[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-blossom-nature-llc-612263-02182021":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},3522,"blossom-nature-llc-612263-02182021","Warning Letter","Blossom Nature, LLC",null,"Center for Food Safety and Applied Nutrition (CFSAN)","New Drug\u002FMisbranded","2021-02-19","2021-02-18","2021-07-21","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fblossom-nature-llc-612263-02182021","612263","DrugsFood & Beverages","Via Overnight Delivery","Natalie Krassowizki","\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\">Natalie Krassowizki\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Blossom Nature, LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1193 Elederberry Circle\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Folsom\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">95630\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: 612263]\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\">\u003Cspan style=\"color:black\">Dear Ms. \u003Cspan style=\"background:white\">Krassowizki\u003C\u002Fspan>,\u003C\u002Fspan>\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\">\u003Cspan style=\"color:black\">This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address, \u003C\u002Fspan>www.blossom-nature.com\u003Cspan style=\"color:black\">, in December 2020. FDA observed that your website directs customers to your Amazon page to purchase your \u003Cspan style=\"background:white\">St. John’s Wort\u003C\u002Fspan> product. \u003Cspan style=\"background:white\">We have also reviewed your \u003C\u002Fspan>product listing on your Amazon page, http:\u002F\u002Fwww.amazon.com\u002FSupplement-National-Antidepressant-Support-Provides-Relief-120\u002Fdp\u002FB082TTLJGP,\u003C\u002Fspan>\u003Cspan style=\"color:black\"> which operates under the name Blossom Nature. The claims on your websites establish that your \u003Cspan style=\"background:white\">product is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product 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=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:#3333ff\">www.fda.gov\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:#3333ff\">.\u003C\u002Fspan>\u003C\u002Fspan>\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\">\u003Cspan style=\"color:black\">Examples of some of the\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">website claims that provide evidence that your \u003Cspan style=\"background:white\">St. John’s Wort\u003C\u002Fspan> is intended for use as a drug include:\u003C\u002Fspan>\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\">On the webpage for “\u003Cspan style=\"background:white\">\u003Cspan style=\"color:black\">St. John’s Wort | Blossom Nature” \u003C\u002Fspan>\u003C\u002Fspan>at www.blossom-nature.com: \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\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\">\"St. John’s Wort is a natural treatment for mental health problems.\" \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\">\"Today, St. John’s Wort is best known as a treatment for depression, anxiety and stress.\" \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\">\"St. John's Wort is effective as prescribed antidepressants but with no side effects.\" \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\">\"St. John’s Wort . . . moderates Seasonal Affective Disorder (SAD)\" \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\">\"Blossom Nature’s 1 capsule of 450 mg taken twice a day relieves symptoms of depression and anxiety for 24 hours with No Side Effects.\" \u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp class=\"paragraph\">\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\">On your Amazon product page at \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">http:\u002F\u002Fwww.amazon.com\u002FSupplement-National-Antidepressant-Support-Provides-Relief-120\u002Fdp\u002FB082TTLJGP\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\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:#3333ff\">:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\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\">On a graphic titled “Blossom Nature’s St. John’s Wort”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\n\n\t\u003Cul style=\"list-style-type:circle\">\n\t\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\">\"NATURAL ANTIDEPRESSANT HYPERCIN\" \u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\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\">\"GET THE BEST TREATMENT FOR DEPRESSION, ANXIETY AND STRESS with BLOSSOM NATURE’s St. John’s Wort.”\u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003C\u002Ful>\n\t\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp class=\"paragraph\">\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=\"background:white\">\u003Cspan style=\"color:black\">St. John’s Wort\u003C\u002Fspan>\u003C\u002Fspan> product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” 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=\"background:white\">\u003Cspan style=\"color:black\">St. John’s Wort\u003C\u002Fspan>\u003C\u002Fspan> product is 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 product safely for its intended purposes. Accordingly, your \u003Cspan style=\"background:white\">\u003Cspan style=\"color:black\">St. John’s Wort\u003C\u002Fspan>\u003C\u002Fspan> product fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug 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\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\">The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with the Act and its implementing regulations.\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\">You should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in enforcement action without further notice, 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=\"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>\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\nNatalie Krassowizki\n\nBlossom Nature, LLC\n\n1193 Elederberry Circle\n\nFolsom, CA 95630\n\nUnited States\n\nIssuing Office:\n\nCenter for Food Safety and Applied Nutrition (CFSAN)\n\nUnited States\n\nRE: [CMS: 612263]\n\nDear Ms. Krassowizki,\n\nThis is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address, www.blossom-nature.com, in December 2020. FDA observed that your website directs customers to your Amazon page to purchase your St. John’s Wort product. We have also reviewed your product listing on your Amazon page, http:\u002F\u002Fwww.amazon.com\u002FSupplement-National-Antidepressant-Support-Provides-Relief-120\u002Fdp\u002FB082TTLJGP, which operates under the name Blossom Nature. The claims on your websites establish that your product is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product 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 St. John’s Wort is intended for use as a drug include:\n\nOn the webpage for “St. John’s Wort | Blossom Nature” at www.blossom-nature.com:\n\n\"St. John’s Wort is a natural treatment for mental health problems.\"\n\n\"Today, St. John’s Wort is best known as a treatment for depression, anxiety and stress.\"\n\n\"St. John's Wort is effective as prescribed antidepressants but with no side effects.\"\n\n\"St. John’s Wort . . . moderates Seasonal Affective Disorder (SAD)\"\n\n\"Blossom Nature’s 1 capsule of 450 mg taken twice a day relieves symptoms of depression and anxiety for 24 hours with No Side Effects.\"\n\nOn your Amazon product page at http:\u002F\u002Fwww.amazon.com\u002FSupplement-National-Antidepressant-Support-Provides-Relief-120\u002Fdp\u002FB082TTLJGP:\n\nOn a graphic titled “Blossom Nature’s St. John’s Wort”:\n\n\"NATURAL ANTIDEPRESSANT HYPERCIN\"\n\n\"GET THE BEST TREATMENT FOR DEPRESSION, ANXIETY AND STRESS with BLOSSOM NATURE’s St. John’s Wort.”\n\nYour St. John’s Wort product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” 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 St. John’s Wort product is 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 product safely for its intended purposes. Accordingly, your St. John’s Wort product fails to bear adequate directions for its intended use and, therefore, the product is 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 this misbranded drug 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 list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with the Act and its implementing regulations.\n\nYou should take prompt action to address the violations cited in this letter. Failure to promptly address these violations may result in enforcement 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","2026-08-20T03:21:47.675+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\u002Fblossom-nature-llc-612263-02182021\">Blossom Nature, LLC\u003C\u002Fa>","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fblossom-nature-llc-612263-06252021\">\u003Ctime datetime=\"2021-07-21T04:00:00Z\">07\u002F21\u002F2021\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:29.460824+00:00","2026-08-20T03:21:49.795692+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"]