Amid the flurry of products making coronavirus-related claims, some without legal approval or scientific support, one class of products raises unique questions:  so-called “pesticide devices,” like ozone generators and ultraviolet (UV) lights, which are instruments that claim to control pests — including viruses and other germs — through physical or mechanical means.  Unlike chemical pesticides, such devices are not required to be registered by EPA and, therefore, are not scrutinized by the agency to ensure they are safe to use or work as intended.

Accordingly, EPA recently issued an advisory that cautions:

Please note that ozone generators, UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.

Pesticide devices, unlike some existing surface disinfectant products that have data on file with EPA showing effectiveness against similar viruses, are not eligible under the agency’s Emerging Pathogens Policy to make claims related to the coronavirus/SARS-CoV-2 or for inclusion on EPA’s “List N” of products deemed to be effective against the virus.

Pesticide devices, though not subject to registration, are subject to other EPA requirements.  For example, while devices will not have an “EPA Registration Number,” they are required to be labeled with an “EPA Establishment Number” to identify the facility at which the device was produced.  In particular, any claims made for devices may not be false or misleading, and, therefore, manufacturers should have data on file to substantiate any claims.  It is possible, therefore, that a device could be effective against coronavirus, and legally could make such claims, though companies should be prepared to defend the statements.  To do so, companies should look carefully at the criteria for claim approval in EPA’s Emerging Pathogens Policy.

EPA is actively pursuing enforcement in regard to illegal coronavirus claims, further information on which can be found at https://www.epa.gov/enforcement/covid-19-enforcement-and-compliance-resources.

Advertising LawEPA issued another in a series of recent advisories aiming to clarify for consumers and companies what they need to know about disinfectant products claiming to kill the coronavirus.  EPA is actively investigating the numerous tips and complaints it continues to receive concerning products marketed with possibly false and misleading coronavirus/COVID-19 related claims.

For some of these products, those claims have not been reviewed or accepted by EPA and, therefore, may present a risk to consumers, and healthcare providers in particular.

Products that claim to disinfect and kill or otherwise inhibit viruses, bacteria and other germs must be registered with EPA before they can be sold.  A disinfectant cannot make legal claims of effectiveness against a particular pathogen, such as SARS-CoV-2, unless EPA has specifically approved the claim as part of the registration process. Registration requires that any claim be supported by valid test data and an EPA determination that the product works as intended and is safe to use.

Earlier this year, EPA issued a list of disinfectants (“List N”) that meet the agency’s criteria for use against the coronavirus (SARS-CoV-2, the strain of coronavirus that causes COVID-19).  While the surface disinfectant products on List N have not been tested specifically against SARS-CoV-2, they are expected to work against the virus because they demonstrate efficacy against other viruses that are deemed harder-to-kill or another similar strain of coronavirus.

Please note that just because the product label states that it kills “99.5% of viruses,” this does not necessarily mean that it will kill coronavirus.

Consumers are reminded to follow the label directions for approved disinfectants — particularly regarding the amount of time the product must remain wet on the surface — to ensure effectiveness in killing the virus.  Use of a disinfectant in a manner inconsistent with label directions can pose safety risks, both from contact with the pesticide and from a false belief that the surface has been cleaned of the pathogen.

See my prior post on EPA enforcement activity in this area, as well as a more detailed description of EPA’s approval policy for products deemed effective against SARS-CoV-2.

EPA’s advisory is available here.  List N can be found at:  www.epa.gov/ListN.

On June 2, California Attorney General Xavier Becerra announced that he had submitted final CCPA regulations to the Office of Administrative Law (OAL) for review. The final regulations are substantively identical to the second set of modified proposed regulations, which the AG released in March. In addition, the AG issued a Final Statement of Reasons that (1) explains the changes between the first draft and final regulations, and (2) is accompanied by Appendices that respond to each public comment received throughout the rulemaking process – including written comments submitted in response to each draft of proposed regulations and those provided at the four public hearings held in December 2019.

We have described below some of the key provisions of the final regulations, which will impose additional requirements on businesses, service providers, and third parties and data brokers, and likely require the design and implementation of new processes. Whatever hardship the regulations may cause, it is clear that the AG is prioritizing consumer privacy, explaining that the office “has made every effort to limit the burden of the regulations while implementing the CCPA” and does not believe the regulations are “overly onerous or impractical to implement, or that compliance would be overly burdensome or would stifle businesses or innovation.” Continue Reading CCPA Update: Final Regulations Submitted but No Changes from Prior Draft

In previous posts, we’ve written about Section 230 of the Communications Decency Act. Like it or hate it, Section 230 has become integral to the internet, and it’s no exaggeration to say that social media probably couldn’t work without it.

