[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-dr-pauls-lab-612964-02162021":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},3530,"dr-pauls-lab-612964-02162021","Warning Letter","Dr. Paul's Lab",null,"Center for Drug Evaluation and Research | CDER","Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)","2021-02-17","2021-02-16","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fdr-pauls-lab-612964-02162021","612964","Drugs","Paul Dettloff, DVM","\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\">Paul Dettloff, DVM\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Dr. Paul's Lab\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">9559 County Road Y\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Mazomanie\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">WI\u003C\u002Fspan> \u003Cspan class=\"postal-code\">53560\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:drpaulslabllc@gmail.com\"> drpaulslabllc@gmail.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 | CDER\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 align=\"center\" class=\"MsoHeader\" style=\"text-align: center;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"tab-stops: center 3.25in right 6.0in;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cb>\u003Cspan style=\"font-family: "Arial",sans-serif;\">WARNING LETTER\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 10.5pt;\">\u003Cspan style=\"tab-stops: 1.0in;\">\u003Cspan style=\"line-height: 11.9pt;\">\u003Cspan style=\"font-family: "Times New Roman",serif;\">\u003Cspan style=\"color: black;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Date:               February 16, 2021\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 10.5pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"tab-stops: 1.0in 3.5in;\">\u003Cspan style=\"font-family: "Times New Roman",serif;\">\u003Cspan style=\"color: black;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">CC:                  drsarahsessentials@gmail.com –      Sarah Slaby, DVM\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 10.5pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"tab-stops: 1.0in 3.5in;\">\u003Cspan style=\"font-family: "Times New Roman",serif;\">\u003Cspan style=\"color: black;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">                                                                                    Dr. Sarah’s Essentials\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 10.5pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"tab-stops: 3.5in;\">\u003Cspan style=\"font-family: "Times New Roman",serif;\">\u003Cspan style=\"color: black;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">                                                                                    W30881 George Lane\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 10.5pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"tab-stops: 3.5in;\">\u003Cspan style=\"font-family: "Times New Roman",serif;\">\u003Cspan style=\"color: black;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">                                                                                    Arcadia, WI 54612\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 10.5pt;\">\u003Cspan style=\"tab-stops: 1.0in;\">\u003Cspan style=\"line-height: 11.9pt;\">\u003Cspan style=\"font-family: "Times New Roman",serif;\">\u003Cspan style=\"color: black;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">RE:                  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">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 http:\u002F\u002Fdrpaulslab.net on January 28, 2021, and February 9, 2021, respectively. Your website directs consumers to various dealers to purchase your products including, https:\u002F\u002Fdrsarahsessentials.com. The FDA has observed that the website, https:\u002F\u002Fdrsarahsessentials.com, offers your product “COVID-Aid Tincture” for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">[1]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan> 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).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">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.\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">[2]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan> In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19.\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">[3]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-family: "Arial",sans-serif;\">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.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Some examples of the claims that establish the intended use of your product and misleadingly represent it as safe and\u002For effective for the treatment or prevention of COVID-19 include: \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">“COVID-Aid Tincture . . . Directions: If illness [is] suspected, take 1 cc (1 dropperful) under tongue 4–6 times daily until symptoms subside.” [from your product label, the product catalog on your website http:\u002F\u002Fdraulslab.net\u002Fwp-content\u002Fuploads\u002F2020\u002F09\u002FCatalog-Final1.pdf and \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">the product page on the website https:\u002F\u002Fdrsarahsessentials.com\u002Fproducts\u002Fcovid-aid]\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">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 \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">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\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">. \u003Cb>Within 48 hours, please send an email to \u003C\u002Fb>\u003C\u002Fspan>\u003Cb>\u003Cspan style=\"font-family: "Arial",sans-serif;\">COVID-19-Task-Force-CDER@fda.hhs.gov\u003C\u002Fspan>\u003C\u002Fb>\u003Cb> \u003C\u002Fb>\u003Cspan style=\"font-family: "Arial",sans-serif;\">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. \u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: black;\">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 \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: black;\">FDA’s\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: black;\"> 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 \u003C\u002Fspan>http:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fhealth-fraud-scams\u002Ffraudulent-coronavirus-disease-covid-19-products\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan style=\"color: black;\">. \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\">Once you have taken actions\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> to address the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19,\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> 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\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">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\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">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\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Please direct any inquiries to FDA at COVID-19-Task-Force-CDER@fda.hhs.gov.