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• FDA Releases Guidance About Use of Social Media Involving Off-Label Uses
  
  

  Tony DiResta 12:18 pm on January 24, 2012 | 0 Comments Permalink | Post Your Comment!
  Tags: Comments (2), FDA (7), guide (2), Healthcare

  
  

  Over 2 years ago, the Food and Drug Administration (FDA) held hearings on the use of social media for pharmaceutical advertising.  WOMMA representatives provided testimony during those hearings.  Comments concerning issues presented by those hearings were provided by many industry groups, including WOMMA.

  Anticipation has been great, with the expectation that clarity would be provided for pharmaceutical companies desiring to use social media platforms as part of the educational and promotional activities.  After years of waiting by the pharmaceutical industry, the FDA quietly released its “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” in the Federal Register.  Unfortunately, the agency declined to provide detailed instructions and rules.

  Read the Guidance Here

  Instead, the draft guidance addresses how manufacturers and distributors of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use related to FDA-approved or -cleared products.

  The guidance divides off-label requests for information into two categories: public and nonpublic.  If a consumer makes a public request – on a Web site or in a third-party discussion platform – the company should limit its response to providing its contact information so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a nonpublic, one-on-one communication.  Yet, when a consumer asks a question in a nonpublic setting, via e-mail or hotline, for example, companies should respond in a private, one-on-one communication.

  The information provided in response should be “truthful, non-misleading, accurate, balanced, and non-promotional,” the agency said, tailored to answer only the specific question asked.  The answer should include complete copies of scientific reprints, technical literature, or other medical information, not just summary documents, and should also include representative publications that reach contrary or different conclusions regarding the use at issue. In addition, the answer should include a copy of the FDA-required labeling, a complete list of references for the information included, and prominent statements that the FDA has not approved the product as safe for the use addressed as well as the indications currently approved and all relevant safety information.

  Companies should maintain a record of their conversation with the consumer.

  The FDA said that the guidance “is the first of multiple draft guidances the agency plans to publish that address questions and issues related to emerging electronic media,” acknowledging that it has received a petition from drug manufacturers, held public hearings, and received over 70 public comments on the topic. Formal Comments on the current draft guidance will be accepted until March 29, 2012.

   

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• FTC closes investigation of blogging campaign involving Hyundai Motor
  
  

  Tony DiResta 12:45 pm on December 21, 2011 | 0 Comments Permalink | Post Your Comment!
  Tags: Blogging, disclosure (5), FTC (7), Social Media Policy

  
  

  The FTC investigated whether bloggers who had been given gift certificates as an incentive to include links to Hyundai videos in their postings or to comment on them violated Section 5, which requires the disclosure of a material connection between an advertiser and endorser.  The FTC closed the investigation on two grounds.

  First, the FTC found that Hyundai did not know in advance about the use of the incentives, that a small number of bloggers received the gift certificates, and that some of them did, in fact, disclose the information.

  Second, the actions were not taken by Hyundai employees, but by an individual who was working for a media firm hired to conduct the blogging campaign.  The actions were actually contrary to Hyundai’s social media policy.  The FTC also noted that upon learning of the misconduct, the media firm promptly took action to address it.

  Key takeaways: Have an established social media policy, and be sure it is enforced.  Upon learning about failures to disclose, take immediate action.

  Read the closing letter from the FTC

   

• Complaint to FTC Against Major Food and Beverage Company Concerning its Social Media Campaign Targeting Teens
  
  

  Tony DiResta 1:46 pm on November 2, 2011 | 0 Comments Permalink | Post Your Comment!
  Tags: Contest, Facebook, FTC (7), Personal Information, Twitter

  
  

  Within the past few days, a Complaint was filed with the FTC concerning the social marketing by PepsiCo, that can be found here.

  The Complaint against PepsiCo makes 3 arguments:

  1. The campaigns are represented to be a contest, video game, or concert performance, rather than advertising for Doritos.  The company’s marketing efforts are “disguised” and accordingly deceptive.  Apparently, the argument is that the company’s not disclosing to teens the fact that the entertainment is advertising is deceptive under Section 5 under the FTC Act;
  2. The manner in which Frito-Lay collects and uses personal information violates Section 5, by (i) making representations that it will protect teens’ personal information and then acting inconsistently with that policy; and (ii) deceiving teens by collecting personal information without adequately disclosing the extent or purpose of that data collection; and
  3. The company’s use of personal information to generate Facebook and Twitter endorsements from teens playing its games violates the FTC Guides on Testimonials/Endorsements.

