The United States Food and Drug Administration Advertising

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

Advertising Law - August 2014 #3

FTC: Telemarketing Sales Rule Ripe For Review - It’s time to review the Telemarketing Sales Rule, the Federal Trade Commission has announced. Enacted in 1995, the Telemarketing Sales Rule (the Rule) has been...more

Advertising Law News & Analysis - August 2014 #2

In this issue: - FTC Announces Agenda for Sept. Big Data Workshop - State AGs Escalate E-Cig Discussion in Comments to FDA - Venable Secures Victory in Putative Class Action on Behalf of Oral Supplement...more

Advertising Law - July 2014 #3

Suit Seeks To Include E-Mail Address Under Song-Beverly Protections - First zip codes, now e-mail addresses? According to a new complaint filed in California federal court against Express Fashion Apparel, LLC,...more

Labeling Laws for the Food and Beverage Industry – Unfair Competition and Mislabeled Products

In a recent unanimous U.S. Supreme Court ruling, the court opened the door for private parties, including competitors, to bring false advertising and misrepresentation claims under the Lanham Act even if the product labels...more

FDA Issues Draft Guidance on Communications Over Internet and Social Media Platforms

On June 17, 2014, the U.S. Food and Drug Administration (FDA or the Agency) issued two draft guidance documents, providing recommendations for two types of communication over internet and social media platforms. The first...more

FDA Hosts Webinar Addressing Social Media Draft Guidance

The Food and Drug Administration hosted a Social Media Draft Guidance Webinar. The July 10 webinar included summary review of the three draft guidances issued this year to date followed by a brief Q&A. Thomas Abrams, director...more

FDA Holds Teleconference re: Social Media Guidance

The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors...more

Advertising Law - July 2014

Online Reviews Not Sufficient To Support Ad Claim, NAD Rules - While recognizing the benefits of using new sources of information, the National Advertising Division (NAD) decided that an advertiser’s use of aggregated...more

Supreme Court: FDCA Compliance Does Not Bar Lanham Act Claims

POM Wonderful LLC v. Coca-Cola Co. - In a unanimous decision, the Supreme Court of the United States reversed the U.S. Court of Appeals for the Ninth Circuit ruling that the Food, Drug, and Cosmetic Act (FDCA) and its...more

POM Wonderful Decision: Companies Cannot Rely on FDCA for Protection from False Advertising Liability

The US Supreme Court allows private parties to bring Lanham Act claims challenging product labels that otherwise satisfy the Food, Drug, and Cosmetic Act. In a battle of the beverages, the Supreme Court recently...more

Advertising Law - June 2014 #4

Don’t Forget: FTC Settlement Over Memory Claims - The marketers of the BrainStrong dietary supplement – which claimed to improve adult memory and prevent cognitive decline – reached a settlement with the Federal Trade...more

POM v. Coca-Cola Further Dilutes Consumer Class Action Claims for Deceptive Labeling

The Supreme Court's recent decision in POM Wonderful LLC v. Coca-Cola Company could have redefined the consumer class action landscape with respect to claims for the deceptive labeling of food products. Instead, the decision...more

Making Use of Social Media: FDA Releases Two Draft Guidelines on the Use of Social Media Platforms by Drug and Device...

The Food and Drug Administration (FDA) has released two long-awaited draft guidance documents for the drug and device industries revolving around the use of social media platforms by drug and device manufacturers —...more

Supreme Court Opens Door to Food and Beverage Label Challenges Under Lanham Act

The United States Supreme Court paved the way on June 12 for competitors to challenge FDA-regulated food and beverage labels under the Lanham Act. The Court's opinion in POM Wonderful LLC v. The Coca-Cola Co, is the latest...more

VitaminsOnline.com Files False Advertising Action Over Competitor's Online Dietary Supplement Offerings and Claims

On May 6, 2014 VitaminsOnline, Inc., a Delaware corporation (“VOI”), filed a complaint against Dynamic Industries, LLC, a Nevada limited liability company, and Christopher Wilson, a resident of Georgia (collectively...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

More of the Same: Recently Released FDA Social Media Guidance for the Life Sciences Industry

On June 17, 2014, the U.S. Food and Drug Administration ("FDA") continued to outline its expectations for pharmaceutical and medical device manufacturer use of social media platforms to promote manufacturers' products in two...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

FDA Issues Draft Guidances Regarding Social Media: Handling Misinformation and Character Space Limits

On June 17, 2014, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents concerning the use of social media and internet platforms for advertising and promotion: Internet/Social Media Platforms:...more

Advertising and Food Alert: The Food, Drug, and Cosmetic Act Does Not Shelter a Beverage Company from Claims of Deceptive and...

On June 12, 2014, the Supreme Court, in an 8-0 ruling, held in POM Wonderful LLC v. Coca-Cola Co. that a competitor may sue another under the Lanham Act for unfair competition because of false or misleading food and beverage...more

The Juicy Truth – Supreme Court Rules that POM May Bring False Advertising Claim Based on Coke’s Misleading Juice Label

On June 12, 2014, the Supreme Court issued an opinion holding that the Federal Food, Drug and Cosmetic Act (FFDCA) does not presumptively bar Lanham Act claims that challenge food and beverage labels. This decision comes at a...more

Supreme Court Rules Compliance with FDA Labeling Guidelines Does Not Bar Lanham Act False Advertising Suits – POM Wonderful v....

In a highly anticipated decision, the Supreme Court on June 12 announced that compliance with food labeling guidelines promulgated by the Food and Drug Administration will not operate as a bar against false advertising claims...more

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