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Food and Drug Administration (FDA) Federal Food Drug and Cosmetic Act (FFDCA) Misbranding

Rivkin Radler LLP

The Case of ‘Gas Station Heroin’

Rivkin Radler LLP on

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

Morrison & Foerster LLP

Implied Preemption for Dietary Supplements Is Here to Stay

On April 15, 2024, in a big win for the continued validity of implied preemption, the Supreme Court declined to hear an appeal of the First Circuit’s preemption-based dismissal of a proposed misbranding class action. The...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues Warning Letter to RightEye, LLC For Misbranding and Adulteration

On January 31, 2023, the U.S. Food and Drug Administration (FDA) published a Warning Letter to RightEye, LLC (RightEye), the manufacturer of the RightEye Vision System, for misbranding and adulteration. The RightEye Vision...more

King & Spalding

Not Quite the Titanic: The Food and Drug Omnibus Reform Act Rescues Some FDA Policy Initiatives

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The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more

King & Spalding

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

Vicente LLP

FDA Enforcement Action Targeted at Hemp-Derived Delta-8 Products

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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

Foley Hoag LLP

Caught in FDA’s Crosshairs: Delta-8 THC Products Invite Increased Scrutiny

Foley Hoag LLP on

The Food and Drug Administration (FDA) issued a consumer alert related to Delta-8 tetrahydrocannabinol (Delta-8 THC), following a recent increase in adverse event reports to FDA and poison control centers. Although Delta-8...more

Hogan Lovells

2020 OPDP Wrap-up: FDA monitoring drug manufacturers’ use of online communication platforms

Hogan Lovells on

In 2020, the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued four warning letters and two untitled letters to pharmaceutical companies for promotional materials that allegedly...more

Hogan Lovells

FDA cracks down on pharmaceutical firm for misbranding drug as COVID-19 treatment

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled letters for the year. These...more

Patterson Belknap Webb & Tyler LLP

Federal Court Wipes Away Challenge to Nivea Lotion on Preemption Grounds

What distinguishes a “cosmetic” from a “drug” under the Federal Food, Drug, and Cosmetic Act (FDCA)? The FDA has struggled to offer clear guidance on the distinction, but the classification as one or the other (or both)...more

Furia Rubel Communications, Inc.

Truth in Advertising, Cannabis, and the Importance of a Crisis Plan and Social Media Policy

If you’ve ever wondered whether Big Brother is watching you online, the answer is yes. I’m not just referring to the big data and privacy breaches such as Equifax’s recent $700 million settlement which has been reported in...more

Harris Beach PLLC

FDA Issues Warning Letters on CBD Dietary Supplements

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On March 28, 2019, the Food and Drug Administration (FDA), in collaboration with the Federal Trade Commission (FTC), issued warning letters to Advanced Spine and Pain, LLC, Nutra Pure, LLC, and PotNetwork Holdings, Inc. The...more

Skadden, Arps, Slate, Meagher & Flom LLP

Failure to Report Adverse Events Results in Criminal Misbranding Settlement and Individual Liability

On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more

Cooley LLP

Blog: Two Enacted State Laws Permit Truthful Off-Label Promotion

Cooley LLP on

Earlier this month, Tennessee House Bill 2220 (substituted for Senate Bill 2361) (Tennessee Law) was enacted, which provides, “A pharmaceutical manufacturer or its representatives may engage in the truthful promotion of...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | October 2017

The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more

Morrison & Foerster LLP - Class Dismissed

The Revival of ECJ Lawsuits: Sweet Tooth For Plaintiffs, or Toothless Claims?

Introduction. On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not to dismiss her lawsuit against Jelly Belly Co. (“Jelly Belly”)...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more

Mintz - Health Care Viewpoints

Amarin/FDA Settlement: A Significant First Amendment Victory for Off-Label Marketing

On March 8, 2016, Amarin Pharma, Inc. and FDA entered into a formal settlement, close to a year after the U.S. District Court for the Southern District of New York granted a preliminary injunction against FDA’s threats to...more

Perkins Coie

Pharma and Medical Device Industry Victory in Off-Label Marketing Decision

Perkins Coie on

The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more

Arnall Golden Gregory LLP

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more

Mintz - Consumer Product Safety Viewpoints

What’s in a Name? When You’re Selling a Food with an Established Federal Standard of Identity, a Whole Lot!

A bluntly labeled section of the Code of Federal Regulations – “Mayonnaise” – provides a description of this particular food dressing, the food’s required ingredients, optional ingredients, and how to declare those...more

Jackson Walker

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs

Jackson Walker on

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more

Mintz - Health Care Viewpoints

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

Mintz - Health Care Viewpoints

FDA Cites Drug Company for Kim Kardashian Endorsement

This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more

Ballard Spahr LLP

Pharmaceutical Companies Get Off-Label Marketing Victory

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Last week, a federal judge ruled that the Food and Drug Administration (FDA) cannot prohibit a pharmaceutical company from marketing its drugs for off-label uses if its claims are truthful and not misleading. This ruling,...more

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