The United States Food and Drug Administration Federal Trade Commission

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

Healthcare Legal News Volume 5 Number 2

According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...more

Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

While FDA’s Proposed e-Cigarette Rule is Pending, FTC Mulls Enforcement Action

Ahead of finalizing FDA’s tobacco products “deeming” rule, the FTC considers taking enforcement action against e-cigarette firms for violative advertising, marketing, and sales practices....more

Alert: Federal Policy Developments Impacting Medical Technology Companies

Health care is always a major issue in Washington, DC but recently how to promote innovation in medtech has become a priority within that conversation. Thus far, 2015 has produced a major legislative initiative in the form of...more

Long-tail Risk on the Horizon for the Tanning Bed Industry

As the United States continues through a winter that included a historic blizzard in the Northeast, many of us may be longing for summer days spent on the beach, soaking up the sun and working on a tan. A number of people,...more

FDA Draft Guidances on General Wellness Products and Device Accessories Continue Risk-Based Approach to Health IT

On January 20, 2015, the United States Food and Drug Administration (FDA) issued two new draft guidance documents, announcing the agency’s plans not to regulate “general wellness products” (including certain software...more

Product labeling requirements aren't all black and white

Your company has created and developed a new, innovative product. You’ve tested your product, you’ve adopted a new trademark, and you’re ready to begin manufacturing. The remaining steps of preparing your product for sale,...more

Advertising Law - November 2014 #3

NAD Sniffs at Odor Protection Claims - Concerned that a 48 hour antiperspirant/deodorant constitutes an overstated claim of “100% odor protection,” the National Advertising Division recommended...more

Advertising Law - October 2014 #3

Permanent Ban From Prize Promotion Business After Sweepstakes Scam - A sweepstakes operator agreed to a permanent ban from the prize promotion business pursuant to a settlement with the Federal Trade Commission after...more

Advertising Law - Oct 2014

FTC Mows Down Astroturfing at Yahoo - The Federal Trade Commission has closed an investigation into “astroturfing” by Yahoo employees and declined to take enforcement action because of the limited number of workers...more

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

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...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

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

Jumping Into The Actavis Briar Patch — Insight Into How Courts May Structure Reverse Payment Antitrust Proceedings And The...

In This Issue: - INTRODUCTION - WHAT ARE REVERSE PAYMENT SETTLEMENT AGREEMENTS? ..The Basic Framework of Hatch-Waxman Litigation ..The Federal Trade Commission’s View of Reverse Payment Settlements and Its...more

Milk Dud? False Advertising Lawsuit Against Makers of Muscle Milk Illustrates Interplay Between Lanham Act, FTC and FDA

In a lawsuit recently filed in the Southern District of Florida, Global Beverage Enterprises, Inc. (“Global”), the manufacturer of specialty carbonated beverages like Mr. Q. Cumber Sparkling Cucumber Beverage, brought Lanham...more

FDA Says Product Containing No Tobacco is a “Tobacco Product” – FDA Expands Authority to Include E-Puffing

In an effort that Food and Drug Administration (FDA) officials say was motivated by the (Big Brother?) desire “to correct a misperception by consumers that tobacco products not regulated by FDA are safe alternatives to...more

Part II: Fair Notice or No Notice? The Wyndham Worldwide Case and the Expanding Power of the FTC to Police Data Security

In our first blog in this series, we provided a summary of the District Court of New Jersey’s recent decision in FTC v. Wyndham Worldwide Corp., in which Judge Salas confirmed the FTC’s authority to bring enforcement actions...more

Advertising Law

FDA “Dislikes” Drug Company’s Facebook Page - Switzerland-based IBSA Institut Biochimique SA recently got a thumbs-down from the Food and Drug Administration over a Facebook ad for its hypothyroidism drug, Tirosint,...more

Food and Beverage News and Trends

This regular publication by DLA Piper lawyers focuses on helping clients navigate the ever-changing business, legal and regulatory landscape. - Citizen petition filed for hummus standard of identity. A citizen’s...more

FDA, IP, and FTC Developments in the Run-up to the First U.S. Biosimilar Approval

As we near the fourth anniversary of the enactment of the Biologics Price Competition and Innovation Act, which established the first abbreviated approval route for follow-on biologics in the United States, multiple federal...more

FTC Cracks Down on False Advertising in Dietary Supplements

Supplements making claims regarding diabetes, genetically customized nutritional benefits, and weight loss are slammed for false advertising. Recent Federal Trade Commission (FTC) enforcement activities—including a...more

Privacy And Data Security For Life Sciences And Health Care Companies

Pepper Hamilton Health Care-Life Sciences Webinar - The explosion of mobile technology and Web applications linking patients with doctors, pharmacies and medical devices is undergoing scrutiny by the FDA, FTC, HHS and...more

FTC Workshop Seeks to Spark Biosimilars Competition

Demand for biologics is growing fast, but even after Congress passed authorizing legislation in 2010, the pace of generic entry appears to have stalled. Seeking to spur increased generic competition, the FTC held an all-day...more

Clash Of Titans over Biosimilars at FTC Workshop

On Tuesday, February 4, the Federal Trade Commission (FTC) conducted an all-day public workshop at its headquarters in Washington, D.C. on competition issues involving biologics and biosimilars. During highly informative...more

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