Companies should use caution when making efficacy claims in marketing and advertising of dietary supplements, foods, biological products and other products purported to treat or prevent COVID-19. Although there are investigational vaccines and treatments for COVID-19 being developed, FDA has approved no vaccine or treatment to cure, treat or prevent COVID-19 and is therefore keenly watching the marketplace.
Products that claim to cure, mitigate, treat, diagnose or prevent disease, but that are not proven safe and effective for those purposes, are considered fraudulent by FDA. Recently, FDA set up a task force to closely monitor social media, online retailers and incoming complaints for fraudulent products related to COVID-19. FDA is issuing warning letters to companies for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure coronavirus disease COVID-19. As part of the effort, the task force has reached out to multiple retailers to ask for their help in monitoring their online marketplaces for fraudulent products claiming to combat coronavirus.
When evaluating whether a particular statement is deemed fraudulent under FDA rules, it is necessary to identify all express and implied claims that the statement conveys to consumer. Thus, FDA will focus not just on individual phrases or statements in the advertisement, but rather will consider the net impression the advertisement creates as a whole, including the text, images, and depictions.
Examples of efficacy or treatment claims, express or implied, that may warrant a warning from FDA include:
- Claims that a product “kills” COVID 19
- Claims to a vaccine for COVID-19
- Claims to any “cures” or “curative effects” relating to COVID-19
- Claims that a product can “inhibit,” “prevent” or “combat” COVID-19
- Claims to help patients “recover” from COVID-19
- Claims to “suppress” the immunological response, such as the productions of cytokines, produced by COVID-19
- Claims to “treating” the symptoms, such as fever and cough, accompanying COVID-19
- Claims that a product is being used abroad to “treat” or “fight” COVID-19
- Claims of “anti-viral” effectiveness relating to COVID-19
- Claims that a product is in “wide use' for “epidemic prevention”
As of the time of publication, FDA reports that no study is known to exist that substantiates any claims that a dietary supplement, food or other product can prevent, treat, or cure COVID-19. Accordingly, companies manufacturing, distributing or otherwise marketing such products should avoid making any COVID-19-specific prevention or treatment claims in advertisements to avoid FDA attention. General references to cure, treatment, or prevention of “epidemics” or COVID symptoms also are under scrutiny.
Originally published 29 July, 2020
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