Objectives:

During the COVID-19 pandemic, numerous products have emerged with claims to prevent, treat, mitigate, or cure coronavirus. Some claims are often false or misleading. Using the economic, clinical, and humanistic outcomes (ECHO) model, this study aimed to review warning letters (WLs) issued by the U.S. Food and Drug Administration (FDA) to manufacturers selling products with fraudulent claims.

Methods: A content-analysis approach was used to review WLs obtained from the FDA website. With seven WLs issued in March 2020, a data collection form (DCF) was developed using relevant literature and FDA guidance document on promotional materials from manufacturers. This DCF was then pilot tested on the other six WLs issued in March 2020. Using this DCF, two researchers reviewed WLs issued from April 2020 to December 2020. If there were disagreements between the two researchers, the third and fourth reviewers arbitrated on the disagreements; or the letters were reviewed together to determine a final classification.

Results:

A total of 141 WLs were analyzed. The products cited in the letters used online media (e.g., company website, Facebook, and Twitter) more commonly as promotional tools than print or broadcast. The products were predominantly drugs (79%), followed by medical device (11%) and food & beverages (6%). The average number of violations reported in each WL was 5.0 ± 3.4. Almost all products (93%) targeted consumers, three products (2%) targeted health providers, and three products (2%) targeted both consumers and health providers. Out of 151 fraudulent claims in 141 letters, 118 claims (78%) were related to clinical outcomes, 22 (15%) were humanistic, and 11 (7%) were related to economic outcomes.

Conclusions:

This study revealed COVID-19 related fraudulent and unproven claims included in the WLs issued by the FDA. Protecting consumers from products with such claims is crucial to promote consumer safety during COVID-19.