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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.

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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 Releases Industry Guidance Regarding Adverse Event Reporting During COVID-19On March 19, the Food and Drug Administration (FDA) released guidance providing recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic, including COVID-19. The guidance revises and replaces final guidance released in 2012 entitled “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.”

At bottom, the FDA recommends that companies should maintain normal adverse event reporting procedures as much possible during a pandemic. However, the guidance recognizes that a pandemic may lead to high levels of employee absenteeism that could delay submission. In such a case, the FDA advises that companies focus their limited resources on the following types of reports:

  • reports related to medical products indicated for the treatment or prevention of the pathogen causing the pandemic;
  • reports on products presenting special concerns as specified and communicated by FDA; and
  • other reports indicated Table 1 of the FDA guidance.

Where a company is able to report more than this minimum amount, the FDA advises that companies prioritize the order of reports. For example, companies should submit 15-day reports before 30-day reports, and should submit both before periodic safety reports.

In the event that adverse event reporting is delayed during a pandemic, the company should retain documentation of:

  1. the declaration of the pandemic, including date of declaration of the pandemic and ending date of the pandemic, and
  2. high absenteeism and/or other factors that prevent the company from meeting normal adverse event reporting requirements.

When business operations return to normal, the FDA expects that companies will submit any adverse event reports stored during the duration of the pandemic. The guidance states that companies should submit all reporting requirements within 6 months of restoration of the adverse event reporting process to its pre-pandemic state. Companies should submit stored reports in order of priority (e.g. 15-day reports first, then 30-day reports, followed by periodic safety reports.)

The guidance also recommends that companies create a continuity of operations plan (COOP) in the event of a pandemic. Such COOP should include instructions for reporting adverse events and provide a plan for the submission of any stored reports at the end of the pandemic. Companies can refer to the HealthCare Emergency Preparedness Information Gateway site, which provides resources for developing a COOP.

More resources on the FDA’s response to COVID-19 are available on its website here. We will continue to monitor for updates from the FDA regarding advice to industry. In the meantime, stay well!

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

This week, the Food & Drug Administration (FDA) made a series of announcements in connection with its efforts to address the outbreak of COVID-19.  The Agency sought to reassure the American public that the U.S. food supply remains safe and that there is no evidence of food or food packaging being associated with the transmission of COVID-19.  The Agency also announced plans to scale back domestic and foreign food facility inspections and temporarily halt enforcement of supplier verification onsite requirements for receiving facilities and importers under the Food Safety Modernization Act (FSMA).

We’ll continue to monitor for updates and post them here.  More details follow on these and other FDA COVID-19 related developments.

  • Food safety, shortages, and COVID-19 transmission.  In a press conference on Wednesday, the Agency reiterated that the food supply is safe and robust, and that industry has reassured the Agency that current shortages in stores are indicative of heavy consumer demand and not an overall issue with food supply.  Also in a release and in FAQs from the Centers for Disease Control and Prevention (CDC) published on FDA’s website, the Agency noted that while “possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes,” this is not thought to be the primary way the virus is transmitted and “there is no evidence to support transmission of COVID-19 associated with food.”  As a result, FDA indicated that food does not need to be recalled or otherwise removed from commerce if a food industry employee tests positive for COVID-19.
  • Domestic food facility inspections.  Also on Wednesday, FDA announced that it would temporarily postpone all domestic routine surveillance facility inspections.  Some for-cause inspection assignments may proceed if determined to be “mission-critical,” and if there is a “way to get there to accomplish them in a way that does not put anyone at risk,” according to Michael Rogers, the assistant commissioner for human and animal food operations in the Office of Regulatory Affairs (ORA).  In a departure from current practice of conducting unannounced inspections, Mr. Rogers indicated that the majority of domestic inspections would be announced for the foreseeable future.
  • Supplier verification requirements.  On Tuesday, the Agency issued guidance announcing its intention to exercise enforcement discretion in connection with supplier verification onsite audit requirements for receiving facilities and importers.  These requirements derive from three separate rules promulgated to implement FSMA, the Preventive Controls for Human Food (PC Human Food) rulePreventive Controls for Animal Food (PC Animal Food) rule, and Foreign Supplier Verification Programs (FSVP) rule– and require receiving facilities and importers to conduct supplier verification activities based on the hazard analysis conducted as part of their written Food Safety Plan or FSVP.   The Guidance explained that FDA does not intend to enforce these requirements, provided the following criteria are met:
    • A receiving facility or FSVP importer has determined that an onsite audit is the appropriate verification activity for an approved supplier, as reflected by its written food safety plan or FSVP;
    • The supplier that is due for an onsite audit is in a region or country covered by a government travel restriction or travel advisory related to COVID-19;
    • Because of the travel restriction or travel advisory, it is temporarily impracticable for the receiving facility or FSVP importer to conduct or obtain the onsite audit of the supplier; and
    • The receiving facility or FSVP importer temporarily selects an alternative verification activity or activities, such as sampling and testing food or reviewing relevant food safety records, and modifies its food safety plan or FSVP to incorporate the alternative activity or activities. The alternative verification activity or activities are designed to provide temporary assurance that the hazard requiring a supply-chain-applied control (or, for FSVP, the hazard that is being controlled by the foreign supplier) has been significantly minimized or prevented during the period of onsite audit delay.
  • Foreign food facility inspections.  Earlier this month, FDA announced that it planned to postpone most foreign facility inspections through April.  The Agency plans to conduct “mission-critical” inspections on a case-by-case basis and work with the U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products.

