Some of the alleged claims in the warning letter include:
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“Better Fly . . . Organic antiviral against COVID-19 [emphasis in original] – to restore health & as prophylactic” [from your website www.reternity.org]
- “[ULTRA IMMUNE SUPPORT KIT] is designed for the patients who are at the highest risk for infection, disease, and death due to COVID-19. If you suffer from chronic disease like cardiovascular disease, diabetes, immune-suppression, etc. then this kit is ideal.”
The agencies advise the companies to take immediate action to correct the alleged violations, noting that failure to do so could result in legal action, including seizure and injunction. The agencies stress that no COVID-19 study is currently known to exist for the product identified within the warning letter, so any coronavirus-related prevention or treatment claims regarding the product are considered to be not supported by competent and reliable scientific evidence.
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This is to advise you that the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at the Internet address https://reternity.org on August 4, 2020, and August 28, 2020, respectively. The FDA has observed that your website offers BetterFly, a niacin containing product, for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Based on our review, this product is an unapproved new drug 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, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19. Therefore, 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 a product that is 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 website that establish the intended use of your product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19 include:
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“Better Fly . . . Organic antiviral against COVID-19 [emphasis in original] – to restore health & as prophylactic” [from your website www.reternity.org]
- Graphics displaying the text “‘COVID-19’ Symptoms” followed by additional graphics of recommended daily dosing schedules of BetterFly tablets. “NOTE: BetterFly can also be used as a prophylactic (1-2 tablets, 2x a day); as antiviral in general . . . Fulfilling the purposes of both a therapeutic and prophylactic, the provided medicine is designed to operate as an antiviral . . . As an antiviral therapeutic, usually only a single dose of 1-2 tablets (500 – 1000 mg) of BetterFly is needed for complete restoration of health by the next day. BetterFly also works as a prophylactic: administration of 1 (500 mg) and sometimes 2 tablets (i.e., 1500 mg or 3 tablets total) . . . will prevent/shield from infection every month.” [from your website www.reternity.org/products/betterfly-organic-therapeutics]
You should take immediate action to correct the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. 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. Within 48 hours, please send an email to 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.
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In addition, it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the product identified above. Thus, any coronavirus-related prevention or treatment claims regarding such product are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims.
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2020 Annual Fund Sponsors: |
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