Warning Letters

News & Analysis as of

The First Cut is the Deepest: FDA Issues a Warning Letter to a Skincare Company for Marketing Unapproved New Drugs

The Food and Drug Administration recently issued a Warning Letter to a skincare company for promoting and selling unapproved new drugs. While the letter itself is not unusual in content, the enforcement action continues a...more

Advertising Law - June 2016

First Circuit Affirms Ruling Against Jerk.com - In a victory for the Federal Trade Commission, the First Circuit Court of Appeals affirmed a Commission ruling that website Jerk.com, a self-described reputation management...more

Pharmaceutical Company Reaches Preliminary Agreement in Principle to Resolve DOJ and SEC Investigations

So On May 12, 2016, Aegerion Pharmaceuticals, Inc., announced that it has reached “preliminary agreements in principle” with the Department of Justice (DOJ) and the Securities and Exchange Commission (SEC) to resolve the...more

CMA warns UK estate agents against colluding in online portal selection

On 21 April 2016, the Competition and Markets Authority (“CMA”) published an open letter to estate agents in the UK stressing the importance of making independent commercial decisions and warning them against unlawful...more

FDA Revisits Nutty Definition of “Healthy” Food

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

Move over GNC: Crackdown on dietary supplement makers continues

In the fourth quarter of 2015, the dietary supplement industry was reminded that the Department of Justice (DOJ) and the federal Food and Drug Administration (FDA) were watching. This reminder came on the heels of the DOJ...more

FDA to Chew Over Meaning of “Healthy”

Although “healthy” might sound like a subjective term, FDA has long-defined “healthy” under nutrient content claim regulations. For example, to be “healthy” an item must be low in fat and saturated fat. Many stakeholders and...more

FDA Regulatory and Compliance Monthly Recap — April 2016

FDA finalizes guidance on drug design in attempt to reduce medication errors - The finalized guidance revises draft guidance published in 2012 to address public comments calling for clarifications and formatting changes,...more

The Writing's on the Wall: Wise Pharma Companies Will Heed FDA Warning in New Draft Guidance on Data Integrity cGMPs

FDA is again shining a spotlight on data integrity violations, announcing in a new draft Guidance for Industry: Data Integrity and Compliance with CGMP that it was “troubl[ed]” by the growing number of such violations that...more

Seeing Double . . . or More: FTC Sends over 50 Warning Letters to Contact Lens Prescribers and Sellers

The FTC recently sent over 50 warning letters to contact lens prescribers and sellers warning them that they may be in violation of the Fairness to Contact Lens Consumer Act, 15 U.S.C. § 7601 et seq., and the Contact Lens...more

You Can Pay Now or You Will Pay Later: FDA Issues a Warning Letter to a Pharmaceutical Company for a Misleading Patient Co-Pay...

On March 29, 2016, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a Warning Letter to a pharmaceutical company for a patient co-pay assistance voucher that failed to include risk...more

The Federal Trade Commission Issues Warning Letters To App Developers

On March 17, 2016, the Federal Trade Commission (“FTC”) announced it had issued warning letters to twelve application (“app”) developers who installed in their apps software created by the company SilverPush that is capable...more

Can You Hear Me Now? Audio Snooping Triggers FTC Warning to Mobile App Developers

This week, a dozen mobile app developers received warning letters from the FTC concerning audio monitoring software used in their apps, but not clearly disclosed to consumers. The app developers allegedly used software...more

2015 Year in Review: OPDP and APLB Warning and Untitled Letter

The drought in enforcement by the Office of Prescription Drug Promotion (OPDP) continued in 2015, as OPDP issued a total of only nine enforcement letters. Two of the nine letters were Warning Letters and seven were Untitled...more

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

“Just Mayo” Maker Convinces FDA That a Different Label Doesn’t Have to Include a Different Name

Back in September we blogged about the Warning Letter that FDA issued to Hampton Creek Foods, Inc. for its vegan food dressing and sandwich spread, “Just Mayo” and a similar product, “Just Mayo Sriracha.” In addition to...more

While Not Quite a Rash of Enforcement, FDA Takes Action in 2015 Against Cosmetic Products Making Unapproved Drug Claims

To paraphrase, admittedly horribly, the Cole Porter classic, “I’ve Got You Under My Skin,” a number of cosmetic companies got under the Food and Drug Administration’s (FDA) skin in 2015 for making unapproved new drug claims....more

Tell Me, Tell Me, Where I’m Going: Recent FDA Presentation Offers a Crystal Ball Into Medical Device Inspectional Priorities and...

In this Bulletin, we highlight some of these findings, which provide a glimpse into FDA’s priority concerns and should help companies proactively and properly plan for their next inspections. To paraphrase from the rock band...more

Red Light for Green Claims: FTC Sends Warning Letters to Green Certifiers

This week, the U.S. Federal Trade Commission (FTC) announced that it has sent warning letters to five marketers of environmental certifications and seals, as well as over 30 product companies displaying those certifications,...more

Weight-Loss Claims: How Many Studies Does the FTC Really Think It Takes?

On Tuesday, the FTC announced that it has sent warning letters to 20 marketers of weight-loss dietary supplements. The letters question whether the companies possess adequate support for claims and describe the scientific...more

Retail and Consumer Products Law Roundup - November 2015

We are pleased to share with you the first issue of Manatt's Retail and Consumer Products Law Roundup. The newsletter will be published on a monthly basis and will survey topics of critical importance to the retail,...more

The benefits of an appeal or review committee

Retaliation claims are some of the most common employment-based claims that employers face. In 2014, the number of retaliation claims filed with the Equal Employment Opportunity Commission reached a record high – 37,955...more

FTC Announces Red Light on Unqualified “Green Approved” Seals

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

"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

“Green” Certifications and Seals Do Not Have FTC Approval

On September 14, FTC staff sent warning letters to five providers of environmental certification seals and 32 businesses that display them online, alerting them to the agency’s concerns that the seals may be deceptive and may...more

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