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  5. Secret of the Islands - 616344 - 08/10/2021
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WARNING LETTER

Secret of the Islands MARCS-CMS 616344 —

Product:
Drugs
Recipient:
Recipient Name
Joanne Bolles
Recipient Title
President
Secret of the Islands

5326 Bush River Rd.
Columbia, SC 29212
United States

privacy@secretoftheislands.com
Issuing Office:
Center for Drug Evaluation and Research

United States

WARNING LETTER

Date:  August 10, 2021

TO:    privacy@secretoftheislands.com      Joanne Bolles, President
                                                                           Secret of The Islands, Inc.
                                                                           5326 Bush River Rd.
                                                                           Columbia, SC 29212


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://secretoftheislands.com on July 26, 2021. We also reviewed your Facebook social media website at https://www.facebook.com/SecretoftheIslands, where you direct consumers to your website, https://secretoftheislands.com, to purchase your products. The FDA has observed that your website offers various salt scrub products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-191   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. 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 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 any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.

Examples of claims on your websites, that establish the intended use of your salt scrub products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include:

• “The world’s first & only doctor approved anti-bacterial & anti-viral salt scrub that kills/deactivates the Coronavirus” [From your webpage https://secretoftheislands.com and from a similar March 19, 2021 posting on your Facebook social media website at https://www.facebook.com/SecretoftheIslands/]
• “Due to the Coronavirus, there is a shortage of 12 oz jars. . .” [From your webpage https://secretoftheislands.com]

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

  • 1As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
  • 2Secretary 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.
  • 3Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19)
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