated Product Monitoring...more
On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to establish additional traceability recordkeeping requirements for companies that manufacture, process, pack, or hold certain high-risk...more
Tell me if you’ve heard this one before – the regulatory issues surrounding CBD will be completely resolved after a certain “legislative fix” is passed. Remember all of the articles in December 2018 declaring CBD legal after...more
The Office of Management and Budget (OMB) recently released the Spring 2020 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
The Council for Responsible Nutrition (CRN) submitted a citizen petition to the Food and Drug Administration (FDA) requesting that FDA: FDA exercise its statutory authority to establish a regulation under which...more
Hemp production, unlike much of the farming industry, has not declined due to COVID-19. Meanwhile, certain CBD companies have wasted no time in making unsubstantiated claims related to COVID-19. In turn, FDA and FTC...more
As the CBD boom continues to gain a foothold in mainstream commerce, the Food and Drug Administration (FDA) has been slow to provide retailers and consumers with meaningful guidance or regulation....more
Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. It was a busy week for the states, as Virginia moved towards decriminalization. The state House and Senate passed...more
Manufacturers, distributors, and suppliers of CBD products should embrace and participate in reform to address public health concerns, write Bilzin Sumberg attorneys. Consumer groups like the Arthritis Foundation are stepping...more
In November 2018, Missouri voters passed Amendment 2, setting in motion state regulated medical marijuana. Over the last month, the Missouri Department of Health & Senior Services (DHSS) began approving license applications...more
LEGISLATION, REGULATIONS & STANDARDS - CBD Explodes In Popularity But Hits Regulatory Wall - Following the passage of the 2018 Farm Bill, which legalized the cultivation of hemp, cannabidiol (CBD) became the star...more
The Office of Management and Budget (OMB) recently released the Fall 2019 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Warning Letters, Consumer Update On CBD, Sparking Litigation Against CBD Cos. - The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Warns Company Selling CBD Oil - The U.S. Food and Drug Administration has published a warning letter it sent in September 2019 to a company selling cannabidiol (CBD) oil as a...more
Hemp and its derivatives – including hemp-derived cannabidiol ("CBD") – were previously classified as Schedule I controlled substances under the Controlled Substances Act of 1972 ("CSA"). That changed in December 2018,...more
FDA recently released a Draft Guidance for Industry entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” (“Draft Guidance”). The Draft Guidance addresses the growing, harvesting,...more
The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule....more
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently issued a statement affirming that Produce Safety Rule inspections will begin this spring. Last year FDA chose to delay routine inspections to allow...more