Time to ”Clean Up” COVID-19 Claims
Health, cleanliness, and germs are at the forefront of everyone’s mind these days. As parents are considering sending kids back to school and businesses are opening, everyone is searching for products to help keep themselves safe. Manufacturers are hustling to produce products that can help. Standard products like sanitizer, hand soap, and antibacterial wipes and new innovations such as no-contact door openers and portable hand washing stations are flying off the shelves. Consumers want anything that they think can help protect them from the coronavirus.
What rules should manufacturers follow to help ensure they are properly communicating their products’ effectiveness and not misleading consumers? In this time of panic, people are more susceptible to misleading claims, even if unintentional. Thus, advertisers need to be careful of what they’re saying and how they’re saying it to avoid confusing consumers and adhere to the heightened level of scrutiny that regulators are using.
In the midst of this health crisis, The Federal Trade Commission (“FTC”) and U.S. Food and Drug Administration (“FDA”) have taken action against many companies over unfounded claims relating to COVID-19.
The Federal Trade Commission
The most scrutinized category of goods by the FTC is health and safety. The FTC requires a high level of substantiation for advertisements that make claims about health or safety under normal circumstances and is heavily monitoring goods in this category during the COVID-19 pandemic. This means that if a marketer is making health and safety claims about its products and services, the marketer should have "competent and reliable scientific evidence" to support those claims, which has been defined in FTC case law as "tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”1
The FTC has sent over one-hundred sixty warning letters to marketers as part of its efforts to protect consumers from purchasing products/services claiming to treat or prevent COVID-19. These letters remind recipients it’s illegal to “advertise that a product or service can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence substantiating that the claims are true at the time they are made.” At this point, no such studies are known to exist for COVID-19 for products and treatments identified in the letters.
U.S. Food and Drug Administration
Even before the COVID-19 pandemic, the FDA sought to protect consumers from health fraud. Like the FTC, the FDA takes action against companies selling products that falsely claim to prevent, diagnose, treat, or cure disease without evidence to support these outcomes. Selling these products with unsubstantiated claims is a violation of the Federal Food, Drug and Cosmetic Act, but equally as important, can also put consumers at risk when the products have not been proven to be safe or effective.
A pertinent example in today’s climate is that the FDA has continually and carefully monitored hand sanitizing products to make sure product claims are substantiated and accurate. The FDA has held that “claims that a hand sanitizer can protect consumers against infection from pathogens are drug claims and therefore, these products are regulated by the FDA as drugs.”2 Thus, products claiming to protect consumers from COVID-19 should be proven to be safe and effective and approved by the FDA for such use.
The FDA has grown concerned at the increase of products claiming to treat or cure serious diseases3 for fear that deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious illness – in the forefront today, COVID-19. The FDA stated that “there are currently no medical products that are approved to treat or prevent COVID-19."4 To help provide some guidance to consumers, the agency released Frequently Asked Questions about COVID-19 including a Q&A for consumers regarding Hand Sanitizer and COVID-19.5
Tips for Consumers
As a consumer, it’s important to do your research and shop with caution. Know the difference between cleaning and disinfecting. The Centers for Disease Control and Prevention (“CDC”) defines cleaning as “the removal of germs, dirt, and impurities from surfaces.” This means that, even if something has been cleaned, it does not necessarily mean that germs have been killed (but rather that they have been removed). While cleaning lowers the risk of spreading infection, if you are eating at a restaurant or grocery shopping and see a sign that says the table or the cart has been cleaned – it’s a good idea to inquire what product they used on it, or bring your own disinfecting product. The CDC defines disinfecting as “use of chemicals to kill germs on surfaces.” The CDC says disinfecting “does not necessarily clean dirty surfaces or remove germs, but by killing germs on a surface after cleaning, it can further lower the risk of spreading infection.”
It’s likely that marketers are using these terms without understanding their meaning, as many do not ordinarily operate in this space (e.g. the aforementioned grocery cart). So, if you want to make sure that something is disinfected, confirm that it is washed with a disinfectant device as defined by FDA (See Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, Guidance for Industry and Food and Drug Administration Staff https://www.fda.gov/media/136533/download).
Tips for Marketers
It’s helpful to understand some of the factors used to evaluate claims made in advertising. Some questions to consider before making claims are:
Is the claim "material"? Is it likely to be important to a consumer's decision to buy or use the product/service (e.g. statements about a product's performance, features, safety, or effectiveness)?
What type of claim is it? Does it claim that the product or services can prevent, treat, or cure human disease?
What is the category of the product? Is it health and safety?
What are the consequences of a false claim (and the benefits of a truthful claim)? Would use of the product/service give consumers a false sense of security potentially resulting in reduction of other safety measures?
Do you have a reasonable6 level of substantiation, such as scientific analysis or clinical study?
When making statements about your product/service, it is often helpful to use assistive language. In the right context, this can be a good tool to get your point across without making a “claim” or potentially confusing consumers. Remember, the intent to mislead consumers is typically not a consideration for regulators. Even with an advertiser’s best intentions, regulators will evaluate an advertisement or package as a whole to assess whether claims made are truthful, substantiated, and not misleading to a reasonable consumer. For example, instead of saying a delivery service is “safe,” say it “helps you avoid going to the store.” Truthfully explaining that it helps you to reduce your risk of exposure, but not stating that it is safe or risk-free is truthful, factual, and not-misleading. Above all, make sure you are always being truthful and never misleading, only make claims that you can support with reliable scientific evidence, and use the resources that are available from the FTC, FDA, and CDC.
1 Vital Basics, Inc., C-4107 (Consent April 26, 2004); see also In Re Schering Corp., 118 F.T.C. 1030, 1123 (1994).
2 FDA News Release June 06, 2018
3 FDA News Release November 1, 2017
4 https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19#faq
5 https://www.fda.gov/drugs/information-drug-class/qa-consumers-hand-sanitizers-and-covid-19
6 Pfizer, Inc., 81 F.T.C. 21 (1972)