WARNING LETTER
Carahealth
MARCS-CMS 605826 —
March 26, 2020
Product:
Drugs
Recipient:
Recipient Name
Carina Harkin
Carahealth
24 Waterlane
Galway
Co. Galway
Ireland
info@carahealth.ie
info@carahealth.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
Date:               March 26, 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) and the Federal Trade Commission (FTC) reviewed your website at the Internet address www.carahealth.com in March 2020. We also reviewed your social media website at www.facebook.com/pg/herbaltonics, where you direct consumers to your website at www.carahealth.com to purchase your products. The FDA has determined that your website offers herbal products, including “Carahealth Immune,” which is also referred to as “Immune Tonic” on your website, for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19
[1]
in people. FDA has determined that 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).
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 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:
“Coronavirus (COVID-19, SARS-CoV-2) pandemic has no medical treatment. Natural antiviral herbs boost immunity & decrease virus virulence to achieve herd immunity.” [from your website at www.carahealth.com]
“Natural medicine to prepare for a global pandemic . . . Covid-19 is a corona virus like Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) and . . . Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV). Haemagglutinin exists in the structure of the coronavirus and is a target for herbal treatment. Neuraminidase inhibitors are the cornerstones of the management of patients hospitalised for suspected MERS-CoV infection and SARS corona virus hence neuraminidase is also a target for herbal treatment” [from your website at www.carahealth.com (citations omitted)]
“Carahealth Immune . . . Contains herbal medicines that have been shown to have the desired action in influenza, to inhibit haemagglutinin (HA), inhibit neuraminidase (NA), increasing interferon (IFN) and prevent the inflammatory cascade (cytokine storm).” [from your website at www.carahealth.com] “Herbal medicines have shown anti-viral action against many viral pathogens that do not have suitable vaccines or where the vaccine is available outbreaks are still apparent, viruses including coronavirus (CoV), coxsackievirus (CV), dengue virus (DENV), enterovirus 71 (EV71), hepatitis B virus (HBV), hepatitis C virus (HCV), herpes simplex virus, human immunodeficiency virus (HIV), influenza virus, measles virus (MV) and respiratory syncytial virus (RSV).” [from your website at www.carahealth.com]
“Regarding the current coronavirus, whilst a lot remains to be seen at this early stage, there is no vaccine or no antiviral treatment for this disease at present. Constituents in herbs exhibit a diverse array of anti-viral, virostatic, immune enhancing and anti-influenza activities that may prevent and treat pandemic influenza.” [from your Facebook page at www.facebook.com/pg/herbaltonics/]
You should take immediate action to correct the violations cited in this letter. The violations cited in this letter are 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 representing your products 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.
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
.
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.
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.
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(s) 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.
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. To make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act.
There currently are no vaccines, pills, potions, lotions, lozenges or over-the-counter products available to treat or cure COVID-19. Thus, the claims cited above are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims for products that you advertise, market, sell, or otherwise promote or make available in the United States. In addition, you are advised to review such claims for your products and immediately cease making claims that are not supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction and an order may require that you pay back money to consumers. Within 48 hours, please send an email to Richard Cleland, Assistant Director of the FTC’s Division of Advertising Practices, via electronic mail at rcleland@ftc.gov describing the specific actions you have taken to address the FTC’s concerns. If you have any questions regarding compliance with the FTC Act, please contact Mr. Cleland at
202-326-3088
.
Sincerely,                                                                    Sincerely,
/s/_________________                                               /s/___________________
Donald D. Ashley
Richard A. Quaresima
Director                                                                       Acting Associate Director
Office of Compliance                                                  Division of Advertising Practices
Center for Drug Evaluation and Research                 Federal Trade Commission
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, 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:
03/27/2020
Regulated Product(s)
Drugs