[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-secret-islands-616344-08102021":3,"fda-latest-sync-dates":28},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":8,"recipient_name":17,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":26,"updated_at":27},3211,"secret-islands-616344-08102021","Warning Letter","Secret of the Islands",null,"Center for Drug Evaluation and Research","Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)","2021-08-11","2021-08-10","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fsecret-islands-616344-08102021","616344","Drugs","Joanne Bolles","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Joanne Bolles\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">President\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Secret of the Islands\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">5326 Bush River Rd.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Columbia\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">SC\u003C\u002Fspan> \u003Cspan class=\"postal-code\">29212\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:privacy@secretoftheislands.com\"> privacy@secretoftheislands.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>WARNING LETTER\u003C\u002Fp>\n\n\u003Cp>Date:  August 10, 2021\u003C\u002Fp>\n\n\u003Cp>TO:    privacy@secretoftheislands.com      Joanne Bolles, President\u003Cbr>\n                                                                           Secret of The Islands, Inc.\u003Cbr>\n                                                                           5326 Bush River Rd.\u003Cbr>\n                                                                           Columbia, SC 29212\u003C\u002Fp>\n\n\u003Cp>\u003Cbr>\nRE:   Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)\u003C\u002Fp>\n\n\u003Cp>\u003Cbr>\nThis is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fsecretoftheislands.com on July 26, 2021. We also reviewed your Facebook social media website at https:\u002F\u002Fwww.facebook.com\u002FSecretoftheIslands, where you direct consumers to your website, https:\u002F\u002Fsecretoftheislands.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-19\u003Ca id=\"footnoteref1_sh53lnk\" class=\"see-footnote\" title=\"As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).\" href=\"#footnote1_sh53lnk\" aria-label=\"See footnote 1\">\u003Csup>1\u003C\u002Fsup>\u003C\u002Fa>  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).\u003C\u002Fp>\n\n\u003Cp>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. \u003Ca id=\"footnoteref2_4b1a5ih\" class=\"see-footnote\" title=\"Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx.\" href=\"#footnote2_4b1a5ih\" aria-label=\"See footnote 2\">\u003Csup>2\u003C\u002Fsup>\u003C\u002Fa> In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. \u003Ca id=\"footnoteref3_yqfc1x5\" class=\"see-footnote\" title=\"Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19)\" href=\"#footnote3_yqfc1x5\" aria-label=\"See footnote 3\">\u003Csup>3\u003C\u002Fsup>\u003C\u002Fa> 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.\u003C\u002Fp>\n\n\u003Cp>Examples of claims on your websites, that establish the intended use of your salt scrub products and misleadingly represent them as safe and\u002For effective for the treatment or prevention of COVID-19 include:\u003C\u002Fp>\n\n\u003Cp>• “The world’s first & only doctor approved anti-bacterial & anti-viral salt scrub that kills\u002Fdeactivates the Coronavirus” [From your webpage https:\u002F\u002Fsecretoftheislands.com and from a similar March 19, 2021 posting on your Facebook social media website at https:\u002F\u002Fwww.facebook.com\u002FSecretoftheIslands\u002F]\u003Cbr>\n• “Due to the Coronavirus, there is a shortage of 12 oz jars. . .” [From your webpage https:\u002F\u002Fsecretoftheislands.com]\u003C\u002Fp>\n\n\u003Cp>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 \u003Ca href=\"mailto:COVID-19-Task-Force-CDER@fda.hhs.gov\">COVID-19-Task-Force-CDER@fda.hhs.gov\u003C\u002Fa> 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.\u003C\u002Fp>\n\n\u003Cp>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\u002For 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 \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fhealth-fraud-scams\u002Ffraudulent-coronavirus-disease-covid-19-products\">http:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fhealth-fraud-scams\u002Ffraudulent-coronavirus-disease-covid-19-products\u003C\u002Fa>. 