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Food and Drug Administration (FDA) Public Safety

Perkins Coie

Dietary Supplements: FDA Issues Final Guidance for NDIN Procedures and Timeframes

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On March 5, FDA published its long-awaited Final Guidance on New Dietary Ingredient Notification (NDIN) Procedures and Timeframes (Final Guidance). This new guidance updates and finalizes Section V of FDA’s revised 2016 Draft...more

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

Troutman Pepper

More States Consider Establishing Vapor Product Directories

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We recently reported that several state legislatures are considering bills to establish vapor product directories this year — namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar...more

Troutman Pepper

Multiple States Consider Establishing Vapor Product Directories

Troutman Pepper on

This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory...more

Foley & Lardner LLP

FDA Issues New Warning Regarding Compounded Ketamine

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On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert...more

Knobbe Martens

Flavored E-cigarette Manufacturers Face Regulatory Challenges

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Manufacturers of e-cigarettes find themselves in a challenging regulatory environment to obtain U.S. Food and Drug Administration (FDA) marketing approval of flavored products.  On October 12, 2023, the FDA denied premarket...more

Troutman Pepper

Takeaways from Listening Session on the Development of FDA’s Center for Tobacco Products Strategic Plan

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On August 22, 2023, the Troutman Pepper Tobacco + Nicotine Team attended the Food and Drug Administration’s Center for Tobacco Products (“CTP”) virtual listening session on the development of CTP’s strategic plan.  We...more

Mintz - Health Care Viewpoints

Recent Developments Signal Headwinds for Homeopathic Drug Products

Homeopathic drugs have an unusual status in the United States. On the one hand, they are incorporated into the Federal Food, Drug, and Cosmetic Act (FD&C Act) within the definition of “drug,” which specifically includes...more

MoFo Life Sciences

Congress Expands FDA Authority Over Cosmetics Regulation

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The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was passed by the U.S. Congress as part of the omnibus Consolidated Appropriations Act enacted on December 29, 2022 and will grant the U.S. Food and Drug...more

MoFo Life Sciences

FDA Final Food Traceability Rule: Overview And Key Takeaways From FDA’s Food Safety Modernization Act Webinar

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On November 21, 2022, the U.S. Food and Drug Administration (FDA) officially published its Final Rule: Requirements for Additional Traceability Records for Certain Foods (“Final Rule”) in the Federal Register. The Final Rule...more

Akerman LLP

FDA Orders JUUL E-Cigarettes Off The Market Over Safety Concerns

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The U.S. Food and Drug Administration (the FDA) issued marketing denial orders (MDOs) to JUUL Labs for all of its products currently marketed in the United States. As a result of this MDO, JUUL must stop selling and...more

Patrick Malone & Associates P.C. | DC Injury...

Better Healthcare Newsletter from Patrick Malone - October 2021

Two of the leading killers of Americans have one preventable cause in common. Many, many cases of lung cancer and cardiovascular diseases are caused by tobacco abuse. Medical scientists long ago proved this beyond a doubt....more

Saul Ewing LLP

The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know

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In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with colleague Justin Danilewitz, a litigator in the Firm’s White Collar and Government...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – August 2020 # 16

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In Washington - The House of Representatives, in a 257-150 vote, passed legislation providing US$25 billion to the United States Postal Service and bans any operational changes to the agency, while reversing...more

Troutman Pepper

FDA Premarket Review Process for Premium Cigars Halted

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On Wednesday, August 19, 2020, the U.S. District Court for the District of Columbia issued an order enjoining FDA from enforcing the premarket review requirement contained in the agency’s “Deeming Rule” against “premium...more

King & Spalding

Trump Administration Continues to Promote Drug Importation as a Way to Lower the Cost of Prescription Drugs

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On July 24, 2020, President Trump issued a series of Executive Orders to address prescription drug costs, one of which specifically focuses on facilitating drug importation, a longstanding goal of the Trump Administration....more

Greenbaum, Rowe, Smith & Davis LLP

New Jersey Authorizes Pharmacists to Conduct COVID-19 Testing

There is substantial support for the view that reliable widespread testing is essential to the restoration of a semblance of normalcy in New Jersey when considering the impact of the COVID-19 pandemic.  In connection with...more

Patrick Malone & Associates P.C. | DC Injury...

Better Healthcare Newsletter from Patrick Malone - May 2020

The United States built a rigorous system over decades to protect patients from harm while receiving new types of medical treatment. New drugs and new vaccines, in particular, have been barred from widespread use until they...more

K&L Gates LLP

COVID-19: K&L Gates Triage: FDA Facilitates Diagnostic Testing and Heightens Public Safety Efforts Amid Outbreak

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In this week’s episode, Kenneth Kennedy discusses several of FDA’s strategies for helping stakeholders in the drug and medical device industry support health care providers in their fight against the COVID-19 outbreak. In...more

Bilzin Sumberg

FDA’s Congressional Report Confirms Slow But Steady Progress on CBD Regulation

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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

Seyfarth Shaw LLP

The Week in Weed: February 2020 #2

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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

The Rodman Law Group, LLC

D.C. Court Supports FDA Regulation of E-Cigs & Vape Products

On 10, December 2019, the United States Court of Appeals for the D.C. Circuit ruled in support of actions by the Food and Drug Administration (“FDA”) on the regulation and classification of electronic nicotine delivery system...more

Patrick Malone & Associates P.C. | DC Injury...

You Should Know - January 2020

As Millions More Vape, Health Effects Clouded in Uncertainty - We thought we had smoking on the run. From 2005 to 2018, the number of Americans that smoke dropped from 21 percent to 14 percent. Then along came...more

Patrick Malone & Associates P.C. | DC Injury...

With new heat on THC and CBD use, will zeal for marijuana keep growing?

Fans of marijuana and its related products may want to take careful note of developments regarding their health and safety effects. Federal researchers are racing to trace thousands of cases of lung damage and dozens of...more

Patrick Malone & Associates P.C. | DC Injury...

$8 billion Risperdal verdict? It’s not the money, it’s the message, Big Pharma

When regular citizens get together in the civil justice system to deliberate difficult claims about complex matters, they may not get everything just right to the satisfaction of the disputing parties. But jurors’ wisdom and...more

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