In the following article authored by University of Arizona Law Professor Jane Bambauer, the professor makes a compelling argument that FTC/FDA regulation of health claims should focus on situations  where the government has compelling evidence of actual harm.   Professor Bambauer offers an opinion that high standards for health benefit claims can effectively silence commercial speech in areas where science may still be developing, to the detriment of consumers.   The current method of analysis, the Professor contends, does not give adequate weight to consideration of the consequences of prohibiting a claim that may actually be true – one of the six Pfizer factors that is regularly overlooked in substantiation analysis.

To read the article, please click here.

The consumer advocacy non-profit Truth in Advertising, Inc. (TINA.org) has set its sights on Goop, the lifestyle brand launched by Gwyneth Paltrow.  In a complaint filed earlier this week with the Santa Clara and Santa Cruz County California district attorneys, both members of the California Food and Drug and medical Device Task Force, TINA alleges they found over 50 instances where claims were made that products Goop produces or promotes “can treat, cure, prevent, alleviate the symptoms of, or reduce the risk of developing a number of ailments.”  TINA has requested that the California district attorneys investigate Goop’s marketing practices. 

This is not the first time Goop has been forced to defend claims that it promotes.  Last summer, the National Advertising Division took issue with claims related to using “dust” dietary supplements, such as Action Dust and Brain Dust, both sold by Moon Juice.  The NAD closed the case after Goop agreed to permanently discontinue the dust claims. Continue Reading TINA Has Eyes on Goop

For the first 28 weeks of 2017, the most frequently alleged claims in new food and beverage false-advertising class actions have related to featured product ingredients that allegedly are absent, or present only in small quantities, in the food at issue.

We reviewed news reports and other mentions of newly-filed food advertising class actions for the first part of 2017 and tabulated the central cause or causes of action to learn where the current substantive focus is in these cases. Out of 52 new food advertising class actions reported between January 1 and July 15 as having been newly filed, the largest single category – 12 cases – alleged the absence of an ingredient that was featured on the product’s label and/or marketing.  Three of the suits concerned truffle-infused cooking oils, alleging that these products actually contained no truffles.  Two cases were filed against makers of ginger ales, which the suits alleged contained no ginger.  Single cases alleged that a guacamole contained very little avocado, that coconut water contained no coconut, that veggie snacks contained no vegetables, that canned octopus was really squid, and that “steak” in a sandwich was really non-steak ground beef.

The other major categories reflect the types of food advertising claims that have been much in the news in recent months. Nine cases concerned “natural” claims.  Nine cases objected to “no sugar added” or similar claims, generally on the basis that evaporated cane juice allegedly was not characterized as a sugar.  Seven cases concerned slack fill, and a further four cases alleged underfill (i.e., not that there was empty space in the package, but that the actual weight of product was less than the stated weight).  Five cases accused the food of overstating its healthiness, and a further three charged that the product falsely claimed a nutritional benefit.  Four cases alleged that an undesirable ingredient claimed not to be in the product, such as trans fat or preservatives, actually was present.

The accompanying chart shows the 52 actions broken down into categories of claims asserted. The total assertions amount to more than 52 because some cases asserted more than one type of claim.

Based on this analysis of 2017 thus far, the two takeaways for food manufacturers are (1) advertising class actions are alive and well and remain a threat, and (2) manufacturers should pay close critical attention to the accurate characterizing of their ingredients. Other well-known controversies over hot-button issues like “natural” claims, slack fill, and the treatment of evaporated cane juice continue to play out in the courts and to be the subject of new challenges.

(Click here to enlarge image.)

A mini-trend in food litigation last year was the spate of class action cases alleging that foods advertised as “natural” contained trace amounts of the herbicide glyphosate.  “Trace” is the operative word; to the extent plaintiffs alleged the amounts they found, those amounts always were far below even what the U.S. Department of Agriculture permits to exist in foods labeled “organic.”  The plaintiffs nevertheless argued that foods labeled as “all natural” cannot contain any traces of a biocide, no matter how small.

Continue Reading Minnesota Federal Judge Says Glyphosate Claims are “Unreasonable”

New York Attorney General Eric Schneiderman recently announced settlements with three mobile health app developers resolving allegations that they made deceptive advertisements and had irresponsible privacy practices. The Attorney General alleged that the developers sold and advertised mobile apps that purported to measure vital signs or other indicators of health using just a smartphone. The apps had over a million downloads, giving these concerns considerable consumer reach. The Attorney General’s office reportedly became aware of the apps through consumer complaints and reports to the Health Care Bureau.

