AD-ttorneys@law – July 8, 2020

Alerts / July 8, 2020
In This Issue:
FTC (Not) Blinded by the Light

In a first, Commission goes after low-level light therapy device makers


The Willow Curve is an attractive device with all the hallmarks of contemporary design. It’s an arc of molded plastic with a live touch screen and a charging dock. The open section of the arc can fit comfortably over a variety of body parts, including over and under the knees, wrists and neck.

The inside of the arc is where the magic (supposedly) happens — low-level light emits from within this “Dynamic Hyper-Pulsed Curve”; the light is meant to provide “smart and safe temporary pain relief right in the convenience and safety of your home.” The touch screen allows the user to adjust the light level, temperature and other configurations. The overall appearance and “vibe” of the Willow Curve is one of its most appealing characteristics: It looks like a piece of sophisticated hospital equipment.

But perhaps the single most important selling point of all: Chuck Woolery — game show host extraordinaire, actor, folk and country musician — pitched the device in a series of television commercials that ran beginning in 2015, the cornerstone of a larger promotional campaign.

The Takeaway

The Federal Trade Commission (FTC or Commission), however, took exception to a number of statements made by the companies behind the Willow Curve (and two of the companies’ officers). It’s the first action involving low-level laser therapy (LLLT).

First off: A slew of false and unsubstantiated claims, covering improvements in mobility and joint function, “significant” pain relief, and specific pain relief for a range of conditions were alleged by the FTC.

Some of these claims were exacerbated by the fact that the Willow Curve was touted as “clinically proven.” The Commission maintains that the Willow Curve team can’t provide scientific justification for its claims. “When LLLT sellers say their devices will relieve pain, they’d better have the scientific proof to back it up,” the FTC’s press release threatens.

Moreover, the Commission claims, the Willow Curve companies “represented … that [the] FDA reviewed, registered, accredited, certified, approved, or cleared Willow Curve” for several therapies. That validation simply does not exist, the Commission claims.

In the face of these allegations, Willow Curve settled with the FTC, accepting an injunction prohibiting further deceptive practices and a $22 million judgment.

FTC Promotes ‘Made in the USA’ Guidance to a Rule

Civil penalties now in play when advertisers fall afoul of the flag

Ad Men vs. Predator

Back in 1997, the FTC issued its “Enforcement Policy Statement on U.S. Origin Claims,” and its outlines have shaped the fate of “Made in the USA” claims ever since.

In case you missed it, the original guidance works like this:

Advertisers and marketers cannot make unqualified Made in the USA claims unless the final assembly or processing of the product occurs in the United States, all significant processing that goes into the product occurs in the United States, and all (or virtually all) ingredients or components of the product are made and sourced in the United States.

Of course, we’ve covered the application of this guidance multiple times — here, here, here, also here and don’t forget about here. You know what? Forget it, here’s an exhaustive search.

There are so many of these dustups that it feels as if the guidance were invisible — an immense beast of prey that is able to strike again and again simply because it doesn’t make any noise. It’s been lurking in the thickets of advertising regulation for more than 20 years, and people keep getting mauled by it.

The Takeaway

Having covered so many of these Made in the USA disputes, it’s hard for us to come up with a novel spin for the takeaway. Something akin to “follow the FTC guidance” is what it always seems to boil down to. But, bless the Commission, it made our job easier this time around.

Just a few days ago, the FTC issued a notice of proposed rule-making for the original enforcement policy guidance. And while the thrust of the policy remains, civil penalties will now be directly provided for in the rule. The FTC Act limits both the Commission’s rule-making and civil penalty authority, but both become possible where regulations are needed to counter a deceptive or unfair practice that the Commission can establish as pervasive.

The new rule is a product of recent activity at the Commission — back in September of last year, the FTC put together a Made in the USA workshop (you can watch it here). A staff report on the workshop was issued in the same release announcing the new rule, and it documents what the Commission sees as the long-standing prevalence of deceptive Made in the USA claims. And the comment period is about to open, so weigh in if you want a say in how the rule develops (or whether it changes at all).

Supplement Producer Suffers Vague-aries

Elderberry syrup maker sets off COVID alarms at NAD

Your Mother Was a Hamster …

We’re dating ourselves once more. But perhaps Monty Python and the Holy Grail is an evergreen classic?

In any case, ever since we first saw the classic historical spoof, we’ve puzzled over one of the most quoted lines in the movie: when John Cleese, playing an insulting French knight, tells Graham Chapman’s King Arthur that his “father smelled of elderberries.”

“What did that even mean?” our teenage selves asked.

Luckily, one of the joys of this blog is the research into random facts we never thought we’d need to know.

Apparently, elderberries — genus sambucus — stink. So that’s straightforward enough. Beyond that, it’s an interesting plant — its juice is used to create deep purple dyes. And while the plant is toxic, parts of it can be cooked and brewed into tea, cordials and medicinal products.

We’re sure you know where we’re headed with this.

Il Mar, Il Suol

Introducing Provezza Laboratories, producers of Provezza Elderberry Syrup. Unlike the Pythons, these people are serious about elderberries. Maintaining that “not all elderberries are created equal,” the company’s founder gets her elderberries “handpicked” from “ancient” farms in Italy. It’s an artisanal touch that goes hand in hand with the company’s earthy, sun-kissed lifestyle brand.

