WARNING LETTER
Jordan’s Crossing Herbal Connections
MARCS-CMS 616001 —
July 20, 2021
Product:
Drugs
Recipient:
Jordan’s Crossing Herbal Connections
568 County Road 2307
Barnsdall
,
OK
74002
United States
email@jordanscrossing.net
Issuing Office:
Center for Drug Evaluation and Research
United States
WARNING LETTER
Date:                 July 20, 2021
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 website at the Internet address https://www.jordanscrossing.net/ on July 14, 2021.  We also reviewed your social media website at https://www.youtube.com/watch?v=dWCJdjcjbfM, where you direct consumers to your website, https://www.jordanscrossing.net/, to purchase your product. The FDA has observed that your website offers “Germaphobe’s Delight Spray” for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19
[1]
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.
[2]
In addition, on March 13, 2020, there was a Presidential declaration of 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 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 any 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:
“The name says it all on this one. Tho’ all of our sprays are good as disinfectants, Germaphobe’s Delight has powerful germ fighting essential oils. Bay Laurel Leaf has been used in the past to kill coronaviruses like SARS. Orange oil has been proven to kill over 22 different varieties of bacteria and germs. Red Thyme oil is antiseptic, antibacterial and antiviral and an immune system stimulant. And Litsea Cubeba has been used in flu epidemics in the past; it also calms the heart and … is anti-bacterial and anti-viral. . . . Tags: . . . coronavirus” [From your webpage https://www.jordanscrossing.net/shop/colds-flu/germaphobes-delight-spray/]
“We have re-vamped our Germaphobe spray to better meet the challenges of COVID-19. There is evidence from a respected herbalist and scientist who worked on the Corona-type virus’ [
sic
] of several years ago (think SARS) that Bay Laurel leaf will kill those corona germs. Of course, this strain of corona-virus is completely new, and no one knows what will work on it yet, but these oils are most promising.
Comprised of 190-proof alcohol, liquid aloe and a squirt of oil for moisturizing, a squirt of soap for germ/corona-killing effect, and anti-bacterial, anti-viral essential oils.” [From your webpage https://www.jordanscrossing.net/shop/colds-flu/germaphobes-delight-spray/]
“[W]e revamped it to meet the need of C-19. It’s got 75% alcohol and that’s not just rubbing alcohol that’s everclear so it’s the good stuff and it has no chemicals that way and that’s why we did it that way. ”[From a April  24, 2020 video post titled “Germaphobe’s Delight Hand Spray Commercial” on your YouTube social media website https://www.youtube.com/watch?v=dWCJdjcjbfM at 0:15 to 0:35 mark]
“[F]irst is orange oil, sweet orange oil, that is supposed to kill 22 different kinds of germs. It’s antiviral, antibacterial etc.” [From a April  24, 2020  video post titled Germaphobe’s Delight Hand Spray Commercial on your YouTube social media website https://www.youtube.com/watch?v=dWCJdjcjbfM at 2:07 to 2:20 mark]
“[T]hen there is also Litsea which was an oil that was used back in the early 1900s and during the Spanish flu outbreak, the pandemic that happened then, so it has some success that way that’s why we put it in.” [From a April  24, 2020 video post titled Germaphobe’s Delight Hand Spray Commercial on your YouTube social media website https://www.youtube.com/watch?v=dWCJdjcjbfM at 2:39 to 3:01 mark]
“[A]nd we can’t say that anything cures anything but laurel leaf has been shown to, in clinical studies has been shown to kill coronaviruses.” [From a April  24, 2020 video post on titled Germaphobe’s Delight Hand Spray Commercial on your YouTube social media website https://www.youtube.com/watch?v=dWCJdjcjbfM at 3:30 to 3:43 mark]
You should take immediate action to address 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 address these violations.  Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation.
Failure to adequately correct any violations 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 actions
to address the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19,
and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.
This letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. 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 may be detained or refused 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
.
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, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed),
available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
.
[3]
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020),
available at
https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/
.
Content current as of:
07/21/2021
Regulated Product(s)
Drugs