The Agency has also emphasized that it has a strong partnership across public and private sectors and is coordinating daily with industry and other agencies.  FDA also noted that the food and agriculture sectors are classified as critical infrastructure for purposes of federal and state directives and thus employees should be able to continue to go to and from work in communities with curfews and shelter-in-place directives.  FDA urged food companies that experience any supply-chain problems to contact FEMA’s National Business Emergency Operations Center at NBEOC@fema.dhs.gov.

More resources on the FDA’s response to COVID-19 are available on its website here.

hat products they can use to disinfect their homes and offices to protect against the coronavirus that causes COVID-19With the ongoing spread of the coronavirus, and as stories of hording Purell and antimicrobial wipes abound, this practitioner* has been inundated recently by questions — from clients, co-workers, family, and friends — about what products they can use to disinfect their homes and offices to protect against the coronavirus that causes COVID-19.  Unfortunately, there is no shortage of unproven remedies being touted on websites and in mass emails, not to mention the rumor mill.  (*Remember, I’m a lawyer practicing in the antimicrobial regulatory field, not a medical doctor!)

The good news:  According to the U.S. Environmental Protection Agency (EPA) and the Centers for Disease Control and Prevention (CDC), coronaviruses are among the class of viruses that are the most easy for many disinfectant products to kill.  EPA’s “emerging pathogens” policy (more details of which can be found here in my prior blog post) establishes a three-tiered hierarchy of viruses according to how resistant they are to being killed (or “inactivated”) by typical disinfectant products.  “Enveloped viruses,” such as the coronavirus, are in the third tier, meaning that they “are the least resistant to inactivation by disinfection.”

The structure of these viruses includes a lipid envelope, which is easily compromised by most disinfectants. Once the lipid envelope is damaged, the integrity of the virus is compromised, thereby neutralizing its infectivity.   

EPA is now implementing its “emerging pathogen” policy and has issued a list of disinfectants that the agency believes to be effective against SARS-CoV-2 (the formal name of the novel coronavirus that causes COVID-19).  The EPA list is available here.

Typically, to be registered for use against a specific bacteria or virus, disinfecting/antimicrobial products must submit to EPA test data showing that the product is effective against that particular microbe.  EPA’s “emerging pathogens” policy was established to allow for the legal use of disinfectants against a novel virus for which no product would as yet have EPA approval and for which test data and methods may not exist.  The policy recognizes that a disinfectant that is effective against viruses in the same family as the novel virus, or which are effective against “harder to kill” viruses under the three-tier hierarchy noted above, should be effective against the new pathogen.

So, as a consumer, how does one know if a particular disinfectant for sale at the store (or, perhaps more likely in these quarantine days, for sale on-line) is likely to be effective against SARS-CoV-2?  Here are a few things to look for:

(1) Any legal disinfectant product must have an EPA registration number on the product label.  Look for “EPA Reg. No.” (followed by a series of numbers) in the fine print on the product label, usually near where other manufacturer or distributor information is provided. (Of course, not all registered disinfectants will be effective against the novel coronavirus, but to be legal it must at least have an EPA registration.)

(2) Check to see if that EPA Reg. No. is on the EPA list noted above.  However, as EPA is still working through submissions to include specific products on that list, there are others out there that may be effective, but just have not finished the expedited approval process for making coronavirus claims.

(3) Look for “coronavirus” in the list of microbes against which the product has been tested to be effective, as specified on the product label.  While no product labels as yet will state effectiveness against the SARS-CoV-2 novel coronavirus, they may have been tested for effectiveness against other coronaviruses (such as SARS and MERS).

(4) While on-product labels are not allowed to carry “emerging pathogen” claims, EPA’s policy allows registrants who meet certain criteria to provide information about effectiveness against an emerging pathogen on a product website, in social media, and in communications with health care professionals.  If the policy criteria are met, these products can include on such platforms a statement similar to the following:

Product X has demonstrated effectiveness against viruses similar to SARS-CoV-2/the novel coronavirus on hard surfaces. Therefore, Product X can be used against the novel coronavirus when used in accordance with the directions for use against [name of similar supporting virus(es)] on
hard surfaces. Refer to the CDC website for additional information.

Hope this is helpful and that everyone stays healthy and well-sanitized!

As the novel coronavirus (COVID-19) has reached pandemic levels, companies of all sizes and in all industries face myriad impacts to business operations and the health and well-being of employees.

To help clients navigate these new challenges, including the unpredictability of any outbreak-related business disruption, Kelley Drye has compiled a free resource center to help businesses navigate this uncertain environment.

Check it out for articles, webinars, and blog posts that cover a range of topics, including the following:

  • Legal exposure due to business interruptions and unsatisfied contracts, including counsel on contractual obligations, especially for significant business concerns.
  • Supply chain disruptions that are impacting the manufacture of consumer goods forcing manufacturers to seek alternative product sources that meet U.S. consumer regulations.
  • All types of employment issues, including how to communicate to your employees, managing affected employees, remote work policies, privacy of record and employee travel, among other pressing issues.
  • Evaluating disruptions to trading and markets, M&A/corporate transactions, commercial contracts, corporate governance (contingency planning for annual meetings) and disclosures for publicly traded companies.
  • Monitoring the federal government’s efforts to address these issues, as well as emerging issues that businesses may face.

We are updating the COVID-19 Resource Center as events unfold so check back regularly.

Wednesday, July 22
Selling Online: How to Avoid Flattening the Curve of an Uptick in Website Traffic
Register Here

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

Register Here

July 29
Cleaning Up From 2020: Guidance for Disinfectant, Germ and Virus Killing Claims
Register Here

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.

Register Here

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.

Register Here

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

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: