[Podcast] Cellular Agriculture and the Evolving Legal/Regulatory Landscape: A Conversation with Ahmed Khan
On August 2, 2024, the Association of American Feed Control Officials (“AAFCO”) announced that its Memorandum of Understanding 225-07-7001 (the “MOU”) with the U.S. Food and Drug Administration (“FDA”) outlining the AAFCO...more
Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale? If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and...more
After formulating an exciting new healthy food or beverage, the packaging it comes in may feel like an afterthought. It should not be. Food packaging has become an increasingly hot topic among federal and state regulators,...more
Whether formulating a new food or developing a novel ingredient, a critical first step is understanding the regulatory framework for bringing a new ingredient (or a food containing a new ingredient) to the market. This...more
Following the social isolation and public health concerns associated with the COVID-19 pandemic, many Americans reevaluated their health and wellness priorities, creating new opportunities for food systems companies to...more
The U.S. Food and Drug Administration (FDA) released a public inventory on July 12, 2023, of certain food ingredients that the agency has determined are unsafe because they are unapproved food additives that are not Generally...more
Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against homeopathic products that it...more
On December 5, 2022, the Minnesota Board of Pharmacy filed a lawsuit against three affiliated Minnesota hemp companies seeking condemnation and destruction of several million dollars worth of gummy edibles. Ironically named...more
On November 16, 2022, the United States Food and Drug Administration (FDA) issued Warning Letters to five companies that market food and beverage products containing cannabidiol (CBD). FDA takes the position that the...more
On May 4, 2022, the FDA issued five warning letters to companies for selling products containing hemp-derived Delta-8 THC. Notably, this is the first time the FDA has issued warning letters specifically for Delta-8 products....more
Aside from a small number of companies the FDA has permitted to pursue the development of psilocybin therapies (e.g., Compass), the majority of psychedelic mushroom sales in the U.S. currently violate both state and federal...more
This article follows our introduction to the alternative protein industry and the legal considerations for companies and investors operating within it. The focus of this article is on the regulation of insects as food and...more
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
The global cannabidiol (CBD) market size is expected to reach USD 13.4 billion by 2028. And yet a large part of that market—CBD-infused food, beverages, and dietary supplements—consists of unlawful sales. This article...more
The month of May was buzzing with good news for the edible insect industry, but this emerging food trend still faces regulatory uncertainty in the United States....more
In an important ruling dismissing a proposed class action, the US District Court for the Southern District of Florida ruled that the US Food and Drug Administration’s (FDA’s) generally recognized as safe (GRAS) regulation...more
On November 25, the Food and Drug Administration (FDA) issued 15 warning letters to companies selling products containing hemp-derived cannabidiol (CBD) and released a summary of its approach to the regulation of CBD...more
We have previously blogged about the Food and Drug Administration’s year of listening and information gathering related to products containing cannabis or cannabis-derived compounds since the 2018 Farm Bill removed “hemp”...more
On November 25, 2019, the U.S. Federal Drug Administration (FDA) took several significant actions regarding sellers of products containing cannabidiol (CBD). The FDA announced that it cannot conclude that CBD is “generally...more
On Friday May 31, 2019, the Food and Drug Administration (FDA) held a public hearing on the topic of cannabis or cannabis-derived compounds. The FDA held the hearing to gather information regarding the safety risks and health...more
Brand owners seeking to register cannabis-related trademarks take note: the U.S. Patent and Trademark Office (USPTO) recently issued guidance regarding the effects of the 2018 Farm Bill on the registration of trademarks for...more
On April 25, 2019, TTB published Industry Circular 2019-1. It addresses the hot topic of alcohol beverages (especially beer) infused with hemp-derived ingredients–with cannabidiol (CBD) as the clear focus of industry...more
Public interest groups challenge FDA’s “Generally Recognized as Safe” Rule as failing to ensure food ingredients are safe for consumers....more
The Food and Drug Administration (FDA) says its final rule allowing outside groups to evaluate food additive risks will streamline its “Generally Recognized as Safe” (GRAS) reviews. The agency recently released its GRAS...more
The U.S. Food and Drug Administration (FDA) has released its final rule “Substances Generally Recognized as Safe” (due for publication on August 17, 2016). Under the Federal Food, Drug, and Cosmetic Act, GRAS substances are...more