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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 -

New York Regulators Lead the Charge to Fill Health Data Protection Gaps Left by Federal Law

by Hogan Lovells on

New York AG Settles Data Protection Enforcement Against Mobile Health Apps - After a year-long investigation into mobile health apps claiming to be able to measure vital signs or health indicators through smartphone...more

Menu Compliance Counts Starting May 5th

by Barley Snyder on

Restaurant calorie labeling: Starting next month, it’s not just for McDonald’s anymore. In an issue Barley Snyder has been tracking for years, the Food and Drug Administration is poised to begin enforcement of its...more

FDA Cleared First DTC Genetic Tests for Health Risks

by Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) granted marketing authorization for 23andMe’s Personal Genome Service (PGS) Test for 10 diseases or conditions. This was the first FDA authorization for a...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

FDA Issues Its First Postmarketing Safety Reporting Regulations for Combination Products

Originally published in FDA Flash! Blog - February 2nd, 2017. The Food and Drug Administration (FDA) recently published a final rule setting forth the first postmarketing safety reporting regulations for combination...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

FDA Launches New Webpage to Report Regulatory Misconduct

by Stinson Leonard Street on

Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting...more

Navigating the Maze of E-Cig Marketing Regulations

by Klein Moynihan Turco LLP on

Federal regulators, and states, counties and cities throughout the country, are enacting new laws, rules and regulations in the e-cigarette marketing space. How can e-cig manufacturers and related marketing affiliates...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

The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

by Cozen O'Connor on

The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law....more

You Wear It Well (or Do You?): FDA Objects To These Skincare Companies’ Unapproved New Drug Claims

by Arnall Golden Gregory LLP on

In the 1972 hit, “You Wear it Well,” Rod Stewart sang about a woman and offered the classic line, “Madame Onassis got nothing on you.” The tune came to mind when reading four Warning Letters issued by the Food and Drug...more

Busy Week for Biosimilars Worldwide

by Goodwin on

United States: On July 13, an FDA advisory committee voted to recommend approval of Sandoz’s biosimilar to Enbrel® (etanercept). The recommendation was to approve the biosimilar for all indications for which Enbrel® is...more

Agreement Reached on Bipartisan Federal GMO Food Labeling Bill

Provides Practical, Mandatory Disclosure and Preempts State GMO Labeling Laws - Senate Agriculture Committee leaders reached agreement June 23, 2016, on a bill that would require food containing genetic material modified...more

AGG Food and Drug Newsletter - June 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

The First Cut is the Deepest: FDA Issues a Warning Letter to a Skincare Company for Marketing Unapproved New Drugs

by Arnall Golden Gregory LLP on

The Food and Drug Administration recently issued a Warning Letter to a skincare company for promoting and selling unapproved new drugs. While the letter itself is not unusual in content, the enforcement action continues a...more

State Safe Harbor Doctrines: A Life Preserver from False Advertising Claims Facing Alcohol Manufacturers?

by Pepper Hamilton LLP on

Food and beverage companies, beset by lawsuits about their product labels, struggle to find consistent application of consumer protection laws across the country. The experience of one distiller and its use of one word on its...more

Center for Veterinary Medicine Releases New Guidance

by Morgan Lewis on

The center makes no bones about dog and cat food health claims. If you have been down a pet food aisle recently, you may have noticed dog and cat foods that claim to treat various conditions, such as claims to treat...more

Ruling Could Put Deceptive Labeling Cases on Hold

by McDermott Will & Emery on

The U.S. Court of Appeals for the Ninth Circuit today placed on hold a consumer class action involving yogurt labels until the FDA issues final guidance on use of the terms at issue in the dispute—a decision that could ripple...more

Essure Has Caused 303 Fetal Deaths, Independent Analysis

A gross discrepancy in the number of fetal deaths attributed to the birth control device Essure has prompted the U.S. Food and Drug Administration to analyze the data and decide whether to change the way the product is...more

Influencer Marketing: Tips for a Successful (and Legal) Advertising Campaign

In an age of explosive growth for social media and declining TV viewership numbers, companies are partnering with so-called “influencers” to help the companies grow their brands. Popular users of Instagram, Vine, YouTube and...more

United States v. Bayer: Preventing or Treating Disease Claims

by Kelley Drye & Warren LLP on

In recent years, the FTC and the Center for Science in the Public Interest (“CSPI”) seem to have seen disease claims everywhere, regardless of whether the FDA has deemed the same claims appropriate, non-disease...more

Be Careful About What you Claim – Or Fail to Claim – FTC Sends Green Guides Warning Letters

by Seyfarth Shaw LLP on

Last week the Federal Trade Commission (FTC) sent warning letters to providers of environmental certification seals, and to businesses using those seals, alerting them to the Commission’s concerns that the seals “could be...more

FDA Regulation of Hospital-Developed Technologies - Hospital Industry Viewpoint

by Morgan Lewis on

As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more

FDA’s Marijuana Q&A: More Questions than Answers?

by Kelley Drye & Warren LLP on

The FDA recently released its current thinking on marijuana in a variety of forms in a web-based document titled “FDA and Marijuana: Questions and Answers.” The most notable question and answer related to whether cannabidiol...more

Pharmaceutical Marketing and Unfair-Trade-Practices Claims

by Ellis & Winters LLP on

Lawsuits against pharmaceutical companies generally center on product-liability claims. A new trend in pharma cases, however, is to include a different kind of claim: a claim for unfair trade practices....more

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