Analysis of FDA-Issued Warning Letters for Fraudulent Claims Within the Economic, Clinical, and Humanistic Outcomes (ECHO) Framework

OBJECTIVES: In response to the proliferation of products making inaccurate or misleading claims regarding the prevention or treatment of coronavirus, the U.S. Food and Drug Administration (FDA) issued warning letters (WLs) to the respective manufacturers. This study employed a content-analysis approach to examine these WLs within the economic, clinical, and humanistic outcomes (ECHO) framework.

METHODS: All WLs available on the FDA website until September 2023 were systematically obtained. A data collection form (DCF) was developed based on relevant literature, and it was pilot tested on WLs issued as early as March 2020. Subsequently, two researchers independently applied the verified DCF to analyze WLs, collecting information such as product details, company name, promotional media type, target audience, number of violations, corrective actions taken, and current product status. Discrepancies between the researchers were resolved through discussion with two additional researchers to ensure consensus.

RESULTS: A total of 218 WLs available on the FDA website were evaluated. The majority of products in these WLs were drugs (n=140; 64.2%), followed by medical devices (n=52; 23.9%), food and beverages (n=14; 6.4%), dietary supplements (n=7; 3.2%), and others (n=5; 2.3%). Approximately 45.2% of WLs reported claims on social media platforms and websites. Nearly all products (n=211; 96.8%) targeted consumers, with four products (1.8%) targeting both consumers and health providers. On average, each WL documented 5.0±3.5 violations (range: 0-21). Clinical outcome claims accounted for the majority (n=212; 97.2%) of the 218 fraudulent claims, followed by humanistic (n=34; 15.6%) and economic outcomes (n=20; 9.2%). Some claims fell under multiple outcome categories. The majority of manufacturers (62.8%) receiving WLs took corrective actions. Currently, n=130 (59.6%) products in WLs are sold without COVID-19 claims.

CONCLUSIONS: This study demonstrated the fraudulent and unproven claims in the WLs issued by the FDA. Safeguarding consumers from products making such claims is imperative for promoting consumer safety.