Every day, heartwarming stories are emerging about selfless acts of kindness that have occurred during the Covid-19 pandemic. Among those selfless actors are companies that have pivoted from their usual operations to the new focus of producing personal protective equipment (“PPE”) for healthcare workers, first responders, essential workers, and the public at large. On the flip side of the coin, when disaster strikes, it is also serves as an opportune time for bad actors to easily defraud consumers. Because of the actions of these unfortunate few, federal authorities have recently grown suspicious of the entire PPE supplier marketplace. To avoid regulatory scrutiny, PPE suppliers should advertise their products in a legally compliant fashion by, among other measures: 1) following the guidelines released by the United States Food and Drug Administration (“FDA”); 2) following Federal Trade Commission (“FTC”) marketing regulations; and 3) consulting with a PPE lawyer concerning the legal issues related to the sale and marketing of PPE.
What are the guidelines for marketing PPE?
FDA PPE Oversight
There is now a worldwide shortage of PPE. Fortunately, large and small manufacturers are stepping up to address this deficit. Depending on who businesses are marketing to will determine what type of regulations they need to follow. Generally, PPE supplies that “are not intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease” are not subject to FDA oversight. However, certain PPE can meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (“FD&C”) when it is intended for medical purposes or use by health care professionals. When determining whether manufacturers are marketing their products for medical purposes, the FDA will consider, among other things: 1) if the PPE is labeled or intended for use by a health care professional; 2) if the PPE is labeled for use in a health care facility or environment; and 3) if the PPE includes any drugs, biologics, or anti-microbial/anti-viral agents. PPE that is intended for medical purposes or use by health care professionals, is subject to premarket notification requirements.
PPE Marketing and the FTC
The FTC is responsible for overseeing consumer advertising practices in the United States. The FTC is especially sensitive to advertising that includes consumer health claims. Federal law dictates that advertising must always be truthful, not misleading and, when appropriate, backed by reliable scientific evidence. The FTC and FDA have already issued many warning letters to businesses making deceptive or scientifically unsupported claims concerning their products’ ability to treat and/or cure coronavirus-related illnesses. In addition, PPE manufacturers that advertise their products as “Made in USA,” must comply with the FTC’s “Made in USA” policy. PPE manufacturers can only represent that their products are “Made in USA,” if “all or virtually all” of their products are, in fact, made in the United States. PPE manufacturers should maintain records to support their “Made in USA” claims in the event that the FTC investigates their overall manufacturing processes and related advertising practices.
In addition to the FDA and FTC, the Federal Bureau of Investigation (“FBI”) is also actively investigating parties who are counterfeiting N95 masks or selling N95 masks without ever shipping product. These bad actors destroy consumer trust and make it even more critical for legitimate PPE suppliers to market their products in compliance with applicable law and regulation.
Hiring a PPE Lawyer
Given the urgent need for PPE during the pandemic, PPE suppliers are in a rush to bring product to market. However, suppliers need to be aware of the fact that the FDA, FTC and other state and federal agencies will make sure that this urgency does not result in the production and distribution of unsafe PPE that may put the consuming public at risk. A PPE lawyer can help analyze the risks associated with bringing PPE to market, draft and review any contracts governing the manufacture and sale of PPE, and generally advise suppliers on PPE marketing guidelines.
If you are interested in learning more about this topic or if you need assistance with setting up a PPE production and supply business, please email us at info@kleinmoynihan.com or call us at (212) 246-0900.
The material contained herein is provided for informational purposes only and is not legal advice, nor is it a substitute for obtaining legal advice from an attorney. Each situation is unique, and you should not act or rely on any information contained herein without seeking the advice of an experienced attorney.
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