Warning Letters

News & Analysis as of

“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

FTC Issues Warning Letters About Environmental Seals and Certifications

On September 14, 2015, the U.S. Federal Trade Commission (FTC) announced that it had issued warning letters to five providers of environmental certification seals and 32 companies using those seals, stating that use of the...more

FDA is “Keeping up with Kardashians’” Social Media Posts

On August 7, 2015, the FDA sent a warning letter to drug maker, Duchesnay, over Kim Kardashian’s endorsement of its pills for morning-sickness. Kardashian had made an Instagram and Facebook post which vouched for the...more

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

Blog: Kim Kardashian Drug Endorsement Results in FDA Warning Letter

The U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a Warning Letter this week to Duchesnay, Inc. related to celebrity Kim Kardashian’s social media posts on Instagram, Twitter and...more

OMG: Kim Kardashian Prompts FDA Warning Letter

Kim Kardashian recently trumpeted the beneficial effects of Diclegis, a pill indicated for the treatment of nausea and vomiting of pregnancy for certain women, to her over 42 million Instagram followers. One such Kardashian...more

FDA Issues Warning Letter to Corporate Sponsor of Clinical Trial

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

Bad News from Europe for Makers of Life-Saving Medical Devices

In over eight years, we’ve never before blogged about a European development in prescription medical product liability. The (relatively) recent decision by the Court of Justice of the European Union (“CJEU”) in Boston...more

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

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

Smart ad disclosures in the social media age

Recent actions by the Federal Trade Commission highlight the need for companies to review the sufficiency of their advertising disclosures. Companies should take particular care when launching an ad campaign using social...more

CFPB issues reverse mortgage focus group report and consumer advisory

The CFPB has issued a report that discusses the results of a focus group study it conducted on reverse mortgage advertisements and a consumer advisory about such advertisements. The report is entitled “A close look at reverse...more

FDA’s Marijuana Q&A: More Questions than Answers?

The FDA recently released its current thinking on marijuana in a variety of forms in a web-based document titled “FDA and Marijuana: Questions and Answers.” The most notable question and answer related to whether cannabidiol...more

Don't bet on bad warnings

It may be obvious, but employers should neither issue nor rely upon a written warning made in bad faith. It is equally plain that any written warning issued in bad faith should not be used to dismiss an employee. Otherwise,...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 Issues First E-Cigarette Warning Letters

While FDA’s tobacco products “deeming rule” is pending, the Agency issues Warning Letters to e-cigarette and e-liquid companies for the first time....more

What You Need to Know About Enforcement Actions by the Contractors State License Board

I questioned whether to even write this post. - Because, of course, YOU would never find yourself hightailing it out of town with the California Contractor’s State License Board (“CSLB”) sniffing down your tail pipes....more

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