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Wednesday, July 22
Selling Online: How to Avoid Flattening the Curve of an Uptick in Website Traffic
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COVID-19 has increased the already dizzying amount of online sales, making the applicable marketing requirements increasingly important. These rules affect not just how companies advertise and promote products and services online, but also how they bill and otherwise interact with consumers before, during, and after a transaction.

This webinar will include practical tips to help companies minimize risk of enforcement and litigation and provide practical guidance. Topics include:

  • Endorsers and Influencers
  • Promotions and Pricing
  • Subscription Plans and “Free” Trials
  • Shipping and Delivery
  • Consumer Reviews and the Consumer Review Fairness Act
  • Customer Service Considerations – how timely refunds and responsiveness can help reduce legal risks

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July 29
Cleaning Up From 2020: Guidance for Disinfectant, Germ and Virus Killing Claims
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COVID-19 has brought a proliferation of products claiming to kill or otherwise inhibit viruses, bacteria and other germs. These products, before they can be legally sold, are heavily regulated by the U.S. Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and sometimes both. Major enforcement actions are pending against companies making illegal claims or selling unregistered products. Meanwhile, the FTC regulates advertising of many sanitizing products and the agency has pursued enforcement on companies that overstate their products’ germ-killing performance.

Please join us for a webinar covering the basics of germ killing and related product claims.

Discussion topics include:

  • The regulatory landscape: Who regulates what – EPA, FDA and FTC jurisdiction and requirements
  • What can you say and when can you say it
  • Potential liability and enforcement considerations
  • What to do if you receive a warning letter or other enforcement action

Anyone who is currently making or planning to make pesticide products, microbiology laboratory personnel with efficacy testing responsibilities, manufacturers of sanitizing products including lights, retailers of sanitizing products, anyone new to claims or in need of a refresher should join us for this webinar.

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July 30
California Consumer Privacy Act (CCPA) for Procrastinators: What You Need To Do Now If You Haven’t Done Anything Yet
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The coronavirus pandemic has put many things on hold, but CCPA enforcement is not one of them. The California Attorney General’s enforcement authority kicked in on July 1, 2020, and companies reportedly have begun to receive notices of alleged violation. In addition, several class actions have brought CCPA claims. Although final regulations to implement the CCPA have yet to be approved, compliance cannot wait.

If you’re not yet on the road to CCPA compliance (or would like a refresher), this webinar is for you.

We will cover:

  • Latest CCPA developments
  • Compliance strategies
  • Potential changes to the CCPA if the California Privacy Rights Act (CPRA) ballot initiative passes

Anyone who has not begun their CCPA compliance efforts or thinks they need a refresher should join us for this webinar.

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Advertising and Privacy Law Resource CenterFind replays of our webinars and other relevant key resources on the Advertising and Privacy Law Resource Center.

COVID-19 has increased the already dizzying amount of online sales, making the applicable marketing requirements increasingly important. These rules affect not just how companies advertise and promote products and services online, but also how they bill and otherwise interact with consumers before, during, and after a transaction.

Join partner Christie Thompson and senior associate Katie Townley for this webinar which will include practical tips to help companies minimize risk of enforcement and litigation and provide practical guidance. Topics include:

  • Endorsers and Influencers
  • Promotions and Pricing
  • Subscription Plans and “Free” Trials
  • Shipping and Delivery
  • Consumer Reviews and the Consumer Review Fairness Act
  • Customer Service Considerations – how timely refunds and responsiveness can help reduce legal risks
Who Should Attend

Anyone who is currently or plans to conduct business online with consumers or otherwise facilitates online transactions should join us for this webinar.

Register Here

Also join us for:

Cleaning Up From 2020: Guidance for Disinfectant, Germ and Virus Killing Claims

COVID-19 has brought a proliferation of products claiming to kill or otherwise inhibit viruses, bacteria and other germs. These products, before they can be legally sold, are heavily regulated by the U.S. Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and sometimes both. Major enforcement actions are pending against companies making illegal claims or selling unregistered products. Meanwhile, the FTC regulates advertising of many sanitizing products and the agency has pursued enforcement on companies that overstate their products’ germ-killing performance.

Please join us for a webinar covering the basics of germ killing and related product claims.
Discussion topics include:

  • The regulatory landscape: Who regulates what – EPA, FDA and FTC jurisdiction and requirements
  • What can you say and when can you say it
  • Potential liability and enforcement considerations
  • What to do if you receive a warning letter or other enforcement action
Who Should Attend

Anyone who is currently making or planning to make pesticide products, microbiology laboratory personnel with efficacy testing responsibilities, manufacturers of sanitizing products including lights, retailers of sanitizing products, anyone new to claims or in need of a refresher should join us for this webinar.

Register Here

On June 15, the Eastern District of California, Judge Morrison J. England, granted CBD retailer Global Widget, LLC’s (“Global Widget”) request to stay the case of Glass v. Global Widget LLC, Case No. 2:19-cv-01906 (E.D. Cal.) until the U.S. Food and Drug Administration (“FDA”) completes its rulemaking regarding the marketing and labelling of CBD ingestible products.  This marks the third time this year that a federal court has paused class action litigation over alleged misbranding of products containing CBD.

