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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 -

Building a Health App? What You Need to Know

Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more

Global Privacy & Cybersecurity Update Vol. 15

by Jones Day on

UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Comments on Improvements to IoT Device Security - On June 19, the Federal Trade Commission ("FTC") submitted comments to a working group organized by the...more

AD-ttorneys@law

by BakerHostetler on

Abbott Nutrition did something unique. It added a new ingredient to its Similac Pro-Advance and Pro-Sensitive infant formulas that, until now, had only been available in human breast milk: 2’-fucosyllactose human milk...more

Dietary Supplement & Cosmetics Legal Bulletin | August 2017

"Miracle Gel" Not a Salon Gel Manicure, Ad Board Says - In an appeal from a ruling by the National Advertising Division (NAD), the National Advertising Review Board (NARB) upheld a recommendation that Coty discontinue...more

FDA and FTC Solicit Consumer Complaints About Dietary Supplement Marketing

by Pepper Hamilton LLP on

The Food and Drug Administration and the Federal Trade Commission have jointly requested that consumers report dietary supplements that “didn’t work as promised” or that are marketed with “unbelievable” claims. Consumers may...more

FTC Competition Director Highlights Enforcement Priorities in the Pharmaceutical Industry

Last week Markus Meier, the Acting Director of the Bureau of Competition at the Federal Trade Commission, gave testimony to the House Judiciary Committee concerning “Antitrust Concerns and the FDA Approval Process.” ...more

Advertising Law - June 2017 #3

FTC Jumps on Trampoline Marketing - The Federal Trade Commission (FTC) bounced purportedly misleading trampoline marketing claims in a new administrative consent order. Son “Sonny” Le and his brother Bao “Bobby” Le...more

As FDA Ramps Up Digital Health Program, BakerHostetler Hosts a Medical Device Connectivity Webinar Addressing Digital Technology...

by BakerHostetler on

Recent reports indicate that Food and Drug Administration (FDA) plans to build a digital health unit within and assign a number of digital scientists to the Center for Devices and Radiological Health. The digital health unit...more

Dietary Supplement & Cosmetics Legal Bulletin | May 2017

Senators Call For Removal of Dioxane from Cosmetic Products - U.S. Sens. Chuck Schumer (DN. Y.) and Kirsten Gillibrand (DN. Y.) have petitioned the Food and Drug Administration to prohibit detectable levels of 1,4dioxane...more

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 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

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Cybersecurity

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