  The Complaint and Request for Investigation was written by the Institute of Public Representation.  It is noteworthy that this Institute was headed by David Vladeck, the current Director of the FTC’s Bureau of Consumer Protection, when he was a Professor at Georgetown before coming to the FTC.

  It will be interesting to see how the FTC reacts to such far-reaching arguments that, as a practical matter, apply to just about all ad campaigns by major brands.  Nonetheless, it highlights the interest of consumer groups to advertising and marketing on social media platforms.

   

• FTC Requires Reebok to Pay $25 Million in Settlement of FTC Charges of Deceptive Advertising
  
  

  Tony DiResta 4:37 pm on September 28, 2011 | 0 Comments Permalink | Post Your Comment!
  

  
  

  Today, the Federal Trade Commission announced that Reebok International Ltd. has agreed to resolve charges that the company deceptively advertised “toning shoes,” which it claimed would provide extra tone and strength to leg and buttock muscles. Reebok will pay $25 million, which will be made available for consumer refunds either directly from the FTC or through a court-approved class action lawsuit.

  “The FTC wants national advertisers to understand that they must exercise some responsibility and ensure that their claims for fitness gear are supported by sound science,” said David Vladeck, Director of the FTC’s Bureau of Consumer Protection.

  Reebok’s EasyTone walking shoes and RunTone running shoes have retailed for $80 to $100 a pair, while EasyTone flip flops have retailed for about $60 a pair. Ads for the shoes claimed that sole technology featuring pockets of moving air creates “micro instability” that tones and strengthens muscles as you walk or run.

  According to the FTC complaint, Reebok made unsupported claims in advertisements that walking in its EasyTone shoes and running in its RunTone running shoes strengthen and tone key leg and buttock (gluteus maximus) muscles more than regular shoes. The FTC’s complaint also alleges that Reebok falsely claimed that walking in EasyTone footwear had been proven to lead to 28 percent more strength and tone in
  the buttock muscles, 11 percent more strength and tone in the hamstring muscles, and 11 percent more strength and tone in the calf muscles than regular walking shoes.

  Under the settlement, Reebok is barred from:

  • making claims that toning shoes and other toning apparel are effective in strengthening muscles, or that using the footwear will result in a specific percentage or amount of muscle toning or strengthening, unless the claims are true and backed by scientific evidence;
  • making any health or fitness-related efficacy claims for toning shoes and other toning apparel, unless the claims are true and backed by scientific evidence; and
  • misrepresenting any tests, studies, or research results regarding toning shoes and other toning apparel.
   

• WOMMA Seeks Comments on its Privacy Guidelines
  
  

  Tony DiResta 9:03 am on September 19, 2011 | 0 Comments Permalink | Post Your Comment!
  

  
  

  WOMMA has just become engaged in an initiative concerning privacy, by providing tentative guidelines or recommendations for prudent business practices, and seeking commentary from its members.

  The “WOMMA Perspective on Privacy” is set forth below:

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  The Word of Mouth Marketing Association (“WOMMA”) http://www.womma.org, recognizes the continued importance of protecting privacy across all marketing and communications channels. While privacy is a multi-faceted issue, WOMMA believes that transparency and choice are at the heart of establishing and sustaining the meaningful connection between brands and consumers.

  To assist its members and the word of mouth/social media marketing industry, WOMMA seeks to commence a dialogue by providing preliminary draft recommendations. These recommendations, relating to the business practices of brands and their partners, are drafted as aspirational core principles designed to incorporate privacy protections into a company’s culture in a meaningful way. We look forward to receiving your feedback.

  I. Transparency, Openness, and Honesty:

  Brands should be open and honest about Personally Identifiable Information (“PII”) that they are collecting, using and sharing from consumers. Brands should communicate with consumers in a clear and conspicuous manner, and in a language that is understandable to the reasonable consumer or intended audience.

  II. Limiting Use:

  Brands should use PII collected from or about consumers for the purposes that they have clearly communicated.

