[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-vitacig-inc-617847-12012021":3,"fda-latest-sync-dates":30},{"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":28,"updated_at":29},2990,"vitacig-inc-617847-12012021","Warning Letter","VitaCig, Inc.",null,"Center for Drug Evaluation and Research | CDER","Unapproved New Drugs\u002FMisbranded","2021-12-07","2021-12-01","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fvitacig-inc-617847-12012021","617847","Drugs","Via Email","Paul Rosenberg","\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 Email\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\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 Rosenberg\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>VitaCig, Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">2375 Watermill Dr.\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Orange Park\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">FL\u003C\u002Fspan> \u003Cspan class=\"postal-code\">32073\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:support@vitaciggroup.com\"> support@vitaciggroup.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:sales@vitaciggroup.com\"> sales@vitaciggroup.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:info@vitaciggroup.com\"> info@vitaciggroup.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 class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>December 1, 2021\u003Cbr>\n\u003Cbr>\n4720 Salisbury Rd.\u003Cbr>\nJacksonville, FL 32256\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">RE: 617847\u003C\u002Fp>\n\n\u003Cp>Dear Mr. Rosenberg:\u003C\u002Fp>\n\n\u003Cp>This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fwww.vitaciggroup.com in September 2021 and has determined that you take orders there for your “VitaCig products,” which include a variety of flavors available as “Classic edition” and “S-edition” inhalers as well as capsules for use in your rechargeable “Excalibur” inhaler. The claims on your website establish that your products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at \u003Ca href=\"\u002F\u002Fwww.fda.gov.\">www.fda.gov.\u003C\u002Fa>\u003C\u002Fp>\n\n\u003Cp>Furthermore, the use of your VitaCig products raises safety concerns for the agency because the ingredients and\u002For impurities in oral inhalation products may trigger laryngospasm or bronchospasm, may be toxic to the tissues in the upper or lower airways, or may be absorbed and exert undesirable systemic effects or organ toxicity.\u003C\u002Fp>\n\n\u003Cp>Based on our review of your website, your VitaCig products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and\u002For intended to affect the structure or any function of the body.\u003C\u002Fp>\n\n\u003Cp>Examples of some of the claims observed on your website https:\u002F\u002Fwww.vitaciggroup.com that provide evidence that your products are intended for use as drugs include, but may not be limited to, the following:\u003C\u002Fp>\n\n\u003Cp>On the website https:\u002F\u002Fwww.vitaciggroup.com\u002F:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>“VitaCig® is a unique NICOTINE & TOBACCO FREE personal aromatherapy device, pre-filled with vitamin-enhanced liquids and diluted natural essential oils. Its formulation is based on the knowledge and centuries-old experience of using herbs and natural extracts to assist our wellbeing, to balance our mental, emotional and physical levels of energy. Each VitaCig® is bursting with flavors and mood enhancing effects. Let yourself feel your emotions with every VitaCig® blend.”\u003C\u002Fli>\n\t\u003Cli>From your “VitaCig® Cool Citrus” product webpage: “The Lemon Essential Oil has a clarifying quality, good for mental fatigue and emotional confusion, stimulates the mind and increase the ability to [sic] memorise.”\u003C\u002Fli>\n\t\u003Cli>From your “VitaCig® Watermelon Wave” product webpage:\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>    o “Watermelons are loaded with antioxidants and have been associated with a wide range of health benefits — such as better heart health, enhanced immunity and increased weight loss.”\u003Cbr>\n    o “Lychee is a wonderful fruit with plenty of health benefits, including its ability to aid in weight loss, protect the skin, boost the immune system prevent cancer, improve digestion, build strong bones, lower blood pressure, defend the body against viruses, improve circulation, and optimize metabolic activities.”\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>From your “VitaCig® Vintage Vanilla” product webpage: “The Valerian Oil can lessen anxiety as well as improve both the quality and duration of sleep”\u003C\u002Fli>\n\t\u003Cli>From your “VitaCig® Focus” product webpage:\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>    o “Asian ginseng is prescribed for those with low energy, tendency to feel cold, and a lack of sex drive. Studies have shown ginseng improves erectile dysfunction in men”\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup>\u003Cbr>\n    o “VitaCig® FOCUS . . . is an inhalable natural cognitive booster. . . . It has a stimulation effect, improves your concentration, helps support optimal cognition and acute focus, bringing clarity of mind.”\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>From your “VitaCig® Rejuvenate” product webpage: “Both calming and uplifting, geranium makes a natural antidepressant and helps to relieve anxiety.”\u003C\u002Fli>\n\t\u003Cli>From your “VitaCig® Sleep” product webpage:\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>    o “Lack of sleep weakens the immune system, slows reaction times and makes you more prone to depression, anxiety and a low mood.”\u003Cbr>\n    o “Neroli Oil …has long been used as a treatment against anxiety and depression, to calm the mind and soothe away tension.”\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>From your “VitaCig® Slim” product webpage: “Hoodia is used as a weight loss aid.”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>Your VitaCig 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 FD&C 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 FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. No approved applications are in effect for your products.