In the wake of the COVID-19 pandemic, product manufacturers and distributors—many of whom have pivoted to create PPE-related products for the first time—are now faced with a veritable morass of guidelines and requirements to navigate from a variety of governmental agencies. Recent enforcement actions by federal agencies have only highlighted the importance of understanding exactly how a product must be produced, advertised, labeled, and sold. This begs the important question: who is the regulator and what is the rule?
Our product risk management team has been speaking to several trade associations in September 2020 about how to navigate the alphabet soup of federal agencies supervising COVID-19 product distribution. The biggest takeaway: How a product is advertised for sale plays a critical role in how it is regulated and by which agency . The regulatory profile can mean the difference between required manufacturing registration or specific requirements as to product labeling.
This article outlines a few of the major players involved in regulating products designed to mitigate or prevent COVID-19—specifically, the Food and Drug Administration (“FDA”), Federal Trade Commission (“FTC”), and Environmental Protection Agency (“EPA”)—and discusses high-level considerations for entities who find themselves caught up in the regulatory alphabet soup.
Food & Drug Administration (FDA)
The FDA, which has played perhaps the largest role in regulating products designed to mitigate or prevent COVID-19, oversees the regulation of “drugs” and “medical devices.” Due to the overwhelming need for medical countermeasures against COVID-19, the Agency has relaxed its usually stringent product approval process for drugs and medical devices designed to help mitigate, prevent or treat the virus, and has instead issued minimal product requirements in a series of “Emergency Use Authorizations” (“EUAs”). Products within the scope of EUAs will not be subject to an FDA enforcement action even if such products are not formally FDA-approved.
However, several important considerations bear mentioning. First, EUA protections are not boundless. EUAs only protect entities from liability in the form of an FDA enforcement action, and do not provide protection from a products liability action in any form. Certain states have issued varying levels of tort immunity for sellers of PPE, but many have yet to implement such protections. Second, EUA protections are not indefinite. EUAs generally only last for the duration of the pandemic, and thus product manufacturers and distributors must be prepared to pull their products from the market whenever the pandemic is deemed over. Third, EUA protections are subject to their own set of conditions. Though products authorized by EUA may not need to undergo specific FDA pre-market review, they still must adhere to requirements listed within the applicable EUA.
For example, EUAs tend to require specific types of labeling and disclosures. To avoid liability, mask sellers must ensure that they adhere to labeling requirements, such as the mandate that non-surgical masks specify that they are “For Use when FDA Cleared Masks Are Not Available.” Producers of non-surgical masks who give in to the temptation of asserting that their product is of “medical quality” or provides a certain level of filtration run the risk of incurring an FDA warning letter or enforcement action. Similar labeling requirements are found in EUAs for other types of masks, face shields, and gloves.
Hand sanitizers, a major commodity during the pandemic, are now regulated under two regimes: (1) the temporary final monograph (“TFM”), which requires testing to meet specified germ kill rates under detailed testing procedures, or (2) the FDA’s temporary policies, which do not require verification testing as long as the products are made using the World Health Organization (“WHO”) formula. Whether produced under the monograph or a temporary policy, labeling is a top concern for hand sanitizer manufacturers. If a hand sanitizer manufacturer makes a claim that goes beyond what the monograph allows (i.e., saying it prevents a particular disease), FDA may issue a warning letter to that company saying it advertised an unapproved drug. In fact, earlier this year, the FDA issued a warning letter to the manufacturer of Purell for asserting the unsubstantiated claim that its hand sanitizers could prevent or reduce the spread of illnesses such as MRSA, norovirus, influenza, and Ebola.
Federal Trade Commission (FTC)
The FTC regulates unfair or deceptive trade acts and practices, such as misleading methods of inducing consumers into making product purchases. The Agency is empowered to bring administrative or judicial enforcement actions against violators, typically seeking restitution or disgorgement for alleged violations or civil penalties. To avoid such liability, all product claims must have substantiation for any meanings that a reasonable consumer would glean from the claim. This includes both express claims (e.g., an ad directly stating that “ABC mouthwash prevents colds”), as well as implied claims (e.g., an ad stating that “ABC mouthwash kills the germs that cause colds”, implying that the product will prevent colds). All health claims require “competent and reliable scientific evidence.”
With an overwhelming number of companies selling products containing medical claims related to COVID-19, the FTC has been issuing hundreds of warning letters. For example, the Agency promptly issued a warning letter to the manufacturer of UV lights claiming to kill airborne coronavirus, requiring the company to alert the FTC of the “specific actions” it had taken to address the agency’s concerns “within 48 hours.” Moreover, the FTC and FDA have recently announced a cooperative program that will exact scrutiny on companies making coronavirus claims, meaning that more such letters are bound to follow for other companies making unsubstantiated assertions.
Environmental Protection Agency (EPA)
The EPA also plays a role in regulating COVID-19 countermeasures. Under federal law, bacteria, viruses and other microbes in the environment are considered a type of “pest,” and, accordingly, products intended to kill, destroy, or otherwise mitigate pests are regulated by EPA as “pesticides” or “pest control devices.” This means that the EPA must specifically approve claims for effectiveness against SARS-CoV-2, and has created a list of products that are allowed to state that they may be used against COVID-19 (accessible at https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2).
Otherwise, whether a claim is “pesticidal” or “non-pesticidal” in nature is assessed by the Agency on a case-by-case basis. Product claims are considered to be pesticidal if they are synonymous with “preventing, destroying, repelling, or mitigating any pest.” Advertising impling that a product has antimicrobial properties may be considered a pesticidal claim. If so, the product in question must be registered in order to retain the claim and be able to be lawfully sold or distributed in the United States. Other factors that may imply an intended use for antimicrobial effect include whether the product is similar in composition to FIFRA-registered products that make antimicrobial claims and whether the product contains an ingredient at levels for which there is no functional reason other than pesticidal activity.
Again, labeling can be determinative of whether a product is EPA-regulated. For example, a bleach product consisting of 5.25% sodium hypochlorite would likely require registration if the label states that bacteria will be killed at certain doses. However, an identical bleach would likely not need to be registered if the labeling only claims to whiten, bleach or clean laundry, and does not contain an explicit or implicit antimicrobial claim.
In sum, a central concern for the FDA, FTC, and EPA is whether a product makes COVID-19-related health claims. Product manufacturers and distributors should thus heed caution when labeling and advertising their products. If any product does purport to prevent or kill the virus, entities must ensure and be prepared to validate that their claims are substantiated by competent and reliable evidence.