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 -
News & Analysis as of

Raising “Cane” in Labeling Claims

Class action plaintiffs again allege that the labeling on Chobani’s Greek yogurt violates FDA regulations and misleads consumers, even though a federal court in California dismissed a similar labeling class action earlier...more

FDA Offers Guidance for Choosing Prescription Drug Names

If you've seen your share of prescription drug commercials, you've likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations...more

FDA issues social media guidance

Earlier this month, the FDA released proposed two-part Guidance on Internet and social media intended to assist prescription drugs and medical device manufacturers to accurately communicate online about their products. The...more

FDA Issues Draft Guidance for Drug and Device Information on Social Media

On June 17, 2014, the FDA issued two draft guidance documents relating to the use of social media and the Internet to promote prescription drugs and medical devices. The FDA described how a company should use a character...more

Drugs and the Internet: FDA Distributes New Draft Guidance Regarding Social Media Platforms and Prescription Drugs

Last week the Food and Drug Administration (FDA) promulgated two much-anticipated draft guidance documents on using social media to present information about prescription drugs and medical devices. The draft guidance...more

FDA Releases Long-Awaited Guidances on Character Limitations and Misinformation on Internet/Social Media

In two separate guidances, the Food and Drug Administration (FDA) advises prescription drug and device manufacturers on its "current thinking" on advertising through space-constrained social media (e.g., Twitter) and on the...more

FDA Issues Draft Guidance Docs On How To Provide Accurate Risk/Benefit Info in 140 Characters Or Less And Clean Up 3rd Party UGC...

Last Tuesday, the FDA issued two draft industry guidance documents advising pharmaceutical companies on how to accurately communicate information concerning prescription drugs and medical devices on social media and other...more

Food and Beverage Alert (US)

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Senators express concern about FDA’s use of draft guidance documents to...more

Putting Testosterone to the Test

Testosterone is the new big drug on the market. Marketed to men with ow T, a vague illness with even vaguer symptoms, there has been a recent explosion in its use. In line with this explosion are also the vast amounts of ways...more

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

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