(1161) Analyzing Food and Drug Administration (FDA) Issued COVID-19 Warning Letters for Type of Promotional Media Used by Companies to Make Fraudulent COVID-19 Prevention and Treatment Claims

Objectives: In the past decade, the number of social media users has markedly increased, creating an opportunity for companies to leverage social media platforms for health communication. At the same time, fake news, misinformation, and conspiracy theories have become prevalent in the age of social media and skyrocketed during COVID-19. During the COVID-19 pandemic, several products emerged with claims to prevent, treat, mitigate, or cure coronavirus. However, the claims are often false or misleading. As such, the U.S. Food and Drug Administration (FDA) issued warning letters to firms for selling products with fraudulent claims to protect consumers. Using a content-analysis approach, the purpose of this study was to review the warning letters issued by the FDA between March 2020-September 2023 for such products. Special emphasis was on the type of media used by companies to make these false claims.

Methods: Full-text copies of all warning letters are available on the FDA website (https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products). A data collection form (DCF) was developed based on past literature on the relevant topic, and pilot tested on warning letters issued in March 2020. Information collected in the DCF included product name, company name, product details, type of media, number of violations, target audience for promotional claims, corrective action taken, and current product status. Two researchers reviewed the warning letters issued March 2020-September 2023 using this DCF. If there was disagreement between the researchers, the third and fourth reviewers arbitrated on the disagreement, or the letters were reviewed together to determine a final classification. Data were analyzed using Statistical Analysis System (SAS). Descriptives analyses were run to meet the study objectives.

Results: A total of 218 warning letters, issued from March 2020-September 2023, were analyzed. Almost all products included in the letters were drugs (n=140; 64%), followed by medical devices (n=52; 24%), food and beverages (n=14; 6%), dietary supplements (n=7; 4%), and others (n=5; 2%). Nearly half (45%) of letters included claims made on social media platforms and websites. About 44% included claims made only on websites. In addition to social media and websites, companies also used Amazon to sell their products. Facebook (n=85; 48%) was the most used social media platform, followed by Twitter (n=36; 20%), Instagram (19%), and YouTube (7%). The average number of violations reported in each warning letter was 5 (range: 0-21). Almost all warning letters (n=211; 97%) included information targeted towards consumers, and a relatively small percentage of warning letters included information targeted towards both consumers and health providers (n=4; 2%). Majority of the firms (63%) receiving the warning letters took corrective actions. Currently, n=130 (60%) products in the letters are sold without COVID-19 claims.

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