WARNING LETTER
GlutaGenic
MARCS-CMS 607271 —
May 06, 2020
Product:
Drugs
Recipient:
GlutaGenic
2033 Wood St, Suite 210
Sarasota
,
FL
34237
United States
info@glutagenic.com
info@AdvancedBiomeCorp.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Federal Trade Commission
WARNING LETTER
Date:                May 6, 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 websites at the Internet addresses www.glutagenic.com and www.advancedbiomecorp.com  on April 22, 2020, and May 1, 2020, respectively.  The FDA has observed that your websites offer Viral Protection Kits
[1]
for sale in the United States and that the products in these kits are intended to mitigate, prevent, treat, diagnose, or cure COVID-19
[2]
in people.  Based on our review, 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.
[3]
In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.
[4]
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 website 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:
“Glutagenic™’s Viral Protection Kit is being introduced due to the recent Cornona [
sic
] Virus outbreak . . . a great prevention strategy to utilize” [from your website, https://www.glutagenic.com/product/viral-protection-kit-mg/].
“Glutagenic™’s Viral Protection Kit is being introduced due to the recent Virus outbreak. . . a good immune boosting strategy to utilize. . . . The coronavirus symptoms are fever, a dry cough, slight nasal congestion, and strong muscular pains.” [from your website https://www.glutagenic.com/product/glutagenic-viral-immunity-kit/]
“Glutathione is one of the best antioxidants for viral immunity and should be considered in both preventions as well as treatment.” [from your websites, https://www.glutagenic.com/product/glutagenic-viral-immunity-kit/
and https://advancedbiomecorp.com/product/abc-viral-immunity-kit/.
“Prevention: [directions for using kit]” [from your websites https://www.glutagenic.com/product/glutagenic-viral-immunity-kit/ and
https://advancedbiomecorp.com/product/abc-viral-immunity-kit/
.
“Treatment: [directions for using kit]” [from your websites, https://www.glutagenic.com/product/glutagenic-viral-immunity-kit/ and
https://advancedbiomecorp.com/product/abc-viral-immunity-kit/.
“Ways to prevent coronavirus . . . use GlutaStat Nasal Spray 2-3 times a day and at the end of the day nebulize GlutaStat.” [from your website
https://www.glutagenic.com/chinese-protocol-for-covid-19/].
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.
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.  For COVID-19, no such study is currently known to exist for the products identified above.  Thus, any coronavirus-related prevention or treatment claims regarding such products are not supported by competent and reliable scientific evidence.  You must immediately cease making all such claims.  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,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Sincerely,
/S/
Richard A. Quaresima
Acting Associate Director
Division of Advertising Practices
Federal Trade Commission
[1]
The kit includes GlutaStat NS, GlutaStat, GlutaMax 600 Glutathione Suppositories, and a Nebulizer through glutagenic.com and GlutaStat NS, GlutaStat, ABC 600 Glutathione Suppositories, and a Nebulizer through advancedbiomedcorp.com.
[2]
As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
[3]
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).
[4]
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:
05/07/2020
Regulated Product(s)
Drugs