[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-native-remedies-dba-silver-star-brands-612268-02182021":3,"fda-latest-sync-dates":31},{"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":13,"case_status":14,"letter_url":15,"reference_number":8,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":29,"updated_at":30},3526,"native-remedies-dba-silver-star-brands-612268-02182021","Warning Letter","Native Remedies dba Silver Star Brands",null,"Center for Food Safety and Applied Nutrition (CFSAN)","New Drug\u002FMisbranded","2021-02-19","2021-02-18","2025-08-04","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fnative-remedies-dba-silver-star-brands-612268-02182021","612268","DrugsFood & Beverages","Via Overnight Delivery","Bruce Valk","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">Via Overnight Delivery\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs\u003Cbr>Food & Beverages                          \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\">Bruce Valk\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Native Remedies dba Silver Star Brands\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">250 City Center\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Oshkosh\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">WI\u003C\u002Fspan> \u003Cspan class=\"postal-code\">54906\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \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 Food Safety and Applied Nutrition (CFSAN)\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 class=\"MsoHeader text-align-center\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">RE: [CMS:612268]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp> \u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Dear \u003Cspan style=\"background:white\">Mr. Valk\u003C\u002Fspan>\u003Cspan style=\"background:white\">,\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fwww.nativeremedies.com\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">in\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">December 2020 and has determined that you take orders there for your \u003Cspan style=\"color:black\">MindSoothe\u003C\u002Fspan>\u003Cspan style=\"color:black\"> Drops and \u003C\u002Fspan>\u003Cspan style=\"color:black\">MindSoothe\u003C\u002Fspan>\u003Cspan style=\"color:black\"> Capsules\u003C\u002Fspan> products. The claims on your website establish that your \u003Cspan style=\"background:white\">products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fhome\" style=\"color:blue; text-decoration:underline\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">www.fda.gov\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">.  \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:7pt\">\u003Cspan style=\"font-family:Tahoma,sans-serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp class=\"Default\">\u003Cstrong>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"color:black\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">MindSoothe Drops\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli class=\"paragraph\" style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\"Relieves feelings of depression\" \u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli class=\"paragraph\" style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\"Regulates disturbed sleep patterns (insomnia or hypersomnia)\" \u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli class=\"paragraph\" style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\"Improves disturbed appetite (loss of appetite or binge eating)\" \u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli class=\"paragraph\" style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\"\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">MindSoothe\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">™ should be taken when there is a noticeable loss of interest in activities that are normally enjoyable, a change in eating habits (such as overeating or appetite loss), or difficulty concentrating, remembering details, and making decisions.\"\u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp class=\"paragraph\">\u003Cstrong>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">MindSoothe Capsules\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli class=\"paragraph\" style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\"Relieves feelings of depression\" \u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli class=\"paragraph\" style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\"Regulates disturbed sleep patterns (insomnia or hypersomnia)\" \u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli class=\"paragraph\" style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\"Improves disturbed appetite (loss of appetite or binge eating)\" \u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli class=\"paragraph\" style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\"MindSoothe is ...formulated to relieve the symptoms of depression. ...without any of the harmful side effects possible with prescription medicine.\" \u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli class=\"paragraph\" style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\"Supporting emotional health... depression-free.\" [ellipsis in original]\u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"text-autospace:none\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Your\u003Cspan style=\"color:black\"> website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include: \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"text-autospace:none\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\"Your \u003C\u002Fspan>\u003Cb>\u003Ci>\u003Cspan style=\"font-family:"Arial",sans-serif\">MindSoothe\u003C\u002Fspan>\u003C\u002Fi>\u003C\u002Fb>\u003Cspan style=\"font-family:"Arial",sans-serif\"> remedy helped my depression so much!\"\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Your \u003Cspan style=\"color:black\">MindSoothe\u003C\u002Fspan>\u003Cspan style=\"color:black\"> Drops and \u003C\u002Fspan>\u003Cspan style=\"color:black\">MindSoothe\u003C\u002Fspan>\u003Cspan style=\"color:black\"> Capsules\u003C\u002Fspan> products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. \u003Cspan style=\"background:white\">§ \u003C\u002Fspan>321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. \u003Cspan style=\"background:white\">§§ \u003C\u002Fspan>331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. \u003Cspan style=\"background:white\">§ \u003C\u002Fspan>352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. \u003Cspan style=\"background:white\">§ \u003C\u002Fspan>201.5).  Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. \u003Cspan style=\"background:white\">§ \u003C\u002Fspan>353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Your \u003Cspan style=\"color:black\">MindSoothe\u003C\u002Fspan>\u003Cspan style=\"color:black\"> Drops and \u003C\u002Fspan>\u003Cspan style=\"color:black\">MindSoothe\u003C\u002Fspan>\u003Cspan style=\"color:black\"> Capsules\u003C\u002Fspan> products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your \u003Cspan style=\"color:black\">MindSoothe\u003C\u002Fspan>\u003Cspan style=\"color:black\"> Drops and \u003C\u002Fspan>\u003Cspan style=\"color:black\">MindSoothe\u003C\u002Fspan>\u003Cspan style=\"color:black\"> Capsules\u003C\u002Fspan> products fail to bear adequate directions for their inte\u003Cspan style=\"color:black\">nded use and, therefore, these products are misbranded under section 502(f)(1) of the Act [21 U.S.C. \u003Cspan style=\"background:white\">§ \u003C\u002Fspan>352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. \u003Cspan style=\"background:white\">§\u003C\u002Fspan> 331(a)]. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family:"Arial",sans-serif\">your firm complies with all requirements of federal law, including FDA\u003Cspan style=\"color:black\"> regulations.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">You should take prompt action to address the violations cited in this letter.  Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure and injunction.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps that you have taken to address these violations.  Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.  If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so.\u003C\u002Fspan> \u003Cspan style=\"font-family:"Arial",sans-serif\">Your reply should be sent via e-mail to \u003C\u002Fspan>\u003Ca href=\"mailto:FDAAdvisory@fda.hhs.gov\" style=\"color:blue; text-decoration:underline\">\u003Cspan style=\"font-family:"Arial",sans-serif\">FDAAdvisory@fda.hhs.gov\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-family:"Arial",sans-serif\">.\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=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Sincerely,\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u002FS\u002F\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">William A. Correll Jr.\u003Cbr>\nDirector\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Food Safety and Applied Nutrition\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:11pt\">\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\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Overnight Delivery\n\nProduct:\n\nDrugs\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nBruce Valk\n\nNative Remedies dba Silver Star Brands\n\n250 City Center\n\nOshkosh, WI 54906\n\nUnited States\n\nIssuing Office:\n\nCenter for Food Safety and Applied Nutrition (CFSAN)\n\nUnited States\n\nRE: [CMS:612268]\n\nDear Mr. Valk,\n\nThis is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fwww.nativeremedies.com in December 2020 and has determined that you take orders there for your MindSoothe Drops and MindSoothe Capsules products. The claims on your website establish that your products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.\n\nExamples of some of the website claims that provide evidence that your products are intended for use as drugs include:\n\nMindSoothe Drops\n\n\"Relieves feelings of depression\"\n\n\"Regulates disturbed sleep patterns (insomnia or hypersomnia)\"\n\n\"Improves disturbed appetite (loss of appetite or binge eating)\"\n\n\"MindSoothe™ should be taken when there is a noticeable loss of interest in activities that are normally enjoyable, a change in eating habits (such as overeating or appetite loss), or difficulty concentrating, remembering details, and making decisions.\"\n\nMindSoothe Capsules\n\n\"Relieves feelings of depression\"\n\n\"Regulates disturbed sleep patterns (insomnia or hypersomnia)\"\n\n\"Improves disturbed appetite (loss of appetite or binge eating)\"\n\n\"MindSoothe is ...formulated to relieve the symptoms of depression. ...without any of the harmful side effects possible with prescription medicine.\"\n\n\"Supporting emotional health... depression-free.\" [ellipsis in original]\n\nYour website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:\n\n\"Your MindSoothe remedy helped my depression so much!\"\n\nYour MindSoothe Drops and MindSoothe Capsules products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.\n\nA drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.\n\nYour MindSoothe Drops and MindSoothe Capsules products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your MindSoothe Drops and MindSoothe Capsules products fail to bear adequate directions for their intended use and, therefore, these products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].\n\nThe violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.\n\nYou should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure and injunction.\n\nPlease notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps that you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so. Your reply should be sent via e-mail to FDAAdvisory@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nWilliam A. Correll Jr.\n\nDirector\n\nOffice of Compliance\n\nCenter for Food Safety and Applied Nutrition\n\nFood and Drug Administration","2026-08-20T03:22:19.077+00:00",[24,25,26,9,10,27,28,27],"\u003Ctime datetime=\"2021-02-19T17:00:00Z\">02\u002F19\u002F2021\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-02-18T05:00:00Z\">02\u002F18\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fnative-remedies-dba-silver-star-brands-612268-02182021\">Native Remedies dba Silver Star Brands\u003C\u002Fa>","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fsilver-star-brands-inc-612268-09272021\">\u003Ctime datetime=\"2025-08-04T04:00:00Z\">08\u002F04\u002F2025\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:29.460824+00:00","2026-08-20T03:22:21.204552+00:00",{"510k":32,"classification":33,"enforcement":34,"event":35,"pma":36,"warning_letter":37},"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"]