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">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 product identified above. Thus, any coronavirus-related prevention or treatment claims regarding such product 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. In addition, pursuant to the COVID-19 Consumer Protection Act, Section 1401, Division FF, of the Consolidated Appropriations Act, 2021, P.L. 116-260, marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of COVID-19 are subject to a civil penalty of up to $43,792 per violation. 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 \u003Cspan class=\"baec5a81-e4d6-4674-97f3-e9220f0136c1\" style=\"white-space: nowrap;\">202-326-3088\u003C\u002Fspan>.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">   \u003Cb>                                                         \u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Sincerely, \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u002FS\u002F\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Donald D. Ashley\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Director\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Office of Compliance\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Center for Drug Evaluation and Research\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Food and Drug Administration\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp> \u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Sincerely,\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u002FS\u002F\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Serena Viswanathan\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Associate Director\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Division of Advertising Practices\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size: 11pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">Federal Trade Commission\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cdiv> \n\u003Chr align=\"left\" size=\"1\" width=\"33%\">\n\u003Cdiv id=\"ftn1\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">[1]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn2\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">[2]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), \u003Ci>available at\u003C\u002Fi> https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn3\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"line-height: normal;\">\u003Cspan style=\"font-family: Calibri,sans-serif;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align: super;\">\u003Cspan style=\"font-size: 10pt;\">\u003Cspan style=\"font-family: "Arial",sans-serif;\">[3]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family: "Arial",sans-serif;\"> Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), \u003Ci>available at\u003C\u002Fi> https:\u002F\u002Fwww.whitehouse.gov\u002Fpresidential-actions\u002Fproclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\u003C\u002Fdiv>\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\nPaul Dettloff, DVM\n\nDr. Paul's Lab\n\n9559 County Road Y\n\nMazomanie, WI 53560\n\nUnited States\n\ndrpaulslabllc@gmail.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWARNING LETTER\n\nDate: February 16, 2021\n\nCC: drsarahsessentials@gmail.com – Sarah Slaby, DVM\n\nDr. Sarah’s Essentials\n\nW30881 George Lane\n\nArcadia, WI 54612\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) and the Federal Trade Commission (FTC) reviewed your website at the Internet address http:\u002F\u002Fdrpaulslab.net on January 28, 2021, and February 9, 2021, respectively. Your website directs consumers to various dealers to purchase your products including, https:\u002F\u002Fdrsarahsessentials.com. The FDA has observed that the website, https:\u002F\u002Fdrsarahsessentials.com, offers your product “COVID-Aid Tincture” 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).\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 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.\n\nSome examples of the claims that establish the intended use of your product and misleadingly represent it as safe and\u002For effective for the treatment or prevention of COVID-19 include:\n\n“COVID-Aid Tincture . . . Directions: If illness [is] suspected, take 1 cc (1 dropperful) under tongue 4–6 times daily until symptoms subside.” [from your product label, the product catalog on your website http:\u002F\u002Fdraulslab.net\u002Fwp-content\u002Fuploads\u002F2020\u002F09\u002FCatalog-Final1.pdf and the product page on the website https:\u002F\u002Fdrsarahsessentials.com\u002Fproducts\u002Fcovid-aid].\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\nIn 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 product identified above. Thus, any coronavirus-related prevention or treatment claims regarding such product 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. In addition, pursuant to the COVID-19 Consumer Protection Act, Section 1401, Division FF, of the Consolidated Appropriations Act, 2021, P.L. 116-260, marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of COVID-19 are subject to a civil penalty of up to $43,792 per violation. 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.\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\nSincerely,\n\n\u002FS\u002F\n\nSerena Viswanathan\n\nAssociate Director\n\nDivision of Advertising Practices\n\nFederal Trade Commission\n\n[1] As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).\n\n[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:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx.\n\n[3] Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https:\u002F\u002Fwww.whitehouse.gov\u002Fpresidential-actions\u002Fproclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F.","2026-08-20T03:22:39.393+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2021-02-17T15:00:00Z\">02\u002F17\u002F2021\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-02-16T05:00:00Z\">02\u002F16\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fdr-pauls-lab-612964-02162021\">Dr. Paul's Lab\u003C\u002Fa>","","2026-08-18T06:42:29.460824+00:00","2026-08-20T03:22:41.531082+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"]