These quality berries are pressed into a syrup that the company was only recently touting on Instagram as “Potent Immune Support During A Severe Season” and “highly concentrated to deliver antioxidant action for immune defense.”

Such advertising is problematic for two reasons. The first is mundane — despite centuries of use in folk medicine, there’s no clinical proof that elderberries have any beneficial medicinal effect. The second is exceptional — the world is being ravaged by a pandemic, and regulators and watchdogs are on high alert for anything that may be construed as a COVID-19-related claim.

The Takeaway

The National Advertising Division (NAD) contacted Provezza as part of its regular rounds. “NAD shares the FTC and FDA’s concerns and is using its monitoring resources to find claims for products touting misleading health-conferring benefits related to COVID-19 as part of its public interest mission to protect consumers particularly during this unprecedented time,” it wrote in a recent press release.

But before the inquiry began, Provezza had removed the Instagram post in question and its claims, which, the company said, had run their natural course. The company agreed to not reiterate such claims in the future, even though it “disagreed that the post challenged by NAD conveyed the implied claim that Provezza Elderberry Syrup protects users against COVID-19.”

The lesson is obvious: The context of the times is as important as the design of the package. In today’s environment, everyone in the dietary supplement business should be as explicit as possible about their claims, even if they seem only vaguely related to the ongoing health crisis.

TINA Fires First Salvo at Virtual Influencers

FTC is reviewing endorsement rules; watchdog group seeks CGI inclusion

It’s About Time

The FTC’s endorsement guides are up for review. And boy, do they need it.

They were last amended in 2009, and we all know how much has changed since then. Now that the world is hurtling forward on Internet time, perhaps it’s time to reevaluate the FTC’s 10-year review schedule?

Given the glacial review process, Truth In Advertising Inc. (TINA) isn’t going to let this opportunity go by without weighing in. They’ve been a prickly burr on the backside of social media influencers since 2016, when they exposed an undisclosed ad for Coca-Cola in a Selena Gomez Instagram post.

TINA is weighing in on the endorsement guide through the open comment period (you can join in too) with a letter that covers a number of topics: disappearing posts, endorsements aimed at children, and audience expansion through fake accounts. These topics are all worth reviewing, but we want to focus on the strangest, coolest aspect of TINA’s recommendations: How should the Commission rein in virtual influencers?

Turing Fail?

A global takeover by a malevolent artificial intelligence (AI) is a mainstay of science fiction. Generally, the AI that seizes control evolves from a military project — think the Terminator franchise, or Colossus: The Forbin Project, if you’re into the oldies. But what if the impending AI overlord was born in the marketing industry?

Before you laugh, consider that virtual influencers — computer-generated characters used to promote brands and products on social media — are regularly brushing shoulders with our online personae. Lil Miquela, for instance — a virtual influencer created by an independent company — endorses a variety of products. She has 2.4 million followers. She also releases spacey pop music.

Will Lil Miquela and her ilk take over our credit card accounts and start shopping for us? The influencer singularity might be closer than you think. Consider the following stat, outlined by TINA in the press release accompanying its comment: 42 percent of respondents to a recent survey followed an influencer without knowing the account was virtual.

The Takeaway

What does TINA want the FTC to do? Well, it should start by officially adding virtual influencers to its definition of endorsement, the watchdog says. Then, it should make the virtual influencers subject to the same disclosure requirements that real humans are.

These suggestions, however, are simply an extension of existing guidance.

Things get more interesting when it comes to the guidance provision requiring that endorsements “reflect the honest opinions, findings, beliefs, or experience of the endorser.” What can that mean when applied to a virtual influencer? TINA suggests new disclosures to reveal the virtual nature of the influencer, which cannot have “opinions” or “beliefs” in the normal sense of the word.

Read the letter. It’s chock-full of interesting recommendations and contains a helpful historical perspective on influencer advertising.

FDA Launches Aptly Named Podcast

“FDA Insight” will lift the curtain on FDA goings-on for the layperson

Before It Was Cool

Remember when podcasts were edgy?

They never were. Right. Of course not.

But since podcasts flooded the cultural landscape, the arch pleasure of letting a friend in on a “Serial” or a “WTF” or a “How Did This Get Made?” before they blew up counted for something. Didn’t it?

Well, buckle up. We’re letting you in on the ground floor of something that promises to be hot. Or as hot as podcasts can be. So kinda not at all.

The Food and Drug Administration (FDA or Administration) just dropped — that’s hip lingo for “released” — the first episode of its new podcast, “FDA Insight.”

Don’t you love the enigmatic title?

The Takeaway

Kidding aside, it’s worth a listen. The inaugural episode features FDA Commissioner Dr. Stephen Hahn and FDA Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah in a wide-ranging discussion of the Administration’s COVID-19 efforts, including drug development initiatives.

That said, it’s not a COVID-19-only exercise; in the words of Shah, the podcast will break down “FDA actions into plain language, and [provide] insight for patients, consumers, and healthcare professionals.” Future episodes will tackle “vaccine development, food safety, sunscreen, and other topics that we at FDA work on every day.”

If you depend on information from the often-inscrutable Administration, this is welcome news. We’re looking forward to the next installment.

Baker & Hostetler LLP publications are intended to inform our clients and other friends of the firm about current legal developments of general interest. They should not be construed as legal advice, and readers should not act upon the information contained in these publications without professional counsel. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you written information about our qualifications and experience.