As a refresher, Section 230 generally states that an online platform can’t be held liable as a publisher or speaker for content provided by someone else. The law does not provide a blanket immunity, however. Platforms can be held liable when they are “responsible, in whole or in part, for the creation or development” of unlawful content. The question in many CDA cases is at what point a platform crosses the line between simply allowing others to post content and playing a role in the creation of that content. (Click here for a look at how one of those cases played out.)

Another provision states that a platform cannot be held liable for actions taken in good faith to restrict access to material that the platform “considers to be obscene, lewd, lascivious, filthy, excessively violent, harassing, or otherwise objectionable, whether or not such material is constitutionally protected.”

The question of when a platform can be liable for content became a little more murky last week, after President Trump signed an Executive Order on Preventing Online Censorship. The Order, which came after Twitter decided to fact-check a pair of the President’s tweets, is purportedly designed to stop online platforms from making content moderation decisions that discriminate against particular viewpoints.

Although the Order includes provisions that have alarmed some social media platforms, there are questions about whether the Order is constitutional, and some experts predict that the impact will be limited. For a more detailed analysis, see what our friends at CommLaw Monitor have to say.

In a victory for cosmetics companies everywhere, the Second Circuit has affirmed the dismissal of slack fill allegations claiming that L’Oréal’s pump dispense mechanism for serums, lotions, and liquid makeup prevents consumers from utilizing every drop of product.

Last August, we reported on the Southern District of New York’s decision granting L’Oréal’s motion to dismiss a putative class action alleging that a common pump dispense mechanism used on L’Oréal’s cosmetics bottles deceptively prevented consumers from accessing the entirety of the product.  Judge Koetl disagreed, finding that consumers are familiar with pump dispensers on cosmetics packaging, and that the plaintiffs’ alleged “disappointment” did not “establish deception” or “transform [L’Oréal’s] accurate labeling of the product’s net weight into fraud by omission.”  Judge Koetl also found that the plaintiffs’ claims were preempted by the Federal Food, Drug and Cosmetics Act (“FDCA”).  Because federal law requires L’Oréal to label its cosmetics products with the net quantity of the product, irrespective of the amount that is accessible through the pump, Judge Koetl found that the plaintiffs’ claims were preempted.

The Second Circuit agreed.  Because the plaintiffs conceded that L’Oréal’s packaging complied with the FDCA with respect to the net-quantity of the product, the court found that, in order to avoid liability under the plaintiff’s theory, L’Oréal would have to “make an additional disclosure on its packaging, indicating that some cream cannot be retrieved or that the cream that is accessible is less than the net quantity displayed on the package label.”  (emphasis added).  Because such a theory would “impose labeling requirements on top of those already mandated in the FDCA,” the claims were preempted.

The Second Circuit did not reach the “reasonable consumer” grounds for the District Court’s decision, and we expect that the plaintiffs’ bar will continue to try to plead around FDCA preemption in slack fill cases.  But this decision will severely hinder their ability to do so—at least in the Second Circuit—and plaintiffs may start looking elsewhere to pursue these allegations.

Advertising and Privacy Law Resource Center - Another Slack Fill Preemption Win for the Cosmetics Industry (Jaclyn Metzinger)

A recent Marketplace Tech podcast episode on the spike in demand for mental health apps caught our attention.  As shocking headlines and stay-at-home orders rolled across the country, demand for mental health apps increased almost 30% since the pandemic began, according to CNBC.  And there is a wide variety of options to choose from, with roughly 20,000 mental health apps available across app stores.  This got the editors of Marketplace Tech asking two questions:  Do mental health apps work?  And what are the regulatory and privacy implications?  It’s worth a listen when you have time and we figured that we could weigh in as well.

Do they work?

One psychiatrist interviewed for the Marketplace Tech story questioned whether the apps should be required to demonstrate effectiveness to the FDA prior to being marketed.  In fact, some of them are, but many are not.

