[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-enlifta-llc-612253-02182021":3,"fda-latest-sync-dates":29},{"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":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},3529,"enlifta-llc-612253-02182021","Warning Letter","Enlifta, LLC",null,"Center for Food Safety and Applied Nutrition (CFSAN)","New Drug\u002FMisbranded","2021-02-19","2021-02-18","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fenlifta-llc-612253-02182021","612253","Food & Beverages","Via Overnight Delivery","Nathan Schumacher","\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\">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\">Nathan Schumacher\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>Enlifta, LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">16372 Page St.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Omaha\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">NE\u003C\u002Fspan> \u003Cspan class=\"postal-code\">68118\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:612253]\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 Mr. Schumacher,\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\">This is to advise you that the Food and Drug Administration (FDA) reviewed your websites at the Internet address, www.enlifta.com\u003Cspan style=\"color:#1f497d\">, \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family:"Arial",sans-serif\">in December 2020 and February 2021. FDA observed that your website directs customers to your Amazon pages to purchase your “Enlifta Mood Elevator” and “Enlifta Anxiety” products. \u003Cspan style=\"background:white\">\u003Cspan style=\"color:black\">We have also reviewed \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"color:black\">product listings on your Amazon page,\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Fwww.amazon.com\u002FDoctor-Designed-Depression-Enlifta-Supplement\u002Fdp\u002FB00STR2MLQ\u002Fref=sr_1_2?dchild=1&keywords=Enlifta&qid=1608252523&sr=8-2\u003Cspan style=\"color:black\"> and \u003C\u002Fspan>https:\u002F\u002Fwww.amazon.com\u002FEnlifta-Supplement-Ashwagandha-L-Theanine-supplement\u002Fdp\u002FB071P2YZNC\u002Fref=sr_1_5?crid=3MDQSIYFRH3C8&dchild=1&keywords=enlifta+anxiety&qid=1608252697&sprefix=Enlifta+an%2Caps%2C169&sr=8-5\u003Cspan style=\"color:black\">. \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family:"Arial",sans-serif\">The claims on your websites and Amazon pages 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>\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\">www.fda.gov\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"background:white\">\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\">Examples of some of the\u003C\u002Fspan> \u003Cspan style=\"font-family:"Arial",sans-serif\">website claims that provide evidence that your “Enlifta Mood Elevator” and “Enlifta Anxiety” are intended for use as drugs include:\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 “Enlifta Mood Elevator”: \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=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">\"The Only Doctor Designed Depression Pill, Enlifta Depression Supplement - Best Natural Antidepressant.\"\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">\"ENLIFTA: OUR #1 BEST-SELLING DEPRESSION SUPPLEMENT\"\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">“‘Every day a patient was unhappy that their expensive prescription medications for depression weren’t working.  They wanted something more natural & without all the side effects of ‘hard’ prescription drugs.’\"\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\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 “Enlifta Anxiety”: \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=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">“‘A new natural supplement is providing relief to people across America suffering with severe anxiety and stress!’” \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">The product was created “‘. . . with 7 proven ingredients that remedy severe anxiety.’”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\"> \"Chamomile Flower [an ingredient in “Enlifta Anxiety”] . . . can provide treatment as an anti-inflammatory, . . . for insomnia, and for anxiety relief.\"\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">\"English Lavender Flower Powder [an ingredient in “Enlifta Anxiety”] . . .for the treatment of insomnia and anxiety.