IO Updates: FDA sends warning letters relating to COVID-19 products

IO Updates: FDA sends warning letters relating to COVID-19 products

FDA Warning Photo

FDA and FTC send slew of warning letters to brands selling COVID-19 related supplements

2020 was supposed to be the start of a new decade with great potential; instead, it has been marred by one microscopic pathogen – SARS-CoV-2. When the novel coronavirus began its path of destruction in Wuhan, China in the latter half of 2019, no one could have expected the global wrath it would cause in 2020. While we are all aware of the lives lost, lifestyles changed, and companies burdened due to COVID-19, many do not realize how certain businesses, whether intentionally or not, have taken advantage of this unprecedented time.

The demand for immune-boosting supplements was clear. If a miracle product claiming to protect against COVID-19 appeared, consumers would buy it. With that in mind, some supplement brands and retailers have capitalized on this fear of infection by claiming their products can treat, cure, or prevent COVID-19. The problem with this is dietary supplements do not treat, cure, or prevent diseases; drugs do. Once a claim has been made that a supplement treats, cures, or prevents COVID-19, or any other disease, the product is now being misbranded because the FDA has not approved your new drug product.

To date, the FDA has issued 97 warning letters[1] to companies for marketing unapproved and misbranded products related to the coronavirus disease accounting for over 36% of all published warning letters since March. Many of these warning letters were also issued in partnership with the FTC, which has also sent over 275 warning letters[2] of their own, showing that not only are government agencies concerned with the safety and efficacy of such misbranded products, they are also concerned with how consumers can be easily misled into a false sense of security by trusting in these unsubstantiated claims. While the details of each warning letter may be different, the overall message is consistent: “FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19.”

So, what can we take away from this? For supplement brands, do not make scientific claims that are not backed by science, or use public fear to lure unsuspecting consumers to use a product that cannot deliver what it says it can. The backlash and dangers of trying to do this is much worse than the gratification any immediate sale you can make.


Felicia Ly

by Felicia Ly

Quality Control Manager
[email protected]

Felicia Ly is the QA/QC Manager for with 10 years of industry experience. After earning her Bachelor’s Degree in Microbiology, Immunology, and Molecular Genetics from UCLA, she spent the next several years working for dietary supplement contract manufacturers doing everything from microbiological lab work, inspecting production lines, auditing facilities, to finally developing and managing her own quality department. Felicia’s goal at is to affirm the regulatory compliance of the company’s factory partners and provide customers with above standard buying options.

6 months ago