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Marketing The United States Food and Drug Administration

10 Marketing Law Takeaways From ANA/BAA 2017

We just got back from the Association of National Advertising (ANA) and Brand Activation Association (BAA) Marketing Law Conference in Chicago, held earlier this week. With hundreds in attendance, and dozens of speakers...more

FDA Warns Companies Marketing Unsubstantiated Marijuana-Derived Products That Claim to Treat or Cure Cancer

Earlier this week, the U.S. Food and Drug Administration (FDA or the Agency) issued Warning Letters to four companies – Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers...more

Bad For Your Health: Lawsuit Advertising Implications And Solutions

by Shook, Hardy & Bacon L.L.P. on

Shook, Hardy & Bacon Partner Cary Silverman has authored a report for the U.S. Chamber Institute for Legal Reform examining the effects of advertising soliciting plaintiffs for lawsuits targeting prescription drugs and...more

Food & Beverage Litigation Update | October 2017 #4

by Shook, Hardy & Bacon L.L.P. on

Furans in Baby Food May Pose Health Risk, EFSA Reports - The European Food Safety Authority (EFSA) has issued an assessment of the risks of furans and related compounds 2- and 3-methylfurans, concluding that they pose a...more

Dietary Supplement & Cosmetics Legal Bulletin | October 2017

by Shook, Hardy & Bacon L.L.P. on

The use of beauty products is “an understudied source of environmental chemical exposures” with a disparate effect on women of color, George Washington University and Occidental College researchers argue. Ami R. Zota, et al.,...more

Food & Beverage Litigation Update | September 2017 #2

FDA Seeks Comment on Regulation Changes for "Meaningful Burden Reduction" - Implementing an executive order titled "Reducing Regulation and Controlling Regulatory Costs," the U.S. Food and Drug Administration (FDA) has...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

Trimming the Fat: Restaurant Menu Labeling Rule Under Further Review

by Lewitt Hackman on

In 2010 as part of the Patient Protection and Affordable Care Act a/k/a “Obamacare”, the federal government set provisions mandating restaurant chains provide nutrition information for menu items. The U.S. Food and Drug...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

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

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

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

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

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