The starting point for this analysis is whether the app or the software is regulated as a medical device.  The Food Drug and Cosmetic Act defines a device as “…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory”, that is “… intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man …” or “… intended to affect the structure or any function of the body of man or other animals…”  Apps that meet this definition are regulated as medical devices and are subject to FDA’s pre-market review requirements, unless they are low risk and subject to FDA’s enforcement discretion policy.

Given the need for patients and consumers to access mental health therapy remotely and in increased numbers over recent weeks, FDA relaxed its requirements for apps intended to help treat depression, anxiety, obsessive compulsive disorder and insomnia.  FDA’s Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency suspends the 510(k) premarket notifications, corrections and removal notifications, registration and listing requirements, and unique device identification (UDI) requirements for computerized behavioral health devices and other digital health therapeutic devices for psychiatric disorders where those devices do not create an undue risk during the COVID-19 emergency.

There are thousands of apps that relate to mental health and overall wellbeing in some way, however, many of which are not within the definition of “medical device” and do not require premarket review.  FDA’s General Wellness:  Policy for Low Risk Devices explains the agency’s enforcement discretion approach more generally.

In addition, thinking about the “do they work” question, companies marketing these products should also be mindful of the FTC’s claim substantiation requirements.  Health claims are subject to a particularly high bar for claim substantiation – competent and reliable scientific evidence.  In simple terms, this means evidence that is sufficient in quantity and quality such that experts in the field would agree that it supports the claim.  The FTC has pursued app developers (see here and here) whose claims exceeded their substantiation and has issued dozens of warning letters to marketers making aggressive claims that their products can prevent or treat COVID-19.  Companies marketing apps that claim to help address mental and physical health conditions should be mindful of the substantiation requirements and of closely tailoring their claims to their evidence.

What about privacy?

Many apps used by physicians are subject to HIPAA, but the vast majority of health-related apps are not covered by HIPAA.  As health-related apps have proliferated, companies are collecting and storing massive amounts of consumer data.  Many apps do not feature a clear explanation about privacy practices and how data is being stored or used.  As we’ve chronicled here, non-HIPAA health privacy and the need for developers to be transparent with consumers about their privacy practices has been an FTC concern for several years.  Our Advertising and Privacy Law Resource Center provides a wealth of free content to help app developers understand the applicable legal framework.

More specifically related to privacy and data tracking in the era of COVID-19, our “Data Privacy Considerations for Coronavirus Data Tools” provides key considerations for companies seeking to build contact tracing and related health apps.  These include issues such as the following: whether personal information is involved, what level(s) of transparency are appropriate relative to data practices, how to address government requests for information, and considerations related to licensing COVID-19-related personal information.

What’s the takeaway?

As daily life has increasingly shifted online, it’s more important than ever for app developers to understand how their products are regulated and to build those features in to the product and how it is marketed.  In addition, FDA’s temporary relaxation of pre-marketing review standards for certain mental health apps does not mean that the FTC’s claim substantiation and privacy compliance requirements are relaxed for health-related apps more generally.  If anything, we should anticipate an increased regulatory focus on these issues.

* * * *

Ad Law Access Podcast

On the latest episode of the Ad Law Access Podcast, Advertising and Marketing partner Kristi Wolff discusses three keys to making compliant health claims:  determining the product regulatory classification, claim substantiation standards, and the importance of context.  This episode is a prequel to her earlier Health Claims in the Context of COVID-19 episode which focused on recent FTC and FDA enforcement relating to false COVID-19 health claims and the importance of considering the current pandemic context in health-related marketing.

Listen on Apple,  SpotifyGoogle Podcasts,  Soundcloud or wherever you get your podcasts.

For more information, visit:

Ad Law Access Podcast -        Health Claims 101: Key Considerations For Making Compliant Health Claims On the latest episode of the Ad Law Access Podcast, Advertising and Marketing partner Kristi Wolff discusses three keys to making compliant health claims:  determining the product regulatory classification, claim substantiation standards, and the importance of context.  This episode is a prequel to her earlier Health Claims in the Context of COVID-19 episode which focused on recent FTC and FDA enforcement relating to false COVID-19 health claims and the importance of considering the current pandemic context in health-related marketing.

Listen on Apple,  SpotifyGoogle Podcasts,  Soundcloud or wherever you get your podcasts.

