Tag Archives: Federal Trade Commission (FTC)

Recent Regulatory Actions on Advertisement Disclosures

An article in Compliance Week discusses recent actions by the Federal Trade Commission (FTC) and Food and Drug Administration concerning advertisement disclosures. The FTC launched Operation Full Disclosure in fall 2014, which involved sending warning letters to more than 60 companies across "a wide range of industries" for failing to properly disclose information in their advertisements. These letters serve as a reminder to all companies, even those that did not receive letters, to review their disclosures in order to minimize the likelihood of a violation in the future.… Continue Reading

False Advertising Claims & The First Amendment

The U.S. Court of Appeals for the District of Columbia Circuit ruled on January 30th that the Federal Trade Commission can prohibit POM Wonderful LLC from making the advertising claim that its products can help in fighting afflictions and ailments such as heart disease, prostate cancer and erectile dysfunction. The appeals court also decided that POM Wonderful requires the support of one clinical trial before it can make any subsequent claims that its products are effective in fighting disease. POM Wonderful had maintained that its advertisements and claims are protected under the First Amendment, a position that was rejected by the appellate court's decision.… Continue Reading

Federal Trade Commission Fines Manufacturers of Weight Loss Supplement $9 Million for Alleged Deceptive Advertising

The Federal Trade Commission (FTC) voted to fine two manufacturers of green coffee bean extract $9 million for making claims that consumers could lose body weight and fat by using the extract. The FTC alleges that the manufacturers' advertised claims were deceptive and the result of a flawed research study. However, two dissenting FTC commissioners believe that the amount of the fine was excessive because it took into account sales attributed to televised statements that were constitutionally protected and non-commercial in nature.… Continue Reading

FTC Offers Privacy and Security Guidance for Medical Devices in ‘Internet of Things’ Report

On January 27, the Federal Trade Commission (FTC) issued a 71-page Staff Report on privacy and security issues with the Internet of Things (IoT) - the growing ability of everyday devices to monitor and communicate information through the Internet. The Staff Report - which follows up on the FTC's public workshop over concerns with the IoT, as well as the FTC's first enforcement action brought in September 2013 - is especially relevant in the life sciences industry, which may see potentially revolutionary advances as a result of the IoT.… Continue Reading

U.S. Senator Schumer Calls for Increased Regulation of Wearable Electronic Devices to Avoid Data Privacy Issues

Reed Smith's Global Regulatory Enforcement Law Blog features a post on the recent phenomenon of wearable electronic devices and the legal issues that may arise from these gadgets. "Wearable Device Privacy - A Legislative Priority?," written by Reed Smith attorneys Frederick Lah and Khurram Gore, discusses a recent press release issued by U.S. Senator Chuck Schumer of New York expressing concern that personal health data collected by wearable devices and fitness apps, including medical conditions, sleep patterns, calories burned, GPS locations, blood pressure, weight, and more, will be provided to third parties without the user knowing it. Schumer, citing this as a threat to personal privacy, has urged the Federal Trade Commission to mandate that device and app companies provide users with an explicit "opt-out," allowing them to block the distribution of this information to any third parties.… Continue Reading

Do You Know Where Your Pharmaceuticals Are From? Navigating the “Country of Origin” Question for Pharmaceutical Products

Drug and medical device manufacturers are often faced with difficult challenges in determining the country of origin for their products, which are often sourced, processed and manufactured in multiple countries. As detailed by the article "Origin of the Pieces: How to Determine a Pharmaceutical Product's 'Country of Origin,'" written by Reed Smith lawyers Jeffrey Orenstein and Lorraine Campos, there are a variety of factors that must be taken into consideration when answering the country of origin question for a pharmaceutical product - chief among which is who is asking the question. This article provides an overview of the principal regulatory schemes and their country of origin standards in order to help provide clarity to pharmaceutical companies in an often confusing and frustrating process.… Continue Reading

Supreme Court Decision on Reverse Payments has Significant Implications for Pharmaceutical Manufacturers

Reed Smith’s Global Regulatory Enforcement Law Blog recently featured a detailed analysis of the Supreme Court’s decision in FTC v. Actavis, where the court ruled five-to-three that reverse payments, also called pay-for-delay settlements, can violate antitrust laws and are subject to antitrust review under the rule-of-reason. As reverse payments are commonly used by branded drug … Continue Reading

FTC Issues Guidance to Mobile App Developers

Reed Smith’s AdLaw By Request blog features a post on the Federal Trade Commission’s recently published "Marketing Your Mobile App: Get It Right from the Start," a set of guides addressing compliance with truth in lending and privacy principles for mobile app developers. Reed Smith partner Doug Wood notes that disclosures and privacy protection for … Continue Reading

FTC’s Proposed Rule Changes Modify HSR Reporting Requirements for Pharmaceutical Exclusive Licensing Deals

Reed Smith’s Global Regulatory Enforcement Law Blog recently featured a post regarding the Federal Trade Commission’s proposed changes to the premerger notification rules to clarify when the transfer of exclusive marketing, sales and manufacturing rights to a patented pharmaceutical product requires notification to the agencies under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (15 U.S.C. … Continue Reading

