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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 -

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

FDA Warns Against Products Claiming to Cure Cancer

by Fox Rothschild LLP on

The Food & Drug Administration (“FDA”) regulates cancer drugs and devices, both for use by humans and pets. Such drugs and devices must obtain FDA approval or clearance before they can be marketed or sold to consumers, so...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy...more

FDA to Extend E-Cig Marketing Compliance Deadline

by Klein Moynihan Turco LLP on

Last week, the U.S. Food and Drug Administration (“FDA”) disclosed in an Alabama federal court filing its plan to defer enforcement of all future e-cig marketing compliance deadlines for a period of three months....more

Hold That Order! FDA Freezes Menu Labeling Rules Until 2018

by Seyfarth Shaw LLP on

The Food and Drug Administration (“FDA”) has extended the compliance date for its menu labeling rules just days before the final rules were set to take effect....more

FDA Delays Menu Compliance Date … Again

by Barley Snyder on

NOTE: This is an update to a previous alert, “Menu Compliance Counts Starting May 5th.” The effort to delay the compliance date for calorie labeling in restaurants and other retail food establishments has succeeded, with...more

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

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