For more information on health claims and other topics, visit:

Advertising and Privacy Law Resource Center -        Health Claims 101: Key Considerations For Making Compliant Health Claims

FDA and FTC Joint Warning Letters Target Amazon Affiliates Making False COVID-19 ClaimsEarlier this week, federal regulators continued their efforts to combat the spread of products featuring allegedly false and misleading claims that products can diagnose, treat, cure, or prevent COVID-19.  In warning letters issued to CBD Gaze, Alternavita, Musthavemom.com, and Careful Cents LLC, the agencies identify the respective recipients as participants in the Amazon Affiliate program.  Amazon Affiliates are marketers who earn commissions by promoting products sold on Amazon.  The letters state that the products at issue, which include essential oils, grapefruit seed extracts, cod liver oil, and others, feature false treatment and prevention claims such as the following:

  • CBD Gaze:  “Find the best CBD Oil to help fight Coronavirus.”
  • Alternavita:  “4 Proven Ways To Protect Yourself Against Coronavirus,” you represent that “Everyone is concerned about Coronavirus and looking for ways to protect themselves,” and then state the following:

“Grapefruit Seed Extract If you want a little extra daily protection GSE is a safe antibiotic . . . [Amazon associate link].”

  • Musthavemom.com:  “NATURAL REMEDIES FOR CORONAVIRUS. . .There are plenty of things you can do to boost your immune system and fight off any virus including coronavirus. Here are a few!”  … “2. Vitamin D . . . This important vitamin plays a crucial role in immune health. Being deficient in Vitamin D can increase your risk of infection. I recommend this brand of Vitamin D [Amazon associates link] and starting at a minimum dose of 5,000 IU.” [from your website https://musthavemom.com/coronavirus-prevention-treatment-plan/]
  • Careful Cents LLC:  “How to Boost Your Immune System Naturally With Essential Oils to Fight Coronavirus” you state: “Can you use essential oils to boost your immune system and fight coronavirus? Yes! Essential oils are one of the best tools to strengthen your immune system naturally . . .”

The letters state that the products are unapproved new drugs and misbranded pursuant to the Food Drug and Cosmetic Act.  Causing the introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).  The letters also state that “it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.  For COVID-19, no such study is currently known to exist for the product identified above.  Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence.”

What’s the lesson?  The difference between these letters and the warning letters that FDA and the FTC issued earlier this year is that these are targeted not to the company making the product or even the retail platform on which they are sold.  They were sent to the middleman marketer, who likely does not produce or possess the product, but who is promoting and profiting from its sale.  This is consistent with the FTC’s letters to product influencers in other marketing contexts but is a departure from FDA’s typical enforcement approach.  Although we have seen FDA pursue retailers (particularly online ones), FDA has not made pursuit of marketing affiliates a priority.  Clearly, regulators want affiliate marketers (Amazon or otherwise) to understand that they are not immune from enforcement if they are making aggressive or unsubstantiated health claims.

Ad Law Access Podcast

 

Ad Law Access Podcast - Operationalizing CCPACCPA compliance is a cross-functional exercise that requires active participation and buy-in from business units across the organization to tackle data mapping, work flows and employee training. On the latest episode of the Ad Law Access Podcast, special counsel Tara Marciano and associates Carmen Hinebaugh and Alexander Schneider discuss the ongoing challenges of operationalizing CCPA compliance focusing broadly on two areas: rights requests and vendor agreements.

Listen on Apple,  SpotifyGoogle Podcasts,  Soundcloud or wherever you get your podcasts.

For more information on CCPA and other topics, visit:

Advertising and Privacy Law Resource Center - Operationalizing the California Consumer Privacy Act (CCPA)

Green Marketing PodcastAs we have written about extensively on this blog, consumers continue to grow more environmentally conscious and demand products that reflect this concern. To meet consumer demands and as part of social responsibility initiatives, companies are increasing their “sustainable” practices, recycling materials, upcycling other products, and working to reduce waste and environmental harms.  As companies look to communicate their efforts to consumers, they must proceed with caution to avoid allegations of “greenwashing” or overstating the environmental benefits.

On the latest episode of the Ad Law Access Podcast, Advertising and Marketing practice Christie Thompson and associate Lee Baumgardner discuss the key regulatory requirements (the FTC’s “Green Guides”) and practical tips for companies to consider when engaging in green marketing in the United States.

Listen on AppleSpotify, Google PodcastsSoundcloud or wherever you get your podcasts.

For more information on these and other topics, visit:

Advertising and Privacy Law Resource Center Green Marketing