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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 -

Outlook 2017 Teleconference: Revisiting the Trump Administration’s Impact on Life Sciences and Health Care—the First 100 Days

by Ropes & Gray LLP on

On Tuesday, May 2, Ropes & Gray hosted a teleconference, “Outlook 2017 Teleconference: Revisiting the Trump Administration’s Impact on Life Sciences and Health Care – the First 100 Days,” on the potential regulatory and...more

Doctor, Doctor, Give Me the News, I’ve Got a Bad Case of Medical App Blues: Mobile Medical Application Developers Settle with New...

by Arnall Golden Gregory LLP on

The New York Office of the Attorney General recently announced settlements with developers of three mobile health applications due to misleading claims and deficient privacy practices. As a result of these settlements, the...more

New York Attorney General Settles Claims against Three Health Apps

by Morgan Lewis on

Health app developers must be vigilant not only of federal laws, but of state laws as well. On March 23, New York Attorney General Eric T. Schneiderman announced a settlement with developers of three health-related...more

Guidebook: Cybersecurity in the Pharma, Biotech, and Medical Devices Industries

by Foley & Lardner LLP on

As a life sciences or medical device company, it is mission critical to protect lab books, drug and clinical test data, product formulas and production processes that underlie your patents, trade secrets and know-how from...more

What’s New in Washington: 10 Things You Need to Know

As the Trump presidency completes its first 10 weeks, the administration is celebrating big wins on the regulatory reform front while nursing some wounds from a major defeat on efforts to repeal and replace the Affordable...more

Federal Trade Commission Deploys Antitrust Weaponry Against Pharmaceutical Company

by Shipman & Goodwin LLP on

In Federal Trade Commission v. Shire ViroPharma Inc. (D. Del. Feb. 7, 2017), the FTC has, for the first time, deployed its antitrust weaponry against a pharmaceutical company’s alleged practice of using the FDA’s...more

FTC Cries Foul On Breathometer Accuracy Claims

by Kelley Drye & Warren LLP on

The FTC recently announced a settlement with Breathometer, Inc., a company that marketed a smartphone accessory that it claimed could detect blood alcohol levels. Users could simply plug the accessory into the headphone...more

McNees 2016 In Review – Advertising Law

Advertising and marketing laws affect all businesses that expose consumers to their goods and services. In 2016, highlights of advertising and marketing law issues included disclosures and celebrity endorsements, “Made in...more

Health Update - January 2017

Top Five Healthcare Antitrust Trends to Watch in 2017 - Antitrust enforcement and litigation had a big year in 2016. In this article, we look back at the most significant cases for the healthcare industry over the last...more

Guest Post — Do It If It Makes You Feel Good: FTC’s Report on Homeopathic Medicine Advertising

by Reed Smith on

What follows is a guest post by John Feldman, a partner in Reed Smith’s Entertainment and Media Industry Group. John closely follows all things Federal Trade Commission and approached us when he saw the FTC weighing in a...more

FTC Addresses Homeopathic Drug Advertising

by Klein Moynihan Turco LLP on

The Federal Trade Commission (“FTC”) recently released an enforcement policy statement regarding marketing claims for products in the over-the-counter (“OTC”) homeopathic drug market. Long permitted to fly under the FTC’s...more

FTC Issues Long-Awaited Enforcement Policy on OTC Homeopathic Drugs

We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that post we mentioned that both FDA and the Federal Trade...more

NYSBA’s REMS and Other Drug Distribution Restrictions Program Provided an Excellent and Informative Discussion

by McGuireWoods LLP on

On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, held a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company...more

Check the Box to Avoid Food & Beverage Packaging Litigation

by Nutter McClennen & Fish LLP on

Shagha Tousi, a partner in Nutter’s Litigation Department and a member of the firm’s Business Litigation and Product Liability and Toxic Tort Litigation practice groups, addressed product packaging litigation in the food and...more

AGG Food and Drug Newsletter - October 2016

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Don’t Forget About FTC Compliance: Substantiating Claims to Avoid Misleading Consumers

by Arnall Golden Gregory LLP on

Life sciences companies regularly review their labeling and promotional materials to ensure compliance with Food and Drug Administration requirements. FDA makes its Warning Letters publicly available, and failure to correct...more

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

by Foley & Lardner LLP on

With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more

The Tech Industry’s Next Frontier?

by Robins Kaplan LLP on

Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more

Advertising Law - October 2016 #2

No Shades of Gray in Order Banning Supplement Claims - In a case based on a referral from the National Advertising Division, the Federal Trade Commission obtained summary judgment and a final order against an advertiser...more

Advertising Law - October 2016

Suit Over Block Voting on Reviews Moves Forward - A Lanham Act suit brought by a competitor over a company's efforts to minimize negative consumer reviews will move forward, a Utah federal court judge has...more

When smart goes bad: Why internet security does not just refer to computers

by Thompson Coburn LLP on

A growing trend in the consumer electronics industry is the use of so-called “smart” devices — electronics that use wi-fi connections to allow them to be controlled remotely over the internet. From smart thermostats that can...more

Can Antitrust Prevent Excessive Drug Price Increases?

The antitrust agencies are often asked to intervene in markets where pricing appears to be excessive to help protect consumers and stabilize markets. In the drug arena, healthcare providers, consumers and politicians have...more

I May Not Be Able To Pronounce Acai But I Know It Doesn’t Burn Fat Cells: 5 Recent Over-the-Top Weight Loss Advertising Claims And...

Some say “ah-sigh;” I say “ah-kai;” but apparently the proper pronunciation of “acai” — the so-called super berry — is actually “ah-sigh-ee.” Who knew? Acai berries are native to the Amazon rainforest and have been hailed...more

Food and Beverage Law Update: August 2016

by Holland & Knight LLP on

When food and beverage companies think of their largest risks, data breaches have not historically come to mind, but this is changing because of reports in the past few months of major breaches by companies such as Noodles &...more

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

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