Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries....more
As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more
As we enter 2024, more and more brands are joining the nonalcoholic beverage space. An increasing variety of nonalcoholic, single-serve, ready-to-drink beverages are marketing the innovative use of indigenous botanicals,...more
The Learned Concierge - Welcome to your monthly legal insights on the trends impacting the Retail, Hospitality, and Food & Beverage Industries. Labor and Employment: Child Labor Compliance and “Hot Goods” - Many employers may...more
LEGISLATION, REGULATIONS & STANDARDS - Report: FDA Food Recalls Jumped 700% from 2021 to 2022 - The number of individual units of food and drink recalled by the U.S. Food and Drug Administration (FDA) in 2022 increased...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Announces Update on Human Foods Program Restructuring - The U.S. Food and Drug Administration (FDA) has issued a news release with an update on the restructuring of its Human Foods...more
Distilled spirits manufacturers recently find themselves in proverbial hot water when it comes to incomplete or misleading representations on labels. Recent state and federal court cases highlight that while mere "puffery" –...more
The rapid evolution of the cannabis industry in the United States poses many unique questions, the most interesting of which is what cannabis regulation will look like under federal legalization. Although (legal) cannabis is...more
Update April 5: This advisory has been updated to include the latest information on distillery-produced hand sanitizer. In response to the nationwide hand sanitizer shortage in the wake of the COVID-19 pandemic, many...more
Update March 27: This advisory has been updated to include the latest information on distillery-produced hand sanitizer. In response to the nationwide hand sanitizer shortage in the wake of the COVID-19 pandemic, many...more
With the increasing pace of the spread of the Coronavirus (COVID-19) and the related emergent need to increase the available supply for hand sanitizer products across the United States, the Alcohol and Tobacco Tax and Trade...more
A federal judge in the Southern District of Florida recently dismissed an action alleging that Bacardi’s use of a botanical called “grains of paradise” in its gin was “harmful and illegal,” holding that the statute on which...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
LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Guidance on Intentional Adulteration - The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional...more
LEGISLATION, REGULATIONS & STANDARDS - France to Ban Mass Culling of Male Chicks - France’s agriculture minister has reportedly announced that the country will prohibit the mass culling of male chicks shortly after they...more
LEGISLATION, REGULATIONS & STANDARDS - Virginia Law Limiting Use of “Milk” Advances - Following a vote in the Virginia House Agriculture Subcommittee, the state’s House of Delegates will reportedly consider a bill that...more
LEGISLATION, REGULATIONS & STANDARDS - USDA Receives Hundreds Of Comments On Hemp Interim Rule - Two weeks after opening a comment period on an interim final rule on hemp farming, the U.S. Department of Agriculture...more
LEGISLATION, REGULATIONS & STANDARDS - Advertising Complaint Upheld Against U.K. Hemp Rum Co. - The U.K. Advertising Standards Authority (ASA) has upheld a complaint against The Cornish Rum Co. against its ads marketing...more
Bacardi U.S., Inc. is facing a class action lawsuit in Florida due the use of grains of paradise in Bombay Sapphire® Gin. In Uri Marrache v. Bacardi USA, Inc., et al., Case No. 2019-023668-CA-01 (Miami-Dade Cir. Ct. Aug. 9,...more
In August, the US District Court for the District of Columbia issued its final decision in Bellion Spirits, LLC v. United States, Civ. No. 17-2538 (JEB). The Bellion case was brought by spirits company Bellion Spirits after...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Issues First Warning Letter for FSMA Foreign Supplier Program - The U.S. Food and Drug Administration (FDA) has issued the first warning letter enforcing the Food Safety...more
Shook Takes the Pulse of General Counsel on Maturation of Global Cannabis Market - More than half of in-house counsel surveyed in a new white paper by Shook, Hardy & Bacon plan to increase legal spending in the next two...more
Wage and Hour - 80/20 Rule Still Followed in Some Parts - The U.S. Department of Labor (DOL) issued guidance doing away with the so-called "80/20 rule" in November 2018. District courts have greeted the new guidance...more
The Cannabis Conundrum: The Evolving Landscape & Risk Mitigation for Hemp & CBD - The cannabis industry, including marijuana, hemp and cannabidiol (CBD), is complex and rapidly evolving. Shook Partners Mike Barnett,...more
In late 2018, President Trump formally signed the Agricultural Improvement Act of 2018 (2018 Farm Bill) into law, and in turn declassified hemp as a Schedule 1 substance under the Controlled Substances Act (CSA). Hemp is...more