Judge England’s decision relied heavily on the CV Sciences, Inc. decision from Judge Phillips that we wrote about previously.  In both cases, the class action plaintiffs alleged that they would not have purchased the defendants’ CBD products if they had known that the products were not legally sold in the United States (as they alleged).  Judge England adopted the same analysis from the CV Sciences, Inc. decision and stayed the case pursuant to the primary jurisdiction doctrine.  This is another decision in a constantly-growing string of authority pausing false advertising claims over CBD products, and we expect a wave of motion practice, as well as new complaints being filed, once FDA’s final guidelines are released.

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.

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.

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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:

Earlier 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

 

Despite the lack of a private right of action to enforce the U.S. Federal Food, Drug and Cosmetics Act (“FDCA”), the plaintiffs’ bar continually tries to use the FDCA to support other causes of action, and more often than not class actions, challenging the marketing or labeling of cosmetics.  A recent decision by the Southern District of California, where many of these cases are filed, will hopefully deter this practice.  See Franz v. Beiersdorf Inc. et al., Case No. 3:14-cv-02241, (S.D. Cal. Apr. 15, 2020).

The FDCA defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body… for cleansing, beautifying, promoting attractiveness, or altering the appearance.”  Drugs, by contrast, are articles “intended to affect the structure or any function of the body of man.”  While a seller must seek approval from the FDA before selling a drug, there is no pre-approval requirement for cosmetics, and Congress gave FDA the sole authority to police violations of the FDCA.

The original complaint in Franz, filed in 2014, alleged that Beiersdorf’s Nivea Skin Firming Hydration Body Lotion (the “Lotion”) claimed on its label that it provided skin firming hydration, improved skin’s firmness in as little as two weeks, and was proven to firm and tighten skin’s surfaces in as little as two weeks.  According to the plaintiff, because the Lotion was marketed to affect the structure or function of the skin, it was a drug (not a cosmetic), and should have gone through FDA’s pre-approval process.

After an amended complaint and two motions to dismiss, as well as an appeal to the Ninth Circuit, the Defendant filed a third motion to dismiss, arguing that the complaint failed to state a claim that the Lotion was, in fact, a drug.  The Court denied the motion.  Beiersdorf then filed a motion for summary judgment arguing that the plaintiff was preempted by the FDCA from privately enforcing the federal pre-market approval process for drugs and, in the alternative, asked the court to find that the Lotion was a cosmetic as a matter of law.

The Court granted Beiersdorf’s motion, explaining that claims seeking to enforce the FDCA must thread a “narrow gap” to escape preemption – the plaintiff must be suing for conduct that violates the FDCA, but not because the conduct violates the FDCA.  The plaintiff failed to meet this standard because she repeatedly referenced provisions of the FDCA and specifically alleged that “Defendant engaged in illegal conduct by unlawfully making skin firming representations about [the Lotion] that resulted in its being deemed a drug under FDA regulations, but did so without obtaining required FDA approval through the FDA NDA [New Drug Approval] process.”  Because there was “no reasonable way to construe this allegation except as an attempt to privately enforce the FDCA,” the claim was preempted.

Interestingly, the Court noted that because the relevant facts were not in dispute and because the motion largely turned on a question of law, a motion to dismiss would have been the better procedural vehicle for resolving the issue.  Cosmetics companies should always consider whether they have valid preemption arguments at the motion to dismiss stage.  This decision (from one of the more plaintiff-friendly jurisdictions in the country no less) is hopefully another tool to resolve costly class actions litigation at an early stage.

The decision was appealed to the 9th circuit on May 18, 2020.

 

Advertising Law - Advertising and Privacy Resource Center

As business people, airport management, and event hosts everywhere try to figure out how they can return to business as usual, many are considering telethermographic device systems.  These are cameras that can detect human temperature in comparison to their surroundings to help identify fevers.  Reuters reported last week that Amazon implemented thermal cameras at its warehouses to scan for feverish employees.  This has prompted many to wonder how telethermographic devices are regulated.

FDA helped answer this question last Friday.  In its “Enforcement Policy For Telethermographic Systems During the COVID-19 Public Health Emergency,” FDA explains that use of such cameras to detect human temperature – even when used outside of a medical facility such as in an airport – may render the systems medical devices typically subject to pre-market clearance, registration, listing, and quality regulations.  However, during the current pandemic, FDA is relaxing those regulations provided that the systems meet performance and labeling criteria.

The systems must be tested and labeled consistent with the following:

1) IEC 80601-2-59:2017: Medical electrical equipment – Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening; OR

2) Alternative performance specifications that provide similar results to IEC 80601-2-59:2017. The guidance lists several alternative standards.