Failure to Properly Substantiate Health Benefit Claims

The NY AG’s core concerns regarding the advertising claims were as follows:

  • Runtastic created “Heart Rate Monitor, Heartbeat & Pulse Tracker”. The NY AG alleged that Runtastic promoted its app as a product that purports to measure heart rate and cardiovascular performance under stress but had not tested the app with users engaged in vigorous exercise.
  • Cardiio created and sold the “Cardiio Heart Rate Monitor”. Cardiio allegedly also marketed its app as a means of monitoring heart rate following vigorous movement but had not tested the app under those conditions. In addition, the NY AG alleged that Cardiio’s representations that its product was endorsed by MIT were deceptive.

Representations Consistent with a Regulated Medical Device

  • Matis’s “My Baby’s Beat-Baby Heart Monitor App” raised slightly different concerns. Matis allegedly promoted the app with statements such as “Turn your smartphone into a fetal monitor with My Baby’s Beat app” and language that encouraged consumers to use the app as an alternative to more conventional fetal heart monitoring tools.  The app allegedly had not undergone proper review by the FDA to be marketed as such, however.

As readers of this blog and our sister blog, Food and Drug Law Access, know, the FDA has authority to regulate medical devices and has taken a risk-based approach to consumer-directed mobile health products.  The FTC has been even more active than the FDA in bringing health-related enforcement actions, as we have written about here, here, and here.  As these federal agencies transition into a new administration, the NY AG is making clear with these settlements that regulators are still watching for potentially misleading health claims.

The NY AG also alleged several problematic privacy practices, including the following:

  • Failing to disclose the risk that third parties could re-identify de-identified user information,
  • Issuing conflicting statements on data sharing under the Privacy Policy and under the Privacy Settings,
  • Failing to disclose that the company collected and provided to third parties consumer’s unique device identifiers,
  • Employing a practice of consent by default, where a consumer is deemed to have consented to a privacy policy just by using the website, and
  • Failing to disclose that protected health information collected, stored, and shared by the company may not be protected under the Health Insurance Portability and Accountability Act.

As we noted in a previous post on privacy and data security in mobile health apps, legal compliance is all too often an afterthought when it comes to app development. These allegations underscore the importance of understanding and reconciling data collection and use practices with the statements companies make to consumers.

The Oregon AG recently announced a $545,000 settlement with the Vitamin Shoppe over allegations that the store violated Oregon state law by selling dietary supplements containing ingredients that FDA has deemed unsafe or unlawful. The new settlement agreement places significant burdens on the Vitamin Shoppe to monitor developments on ingredient status. The burdens are the same regardless of whether the Vitamin Shoppe sells a product under one of its own brands – or if it sells a product that was manufactured, labeled, and sold to it by a third party vendor.

Under the terms of the agreement, if the Vitamin Shoppe “receives or learns of” a “written notice” from FDA that an ingredient may be unsafe or unlawful, it must “take immediate action to suspend the sale of such products or products known to contain the ingredients.” If the Vitamin Shoppe becomes aware of any other “public announcement, warning, alert, publication, notice, or report” suggesting that the U.S. government, Australia, Canada, Britain, or the EU might consider a dietary ingredient unsafe or unlawful under the FDCA, then the Vitamin Shoppe must conduct a “reasonable due diligence review,” which may result in a decision not to sell any products containing the ingredient.

This settlement is notable for at least two reasons:

  1. It identifies FDA warning letters sent to the Vitamin Shoppe or anyone else as “written notice” that FDA has deemed an ingredient unsafe or unlawful.  Warning letters, however, state only allegations and are not considered “guidance” under FDA’s rule on “good guidance practices.”  Well after a warning letter is issued, the lawfulness of a particular dietary ingredient can be the subject of much ongoing debate, and even the FDA’s official guidance document on ingredient status remains in flux after years of debate.
  2. The settlement represents an aggressive stance by Oregon on a retailer’s liability for product formulation and labeling by third parties.  As we’ve discussed before, there isn’t a whole lot of precedent for regulators going after the retailer, rather than the product seller.

The Oregon Attorney General is currently in litigation against another retailer over similar allegations related to the legal status and safety of a dietary ingredient.