  III. Relevance and Necessity:

  Brands should collect PII that is relevant and necessary to accomplish the specified purposes.

  IV. Retention:

  Brands should not retain PII for longer than necessary to fulfill the specified purposes or to otherwise meet legal requirements.

  V. Consumer Participation:

  Brands should seek to provide mechanisms for appropriate consumer review, access, and correction of PII that they maintain, to the extent practicable.

  VI. Data Quality and Integrity:

  Brands should strive to keep PII about consumers accurate and up-to-date.

  VII. Security:

  Brands should employ measures to protect PII based on the sensitivity of the information, the nature of the brand’s business, the potential of risks the brand faces, and the reasonable protections available to the brand. Brands should require that business partners who collect or use such PII on the brand’s behalf also adopt appropriate security measures.

  VIII. Accountability and Monitoring:

  Brands should be accountable for complying with these principles, by providing consumers with a readily accessible means to express concerns or complaints regarding adherence to these principles, and brands should respond to such concerns or complaints appropriately.

  ---

  In addition, WOMMA has released a Q&A to its members concerning the initiative and request for comments, which is set forth below:

  Q: What is the purpose of the WOMMA Perspective on Privacy?

  A: Privacy is a key concern of regulators, legislators, policy makers, trade associations as well as consumer groups —each one e weighing in on the debate. WOMMA wants to be a part of that conversation as the issues being discussed impact the ways in which members do business. Specifically, the principles set forth in the WOMMA Perspective are designed to educate our members about the ways in which privacy impacts a company’s core business practices as well as its marketing efforts. WOMMA wants to start a conversation as to what type of self-regulatory guidelines are appropriate and necessary.

  Q: How did WOMMA come up with the principles or framework?

  A: WOMMA’s Legal Affairs Committee initially created a framework that was then reviewed by the legal staffs of some brand members. The version was then submitted to the Board for its review and feedback, which included review by some of their legal staffs as well.

  Q: Is WOMMA mandating guidelines for privacy the way it did for disclosures in the Ethics Code?

  A: No. The current draft is aspirational, using the word “should” not “shall” in the draft. In addition, at this stage, WOMMA is merely seeking comments and feedback from its members as to the necessity of such guidelines, and, if so, what types of principles should be provided.

  Q: Why is privacy important to advertisers, marketers and communicators?

  A: Marketers sell products and services, and seek to create loyal customers who will share their enthusiasm for those products or services. During that “conversation” between the advertiser and customer, sensitive information can be transmitted, whether financial or personal. It is the sensitivity of that information that creates concerns about privacy. As noted in the Perspective on Privacy, WOMMA believes that transparency and choice are at the heart of establishing and sustaining the meaningful connection between companies and their customers.

  Q: Should I share this with others in my organization or company?

  A: Yes. Gaining feedback from not only marketers, but customer service representatives as well as lawyers would be very valuable. Privacy issues cut across many dimensions of a company’s business, and input from as many stakeholders as possible in an organization is truly necessary.

  Q: How do I provide comments on the Initiative?

  A: Feedback should be posted directly to the Living Ethics Blog http://womma.org/ethicsreview/ and please pass it along to others and encourage industry-wide participation in the conversation. Comments should be sent by September 30, 2011.

  The topic of privacy is obviously an important issue for consumers as well as regulators and legislators, and WOMMA is excited to become involved in the conversation. We look forward to receiving feedback concerning this initiative and guidelines. Please let me know if you have any questions.

  Many thanks for your interest,
  Tony DiResta
  adiresta@winston.com
  (202) 282-5782

   

• FTC Brings First Case Against Mobile Apps
  
  

  Tony 12:27 pm on August 24, 2011 | 0 Comments Permalink | Post Your Comment!
  

  
  

  In the FTC’s first case involving mobile applications, the Commission charged a developer of apps as well as the company’s president and owner with violations of the Children’s Online Privacy Protection Act (“COPPA”). Specifically, W3 Innovations (d/b/a Broken Thumbs Apps) develops and distributes mobile apps that allow users to play games and share information online. Several of W3’s apps were specifically directed to children, and were listed in the Games-Kids section of Apple’s App Store. W3’s games include “Cootie Catcher” and “Truth or Dare,” as well as a group of apps that invited kids to email questions and comments to “Emily” and submit postings to the Emily Blog.