Red Flags Rule Enforcement Postponed Again

On May 28, 2010, just shy of the June 1st compliance deadline, the Federal Trade Commission announced that it would again be postponing enforcement of the Red Flags Identity Theft Prevention Rule through December 31, 2010. This delay comes at the request of Congress, which has been considering legislation (which has been referred to the Senate Committee on Banking, Housing, and Urban Affairs) that would affect the scope of entities covered by the Rule. The FTC "urges Congress to act quickly to pass legislation that will resolve any questions as to which entities are covered by the Rule and obviate the need for further enforcement delays." If Congress passes legislation limiting the scope of the Red Flags Rule with an effective date earlier than December 31, 2010, the Commission will begin enforcement as of that effective date.… Continue Reading

FCC Proposes Tougher Rules on Telemarketing

The Federal Communications Commission ("FCC") has proposed changes to its Telephone Consumer Protection Act ("TCPA") rules that would conform to the Federal Trade Commission's Telemarketing Sales Rule ("TSR"). The primary change in the regulations would affect the sending of prerecorded messages (a/k/a "robocalls") by barring them even to existing customers without first obtaining prior written consent. At first blush, this seems routine, but because of differences in the FCC's and FTC's statutory jurisdiction, there are complicated implementation issues that could trap unsuspecting companies. Other key issues for the health care industry is whether the FCC should create an exemption for prerecorded messages that are subject to Health Insurance Portability and Accountability Act ("HIPAA") and, if so, how such exemption should be implemented. For more information about these changes, please read our client alert written by Robert Jackson.… Continue Reading

FTC (Revised) Endorsement Guides Go Into Effect

As noted by our colleagues at Legal Bytes, on December 1, 2009, the revised "Guides Concerning the Use of Endorsements and Testimonials in Advertising" released by the Federal Trade Commission ("FTC") came into effect. Washington, D.C. partner John P. Feldman, an authority in advertising regulations and compliance, recently outlined some considerations every advertiser should take … Continue Reading

FTC Issues Final Rule on Notifying Consumers About Breaches of Electronic Health Records

Until now, the loss or theft of protected health information rarely resulted in notice to consumers. Very few state data security breach notification laws encompass medical information. The Health Insurance Portability and Accountability Act ("HIPAA") merely required an "accounting" of such events to a patient upon the patient's request. All that has changed. Congress, in enacting the Health Information Technology for Economic and Clinical Health Act ("HITECH"), imposed breach notification obligations on many of the individuals and business entities that receive, create, or maintain patients' individually identifiable health information. Pursuant to HITECH, on Aug. 17, the Federal Trade Commission ("FTC") issued its Health Breach Notification Rule, governing the breach notification obligations of three new categories of entity: "vendors of personal health records," "PHR related entities" and "third party service providers."… Continue Reading

FTC Further Postpones Identity Theft Red Flags Rule

On July 29, 2009 the Federal Trade Commission (FTC) issued a News Release announcing that it is granting industries under the FTC's jurisdiction an additional 3 months to develop and implement their identity theft prevention programs as required under the FTC's Identify Theft Red Flags Rule. Additionally, the FTC staff will "redouble" its education efforts and ease compliance by providing additional resources and guidance to clarify whether businesses are covered by the Rule and what they must do to comply. By extending the enforcement date of the Rule until November 1, 2009, the FTC intends to give creditors and financial institutions more time to review the forthcoming guidance and to develop and implement written Identity Theft Prevention Programs. The announcement of the extension is also available at www.ftc.gov.… Continue Reading

Identity Theft Red Flag Rule Further Postponed

This post was written by Carol Loepere. On April 30, 2009 the Federal Trade Commission (FTC) issued a News Release announcing that it is granting industries under the FTC’s jurisdiction an additional 3 months to develop and implement their identity theft prevention programs as required under the FTC’s so-called Identify Theft Red Flag Rule. The FTC … Continue Reading

Testimonials and Endorsements: Complying with the FTC Guides in Light of Proposed Changes

One of the most frequent strategies employed by advertisers is to let the consumer hear about the advertised product or service from a third party, someone other than the advertiser itself. At its root, an endorsement or testimonial when used in advertising is the advertiser's way of saying, "Don't just take my word for how wonderful my product or service is, listen to this unbiased person whose opinion you should rely upon to make a purchasing decision." The Federal Trade Commission (FTC or Commission) originally published Guides Concerning the Use of Endorsement and Testimonials in Advertising (The Guides) in 1972. The Guides have not been updated since 1980. In January, 2007, the FTC sought comments on proposed modifications and updates to the Guides. In particular, the Commission sought comments on whether so-called "disclaimers of typicality," statements like "Results not typical" or "Your results may vary," should continue to be a valid way to communicate that a testimonial does not represent experiences consumers will generally achieve with the advertised product or service.… Continue Reading

FTC Grants Six-Month Delay on Enforcement of the “Red Flag Rules”

This post was written by Carol C. Loepere. Today, the Federal Trade Commission (FTC) issued a press release to announce that it will suspend enforcement of the new “Red Flag Rules” until May 1, 2009, to give "creditors" and financial institutions additional time in which to develop and implement written identity-theft prevention programs. Reed Smith has worked … Continue Reading

FTC’s Identity Theft Red Flag Regulations: Implications for Health Care Providers

In November 2007, the Federal Trade Commission ("FTC") issued sweeping regulations aimed at deterring, detecting and preventing identity theft. Under these rules, known as the Red Flag Regulations, 16 C.F.R. § 681.1 et seq. and Final Rule ("Red Flag Regulations"), financial institutions and creditors of covered accounts must establish a program to detect, prevent and mitigate identity theft.… Continue Reading