During this coronavirus pandemic, consumers want products that can protect them from Covid-19, and many businesses are responding with new products to meet that demand. But if the intended human health benefits are possible only if the finished product or its components have been treated with an additive, the manufacturers and retailers of those products must meet several important regulatory requirements before they can market the public health attributes of their products in the United States.
BedTimes recently interviewed Ryan Trainer, president of the International Sleep Products Association, to discuss these issues.
BedTimes: A number of companies are responding to the Covid-19 pandemic with products and materials intended to protect consumers from the virus. For example, some bedding suppliers have announced new fabrics that have been treated with additives designed to prevent Covid-19 transmission. Should sleep products manufacturers consider these new materials as they develop new products?
Ryan Trainer: The bedding industry is very creative in developing new materials and product features that meet consumers’ needs. But in the United States, a finished product manufacturer that wants to make public health claims about a product must first meet several important regulatory requirements if the product’s benefits result from an additive having been applied to the product or its components. This requirement applies to not only claims made on the treated article’s label and packaging, but also to related advertising and marketing claims.
If you are thinking about offering new products along these lines, it is important that you talk with your attorney early in the process because this can be a complex subject and mistakes can be costly in terms of penalties and harm to your company’s reputation.
Many other countries have their own regulations that finished product suppliers also must follow in this situation.
BT:What kinds of U.S. requirements are relevant?
RT: There are two basic sets of requirements. First, under U.S. law, a manufacturer or retailer may make public health claims about a finished article (like a mattress) that has been treated to have antimicrobial or antiviral properties only if that article has been registered with the U.S. Environmental Protection Agency. EPA considers the treatment applied to an article to be a “pesticide,” which it broadly defines as “any substance or mixture of substances intended for preventing, destroying, repelling or mitigating any pest.”
Second, even if EPA has registered a treated article, the manufacturer or retailer must not make false or misleading statements. This means that all claims must be substantiated, as required by the Federal Trade Commission’s guidelines for substantiating advertising.
BT:Would an antiviral COVID-19-related public health claim be subject to this registration requirement?
RT: Yes. Public health claims that are subject to regulation would include, for example, a statement that a treated article controls specific microorganisms that are infectious to humans. This would include Covid-19-related claims.
When Is an EPA Product Registration Required?
An article treated with a pesticide to provide claimed public health benefits (such as controlling specific microorganisms infectious to humans) must be registered by the Environmental Protection Agency.
An article treated with a pesticide to protect the article itself (such as paint treated with a pesticide to protect the paint coating from mildew, or wood products treated to protect the wood against insects) does not require EPA registration if the pesticide itself is registered for such use and no public health claims are made.
BT:What is involved in getting EPA to register a treated article?
RT: Although EPA recently has taken steps to expedite the process for some types of registrations, that process for most treated articles still can be difficult, time-consuming and expensive. EPA will require scientific data to demonstrate that the product will be effective in providing the claimed public health benefit. However, EPA has no standard approach for deciding what kind of data is necessary to demonstrate efficacy. Instead, EPA requires the party seeking registration to propose a testing protocol that reflects the actual conditions under which its article will be used. EPA must approve the proposed protocol before product testing and data collection begin and will require that the proposed protocol be validated independently for accuracy and reproducibility.
BT:What if the pesticide itself already has been registered with EPA. Isn’t this enough? Is registering the finished article still necessary under those circumstances?
RT: EPA is clear that a treated article must be registered before a manufacturer or retailer may make public health claims for that product, regardless of whether EPA has registered the pesticide used to treat the article.
Registering the treated article is not necessary only if the performance claim is limited strictly to protecting the product and includes no public health claim. For example, a paint may be treated to protect the paint when dried from mildewing, and a fabric may be treated to resist odors. Provided that no direct or indirect public health claims are made in addition to these product protection claims, then EPA registration of the pesticide used to treat these articles is sufficient.
BT:If EPA has registered another mattress that uses the same additive, will that simplify the process?