  The FTC alleged that the company collected and maintained thousands of email addresses through the Emily apps, as well as allowed children to publicly post information, including personal information, on message boards. According to the FTC complaint, the company did not provide notice of their information-collection practices and did not obtain verifiable parental consent prior to collecting or disclosing personal information from children. The FTC complaint indicated that these apps were “online services directed to children,” and thus subject to the COPPA Rule.

  The parties settled with the FTC obtaining a $50,000 civil penalty from W3 and W3 agreeing to delete all information collected from children through the apps.

  This case demonstrates that the FTC views apps as “online services” potentially subject to COPPA. Companies should thus ensure that where appropriate their apps comply with COPPA. In particular, companies should take care with the following types of apps: apps that are directed to children, apps that are appealing to children, or apps through which companies know that they collect children’s information.

   

• WOMMA Submit Comments to FTC Concerning Dot Com Disclosures
  
  

  Tony DiResta 9:55 am on August 10, 2011 | 1 Comments Permalink | Post Your Comment!
  

  
  

  Today, WOMMA submitted formal Comments to the FTC concerning the Commission’s potential modification to Dot Com Disclosures: Information About Online Advertising. This promises to be a critical initiative by the Commission’s staff, as it seeks to provide guidance on the application of the “clear and conspicuous” standard to emerging technologies and new media platforms.

  WOMMA’s Comments are in set forth in several sections. Once section provides a snapshot of the current marketing environment, and discusses how the marketing and advertising industry is in the midst of a fundamental paradigm shift. Specifically, WOMMA notes that in our current environment, advertisers, marketers, consumers, brands, interested consumers groups, and associations, as well as governmental regulators, are witnessing the explosion of “social media platforms” through:

  • media fragmentation through the proliferation of new media devices;
  • the acceptance – - and daily use – - of consumer-generated content (such as YouTube, Facebook, and Twitter);
  • the acceptance and utilization of “search” in the consumer experience that encourages consumer-to-consumer communications about brands; and
  • a shift in the nature of commercial discourse – - whereby consumers are playing a more active role in shaping and sharing commercial messages.

  Another section discusses the FTC jurisprudence concerning the application of the “clear and conspicuous” standard and the consideration by the Commission of four key factors: (i) prominence; (ii) presentation; (iii) placement; and (iv) proximity; while another section provides a high-level discussion of emerging technology, identifying five general categories with examples for consideration: (1) location-based tools; (2) Twitter; (3) generic endorsements; (4) question and answer sites; and (5) recommendation/listing sites.

  The final section outlines general recommendations by WOMMA, and proposes that any guidance by the staff should be flexible and fluid, recognizing the practical constraints of certain media platforms, and without stifling innovation that may benefit consumers’ access to and control over their commercial and personal information and communications. In particular, WOMMA recommends that the FTC hold a public workshop on these issues to obtain the full input from all stakeholders.

  The Comments note that while WOMMA is committed to four key concepts that reside at the heart of consumer protection jurisprudence – - (i) transparency (or the disclosure of “material connections”); (ii) accuracy (or the communication of truthful information to consumers); (iii) honesty (or the avoidance of misleading or deceptive communications); and (iv) respect (or the recognition of the personal rights of others) – - WOMMA is committed to the appropriate development of emerging media that is designed not only to enhance commercial transactions but to provide mechanisms for meaningful social dialogue and appropriate entertainment for consumers of all ages.

  WOMMA recommends, therefore, that any guidance by the FTC should be flexible and fluid, recognizing the practical constraints of certain media platforms, and without stifling innovation that may benefit consumers’ access to and control over their commercial and personal information and communications. In a practical voice, WOMMA notes that the fundamental intent of consumers communicating on many of these emerging technologies is to engage in social interaction or entertainment, not obtain information that could materially influence their commercial business decisions.

  I look forward to your thoughts about WOMMA’s Comments and perspectives on the FTC initiative.

   

  • WOMMA Asks FTC for Clearer Disclosure in Online Advertising « Ad Network Magazine 11:22 am on August 12, 2011 Permalink
    

    [...] “Emerging technologies provide significant consumer benefits, and new media marketing and promotions have been embraced by brands and consumers alike, said Anthony DiResta, WOMMA General Counsel, in a press release. [...]

