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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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.

 

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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.

 

 

 

On March 25, FDA issued immediately effective guidance regarding its enforcement policy for face masks and respirators.  In light of widespread reports of mask and respirator shortages, the purpose of the guidance is to expand the availability of general use face masks for use by the general public, and of filtering facepiece respirators (N95 respirators) for use by health care professionals.  The guidance applies to the following products:

DA issued immediately effective guidance regarding its enforcement policy for face masks and respirators

FDA acknowledges that face masks and respirators are regulated by FDA when they meet the definition of a medical device and are intended for a medical purpose.  The intended use may be indicated by labeling indicated that the products that are intended for use by a health care professional or in a health care facility or environment.  It may also be indicated by inclusion of any drugs, biologics, or anti-microbial/anti-viral agents.

FDA Does Not Intend To Object To Use Of Non-FDA-Cleared Masks When FDA-Cleared Masks Are Not Available

However, FDA also acknowledges that these same products may be manufactured to the same specifications but not intended for use as a medical device.  Face masks and filtering facepiece respirators are marketed to the general public for non-medical purposes, such as use in construction.  Because these are non-medical uses, FDA does not have jurisdiction over these products.  The agency does not intend to object to individuals’ distribution and use of improvised PPE (a mask that is not FDA-cleared) when no FDA-cleared alternatives are available.

Face Masks (Not Respirators) That Are and Are Not Intended To Provide Liquid Barrier Protection

The guidance delineates specific conditions under which it will not object to the distribution of face masks (but not respirators) that are not intended to provide liquid barrier protection along with surgical masks intended to provide liquid barrier protection, e.g., required labeling and directions, compliance with consensus standards, and compliance with flammability standards.

Reprocessing FFRs and Emergency Use Authorizations (EUA) for Face Masks Intended For A Medical Purpose, Surgical Face Masks and N95 Respirators

The guidance also addresses EUAs of filtering facepiece respirators (FFR) and face masks intended for a medical purpose, surgical face masks and N95 respirators.  FDA is interested in interacting with manufacturers regarding reprocessing of otherwise disposable N95 particulate filtering facepiece respirators to facilitate marketing via an emergency use authorization.  The guidance lists specific reprocessing informational standards that FDA would find useful.

Further, regarding face masks intended for a medical purpose, surgical face masks, and N95 respirators, FDA is seeking to interact with manufacturers whose products do not fall within the prior EUAs to determine whether their products may be able to meet EUA requirements. The guidance lists specific informational elements that FDA would find useful in such discussions.

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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.

FDA issued updated guidance regarding manufacture of alcohol-based hand sanitizerAs reports of hand sanitizer shortages have circulated and consumers have taken to using even Tito’s Vodka as a replacement (yes, on their hands), FDA has stepped in to provide clarity.  Last Friday, FDA issued updated guidance regarding manufacture of alcohol-based hand sanitizer.

The first guidance document, Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), is immediately in effect. It outlines that the agency does not intend to take action against manufacturing firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs during this ongoing public health emergency, provided they comply with specific conditions, including the following:.

  1. The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
  2. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or Isopropyl Alcohol (75%, v/v) in an aqueous solution.
  3. Glycerol (1.45% v/v).10
  4. Hydrogen peroxide (0.125% v/v).
  5. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients.

  1. The firm pays particular attention to ensure the ethanol or isopropyl alcohol active ingredient is correct and the correct amount of the active ingredient is used. A simple record should be used to document key steps and controls to assure each batch matches the formula developed for the drug product.
  2. The hand sanitizer is prepared under sanitary conditions and equipment utilized is well maintained and fit for this purpose.
  3. The firm uses the most accurate method of analysis available at the site for verification of alcohol content in samples of the finished drug product before each batch is released for distribution. Methods can include gas chromatography (GC), alcoholmeter, hydrometer, or other chemical analysis of at least equivalent accuracy.  The sample tested can be performed on in-process material before filling into the final containers to be distributed.
  4. The hand sanitizer is labeled consistent with the antiseptic monograph. Sample Drug Facts labels are included with the guidance.
  5. Firms register their facility and list these products in the FDA Drug Registration and Listing System.

In addition, FDA released a second guidance for pharmacies seeking to compound hand sanitizer.  The second guidance, Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency, is in effect for the temporary compounding of certain alcohol-based hand sanitizers by pharmacists in state-licensed pharmacies or federal facilities and registered outsourcing facilities.

Finally, on the medical device side, FDA has also expressed flexibility to undertake expedited reviews for manufacturers seeking to address PPE shortages.  Earlier this month, FDA released answers to frequently asked questions regarding the shortages of certain types of personal protective equipment (PPE).  FDA states that it may offer expedited review of submissions from manufacturers looking to produce PPE, especially surgical masks and gowns.  Interested parties can contact FDA per the FAQ.

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