Kelley Drye Ad Law publishes News & Views: Dietary Supplement Advertising, which covers developments ranging from FTC and FDA regulation, class actions, Customs developments, and Prop 65. Subscribe to future issues by filling out your information and checking the Dietary Supplements Practice Group box here.

Did you know Kelley Drye’s Advertising Law practice produces a newsletter, Ad Law News and Views, every two weeks to help you stay current on ad law and privacy matters? Click here to access our Publication Sign Up and select Advertising and Marketing to subscribe. Find contents from the latest issue below:

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Recent News

Chairman Kaye Steps Down as CPSC Chair; Republican Buerkle Assumes Role of Acting Chair

CFSAN Director Anticipates “Tweaks,” Not Rollbacks Despite Administration’s De-Regulation Emphasis

Smart TV Manufacturer “Smarting” after $2.2 Million Privacy Enforcement

FTC Announces Changes at the Helm of the Bureau of Consumer Protection; Thomas Pahl to Take Over as Acting Bureau Director Following Jessica Rich’s Departure

Not a Passing Grade: FTC Settles with Company Over Alleged False Advertising for High School Diploma Program

EU Data Protection Authority Issues GDPR Action Plan, Swiss Sign Privacy Deal with U.S.

New FTC Acting Chair Maureen Ohlhausen Offers Insight into Consumer Protection Priorities

CIT Adds New Requirements for ‘Assembled in USA’ Claims Analysis

FTC Cries Foul On Breathometer Accuracy Claims

Spotlight On Our New Texas Offices

Kelley Drye & Warren LLP recently merged with Jackson Gilmour & Dobbs, P.C., a highly respected Texas law firm best known for success in environmental litigation matters. The team also brings substantial experience in sophisticated regulatory and commercial litigation matters. The merger strengthens Kelley Drye’s litigation and environmental practices, as well as extends our national presence.

The collective environmental practices broaden Kelley Drye’s nationwide capabilities in site remediation, cost recovery, natural resource damages, and related insurance litigation, creating a powerhouse firm for businesses contemplating sales and acquisitions, debt and equity financings, and real estate development and construction where environmental issues may be present.

Please read more about our Environmental Law and Environmental Litigation capabilities, as well as our new offices in Houston and Austin

Analysis 

Marketing in a Multi-Device World: Update on Cross Device Tracking

On January 25, Kelley Drye hosted a webinar on maintaining transparency and respecting consumer choice while achieving marketing objectives. Megan Cox, Attorney at the Federal Trade Commission, J. Jurgen Van Staden, Vice President, Policy & Technology at the Network Advertising Initiative, and partner Dana Rosenfeld discussed recent law enforcement activity, such as the FTC’s recent settlement with Turn Inc., as well as self-regulatory guidance and enforcement issues surrounding cross device information tracking and uses. For a copy of the slide deck, please click here.

Our next webinar will be on “Litigation is Inevitable: Update on Recent Advertising Class Actions” February 22. Please click here for more information and to register.

To sign up to receive future webinar invitations, please click here and sign up to receive communications from the Advertising and Marketing practice group.

Suing over Empty Space: Why Lawsuits over Slack Fill in Packaging Are Growing

Partner Kristi Wolff co-authored the Nutritional Outlook article “Suing over Empty Space: Why Lawsuits over Slack Fill in Packaging Are Growing.” The article discusses the rise in lawsuits regarding slack fill, or the difference between the capacity of a container and the volume of the product inside. Read more…

ABA Section of Antitrust Law Presidential Transition Report

Partner Bill MacLeod addressed the American Bar Association’s Section of Antitrust Law with an introductory note to the Section’s 2017 Presidential Transition Report. The American Bar Association Section of Antitrust Law released its 60-page eighth sequential Presidential Transition Report, which offers a retrospective of current state and federal antitrust and consumer protection law and policy, as well recommendations for ways the new Trump administration might consider further strengthening policy and enforcement to deal with new antitrust challenges on the horizon. Read more…

Has the Supreme Court’s Resolution of Spokeo Played Out as Expected?

Partner Lee S. Brenner co-authored the Bloomberg BNA article “Has the Supreme Court’s Resolution of Spokeo Played Out as Expected?” On May 16, 2016, the United States Supreme Court held in Spokeo Inc. v. Robins that a consumer cannot satisfy the injury-in-fact demands of Article III by alleging only a bare procedural violation of a statute, divorced from any concrete harm. The article examines the Spokeo decision and how that case impacted litigation in various contexts, including data privacy, the Truth in Lending Act (TILA), the Fair and Accurate Credit Reporting Act (FACTA), and the Telephone Consumer Protection Act (TCPA). Read more…

Fifty Countries and Counting, Sixty Sessions and More – at Spring Meeting: A Message From Bill MacLeod, Chair, Section of Antitrust Law

Partner William MacLeod authored his monthly address to the American Bar Association’s Section of Antitrust Law. This month’s message features The Spring Meeting of the Section of Antitrust Law. Read more…

Upcoming Events and Speeches

Toys for Sale: IoT Devices and Connected Kids
February 15, 2017 |WEBINAR
American Bar Association
Dana B. Rosenfeld

Litigation is Inevitable: Update on Recent Advertising Class Actions
February 22, 2017 | WEBINAR
Jeffrey S. Jacobson

Regulation of Cosmetics
March 3, 2017 | WASHINGTON, DC
Introduction to U.S. Food Law and Regulation
Kristi L. Wolff

Doing Data Right: Legal Best Practices for Making Your Data Work
March 16, 2017 |SAN JOSE, CA
Strata + Hadoop World 2017
Alysa Zeltzer Hutnik

Eyes on the 1-800 Prize: IP Restrictions and Online Competition
March 29, 2017 | WASHINGTON, DC
65th Antitrust Law Spring Meeting
David H. Evans

Multi-State Privacy/Security Investigations: Expert Roundtable
April 20, 2017 |WASHINGTON, DC
Global Privacy Summit 2017
Alysa Zeltzer Hutnik

Impact of the 2016 Election on Antitrust and Consumer Protection Class Actions
April 27, 2017 |SEATTLE, WA
Law Seminars International’s Litigating Class Actions
Jeffrey S. Jacobson

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The FTC recently announced a settlement with Breathometer, Inc., a company that marketed a smartphone accessory that it claimed could detect blood alcohol levels.  Users could simply plug the accessory into the headphone jack, open the Breathometer app, blow, and receive a reading of their blood alcohol content within five seconds.  Breathometer marketed the products as “FDA registered devices,” featuring “law enforcement”-grade technology, to help you “make informed, dependable decisions” about whether to drive after drinking.

The FTC alleged that Breathometer did not have adequate substantiation for its performance claims. Specifically, the products were tested to determine accuracy at .02% blood alcohol content, not .08%, which is the legal limit under state laws.  In addition, testing revealed that the accuracy of the Breeze version of the product degraded over time and the company did not have a means of recalibrating it remotely.  Breathometer stopped selling the Breeze product but allegedly did not adequately inform consumers of the issue.

This case is yet another illustration of the FTC taking the lead on mobile health products that are or could potentially be regulated by the FDA. As readers of our Food and Drug Law Access blog may know, FDA has taken a risk-based approach to regulation of such products and, with the exception of products that could cause patient harm or death upon malfunction, is exercising regulatory discretion. Yet, many companies, particularly those who are new to the health market, presume that FDA is the primary, if not the only, regulator likely to have an interest in their product and claims.

Not so. The FTC has repeatedly voiced concerns about the proliferation of mobile health apps and whether claims were being properly substantiated, particularly where disease diagnosis, treatment, or mitigation claims are featured.  Along with the Breathometer matter, the Lumosity, Melanoma Detective and Aura Labs cases collectively demonstrate that when it comes to many consumer-directed mobile health products, the regulator most likely to take interest is the FTC.

Please join Kelley Drye in 2017 for the Advertising and Privacy Law Webinar Series. Like our annual in-person event, this series will provide engaging speakers with extensive experience and knowledge in the fields of advertising, privacy, and consumer protection. These webinars will give key updates and provide practical tips to address issues faced by counsel.

This webinar series will commence January 25 and continue the last Wednesday of each month, as outlined below.

January 25, 2017 | February 22, 2017 | March 29, 2017 | April 26, 2017 | June 28, 2017
July 26, 2017 | September 27, 2017 | October 25, 2017 | November 29, 2017

Kicking off the series will be a one-hour webinar on “Marketing in a Multi-Device World: Update on Cross Device Tracking” on January 25, 2017 at 12 PM ET. For more information and to register, please click here. CLE credit will be offered for this program.

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