WARNING LETTER
Fusion Health and Vitality LLC
MARCS-CMS 607545 —
May 11, 2020
Product:
Drugs
Recipient:
Recipient Name
Polly Ryncarz
Fusion Health and Vitality LLC
1360 Union Hill Road Suite 11B
Alpharetta
,
GA
30004
United States
help@pharmorigins.com
info@pharmorigins.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
Date:               May 11, 2020
RE:                  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your websites at the Internet addresses at www.pharmorigins.com, http://www.freecoreoffer.online, and http://www.immune-shot.com
,
on April 28, 2020. The FDA observed that your websites offered “CORE” and “IMMUNE SHOT” products for sale in the United States and that these products were intended to mitigate, prevent, treat, diagnose, or cure COVID-19
[1]
in people. Based on our review, these products were 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 were 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 violated 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.
[2]
In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.
[3]
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 sold products that were intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
Some examples of the claims on your websites
that established the intended use of your products and misleadingly represented them as safe and/or effective for the treatment or prevention of COVID-19 include:
On the same webpage where you represented that “Immune Shot is pure, sublingual Vitamin D3 FORMULATED to boost your Vitamin D3 levels which has been shown to help increase your immunity to infectious diseases,” you describe vitamin D’s uses as follows:
“Finally, A Top Doctor Believes It Could Help Our Current Pandemic . . . On March 15th, 2020 His Clinical Review Titled ‘Vitamin D Supplementation Could Prevent and Treat Influenza, Coronavirus and Pneumonia Infections’ Was Published Worldwide”
“From the available evidence, we hypothesize that raising serum D3 concentration through vitamin D supplementation could reduce the incidence, severity, and risk of death from influenza, pneumonia, and the current COVID-19 epidemic.”
“He Believes Vitamin D3 May Be a Way to Fight COVID-19”
“On March 23rd, a very prominent Doctor wrote an Op Ed . . . title “Coronavirus Infection Risk May Be Reduced By Vitamin D” [from your website www.immune-shot.com/boost-your-immunity]
“[H]e laid out a full clinical trial with a possible way to prevent and even treat coronavirus and COVID-19 . . .  providing a product that every single American needs during this time as we’re all waiting for a possible vaccine, or a way to fight this terrible, terrible virus. If you’re older, the stakes are even higher. So obviously the risks of coronavirus and COVID-19 go up with age . . . I think you’re gonna find that there’s no way that you wanna go . . . another day without this level of protection that Immune Shot can provide . . .  we’ve been able to . . . help thousands and thousands of people already feel more confident in their fight against coronavirus” [from your YouTube video, “This Could Save Your Life…,” posted on April 1, 2020 on www.youtube.com/watch?v=6v1rHUwGdNg]
“Based on the current health crisis, we are allowing you and your family to order our immunity booster named Core, at no charge. . . . This is a powerful way for you and your family to bring the fight to COVID 19.” [from a April 8, 2020 commercial email message, sent from noreply@pharmorigins.co, that refers consumers to www.freecoreoffer.online]
We note that, as of the date of this letter, you no longer appear to be marketing “Immune Shot” and the claims cited above for “Core” appear to have been removed. Due to the serious public health concerns related to the marketing and sale of unapproved drugs for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, it is essential that these violations do not recur.
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 prevent the recurrence of future violations.
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, with a notation that, as of the date of this letter, your firm’s aforementioned products are no longer sold for the prevention, treatment, mitigation, diagnosis or cure of COVID-19. This list can be found at
http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products
.
If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs are subject to detention and refusal of admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your product referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.
Please direct any inquiries to FDA at COVID-19-Task-Force-CDER@fda.hhs.gov.
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
[1]
As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
[2]
Secretary of Health and Human Services Alex M. Azar II, Determination that a Public Health Emergency Exists. Jan. 31, 2020. (Accessible at https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx).
[3]
President Donald J. Trump, Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19). Mar. 13, 2020. (Accessible at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/).
Content current as of:
05/12/2020
Regulated Product(s)
Drugs