FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
We request that you take immediate action to cease the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Some examples of the claims on your websites that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include:
- “NMN shows great promise in case studies of humans with COVID-19. . . . The NMN mixture lead to a surprisingly rapid and thorough reversal of COVID-19. . . . A strong causal relationship is established between an oral boosted NMN and the clinical improvement seen with the below described COVID-19 patient. . . . NMN cocktail may play a role in reversing potentially fatal cytokine storm. . . . COVID-19 complications may be reversible by NAD+ repletion. . . . There is growing evidence that supplementation with NAD+ boosters may be an effective tool in preventing the ‘cytokine storm’ in response to excessive inflammation from COVID-19.” [from your website https://alivebynatur...-case-studies/]
- “Research shows NAD+ treatment may help prevent death from bacterial infection . . . COVID-19 parallel . . . COVID-19 also provokes a ‘cytokine storm’ from the immune system that increases inflammation and drains the body of NAD+ in response. The authors or [sic] this review believe NAD+ supplementation may prove beneficial in fighting COVID-19 for the same reason NAD+ injections prevented death in E.coli infections. NAD+ supplementation provides the body with the NAD+ needed to fight inflammation while continuing to carry out all necessary cellular functions.” [from your website https://alivebynatur...-septic-shock/]
- “New study ties low NAD+ levels to high morbidity rates in COVID-19 . . . Low NAD+ Levels Could Be Tied to Higher Severity and Morbidity Rates in COVID-19 Pandemic . . . NAD+ is essential for our resistance to viral infections . . . NAD+ supplementation may help our immune system fight COVID-19 . . . The added immunity protection provided by our NAD+ boosters is a good precautionary step in the fight to protect yourself from COVID-19. Discover supplements to boost your NAD+ levels and fortify your immune system here.” [from your website https://alivebynatur...-19-pandemic/]
- “Given the developments of the Coronavirus (COVID-10) [sic], we wanted to stress that all of our products contain high-performance, clinical grade ingredients that are 100% natural and created without the use of solvents, toxins or additives. Our products have immune boosting capabilities and potential to support a healthy immune system. . . . Could NAD+ change the trajectory of the COVID-19 pandemic?” [from a March 16, 2020 posting on your social medial website, www.facebook.com/alivebynature/]
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.
Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act.
This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products.
https://www.fda.gov/...607435-05062020