News & Analysis as of

Dietary Supplements Pharmaceutical Industry

Rivkin Radler LLP

The Case of ‘Gas Station Heroin’

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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

Nelson Hardiman, LLP

Cracking the Whip: The FTC’s Clampdown on Healthcare Marketing

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The American reverence for entrepreneurial spirit and free enterprise is reflected in the profound influence of capitalism on our healthcare system. In contrast to many other advanced industrialized countries with state-run...more

Holland & Knight LLP

Changes in FDA, Cannabis Policies and AI Developments

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In the latest episode of Holland & Knight's Public Policy & Regulation Group "Eyes on Washington" podcast series, Healthcare & Life Sciences attorney Michael Werner and Sara Klock examine pivotal shifts in U.S. Food and Drug...more

Polsinelli

FDA Preemption of State Law for False Labeling Survives Appeal to Supreme Court

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Manufacturers of dietary supplements, food, beverages, and even medical devices can breathe a little easier following the Supreme Court’s denial of certiorari this week in a case seeking to overturn a First Circuit decision...more

K&L Gates LLP

Litigation Minute: Beauty From Within and the Confusing Claims Landscape

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What You Need To Know In A Minute Or Less - The current industry trend “beauty from within” refers to a focus on wellness—namely physical, mental, and lifestyle—and its impact on beauty. Oral supplements that consumers can...more

Epstein Becker & Green

FDA Releases Updated Directory on Select Dietary Supplement Ingredients

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Whether a consumer is taking calcium carbonate for strong bones, magnesium to fall asleep, or high-dose caffeine to stay awake, the U.S. Food and Drug Administration (FDA) does not approve dietary supplements for safety and...more

Clark Hill PLC

Food for Thought: When Is Food a Drug

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While we know the old adage chicken soup “cures” the common cold, decades of federal Food Drug Administration (FDA) enforcement have taught the industry that selling food as a “cure” renders it subject to criminal...more

Shook, Hardy & Bacon L.L.P.

Congress Gives FDA Oversight Over Cosmetics, Punts on Dietary Supplement Reforms

In a year-end $1.7 trillion spending package in late December, Congress voted to increase FDA's oversight of cosmetics and their ingredients. A portion of the bill titled the Modernization of Cosmetics Regulation Act requires...more

Console and Associates, P.C.

Some OTC Supplements Contain Tadalafil, According to the FDA

In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its...more

McDermott Will & Emery

Intellectual Property & Health | News To Know – June 2022

McDermott Will & Emery on

RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more

BakerHostetler

AD-ttorneys@law - May 2022

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NAD Won’t Rename Supplement Maker - Innovix Pharma loses on product claims but gets to keep its calling card. Nerding Out - Aside from the intricacies of advertising, advertising law, and the disputes engendered...more

MoFo Life Sciences

Fluoride Supplement Manufacturer Forced To Address Misleading Labeling Allegations

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Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC, a dispute concerning labeling for fluoride products that raised a variety of issues with...more

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2021

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From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more

Wilson Sonsini Goodrich & Rosati

Clinical Studies of Dietary Supplements Could Trigger IND Requirements

In September 2021, the Office of Scientific Investigations of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) issued a Warning Letter to dietary supplement company RAAS Nutritionals,...more

Womble Bond Dickinson

[Webinar] The Buzz on Understanding the FDA Regulatory Landscape for Cannabis - October 5th, 12:00 pm - 1:00 pm EDT

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In this webinar, we’ll discuss what we know about FDA regulation of cannabis and cannabis-derived products and look at trends in recent FDA enforcement over CBD products. Topics include: - Pathways for FDA...more

Smart & Biggar

Amendments to Food and Drug Regulations (Exports), Natural Health Products Regulations (Labelling)

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The Federal Government has published the following proposed amending regulations in Part 1 of the Canada Gazette: - Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs): The amendments...more

Manatt, Phelps & Phillips, LLP

FTC Prohibits Medical Director of $23,000 COVID-19 ‘Treatment’ Plan From Making False Health Claims

The medical director of Golden Sunrise Nutraceutical, Inc., agreed to settle Federal Trade Commission (FTC) charges that he took part in deceptively advertising a $23,000 treatment plan as a scientifically proven way to treat...more

Womble Bond Dickinson

Dietary Supplement Use and COVID-19: What You Need to Know

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It is no surprise that four in five Americans (86 percent) reportedly take dietary supplements to improve their overall health. Now more than ever, health consciousness is at the forefront – we are focused on improving our...more

Hogan Lovells

FDA signals uptick in enforcement with market sweep on depression claims

Hogan Lovells on

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

Dechert LLP

Election 2020: How a Biden-Harris Administration May Impact OTC and Supplement Companies

Dechert LLP on

As we look ahead to a Biden-Harris administration and its potential impact on the over-the-counter (“OTC”) and dietary supplements industries, we see both opportunities and risks. While democratic control is typically...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - October 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more

Wilson Sonsini Goodrich & Rosati

FDA Issues Proposed Rule Clarifying the Types of Evidence It Considers When Determining the Intended Use of a Product

Recently, the U.S. Food and Drug Administration (FDA) issued a statement and proposed rule clarifying the types of evidence that the FDA considers when determining the "intended use" of a product. Intended use is important...more

Seyfarth Shaw LLP

FDA Aggressively Monitoring and Pursuing Advertisements Touting Treatments, Preventions and Cures for COVID-19

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Companies should use caution when making efficacy claims in marketing and advertising of dietary supplements, foods, biological products and other products purported to treat or prevent COVID-19. ...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - June 2020

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more

Morgan Lewis

FDA Issues Guidance on Postmarket Adverse Event Reporting During Pandemics

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In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products...more

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