The United States Food and Drug Administration Marketing

The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the... more +
The United States Food and Drug Administration is the oldest consumer protection agency in the United States. The agency was not officially known as the FDA until 1930, but its regulatory functions began with the passage of the 1906 Pure Food and Drugs Act. The agency is charged with protecting the integrity of the nation's food supply and cosmetic products, as well as monitoring the safety and efficacy of drugs, medical devices, and biological products.  less -
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E-Cigarettes Reputation As Safe Alternative To Tobacco Is Just More Smoke and Mirrors

E-Cigarettes Reputation As Safe Alternative To Tobacco Is Just More Smoke and Mirrors The dangers of e-cigarettes exposed by a new study showing e-cigarettes can cause cancer and the realization that many of the “safe”...more

Recent FDA Social Media Marketing Enforcement Actions and the Likely Impact of Social Media Promotion Guidance

In recent years, guidance by the U.S. Food and Drug Administration ("FDA" or "Agency") for industry on the use of social media has continued to evolve in incremental steps, but the pharmaceutical and medical device industries...more

First Lady And Nutrition: USDA And FDA Propose Sweeping Food Labeling And Marketing Regulations

Today, First Lady Michelle Obama and the Food and Drug Administration released two long-awaited proposed regulations that would for the first time in 20 years make significant changes to the nutrition information found on...more

A Guide to FDA Postmarketing Submission Requirements and Reporting Interactive Promotional Media

As part of existing FDA postmarketing reporting requirements, manufacturers, packers, and distributors that are FDA applicants or that act on behalf of FDA applicants (for simplicity, “Applicants”) are required to submit all...more

FDA Issues Draft Guidance Addressing Postmarket Submission Requirements for Internet-based Promotional Materials

On January 14, 2014, the U.S. Food and Drug Administration (Agency) published a long-awaited draft guidance entitled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for...more

The FDA Gets Social: Interpreting Its Draft Social Media Guidance

The U.S. Food and Drug Administration (FDA) recently released draft guidance that paves the way for regulated companies to harness the power of social media. This draft guidance addresses how FDA-regulated manufacturers,...more

"Food and Beverage Labeling and Marketing Litigation Continues to Play out in the Courts and Legislatures"

The food and beverage industry has experienced a recent spate of consumer class actions attacking various aspects of the labeling and marketing of products. Advertising and marketing claims by manufacturers that a product is...more

Supreme Court Grants Certiorari in POM’s Attack on FDCA/Lanham Act Preemption

On Friday, the Supreme Court granted the certiorari petition of Pom Wonderful in its Lanham Act false advertising case against Coca-Cola. Pom Wonderful LLC v. Coca Cola Co., 679 F.3d 1170 (9th Cir. 2012), cert granted, ___...more

Advertising News & Analysis - August 15, 2013

In this issue: - Register Now for ERA D2C Convention - NAD Has FTC's Number...And is Not Afraid to Use It - Venable Obtains Decisive Victory for Email Advertisers and Marketers - More on...more

Court Dismisses Labeling Claims Against Wholesoy, Deferring to the Authority and Expertise of the FDA

Are judges in the Northern District of California losing their taste for food labeling litigation? In a recent win for Wholesoy & Co., Judge Yvonne Gonzalez Rogers dismissed plaintiff’s “misbranding” claims concerning the...more

FDA Tobacco Regulation Update: FDA announces first substantial equivalence decisions for tobacco products

On June 25, 2013, the FDA announced that for the first time since the passage of the Family Smoking Prevention and Tobacco Control Act, which granted the agency the authority to regulate cigarettes and other tobacco products,...more

Caronia And The First Amendment Defense To Off-Label Marketing: A Six Month Re-Assessment

When the Second Circuit issued its December 3, 2012 decision in United States v. Caronia, the opinion was proclaimed by many to signal a sea change in the prosecution of off-label promotion....more

As a consultant, what can I say about a MLM company’s nutritional/dietary supplement products?

As a general matter, MLM companies will be very specific about what distributors can and cannot say about the company’s products. Usually, this information will appear in the company’s literature. MLM companies can find...more

Dechert Survey of Securities Fraud Class Actions Brought Against U.S. Life Sciences Companies

Publicly Traded Life Sciences Companies in the United States Remain an Increasingly Popular Target of Securities Fraud Class Action Lawsuits: The past year was particularly noteworthy with respect to the absolute and...more

Z-Pack: Pfizer Can’t Assume That Science Will Trump A Scare Story

This week, the U.S. Food and Drug Administration (FDA) issued a warning that Pfizer’s popular Z-pack antibiotic (also known as Zithromax or Zmax) may cause sudden death in some patients with preexisting heart conditions....more

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more

Ninth Circuit Affirms Prosecution for Off-label Marketing

Over the past two years, courts began to recognize that at least some off-label marketing is protected lawful commercial speech under the First Amendment. Specifically, the Second Circuit in New York in a case called United...more

Advertising Law -- Mar 08, 2013

In This Issue: Marc Roth to Lead Social Media and Mobile Marketing Discussion at PACE Association Convention; UK Court Finds Google Could be Liable for Blog Comments; TCPA Plaintiffs Victorious in Illinois, New Jersey;...more

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more

Advertising News & Analysis - February 14, 2013

In this issue: - Recent NAD Decision Illuminates FDA’s “Light” Requirements - CA Supreme Court Rules Song-Beverly Doesn’t Apply to Online Downloadable Purchases - Comments in Four Loko Settlement May Drive...more

Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenon (2nd Edition)

In October 2009, we published the first edition of this White Paper, focusing primarily on social media issues in the United States. The response was overwhelming and far beyond our expectation — clients, friends, press and...more

Are the Feds Enlisting FedEx to Police the Illegal Pharma Market?

The government may be coming up with a new cost-effective measure to help balance the federal budget – enlisting private companies to do their policing. A 2011 settlement between the Justice Department and Google for $500...more

Telling People They Can Use A Drug In A Way Different Than How The FDA Says They Can Use A Drug Is Not A Crime, Says the Second...

Alfred Caronia was a sales rep for a pharmaceutical company. And, despite what you might think by reading some of the literature, being a pharmaceutical sales rep is not a crime. It's even more emphatically not a crime after...more

Second Circuit Vacates Off-Label Promotion Conviction on First Amendment Grounds in U.S. v. Caronia

On December 3, 2012, a panel of three judges on the U.S. Court of Appeals for the Second Circuit overturned the November 2009 conviction of Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce...more

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