News & Analysis as of

FDA Warning Letters

FDA Issues Warning Letters To Cannabidiol Product Manufacturers Over Health Claims

by Farrell Fritz, P.C. on

On November 1, 2017, the Food and Drug Administration (FDA) published a release concerning its issuance of warning letters to four companies concerning the marketing of products containing cannabidiol (CBD)....more

Look Before You Leap – FDA Issues Warning Letters to Four Cannabis-Based Businesses Over Unlawful Product Claims

While the phrase “Green Rush” has been applied to the recent relaxation of state and local laws pertaining to the sale of medicinal and recreational marijuana, perhaps a more apt phrase is: “Check yourself before you wreck...more

Check the Box to Avoid Food & Beverage Packaging Litigation

by Nutter McClennen & Fish LLP on

Shagha Tousi, a partner in Nutter’s Litigation Department and a member of the firm’s Business Litigation and Product Liability and Toxic Tort Litigation practice groups, addressed product packaging litigation in the food and...more

“KIND” of Nutritious—FDA Permits “Healthy” Label and Agrees to Rethink Its Definition of “Healthy” Foods

The Food and Drug Administration has kindly permitted Kind LLC to use the term “healthy” on its snack bars again, but with the caveat that the term must only be used in text clearly presented as part of Kind’s corporate...more

FDA Allows KIND to Use “Healthy” Claim on its Labels and Will Reevaluate “Healthy” Claims

by Freeborn & Peters LLP on

On May 10, 2016, the FDA announced that Kind LLC may label its snack bars “healthy” so long as it’s clearly part of its “corporate philosophy” and not a nutritional statement. In conjunction with this statement, the FDA...more

Lessons from Latham & Watkins’ Representation of Pacira Pharmaceuticals In Ground-Breaking Settlement with FDA

by Latham & Watkins LLP on

FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn? On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food &...more

Ropes & Gray Advises Pacira Pharmaceuticals in Reaching Landmark Settlement Agreement with FDA

by Ropes & Gray LLP on

A cross-disciplinary team of Ropes & Gray attorneys advised Pacira Pharmaceuticals on its December 14 settlement agreement with FDA. On behalf of Pacira, Ropes & Gray had filed suit against FDA in September 2015 in the U.S...more

Breaking News – Pacira First Amendment Case Settles

by Reed Smith on

We learned about it yesterday from a reporter, but were sworn to secrecy until today. Pacira Pharmaceuticals and the FDA settled their litigation with Pacira getting essentially everything it wanted – what the company calls...more

GNC lawsuit reflects FDA’s crackdown on dietary supplement industry

by Thompson Coburn LLP on

The Oregon Attorney General’s Office hit General Nutrition Centers (GNC) with a lawsuit last week alleging that the company knowingly sold supplements that contained FDA-banned ingredients. The action should serve as a...more

First Amendment Notes: Amicus Briefs In Pacira & Application of IMS v. Sorrell

by Reed Smith on

Here we discuss a couple of developments involving (actually or potentially) the application of the First Amendment to the FDA’s increasingly battered prohibition against truthful promotion of off-label use....more

Updates Regarding the Pacira Pharmaceutical Inc. v. FDA Lawsuit Regarding First Amendment and Off-Label Promotion Issues

by Reed Smith on

As readers of this blog know, following Amarin’s success in obtaining a preliminary injunction limiting FDA enforcement action against it for truthful, non-misleading off-label promotion of its prescription drug Vascepa,...more

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

by Arnall Golden Gregory LLP on

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

FDA Warns Companies About Powdered Caffeine

We Americans love our energy-boosting drinks, never mind that so many have been shown to pose threats of heart disease, high blood pressure and other problems for some people. The newest form of caffeine-infusion is a powder...more

First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA

by Reed Smith on

The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved...more

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

Warning Letters and Jurisfiction

by Reed Smith on

“Jurisfiction” is a word coined by Jasper Fforde, author of the Tuesday Next series, one of the more sophisticated set of children’s works that has come to populate this post-Harry Potter era. To be very brief, Jurisfiction...more

Food and Beverage Alert (US)

by DLA Piper on

Former food executive faces possible life sentence for salmonella outbreak. The possible fate of Stewart Parnell, a former president of the Peanut Corporation of America, is being discussed in media worldwide. Federal...more

Advertising Law - August 2015 #4

In Case You Missed It: Possible Jail Time for TCPA Violations, Microsoft Gets Slammed With Solicitation Scam Class Action, and 'Do Not Disturb' Technology Gets Pushed on FCC - The world of the Telephone Consumer...more

Drug Pumps Are Vulnerable to Hacking, FDA Warns

Last Friday, the Food and Drug Administration (FDA) issued a statement warning that certain drug infusion pumps that administer medication to patients are vulnerable to being hacked. The statement focused on the Symbiq...more

A Gathering Storm in the Dietary Supplement World

by Baker Donelson on

This past February, the New York State Attorney General's office accused four major retailers of selling fraudulent and possibly dangerous herbal supplements and demanded that they remove the products from their shelves. The...more

FDA Flexes Muscles Over Dietary Supplements

by McGuireWoods LLP on

In a move designed to halt sales of popular workout stimulants, the U.S. Food and Drug Administration (FDA) recently issued warning letters to some 14 dietary supplement companies....more

Harsh Words for KIND Bars

by Cozen O'Connor on

Kind, LLC received a rude awakening from the FDA when it notified the popular snack-maker that it was violating numerous federal regulations by allegedly misbranding four popular products. Kind is known for its widely-popular...more

FDA Increasing Scrutiny of Cosmetic Marketing Claims, New Agency Warnings Suggest

In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food,...more

FDA Warning on Hysterectomy Procedure Raises Awareness of Cancer Risk

A cancer risk surrounding a technologically advanced and minimally invasive surgery for removing the uterus has prompted the Food and Drug Administration to issue a warning discouraging the medical procedure. ...more

Pro Te Solutio - Vol. 5 No. 4 November 2012

by Butler Snow LLP on

In This Issue: - Forecast for the Physician Payments Sunshine Act: Partly Cloudy - Document Preservation Notices and the Lists of Who Receive Them: Are They Discoverable? - FDA Warning Letters Through...more

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