As the Covid-19 pandemic swept across the world, businesses rushed to satisfy the demand for personal protective equipment (“PPE”). The intention was often noble, but sometimes it was opportunistic, and some PPE advertising toed the line of legality. As a result, the U.S. Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) began investigating businesses that made deceptive or scientifically unsupported PPE claims. Since March 6, 2020, the FDA and FTC have issued sixty-four (64) joint warning letters to businesses that may have violated federal law in their PPE advertising. Given the foregoing risk, businesses must be aware of relevant FDA and FTC regulations before bringing PPE products to market.
What are the FDA and FTC guidelines for PPE advertising?
Compliant PPE Advertising
The FDA and FTC’s joint warning letters were sent in reaction to PPE advertising containing claims that certain products, without approval or authorization from the FDA, mitigate, prevent, treat, diagnose, or cure COVID-19. Generally, PPE products 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. Certain PPE can meet the “device” definition under section 201(h) of the Federal Food, Drug, and Cosmetic Act (“FD&C”) when the PPE product is intended for medical purposes or use by health care professionals. PPE that is intended for medical purposes or use by health care professionals is subject to premarket notification requirements. Additionally, the FTC Act makes it unlawful for businesses to advertise that a product can prevent, treat, or cure a human disease unless competent and reliable scientific evidence can corroborate the veracity of such claims.
| Your education on compliance with Internet, telemarketing, and trademark law should begin with a discussion between you and an experienced attorney. Scheduling a free consultation with Klein Moynihan Turco is a great place to start. |
FDA and FTC Enforcement
The FDA and FTC have issued joint enforcement letters to PPE advertisers, but have also sent individual letters from their respective agencies when appropriate. Enforcement letters typically direct businesses to cure violations of the FD&C Act and/or the FTC Act, and require that the subject companies contact the respective agency(ies) within forty-eight (48) hours describing the specific steps that were taken to correct the applicable violations. Failing to immediately remedy such violations can result in legal action including, but not limited to, seizure, injunction and refunds to customers. In addition, businesses may also be added to a published list of businesses that have received warning letters for COVID-19 related product violations.
It goes without saying that businesses should take appropriate measures to avoid regulatory investigation. Consulting with attorneys that are well-versed in PPE advertising before PPE products are brought to market can save time, money and reputational harm.
If you need assistance with your PPE advertising or are being investigated by the FDA or FTC, 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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