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.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>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. \u003C\u002Fp>\n\n\u003Cp>Please direct any inquiries to FDA at \u003Ca href=\"mailto:COVID-19-Task-Force-CDER@fda.hhs.gov\">COVID-19-Task-Force-CDER@fda.hhs.gov\u003C\u002Fa>.\u003C\u002Fp>\n\n\u003Cp>\u003Cbr>\nSincerely,\u003Cbr>\n\u002FS\u002F\u003Cbr>\nDonald D. Ashley\u003Cbr>\nDirector\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Drug Evaluation and Research\u003Cbr>\nFood and Drug Administration\u003C\u002Fp>\n\n\n\u003Col class=\"footnotes\">\n                  \u003Cli class=\"footnote\" id=\"footnote1_sh53lnk\">\u003Ca class=\"footnote-label\" href=\"#footnoteref1_sh53lnk\" aria-label=\"Back to reference 1\">1\u003C\u002Fa>As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).\u003C\u002Fli>\n                      \u003Cli class=\"footnote\" id=\"footnote2_4b1a5ih\">\u003Ca class=\"footnote-label\" href=\"#footnoteref2_4b1a5ih\" aria-label=\"Back to reference 2\">2\u003C\u002Fa>Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx.\u003C\u002Fli>\n                      \u003Cli class=\"footnote\" id=\"footnote3_yqfc1x5\">\u003Ca class=\"footnote-label\" href=\"#footnoteref3_yqfc1x5\" aria-label=\"Back to reference 3\">3\u003C\u002Fa>Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19)\u003C\u002Fli>\n      \u003C\u002Fol>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Product:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nJoanne Bolles\n\nRecipient Title\n\nPresident\n\nSecret of the Islands\n\n5326 Bush River Rd.\n\nColumbia, SC 29212\n\nUnited States\n\nprivacy@secretoftheislands.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research\n\nUnited States\n\nWARNING LETTER\n\nDate: August 10, 2021\n\nTO: privacy@secretoftheislands.com Joanne Bolles, President\n\nSecret of The Islands, Inc.\n\n5326 Bush River Rd.\n\nColumbia, SC 29212\n\nRE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)\n\nThis is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fsecretoftheislands.com on July 26, 2021. We also reviewed your Facebook social media website at https:\u002F\u002Fwww.facebook.com\u002FSecretoftheIslands, where you direct consumers to your website, https:\u002F\u002Fsecretoftheislands.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).\n\nThere 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.\n\nExamples of claims on your websites, that establish the intended use of your salt scrub products and misleadingly represent them as safe and\u002For effective for the treatment or prevention of COVID-19 include:\n\n• “The world’s first & only doctor approved anti-bacterial & anti-viral salt scrub that kills\u002Fdeactivates the Coronavirus” [From your webpage https:\u002F\u002Fsecretoftheislands.com and from a similar March 19, 2021 posting on your Facebook social media website at https:\u002F\u002Fwww.facebook.com\u002FSecretoftheIslands\u002F]\n\n• “Due to the Coronavirus, there is a shortage of 12 oz jars. . .” [From your webpage https:\u002F\u002Fsecretoftheislands.com]\n\nYou 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.\n\nFDA 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\u002For 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:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fhealth-fraud-scams\u002Ffraudulent-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.\n\nThis 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.\n\nIf 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.\n\nPlease direct any inquiries to FDA at COVID-19-Task-Force-CDER@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nDonald D. Ashley\n\nDirector\n\nOffice of Compliance\n\nCenter for Drug Evaluation and Research\n\nFood and Drug Administration\n\n1As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).\n\n2Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx.\n\n3Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19)","2026-08-20T02:42:11.467+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2021-08-11T14:00:00Z\">08\u002F11\u002F2021\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-08-10T04:00:00Z\">08\u002F10\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fsecret-islands-616344-08102021\">Secret of the Islands\u003C\u002Fa>","","2026-08-18T06:42:29.386127+00:00","2026-08-20T02:42:13.58501+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"pma":33,"warning_letter":34},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]