\u003C\u002Fp>\n\n\u003Cp>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. 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\u002For injunction.\u003C\u002Fp>\n\n\u003Cp>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 FD&C 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\u002Fp>\n\n\u003Cp>Your written reply should be directed to the U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Carolyn E. Becker\u003Cbr>\nDirector\u003Cbr>\nOffice of Unapproved Drugs and Labeling Compliance\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Drug Evaluation and Research\u003Cbr>\nFood and Drug Administration\u003C\u002Fp>\n\n\u003Cp>_________________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> This claim also appears on your “VitaCig® Surge” product webpage.\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 Email\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nPaul Rosenberg\n\nVitaCig, Inc.\n\n2375 Watermill Dr.\n\nOrange Park, FL 32073\n\nUnited States\n\nsupport@vitaciggroup.com\n\nsales@vitaciggroup.com\n\ninfo@vitaciggroup.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWARNING LETTER\n\nDecember 1, 2021\n\n4720 Salisbury Rd.\n\nJacksonville, FL 32256\n\nRE: 617847\n\nDear Mr. Rosenberg:\n\nThis is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fwww.vitaciggroup.com in September 2021 and has determined that you take orders there for your “VitaCig products,” which include a variety of flavors available as “Classic edition” and “S-edition” inhalers as well as capsules for use in your rechargeable “Excalibur” inhaler. The claims on your website establish that your products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.\n\nFurthermore, the use of your VitaCig products raises safety concerns for the agency because the ingredients and\u002For impurities in oral inhalation products may trigger laryngospasm or bronchospasm, may be toxic to the tissues in the upper or lower airways, or may be absorbed and exert undesirable systemic effects or organ toxicity.\n\nBased on our review of your website, your VitaCig products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and\u002For intended to affect the structure or any function of the body.\n\nExamples of some of the claims observed on your website https:\u002F\u002Fwww.vitaciggroup.com that provide evidence that your products are intended for use as drugs include, but may not be limited to, the following:\n\nOn the website https:\u002F\u002Fwww.vitaciggroup.com\u002F:\n\n“VitaCig® is a unique NICOTINE & TOBACCO FREE personal aromatherapy device, pre-filled with vitamin-enhanced liquids and diluted natural essential oils. Its formulation is based on the knowledge and centuries-old experience of using herbs and natural extracts to assist our wellbeing, to balance our mental, emotional and physical levels of energy. Each VitaCig® is bursting with flavors and mood enhancing effects. Let yourself feel your emotions with every VitaCig® blend.”\n\nFrom your “VitaCig® Cool Citrus” product webpage: “The Lemon Essential Oil has a clarifying quality, good for mental fatigue and emotional confusion, stimulates the mind and increase the ability to [sic] memorise.”\n\nFrom your “VitaCig® Watermelon Wave” product webpage:\n\no “Watermelons are loaded with antioxidants and have been associated with a wide range of health benefits — such as better heart health, enhanced immunity and increased weight loss.”\n\no “Lychee is a wonderful fruit with plenty of health benefits, including its ability to aid in weight loss, protect the skin, boost the immune system prevent cancer, improve digestion, build strong bones, lower blood pressure, defend the body against viruses, improve circulation, and optimize metabolic activities.”\n\nFrom your “VitaCig® Vintage Vanilla” product webpage: “The Valerian Oil can lessen anxiety as well as improve both the quality and duration of sleep”\n\nFrom your “VitaCig® Focus” product webpage:\n\no “Asian ginseng is prescribed for those with low energy, tendency to feel cold, and a lack of sex drive. Studies have shown ginseng improves erectile dysfunction in men”1\n\no “VitaCig® FOCUS . . . is an inhalable natural cognitive booster. . . . It has a stimulation effect, improves your concentration, helps support optimal cognition and acute focus, bringing clarity of mind.”\n\nFrom your “VitaCig® Rejuvenate” product webpage: “Both calming and uplifting, geranium makes a natural antidepressant and helps to relieve anxiety.”\n\nFrom your “VitaCig® Sleep” product webpage:\n\no “Lack of sleep weakens the immune system, slows reaction times and makes you more prone to depression, anxiety and a low mood.”\n\no “Neroli Oil …has long been used as a treatment against anxiety and depression, to calm the mind and soothe away tension.”\n\nFrom your “VitaCig® Slim” product webpage: “Hoodia is used as a weight loss aid.”\n\nYour VitaCig 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 FD&C 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 FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. No approved applications are in effect for your products.\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. 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\u002For 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 FD&C 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.\n\nYour written reply should be directed to the U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nCarolyn E. Becker\n\nDirector\n\nOffice of Unapproved Drugs and Labeling Compliance\n\nOffice of Compliance\n\nCenter for Drug Evaluation and Research\n\nFood and Drug Administration\n\n_________________________\n\n1 This claim also appears on your “VitaCig® Surge” product webpage.","2026-08-20T02:22:04.961+00:00",[23,24,25,9,26,27,27,27],"\u003Ctime datetime=\"2021-12-07T14:20:00Z\">12\u002F07\u002F2021\u003C\u002Ftime>\n","\u003Ctime datetime=\"2021-12-01T05:00:00Z\">12\u002F01\u002F2021\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fvitacig-inc-617847-12012021\">VitaCig, Inc.\u003C\u002Fa>","Unapproved New Drugs\u002FMisbranded \u003Cbr \u002F>\r\n\u003Cbr \u002F>\r\n","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.623189+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"pma":35,"warning_letter":36},"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"]