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Consumer Protection Communications & Media Health

Read Consumer Protection updates, news, and legal commentary from leading lawyers and law firms:

Soy Vey! FDA May Revoke Soy’s Heart Health-Claim

by Reed Smith on

The FDA has called into question its health claim finding a link between consumption of soy protein and reduced risk of heart disease. Since 1999, the FDA has allowed manufacturers and advertisers to label soy products with...more

FCC Closes Loopholes and Expands Telephone Consumer Protection Act “TCPA” Consumer Protections in Declaratory Ruling and Order

by Womble Bond Dickinson on

On July 10, 2015, the Federal Communications Commission (“FCC” or “Commission”) released a Telephone Consumer Protection Act (“TCPA”) Declaratory Ruling and Order (“TCPA Declaratory Ruling and Order” or “Order”) offering...more

ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria

by McDermott Will & Emery on

In September, the Office of the National Coordinator for Health Information Technology (ONC) announced that it is scaling back requirements for third-party certification of criteria related to certified electronic health...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 5

In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more

AD-ttorneys@law

by BakerHostetler on

On paper, FemaLife’s benefits sound great. The company made a series of boasts regarding its Super Flora Probiotic that positioned it as the answer to numerous problems: “If [your body] doesn’t receive the adequate nutrition...more

Building a Health App? Part 4: Avoiding an FTC Enforcement Action

The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more

FDA Approves First Qualified Health Claim about Allergy Prevention on Baby Food Labels

by Proskauer - Advertising Law on

Last month, the FDA announced that companies will be able to label baby food products with advice about how the early introduction of peanuts in an infant’s diet may reduce the risk of developing a peanut allergy. This marks...more

The State AG Report Weekly Update

by Cozen O'Connor on

AG Elections- Democrat Peter Neronha Declares Candidacy for Rhode Island Attorney General- Democrat Peter Neronha formally announced his bid to become Rhode Island AG in 2018. Neronha served as U.S. Attorney for the...more

The Devil is Really in the Details: FDA Issues Warning Letter to a Drug Company for Disseminating False and Misleading Information

by Arnall Golden Gregory LLP on

They’re back. The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP), which has been relatively quiet on the enforcement front, issued a Warning Letter to a pharmaceutical company for distributing...more

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

The State AG Report Weekly Update

by Cozen O'Connor on

Consumer Protection- 14 AGs Oppose Rollback of FCC Net Neutrality Protections- 14 Democratic AGs, led by Illinois AG Lisa Madigan, submitted comments urging the Federal Communications Commission (“FCC”) to ensure open...more

FDA Says Viewers Catch a Fleeting Glimpse; Can’t Hear What You’re Saying to Sponsor of Ad with Mismatched Audio and Visual Risk...

by Arnall Golden Gregory LLP on

Recently, FDA’s Office of Prescription Drug Promotion (OPDP) issued its first Untitled Letter of the year, citing a direct-to-consumer TV advertisement for a prescription weight- loss drug. According to OPDP, the ad made...more

FDA Announces Delay in Compliance Dates for Revised Nutrition Fact Requirements

by Kelley Drye & Warren LLP on

The FDA announced today that it was delaying implementation of the final rule promulgated in May 2016 that revised regulations governing Nutrition Facts labels on food and dietary supplements. The rule initially set a...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

Eighth Circuit Court of Appeals Affirms Dismissal of TCPA Claims on Grounds of Prior Express Consent

by Stinson Leonard Street on

In Zean v. Fairview Health Services, the U.S. Court of Appeals for the Eighth Circuit recently affirmed the district court's dismissal of a putative class action complaint under the Telephone Consumer Protection Act (TCPA)....more

National Pharmacy Avoids TCPA Claim for Flu Shot Robocall under Health Care Rule Exemption

by Hinshaw & Culbertson LLP on

A judge in the Southern District of New York recently held that an automated, pre-recorded message sent on behalf of Rite Aid informing recipients to obtain a flu vaccine shot was exempted from the Telephone Consumer...more

TCPA Class Action Tossed out After Hospital Provides Records Indicating Consent

Central Florida Regional Hospital (the Hospital) was released from a proposed class action last week for its alleged violations of the Telephone Consumer Protection Act (TCPA). The Hospital’s debt collector, Transworld...more

Health Care Providers Pay $1.35 Million in TCPA Fax Settlement

by Reed Smith on

Although the spotlight is usually on unwanted phone calls and text messages when it comes to class actions under the Telephone Consumer Protection Act (TCPA), a recent settlement over the sending of faxes is a reminder to...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

Menu Labeling On Hold – Again

It appears the FDA is again pushing back the compliance date for its menu labeling regulations, which had been set for May 5, 2017. Although the agency has not yet made an announcement of the 11th-hour delay, on Thursday it...more

Rite Aid Wins Summary Judgment in TCPA Action Involving Prerecorded, Automated Call for Flu Shot Reminder

by Womble Bond Dickinson on

In an outright win for pharmacies, the U.S. District Court for the Southern District of New York, in the attached opinion, granted Rite Aid’s motion for summary judgment in a class action alleging violations of the TCPA....more

Mobile targeting: A ‘secret weapon’ for good or ill?

by Thompson Coburn LLP on

It’s an advertiser’s dream — the ability to target customers through their mobile devices, right to down to where they are and what they are doing. But can such precisely targeted messages become a recipient’s nightmare?...more

FDA Delays Effective Date of Amended Regulations Affecting "Intended Use" Definition

by Jones Day on

One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding 'Intended Uses,'" would have taken...more

The TCPA: An Unexpected Deterrent to Patient Engagement Tools

by McDermott Will & Emery on

In an age where providers are increasingly taking the management of their patient’s health online and out of the doctor’s office, the creation of scalable and nimble patient engagement tools can serve to improve patient...more

FDA’s Public Meeting on the Use of the Term “Healthy” in the Labeling of Human Food Products – A Summary of Key Points

On March 9, 2017, the Food and Drug Administration (FDA or Agency) held a public meeting in Rockville, MD, which FDA officials described as a way to engage in a dialog with the public and regulated industry and allow for...more

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