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unapproved products related to covid-19
Alive by Nature, now Alive by Science were sent an FDA warning letter on the 6th of May 2020; this time for offering “NAD+” and “NMN” sublingual gel products that were marketed as ‘intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people’. This is the second time the FDA has opened such an investigation, the first investigation revolved around misleading supplement claims.
marketing in violation of the federal food, drug, and cosmetic act
Based on their review the FDA stated in their warning letter ‘these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a)’.
Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).
fraudulent coronavirus disease 2019 (covid-19) products
The FDA continue in their instruction to Alive by Nature (now Alive by Science) by stating that ‘The 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’.
misleading claims
In this warning letter to Alive by Nature (now Alive by Science) the FDA lists some examples of the claims made on the website that establish the intended use of the Alive by Nature’s (now Alive by Science) products that misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19.
the FDA examples of misleading claims
“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://alivebynature.com/nmn-shows-promise-for-treatment-of-covid-19-in-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://alivebynature.com/new-research-shows-nad-treatment-may-ward-off-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://alivebynature.com/could-nad-change-the-trajectory-of-the-covid-19-pandemic%e2%80%8b/]
“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/]
advice to alive by nature (now alive by science)
The letter offers this advice to Alive by Nature (now Alive by Science) ‘You should take immediate action to correct the violations cited in this letter…It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA’s implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act’.
fda deadline
The FDA warning letter states Within 48 hours, please send an email to the FDA COVID TASK FORCE at: COVID-19-Task-Force-CDER@fda.hhs.gov describing the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Failure to immediately correct the violations cited in this letter may result in legal action, including, without limitation, seizure and injunction.
If you cannot complete corrective action within 48 hours, state the reason for the delay and the time within which you will complete the corrections. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
fraudulent coronavirus disease 2019 (covid-19) products list
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. At time of publishing Alive by Nature (now Alive by Science) are listed on page 12.
Once you have taken corrective actions to cease the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and such actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken appropriate corrective action.
conclusion
The FDA sent a warning letter to Alive by Nature, now Alive by Science explaining that they had observed that Alive by Nature (now Alive by Science) offers “NAD+” and “NMN” sublingual gel products for sale, and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. These claims violate the Federal Food, Drug, and Cosmetic Act.
This is the second time the FDA has opened such an investigation, the first investigation revolved around misleading supplement claims.
In the warning letter sent to Alive by Nature (now Alive by Science) on the 6th of May 2020 the FDA lists some examples of the claims made on the website that establish the intended use of products that misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19.
The FDA gave Alive by Nature (now Alive by Science) 48 hours to correct the violations, where they had to include an explanation of each step being taken to prevent the recurrence of the violations, as well as copies of related documentation, and that failure to immediately correct the violations cited in the warning letter may result in legal action, including, without limitation, seizure and injunction.
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