News & Analysis as of

Warning Letters Food and Drug Administration (FDA) False Advertising

Arnall Golden Gregory LLP

OPDP is Still Standing: FDA’s Office of Prescription Drug Promotion Issues Two Enforcement Actions Since Recent Layoffs

Taking a note from Sir Elton John’s 1983 hit, “I’m Still Standing,” the Food and Drug Administration’s Office of Prescription Drug Promotion issued two enforcement actions (one Notice of Violation and one Warning Letter)...more

Husch Blackwell LLP

A Cannabis Pivot to Smokable Herbs

Husch Blackwell LLP on

As the cannabis industry continues to navigate choppy economic and legal waters into 2024, some cannabis companies are pivoting to the smokable herbs market. And I do not mean to those hemp-derived intoxicating cannabinoids...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

Womble Bond Dickinson

Can hashtags get you in trouble?

Womble Bond Dickinson on

They can if you operate in a regulated industry, such as pharma, med devices, cannabis, dietary supplements, etc. FDA has specific labeling requirements for products and they look at hashtags related to products the same...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

Nilan Johnson Lewis PA

Avoiding False Advertising Claims During COVID-19

Nilan Johnson Lewis PA on

With the unprecedented steps being taken to slow down the spread of COVID-19, it is important that those companies whose products effectively kill or contain the spread of Coronavirus be able to market their products’...more

BCLP

FDA and FTC Warn Against Making Unapproved COVID-19 Claims

BCLP on

In response to the outbreak of COVID-19, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have issued several new warning letters to companies claiming their products prevent, treat or cure the novel...more

Seyfarth Shaw LLP

Consumer Fraud Increases in the Wake of COVID-19 and Enforcement Activities Quickly Follow

Seyfarth Shaw LLP on

Last week, the Federal Trade Commission (“FTC”) and Food & Drug Administration (“FDA”) ramped up their enforcement letters since they first issued COVID-19 related warning letters a month ago. ...more

BakerHostetler

AD-ttorneys@law - March 2020 #2

BakerHostetler on

Don’t Panic, but Purell Just Got Sued Over Hand Sanitizer Packaging Claims - Class action follows FDA letter, hints at lawsuit pandemic to come - Headaches - Coronavirus news is saturating everything, and stress is...more

Mintz - ML Strategies

Tackling False Claims Being Made for COVID-19 Treatments and Products

Mintz - ML Strategies on

Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to...more

Fox Rothschild LLP

FTC And FDA Warn Companies About Making Unsupported Claims That Products Can Prevent Or Treat Coronavirus

Fox Rothschild LLP on

As the effects of coronavirus continue to ripple across the globe, the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) have warned seven companies for purportedly “making deceptive or scientifically...more

Morrison & Foerster LLP - Class Dismissed

FDA And FTC Send Warning Letters To Companies Marketing Products To Treat Coronavirus; State Attorneys General Follow Suit

The rapid spread of coronavirus has spawned prolific marketing claims that any number of products can treat or prevent coronavirus. It comes as no surprise then that the Food and Drug Administration (FDA) and Federal Trade...more

Rivkin Radler LLP

FTC and FDA Take Joint Action to Stop COVID-19 Fraud

Rivkin Radler LLP on

On March 6, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint Warning Letters to seven companies calling for them to cease marketing products appearing to violate federal law by...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l July 2019 #4

LEGISLATION, REGULATIONS & STANDARDS - FDA Issues Warning Letter to CBD Co. for Unsubstantiated Claims - The U.S. Food and Drug Administration (FDA) has issued a warning letter to Curaleaf Inc. for “illegally selling...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

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | February 2018

FDA Issues Draft Guidance for Homeopathic Drug Products - The U.S. Food and Drug Administration (FDA) has issued draft guidance, "Drug Products Labeled as Homeopathic," that would prioritize enforcement and regulatory...more

McGuireWoods LLP

FDA Revisits Nutty Definition of “Healthy” Food

McGuireWoods LLP on

On May 10, the Food and Drug Administration announced it will be reevaluating how it defines “healthy” food. The move constitutes a reversal of an FDA warning letter issued in March 2015 to Kind, LLC, accusing the snack bar...more

Kelley Drye & Warren LLP

FDA Targets CBD Products, Claims Made in Social Media

Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat...more

Cozen O'Connor

FTC Announces Red Light on Unqualified “Green Approved” Seals

Cozen O'Connor on

Updated to clarify that this post is not about Green Seal, Inc. but the environmental seals or certifications warned against in a recent FTC update. Manufacturers of consumer products labeled with unspecified environmental...more

Skadden, Arps, Slate, Meagher & Flom LLP

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

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