RT: Yes, it may to some extent. Although each treated article must be registered, if EPA has registered a similar product treated with the same additive, it is possible that the agency may agree to follow the same or similar protocols for testing the article and collecting the relevant data, which could save time and expense. But EPA still will want to take into account design differences between the new article and the article that already has been registered. It also may consider whether the additive has been applied to the registered and nonregistered articles in the same manner and same amounts, the specific public health claims the manufacturer wants to make for the new product and other factors that may be relevant to whether the treated article will be effective in providing the claimed benefits.
BT:What if the public health claims for a finished article are possible without adding a treatment to an article? For example, think about a pillowcase made with an airtight material that can be placed over a hotel pillow to protect the sleeper from being exposed to viruses on the surface of the pillow left by earlier occupants of the hotel room. Would EPA need to register that article before it could be marketed with that public health claim?
RT: EPA’s rules do create a narrow exemption from its registration requirements for articles that “are intended to exclude pests only by providing a physical barrier against pest access, and which contain no toxicants.” If your attorney advises you, based on the specific facts of your product, that your product meets these requirements, then EPA registration may not be necessary. Still, your marketing claims must not be false or misleading, and you must meet the FTC’s guidelines for substantiating advertising.
BT:What are the penalties if a company sells a treated product that is not registered with EPA?
RT: As a settlement announced in October involving Electrolux Home Products illustrates, the consequences for violating presale EPA registration requirements can be significant. Electrolux paid nearly $7 million in civil penalties to settle charges that it imported refrigerators and dehumidifiers that contained air filters treated with a nanosilver additive that were not registered with EPA and were labeled and marketed with public health claims stating that the products contained an “antibacterial filter” and helped “eliminate bacteria in the air that can make breathing difficult.” Nanosilver pesticides currently registered with EPA are approved only for incorporation into textiles to protect those articles themselves from antimicrobial pests, such as mold and bacteria that can cause the articles to deteriorate, discolor or smell. EPA has registered no home appliances that incorporate nanosilver to disinfect the ambient air or protect the health of the consumer.
Once EPA concluded that the treated articles were not registered, EPA worked with U.S. Customs and Border Protection to prevent further imports of the unregistered products from entering U.S. commerce. In addition to the monetary penalty, Electrolux agreed to work under EPA supervision to consolidate all imports, replace the air filters with components that were not treated with nanosilver, and remove the online and on-box public health claims for those products.
Given consumers’ interest today in products that will protect them from Covid-19, we can expect more companies will make public health claims for treated articles that are not EPA-registered and that EPA will announce more enforcement actions. Bedding manufacturers need to be careful so that they are not the object of those actions.
BT: What can mattress manufacturers do so they won’t violate these rules?
RT: Whenever a mattress manufacturer considers using a component that has been treated with an additive intended to provide public health benefits, it must proceed cautiously. The manufacturer should contact legal counsel or other technical experts who are qualified to advise them concerning the relevant EPA and FTC requirements. The manufacturer then must obtain details from the supplier about the nature of the additive, whether the additive itself is an EPA-registered pesticide and whether EPA has registered any other mattresses that contain the treated component and that are marketed with the same or similar health benefits. This information will be relevant to determining the likelihood and difficulty of getting the manufacturer’s finished product registered.
But it is quite possible that the supplier will require the manufacturer to enter into a nondisclosure agreement before disclosing that information to the manufacturer. Once again, legal advice might be warranted before the manufacturer signs that NDA.
Editor’s note: The views expressed in this interview reflect the opinions of Ryan Trainer alone, and not those of the International Sleep Products Association. The information provided in this interview does not, and is not intended to, constitute legal advice. All information in this interview is intended for general informational purposes only. This information may not constitute the most up-to-date legal or other information, and no representations are made that this content is error-free. Readers should contact their attorney to obtain advice with respect to any particular legal matter. No reader should act or refrain from acting on the basis of information in this interview without first seeking legal advice from counsel in the relevant jurisdiction. Only your attorney can advise you whether the information contained herein is applicable or appropriate to your specific situation. All liability with respect to actions taken or not taken based on the contents of this interview is hereby expressly disclaimed.