News & Analysis as of

Medical Foods Food and Drug Administration (FDA)

Console and Associates, P.C.

Parents Bring Kratom Lawsuits Following Overdose Deaths and Other Serious Injuries

Kratom, a natural substance derived from the leaves of the Mitragyna speciosa tree, has recently gained notoriety for its potential dangers. While proponents cite its therapeutic benefits, concerns have surged about its...more

Husch Blackwell LLP

Psychedelic Breakthroughs: Key Considerations for Clinical Trials

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Psychedelics have the potential to treat chronic conditions such as post-traumatic stress disorder (PTSD), depression, obsessive-compulsive disorder (OCD), fibromyalgia, and various behavioral health conditions, yet...more

Husch Blackwell LLP

The Future of Functional Foods

Husch Blackwell LLP on

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

McGlinchey Stafford

9th Circuit Hears Argument Regarding DEA Process for Drug Rescheduling and Remands for Further Consideration

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The Ninth Circuit Court of Appeals recently heard oral argument in the case of Aggarwal v. U.S. Drug Enforcement Administration over whether the DEA’s process to consider controlled substances reclassification was unlawful...more

Warner Norcross + Judd

HHS Recommends DEA Reschedule Marijuana from Schedule I to Schedule III – Now What?

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A year ago today on October 6, 2022, President Joe Biden asked the U.S. Secretary of Health and Human Services (HHS) and the U.S. Attorney General to initiate an administrative process to review how marijuana is scheduled...more

McGlinchey Stafford

DEA Likely to Reschedule Marijuana Based on Congressional Report

McGlinchey Stafford on

According to a report from the Congressional Research Service (the Report), the Drug Enforcement Administration (DEA) is likely to follow the Department of Health and Human Services (HHS) and the Food and Drug...more

Amundsen Davis LLC

FDA Issues First Ever Guidance for Research of Psychedelics

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Earlier this summer, the Food & Drug Administration (FDA) issued draft guidance for those researching the use of psychedelics to treat certain serious medical conditions including major depressive disorder, PTSD, and...more

MoFo Life Sciences

The EU’S New Proposal For Plants Developed Using New Genomic Techniques: How Does It Compare To U.S. Regulation?

MoFo Life Sciences on

After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post....more

Husch Blackwell LLP

Analysis of U.S. Food and Drug Administration Draft Guidance on Clinical Trials with Psychedelic Drugs

Husch Blackwell LLP on

On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more

Manatt, Phelps & Phillips, LLP

FDA Issues New Draft Guidance on Clinical Testing of Psychedelic Drugs

On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the...more

Foley Hoag LLP - Cannabis and the Law

FDA Shares Insights on Potential Pathway to Regulate CBD Products

The Food and Drug Administration (FDA) held a stakeholder call on May 25, 2023 to provide additional information related to the agency’s January 26 announcement that it believes a new regulatory framework for cannabidiol...more

Vicente LLP

Functional Mushrooms: The Difference Between Regulation as a Food, Food Additive, or Dietary Supplement

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Consumers are increasingly interested in incorporating functional or adaptogenic mushrooms into their diets due to their potential health benefits, such as boosting immunity, reducing inflammation, and promoting overall...more

Bradley Arant Boult Cummings LLP

Same As It Ever Was: FDA Reiterates That CBD Cannot Be Included in Food or Dietary Supplements

While we enter a new season this week, the same cannot be said for the FDA which, on November 16, reiterated that its approach to regulating the cannabidiol (CBD) industry will be “the same as it ever was”—a regulatory...more

Hogan Lovells

FDA signals uptick in enforcement with market sweep on depression claims

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On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...more

Hogan Lovells

FDA Will Take Its Time on CBD – But Industry Does Not Have to Wait to Get Ready

Hogan Lovells on

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

Womble Bond Dickinson

Insight into Medical Foods and the Scope of FDA Regulation

Womble Bond Dickinson on

The FDA has issued warning letters to manufacturers of products marketed as medical foods to treat a range of medical conditions, including fibromyalgia, autoimmune disorders, irritable bowel syndrome, arthritis, asthma,...more

Seyfarth Shaw LLP

The Week in Weed: July 2020 #3

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WHERE DO THE CANDIDATES STAND ON MARIJUANA? Vice President Biden and Senator Bernie Sanders formed a “Unity Task Force” in an effort to bring the party together on various issues. One of them is cannabis. The task force...more

Epstein Becker & Green

Federal Courts Say They Will Decide Cases Against CBD Product Manufacturers When the Smoke Clears

Epstein Becker & Green on

The cannabidiol (“CBD”) consumer product marketplace is booming. And, while FDA has maintained its position that CBD, even hemp-derived CBD, may not be included as an ingredient in conventional foods or dietary supplements,...more

Hogan Lovells

Council for Responsible Nutrition Submits Citizen Petition Requesting FDA Rulemaking to Allow CBD and other Hemp-Derived...

Hogan Lovells on

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

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l May 2020 #2

LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Reopening Guidelines for Food Establishments - The U.S. Food and Drug Administration (FDA) has published a food-safety checklist for retail food establishments that...more

Seyfarth Shaw LLP

Seyfarth on CBD – February 2020 Update

Seyfarth Shaw LLP on

CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping. ...more

Seyfarth Shaw LLP

The Week in Weed: February 2020 #2

Seyfarth Shaw LLP on

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

Morgan Lewis

The Next Big Things: Insights for 2020

Morgan Lewis on

Autonomous cars, sports betting, and CBD products have burst onto the scene, setting the stage for major developments in how companies do business and how regulators monitor new innovations....more

Shook, Hardy & Bacon L.L.P.

2019: The Dietary Supplements and Cosmetics Year in Review

LEGISLATION, REGULATIONS & STANDARDS - U.S., States Aim to Regulate Cosmetics Ingredients and Research Methods - Federal and state legislatures aimed to bring more scrutiny to cosmetics in 2019 by considering measures...more

Robinson+Cole Health Law Diagnosis

Bipartisan Bill for Federal Regulation of CBD in Foods and Dietary Supplements

A bipartisan bill was introduced in the U.S. House of Representatives on January 13, 2020, that (1) would allow hemp-derived cannabidiol (CBD) to be regulated as a dietary supplement, if all of the other applicable...more

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