\" \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">\"Passion Flower Herb Powder [an ingredient in “Enlifta Anxiety”] . . . . One study showed it worked as well as a common prescription medication for treating anxiety, but had fewer short-term side effects.\" \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of “Enlifta Mood Elevator” and “Enlifta Anxiety” for the cure, mitigation, treatment, or prevention of disease.  Examples of such testimonials include:\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=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">\"I have tried tons of supplements looking for a depression cure. This is it!!!\" \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">\"It is the perfect blend of several natural, non-drug, anti-depressant supplements all in one pill.\"\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">\"I would recommend enlifta to anyone who needs a [sic] excellent natural remedy for relieving depression and anxiety.\"\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your linked Amazon page for “Enlifta Mood Elevator”: https:\u002F\u002Fwww.amazon.com\u002FDoctor-Designed-Depression-Enlifta-Supplement\u002Fdp\u002FB00STR2MLQ\u002Fref=sr_1_2?dchild=1&keywords=Enlifta&qid=1608252523&sr=8-2\u003Cspan style=\"color:black\">: \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=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“NATURAL SAFE & EFFECTIVE ANTIDEPRESSANT FORMULA: More natural alternative to prescription drugs”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Enlifta is the only natural remedy depression supplement designed & created by a Psychiatrist.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your linked Amazon page for “\u003C\u002Fspan>\u003Cspan style=\"font-family:"Arial",sans-serif\">Enlifta Anxiety”\u003C\u002Fspan>\u003Cspan style=\"font-family:"Arial",sans-serif\">: https:\u002F\u002Fwww.amazon.com\u002FEnlifta-Supplement-Ashwagandha-L-Theanine-Supplement\u002Fdp\u002FB071P2YZNC\u002Fref=sr_1_5  crid=3MDQSIYFRH3C8&dchild=1&keywords=enlifta+anxiety&qid=1608252697&sprefix=Enlifta+an%2Caps%2C169&sr=8-5\u003Cspan style=\"color:black\">,\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=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> “NATURAL SAFE & EFFECTIVE ANXIOLYTIC FORMULA: More natural alternative to prescription drugs”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Enlifta is the only natural remedy anxiety supplement designed & created by a Psychiatrist”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:11pt\">\u003Cspan style=\"font-family:Calibri,sans-serif\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Unlike other supplements and prescription medications, Enlifta Anxiety helps to manage stress and associated anxiety without causing excess fatigue or a ‘medicated’ feeling during the day.”\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 “Enlifta Mood Elevator” and “Enlifta Anxiety” 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 CFR \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 “Enlifta Mood Elevator” and “Enlifta Anxiety” 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 “Enlifta Mood Elevator” and “Enlifta Anxiety” products fail to bear adequate directions for their intended use and, therefore, the 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\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 statement of violations that exist in connection with your marketed 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. \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 legal 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, w\u003C\u002Fspan>\u003Cspan style=\"font-family:"Arial",sans-serif\">ithin 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>\u002FS\u002F\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.\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\">Director\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\">Office of Compliance \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\">Center 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 Administratio\u003C\u002Fspan>\u003Cspan style=\"font-family:"Arial",sans-serif\">n\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\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nNathan Schumacher\n\nEnlifta, LLC\n\n16372 Page St.