FDA recommends labeling that includes the following:

1) A prominent notice that the measurement should not be solely or primarily relied upon to diagnose or exclude a diagnosis of COVID-19, or any other disease;

2) A clear statement that:

  1. a) Elevated body temperature in the context of use should be confirmed with secondary evaluation methods (e.g., an NCIT or clinical grade contact thermometer);
  2. b) Public health officials, through their experience with the device in the particular environment of use, should determine the significance of any fever or elevated temperature based on the skin telethermographic temperature measurement;
  3. c) The technology should be used to measure only one subject’s temperature at a time; and
  4. d) Visible thermal patterns are only intended for locating the points from which to extract the thermal measurement.

FDA also recommends labeling that explains the performance specifications, proper use, installation, and related technical considerations listed in the guidance.

Companies considering using these devices will want to keep in mind that FDA is likely to reinstate the regulatory requirements post-pandemic.  When screening vendors, companies should consider whether the vendor will be able and willing to comply with the medical device standards once the economy has re-opened to a significant degree.

In addition, this technology raises employee and consumer privacy issues.  Prior to using it, companies should consider applicable laws and policies around notice to the public or employees, capturing such data, potentially storing or sharing it.

 

In the midst of continued enforcement regarding coronavirus marketing, FDA sent a warning letter to NeuroXPF concerning advertising for its CBD products alleging that they can boost immune systems to help consumers avoid contracting the virus. Citing the need to take “urgent measures to protect consumers” in the midst of the coronavirus outbreak, FDA advised NeuroXPF to remove claims indicating that the company’s products mitigate, prevent, treat, diagnose, or cure COVID-19.

NeuroXPF’s website included claims that consumers should “take CBD and take advantage of its potential to help prepare your body to fight a coronavirus infection.” According to the company, taking CBD “right now” “can help keep your immune system at the stop [sic] of its game.” NeuroXPF’s products had not, however, undergone the FDA’s new drug approval process.

Suggesting that NeuroXPF products can mitigate, prevent, treat, diagnose, or cure any disease, including coronavirus, without having undergone FDA new drug approval, makes the products unapproved drugs in violation of the FDCA, per the FDA.  NeuroXPF has 48 hours to email the agency detailing the steps the company has taken to correct any violations.

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As we’ve written about on our sister blog, Ad Law Access, federal and state regulators have been active in pursuing purveyors of scam products and price gougers.  For other helpful information during this pandemic, visit our COVID-19 Resource Center and our Advertising and Privacy Law Resource Center.

FDA took action earlier this week to relax regulatory standards for gowns, hoods, and surgeons’ and patient examination gloves during the pandemic.  The policy applies to the following products:

Table 1

Classification
Regulation
Device Type Product
Code6
Class
21 CFR 878.4040 Conductive Shoe and Shoe Cover BWP I (exempt)
21 CFR 878.4040 Operating-Room Shoes FXW I (exempt)
21 CFR 878.4040 Surgical Apparel Accessory LYU I (exempt)
21 CFR 878.4040 Non-surgical isolation gowns OEA I (exempt)
21 CFR 878.4040 Surgical suits FXO I (exempt)
21 CFR 878.4040 Operating-room shoe covers FXP I (exempt)
21 CFR 878.4040 Surgical helmets FXZ I (exempt)
21 CFR 878.4040 Surgical dress FYE I (exempt)
21 CFR 878.4040 Surgical caps FYF I (exempt)
21 CFR 878.4040 Surgical gown/toga FYA II
21 CFR 878.4040 Patient gown FYB II
21 CFR 878.4040 Surgical isolation gown FYC II
21 CFR 878.4040 Surgical hood FXY II

Table 2

Classification
Regulation
Device Type Product
Code
Class
21 CFR 880.6250 Patient examination glove FMC I (reserved)
21 CFR 880.6250 Latex Patient Examination Glove LYY I (reserved)
21 CFR 880.6250 Polymer Patient Examination Glove LZA I (reserved)
21 CFR 880.6250 Finger Cot LZB I (exempt)
21 CFR 880.6250 Vinyl Patient Examination Glove LYZ I (reserved)
21 CFR 880.6250 Powder-Free Guayle Rubber Examination Glove OIG I (reserved)
21 CFR 880.6250 Powder-Free Polychloroprene Patient Examination Glove OPC I (reserved)
21 CFR 880.6250 Radiation Attenuating Medical Glove OPH I (reserved)
21 CFR 880.6250 Specialty Patient Examination Glove LZC I (reserved)
21 CFR 878.4460 Surgeon’s Gloves KGO I (reserved)
21 CFR 878.4460 Powder-Free Non-Natural Rubber Latex Surgeon’s Gloves OPA I (reserved)

As it has for face masks and respirators, FDA is exercising enforcement discretion with respect to non-surgical gowns, surgical gowns, patient exam gloves, and surgeon’s gloves.  Provided that these items are marketed using labeling that expressly delineates the uses for which they are appropriate, warns against uses that may create excessive risk, meets applicable barrier protection/flammability/sterility standards, and does not indicate a use that may increase risk, FDA is relaxing standards for device registration and listing, premarket notification (where applicable), and quality system regulation compliance.  The guidance includes specific labeling criteria for each of these items.  The policy is effective immediately.

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For other helpful information during this pandemic, visit our COVID-19 Resource Center and our Advertising and Privacy Law Resource Center.