• FTC Commissioner Julie Brill: “The screen is small, but Section 5 applies.”
  
  

  Tony DiResta 9:56 am on August 8, 2011 | 0 Comments Permalink | Post Your Comment!
  

  
  

  Last week, at the American Bar Association’s annual meeting, FTC Commissioner Julie Brill said that mobile application developers are ignoring its regulatory guidance with respect to consumer privacy, telling attendees to expect enforcement soon.

  A recent report from the Future of Privacy Forum showed that nearly three quarters of the most popular mobile apps have no privacy policy at all. This market segment has fallen far short of the clear, comprehensive, and transparent privacy notices that are needed to avoid unfairness or deception within the meaning of Section 5 of the FTC Act, Brill said.

  “We will soon be seeing some enforcement actions on apps,” Brill said. “Section 5 covers apps—they are not excluded.”

  Commissioner Brill acknowledged that delivering a privacy policy on a mobile screen is more challenging than on a full-sized screen, which has proven problematic in itself. But the challenge does not excuse noncompliance, she noted. “The screen is small, but Section 5 applies,” Brill remarked. Developers should focus on the Commission’s advice to develop simplified notices, icons, and alternative delivery formats — including layered notices for more in-depth information that a consumer can access at his or her discretion, Brill added.

  Those recommendations were part of the Commission’s “privacy re-think,” as Brill called it.

   

• Potential New FTC Commissioner Strengthens Consumer Protection Focus
  
  

  Tony 10:03 am on July 25, 2011 | 0 Comments Permalink | Post Your Comment!
  

  
  

  The Obama administration has just announced its intention to nominate Maureen Ohlhausen as the next FTC Commissioner. She would replace Commissioner Bill Kovacic, who finishes his term in September of this year. While Kovacic is a strong antitrust academic, Ohlhausen is a practicing lawyer experienced in issues of privacy and consumer protection. This nomination, therefore, illustrates the growing focus on the FTC to address consumer protection issues.

  Ohlhausen served as Director of the Office of Policy Planning and as attorney advisor to former Commissioner Swindle. During her tenure, the OPP encouraged informative labeling and advertising designed to inform consumers, as well as clearer disclosure by mortgage lenders and pharmaceuticals.

  Ms. Ohlhausen clerked for Judge David Sentelle (D. C. Cir.) and Judge Robert Yock (Fed. Cl.). She received a B.A. from the University of Virginia and a J.D. from George Mason University School of Law, and has taught Unfair Trade Practices as an adjunct professor at her alma mater. Ms. Ohlhausen has also contributed academically to the analyses of the relationship between advertising and childhood obesity.

   

• Skin Cream Manufacturer Agrees to Pay $900,000 in Settlement With FTC Over Advertising Claims
  
  

  Tony DiResta 1:35 pm on July 11, 2011 | 1 Comments Permalink | Post Your Comment!
  

  
  

  The producer of the Nivea line of skin creams recently agreed to a $900,000 settlement with the FTC over advertising for its My Silhouette! body cream which claimed the product could dramatically reduce users’ body size. At issue was a television commercial depicting a woman able to fit into a pair of jeans (which had previously been too tight) after using the Nivea body cream. In addition, the FTC took issue with Nivea’s sponsored search results on Google. The sponsored search results included headlines such as “Want a Toned Stomach” and “Thin Waist” when users searched the terms “stomach fat” or “thin waist.” As part of the settlement, the producer may not claim that any product applied to the skin causes substantial weight or fat loss, or a reduction in body size. In addition, the company may not claim any drug, dietary supplement or cosmetic causes substantial weight or fat loss, or reduction in body size unless the claim is backed by reliable clinical studies.

  Takeaway: Efficacy claims must be supported by adequate substantiation. Sponsored search engine ads are subject to the same requirements as traditional advertising, and advertisers should be careful that their sponsored search results and other search engine optimization activities do not make unsubstantiated product claims.

  Link: click to read more.

   

  • FTC Drops a $900,000 Settlement on Skin Cream Manufacturer Over False Ad Claims | Rush.lt 2:45 pm on July 15, 2011 Permalink
    

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