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FDA Warning Letters Enforcement Actions

Gardner Law

FDA Issues Numerous Warning Letters

Gardner Law on

The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more

Oberheiden P.C.

SARMs Enforcement and FDA Escalation

Oberheiden P.C. on

Always on the lookout for unapproved drugs and supplements being sold, the U.S. Food and Drug Administration (FDA) has ramped up its enforcement actions against selective androgen receptor modulators (SARMs), which are banned...more

Perkins Coie

FDA Issues New Warning Letters to Companies Making CBD and Delta-8 THC Edibles

Perkins Coie on

On November 16, 2022, the Food and Drug Administration (FDA) issued five new warning letters to various companies making edible products containing cannabidiol (CBD) and/or Delta-8-tetrahydrocannabinol (THC)...more

Arnall Golden Gregory LLP

It's a Heartache: FDA's OPDP Issues an Untitled Letter for Unlawful Promotion of a Cholesterol-Lowering Drug Product

“It’s a Heartache, Nothing But a Heartache.” Yes, the opening lyrics to Bonnie Tyler’s 1977 hit, but also what might have been felt in FDA’s Office of Prescription Drug Promotion when it issued an Untitled Letter to a drug...more

Oberheiden P.C.

FDA Warning Letter Response Strategies (Step-By-Step)

Oberheiden P.C. on

FDA Warning letters can be harbinger of formal civil and criminal investigations. If your business receives such a notice of non-compliance from the FDA, you should immediately contact an experienced FDA defense attorney....more

Arnall Golden Gregory LLP

Slow Down, You Move Too Fast: OPDP Issues a Warning Letter for Promoting an Investigational New Drug

In 1966, Simon & Garfunkel sang “The 59th Bridge Song,” which opens with the lyric, “Slow down, you move too fast.” A drug company recently found out the hard way that pre-approval promotion does not leave the Food and Drug...more

Arnall Golden Gregory LLP

[Webinar] FDA Enforcement in the Product Promotion and Advertising World: (A Little Late 2021) Year in Review and Issues to...

Please join AGG Food & Drug attorneys Alan G. Minsk and Laura S. Dona for a complimentary webinar reviewing past FDA letters issued to pharmaceutical and medical device companies for unlawful promotion in 2021 and where FDA...more

Hogan Lovells

Time’s really up! FDA authority to crack down on regenerative medicines upheld as grace period ends

Hogan Lovells on

On July 9, 2021, the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) added a Q&A page on its website about the May 31 end of the grace period intended to provide developers of human...more

Ervin Cohen & Jessup LLP

FTC Announces New Enforcement Actions for COVID-19

In April 2021, the Federal Trade Commission (“FTC”) emphasized its commitment to protecting consumers from unsubstantiated claims of products advertised to prevent, treat or cure COVID-19. On April 29, 2021, the FTC announced...more

Arnall Golden Gregory LLP

FDA is (Once Again) Keeping Up with the Kardashians: A Cautionary Tale Involving Endorsements, Testimonials and Influencer...

In March, Khloe Kardashian unwittingly joined her sister, Kim Kardashian, as the subject of a Food and Drug Administration (FDA) Warning Letter relating to the reality star’s influencer-marketing activities. ...more

Hogan Lovells

FDA signals uptick in enforcement with market sweep on depression claims

Hogan Lovells on

On 19 February, 2021 the U.S. Food and Drug Administration (FDA) announced warning letters to ten companies for selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health...more

Mintz - Health Care Viewpoints

Working Together, FDA, NTIA, and Domain Registries Take Down 30 Websites Illegally Selling Opioids

The Food and Drug Administration (FDA) and the National Telecommunications Information Administration (NTIA) in partnership with three domain name registries disabled nearly 30 websites illegally offering opioids for sale....more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year! (Part 3 of 3)

In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug...more

Hudson Cook, LLP

Don't Be That Company: Advertising During a Crisis

Hudson Cook, LLP on

There are two types of advertisers during a crisis. The first type knocks it out of the park by reaching consumers with empathy and graciousness through ads that generate feelings of hope, togetherness, and kindness. A...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

Seyfarth Shaw LLP

False Advertising: Changing Your Business To Meet Market Needs During The COVID-19 Pandemic

Seyfarth Shaw LLP on

From severe shortages in medical masks and ventilation equipment worldwide to the curious “toilet paper desert” in America,  COVID-19 is creating temporary and long-term disruptions in the availability of both highly...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

Perkins Coie

FDA Releases Report to Congress Regarding CBD

Perkins Coie on

The federal Food and Drug Administration (FDA) just released a report to Congress regarding the agency’s progress toward comprehensive regulation of hemp-derived cannabidiol (CBD). The report echoes the hard-line approach to...more

Wilson Sonsini Goodrich & Rosati

FDA Announces Unprecedented Recall of Dietary Supplements

Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more

Brownstein Hyatt Farber Schreck

FTC and State AGs Continue Focus on Deceptive Social Media Marketing

Social media is ever present in the daily lives of the majority of Americans. It has also become one of the main advertising vehicles for companies in recent years. These advertisements and, more specifically, marketing via...more

Perkins Coie

Hot Ad Law Topics for 2020

Perkins Coie on

Resolve this new year to avoid advertising mistakes that could result in class actions, regulator enforcement, or competitor claims. Five advertising law takeaways for brand and legal teams to consider for 2020 follow....more

Ward and Smith, P.A.

Class is in Session: CBD Class Action Lawsuits are Trending Up

Ward and Smith, P.A. on

Products containing hemp-derived cannabidiol ("CBD") have become incredibly popular in the United States, with new product brands entering the market seemingly every day. Consumer demand and public interest in those products...more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

Seyfarth Shaw LLP

FDA Stresses CBD Safety Concerns in 15 Warning Letters and Revised Consumer Update

Seyfarth Shaw LLP on

In its largest mass enforcement action involving cannabidiol (CBD) yet, the U.S. Food & Drug Administration (FDA) announced on November 25 the issuance of 15 warning letters to various companies for illegally selling products...more

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