\n\nOmaha, NE 68118\n\nUnited States\n\nIssuing Office:\n\nCenter for Food Safety and Applied Nutrition (CFSAN)\n\nUnited States\n\nRE: [CMS:612253]\n\nDear Mr. Schumacher,\n\nThis is to advise you that the Food and Drug Administration (FDA) reviewed your websites at the Internet address, www.enlifta.com, in December 2020 and February 2021. FDA observed that your website directs customers to your Amazon pages to purchase your “Enlifta Mood Elevator” and “Enlifta Anxiety” products. We have also reviewed product listings on your Amazon page, https:\u002F\u002Fwww.amazon.com\u002FDoctor-Designed-Depression-Enlifta-Supplement\u002Fdp\u002FB00STR2MLQ\u002Fref=sr_1_2?dchild=1&keywords=Enlifta&qid=1608252523&sr=8-2 and https:\u002F\u002Fwww.amazon.com\u002FEnlifta-Supplement-Ashwagandha-L-Theanine-supplement\u002Fdp\u002FB071P2YZNC\u002Fref=sr_1_5?crid=3MDQSIYFRH3C8&dchild=1&keywords=enlifta+anxiety&qid=1608252697&sprefix=Enlifta+an%2Caps%2C169&sr=8-5. The claims on your websites and Amazon pages 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 “Enlifta Mood Elevator” and “Enlifta Anxiety” are intended for use as drugs include:\n\nOn the webpage for “Enlifta Mood Elevator”:\n\n\"The Only Doctor Designed Depression Pill, Enlifta Depression Supplement - Best Natural Antidepressant.\"\n\n\"ENLIFTA: OUR #1 BEST-SELLING DEPRESSION SUPPLEMENT\"\n\n“‘Every day a patient was unhappy that their expensive prescription medications for depression weren’t working. They wanted something more natural & without all the side effects of ‘hard’ prescription drugs.’\"\n\nOn the webpage for “Enlifta Anxiety”:\n\n“‘A new natural supplement is providing relief to people across America suffering with severe anxiety and stress!’”\n\nThe product was created “‘. . . with 7 proven ingredients that remedy severe anxiety.’”\n\n\"Chamomile Flower [an ingredient in “Enlifta Anxiety”] . . . can provide treatment as an anti-inflammatory, . . . for insomnia, and for anxiety relief.\"\n\n\"English Lavender Flower Powder [an ingredient in “Enlifta Anxiety”] . . .for the treatment of insomnia and anxiety.\"\n\n\"Passion Flower Herb Powder [an ingredient in “Enlifta Anxiety”] . . . . One study showed it worked as well as a common prescription medication for treating anxiety, but had fewer short-term side effects.\"\n\nYour website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of “Enlifta Mood Elevator” and “Enlifta Anxiety” for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:\n\n\"I have tried tons of supplements looking for a depression cure. This is it!!!\"\n\n\"It is the perfect blend of several natural, non-drug, anti-depressant supplements all in one pill.\"\n\n\"I would recommend enlifta to anyone who needs a [sic] excellent natural remedy for relieving depression and anxiety.\"\n\nOn your linked Amazon page for “Enlifta Mood Elevator”: https:\u002F\u002Fwww.amazon.com\u002FDoctor-Designed-Depression-Enlifta-Supplement\u002Fdp\u002FB00STR2MLQ\u002Fref=sr_1_2?dchild=1&keywords=Enlifta&qid=1608252523&sr=8-2:\n\n“NATURAL SAFE & EFFECTIVE ANTIDEPRESSANT FORMULA: More natural alternative to prescription drugs”\n\n“Enlifta is the only natural remedy depression supplement designed & created by a Psychiatrist.”\n\nOn your linked Amazon page for “Enlifta Anxiety”: https:\u002F\u002Fwww.amazon.com\u002FEnlifta-Supplement-Ashwagandha-L-Theanine-Supplement\u002Fdp\u002FB071P2YZNC\u002Fref=sr_1_5 crid=3MDQSIYFRH3C8&dchild=1&keywords=enlifta+anxiety&qid=1608252697&sprefix=Enlifta+an%2Caps%2C169&sr=8-5,\n\n“NATURAL SAFE & EFFECTIVE ANXIOLYTIC FORMULA: More natural alternative to prescription drugs”\n\n“Enlifta is the only natural remedy anxiety supplement designed & created by a Psychiatrist”\n\n“Unlike other supplements and prescription medications, Enlifta Anxiety helps to manage stress and associated anxiety without causing excess fatigue or a ‘medicated’ feeling during the day.”\n\nYour “Enlifta Mood Elevator” and “Enlifta Anxiety” 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 CFR § 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 “Enlifta Mood Elevator” and “Enlifta Anxiety” 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 “Enlifta Mood Elevator” and “Enlifta Anxiety” products fail to bear adequate directions for their intended use and, therefore, the 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 marketed 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","2026-08-20T03:21:58.471+00:00",[23,24,25,9,10,26,26,26],"\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\u002Fenlifta-llc-612253-02182021\">Enlifta, LLC\u003C\u002Fa>","","2026-08-18T06:42:29.460824+00:00","2026-08-20T03:22:00.607963+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"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"]