News & Analysis as of

Warning Letters Enforcement

Mitchell, Williams, Selig, Gates & Woodyard,...

Pretreatment Enforcement/Clean Water Act: Alabama Department of Environmental Management and Polyethylene Terephthalate Pellet...

The Alabama Department of Environmental Management and Indorama Ventures Sustainable Solutions LLC (“IVSS”) entered into an October 19th Consent Order (“CO”) addressing alleged violations of a State Indirect Discharge (“SID”)...more

Arnall Golden Gregory LLP

What Would Al Stewart Think About OPDP’s Latest Untitled Letter: A Sign of More Enforcement?

In his 1973 song, “Nostradamus,” singer-songwriter Al Stewart sang, “I am the eyes of Nostradamus, all your ways are known to me.” So, we started thinking, what would Mr. Stewart think of FDA’s Office of Prescription Drug...more

Sheppard Mullin Richter & Hampton LLP

FDA Maintains Focus on “Intended Use” for Software-Enabled Medical Devices

On June 21, 2023, the U.S. Food and Drug Administration (“FDA”) issued a warning letter to Zyto Technologies, Inc. (“Zyto”), citing Zyto’s promotion of its Hand Cradle Galvanic Skin Response (“GSR”) device and associated...more

BakerHostetler

FTC Reverts to Penalty Letters, Threatening 670 Companies with Penalties for Unsubstantiated Health Claims and Maybe More

BakerHostetler on

Advertisers likely recall that back in 2021, the Federal Trade Commission (FTC) created quite the stir when it sent to more than 700 companies warning letters that threatened penalties if companies engaged in deceptive...more

King & Spalding

2022 Year in Review: FDA Drug and Device Advertising and Promotion Enforcement

King & Spalding on

In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices.  A summary of the noteworthy...more

Bradley Arant Boult Cummings LLP

Warning Sign? A New Round of FDA Warning Letters Over CBD Consumer Confusion May Signal a Shift in Government Enforcement

FDA warning letters are nothing new in the cannabis industry. In fact, we here at Budding Trends have covered this topic a number of times (here, here, and here). Not resigned to playing the hits, however, the FDA issued a...more

Vicente LLP

Recent FDA Enforcement Letters Signal Increased FDA Scrutiny of Hemp Products

Vicente LLP on

On November 21, 2022, the FDA issued five warning letters to companies selling CBD, Delta-8, and other hemp products for humans and pets. These letters are notable for the following five reasons (see additional details...more

Vinson & Elkins LLP

2021 Energy and Chemicals Antitrust Report

Vinson & Elkins LLP on

Antitrust activity increased significantly in 2021. This past year brought numerous changes in merger and non-merger enforcement policies and priorities that signal increased scrutiny in industry transactions. The “Biden...more

Husch Blackwell LLP

FDA Issues Warning Letters On Marketing And Sale Of OTC CBD Products

Husch Blackwell LLP on

The U.S. Food and Drug Administration (FDA) issued Warning Letters this month to two companies concerning the marketing and sale of over-the-counter (OTC) drug products containing cannabidiol (CBD) as an inactive ingredient....more

Arnall Golden Gregory LLP

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - 2020 Year in Review on FDA’s Enforcement of Rx Drug...

In this episode, AGG’s Food & Drug team leader, Alan G. Minsk, and team member, Genevieve M. Razick give an overview of FDA’s Office of Prescription Drug Promotion's (OPDP) enforcement of unlawful advertising in 2020. Each...more

Barnea Jaffa Lande & Co.

The Companies Registrar Rears Its Head – Financial Sanctions for Failing to File Reports

In the past, when companies failed to submit annual reports, the Companies Registrar was satisfied with issuing warning letters. However, recently, we have noticed a change in policy, as the Companies Registrar has increased...more

Eversheds Sutherland (US) LLP

The IRS is sending warning letters to more than 10,000 virtual currency owners

On July 26, 2019, the IRS announced that it has begun to send letters to more than 10,000 taxpayers who might have failed to report income and pay the resulting tax from virtual currency transactions or who did not report...more

Foley & Lardner LLP

FTC Steps up Enforcement Against False Claims of Participation in the EU-U.S. Privacy Shield and Other International Privacy...

Foley & Lardner LLP on

Nearly three years ago, the EU-U.S. and Swiss-U.S. Privacy Shield frameworks replaced the U.S.-EU and U.S.-Swiss Safe Harbor programs as a self-certification mechanism to transfer personal data from the European Union and...more

King & Spalding

FDA Regulation of Cannabis

King & Spalding on

Agency Notice Touts Authority to Regulate Products Containing Cannabis and Cannabis-derived Compounds - On April 4, 2019, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register that it...more

King & Spalding

2017 Year in Review: FDA Office of Prescription Drug Promotion Warning and Untitled Letters

King & Spalding on

In 2017, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a total of five enforcement letters that cited violations related to the advertising and promotion of prescription...more

Latham & Watkins LLP

FCC Finds Fault in User Agreement and Issues Stern Guidance for Telemarketing Calls

Latham & Watkins LLP on

June is proving to be a very active month for the US Federal Communications Commission (FCC) in construing the Telephone Consumer Protection Act, including what sorts of consumer interactions are sufficient to meet the...more

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