[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-alzclipp-uniuni-711274-07292025":3,"fda-latest-sync-dates":28},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":8,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":26,"updated_at":27},699,"alzclipp-uniuni-711274-07292025","Warning Letter","AlzClipp \u002F UniUni",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs\u002FMisbranded","2025-08-26","2025-07-29","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Falzclipp-uniuni-711274-07292025","711274","Drugs","Via Email","\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>\u003C\u002Fdd>\n                    \n            \u003Cdd>AlzClipp \u002F UniUni  \u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">175-14 147th Avenue\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Queens\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">NY\u003C\u002Fspan> \u003Cspan class=\"postal-code\">11434\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@alzclipp.com\"> support@alzclipp.com\u003C\u002Fa>\u003C\u002Fdd>\n    \u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:(b)(6), (b)(7)(C)\"> (b)(6), (b)(7)(C)\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>\u003Cp>July 29, 2025\u003C\u002Fp>\u003Cp class=\"text-align-center\">RE: 711274\u003C\u002Fp>\u003Cp>Dear AlzClipp:\u003C\u002Fp>\u003Cp>This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your product labeling, including your website at the Internet address https:\u002F\u002Fwww.alzclipp.com\u002F in July 2025 and has observed that your website offers “AlzClipp” nasal product for sale in the United States. As described below, your “AlzClipp” nasal product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, “AlzClipp” is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\u003C\u002Fp>\u003Cp>\u003Cstrong>Unapproved New Drug\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Your product is a drug as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and\u002For intended to affect the structure or function of the body. Examples of claims from your product label and website that provide evidence of the intended use of your product as a drug include, but may not be limited to, the following:\u003C\u002Fp>\u003Cp>From your product label:\u003C\u002Fp>\u003Cul>\u003Cli>“\u003Cstrong>Memory-Boost\u003C\u002Fstrong>\u003Cbr>Nasal Inhalation”\u003C\u002Fli>\u003Cli>“Boost Memory”\u003C\u002Fli>\u003Cli>“Enhance Cognitive Function”\u003C\u002Fli>\u003Cli>“Prevent Alzheimer’s”\u003C\u002Fli>\u003Cli>“\u003Cstrong>Indicated for\u003C\u002Fstrong>\u003Cbr>o Patients clinically diagnosed with memory decline\u003Cbr>o Individuals diagnosed with various types of dementia\u003Cbr>o Alzheimer’s disease patients”\u003C\u002Fli>\u003Cli>From your website https:\u002F\u002Fwww.alzclipp.com\u002F:\u003Cbr>“AlzClipp uses unique neural stimulation to activate olfactory neurons, affecting memory and cognition areas in the brain, helping slow degeneration and enhance memory and cognition, and preventing the progression of Alzheimer's and similar diseases.”\u003C\u002Fli>\u003Cli>“Improves sleep”\u003C\u002Fli>\u003Cli>“\u003Cstrong>Reverses dementia, boosts brain cognition, and prevents Alzheimer's disease\u003C\u002Fstrong>.”\u003C\u002Fli>\u003Cli>“AlzClipp uses continuous olfactory stimulation to keep the brain active, rejuvenate brain cells, slow neuronal degeneration, and improve memory and cognition, effectively preventing Alzheimer’s disease.”\u003C\u002Fli>\u003Cli>“AlzClipp can help reverse dementia and restore memory! If other brain cleansing treatments such as patches, drops, or sprays have failed, don't lose hope. AlzClipp addresses the core issues of Alzheimer's and memory loss . . . alleviating anxiety, and enhancing cognitive function!”\u003C\u002Fli>\u003Cli>“\u003Cstrong>The safest and most effective way to bid farewell to memory decline\u003C\u002Fstrong>”\u003C\u002Fli>\u003Cli>Numerous dynamic images and illustrations of the brain demonstrating the nasal use of “AlzClipp” followed by a visualization of brain activity suggesting use of the product will lead to “neural stimulation” and “activate” neurons.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>Your “AlzClipp” product is not generally recognized as safe and effective for the above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, a new drug may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). There are no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 in effect for this product. Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\u003Cp>\u003Cstrong>Misbranded Drug\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Your “AlzClipp” product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because your website includes statements that misleadingly suggest that the drug product is approved or endorsed by FDA in some way. For example, your website https:\u002F\u002Fwww.alzclipp.com\u002F includes an image of an FDA logo with the words “FDA approved” below it. The website also includes an image of a certificate with an FDA logo and the headline, “FDA Approves AlzClipp: A Groundbreaking Brain Health Innovation” next to the image of “AlzClipp.”\u003C\u002Fp>\u003Cp>As previously noted, there are no FDA-approved applications in effect for your “AlzClipp” product. Therefore, this product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because its labeling is false or misleading. The introduction or delivery for introduction into interstate commerce of this misbranded drug is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. 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\u002Fp>\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.\u003C\u002Fp>\u003Cp>Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any 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 product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.\u003C\u002Fp>\u003Cp>Your response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “CMS 711274” in the subject line of the email.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Tina Smith, M.S.\u003Cbr>Captain, U.S. Public Health Service\u003Cbr>Director\u003Cbr>Office of Unapproved Drugs & Labeling Compliance\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003Cbr>U.S. Food and Drug Administration\u003C\u002Fp>\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\nAlzClipp \u002F UniUni\n\n175-14 147th Avenue\n\nQueens, NY 11434\n\nUnited States\n\nsupport@alzclipp.com\n\n(b)(6), (b)(7)(C)\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWARNING LETTER\nJuly 29, 2025\nRE: 711274\nDear AlzClipp:\nThis letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your product labeling, including your website at the Internet address https:\u002F\u002Fwww.alzclipp.com\u002F in July 2025 and has observed that your website offers “AlzClipp” nasal product for sale in the United States. As described below, your “AlzClipp” nasal product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, “AlzClipp” is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\nUnapproved New Drug\nYour product is a drug as defined by section 201(g)(1) of the FD&C Act 21, U.S.C. 321(g)(1) because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and\u002For intended to affect the structure or function of the body. Examples of claims from your product label and website that provide evidence of the intended use of your product as a drug include, but may not be limited to, the following:\nFrom your product label:\n“Memory-Boost\nNasal Inhalation”\n“Boost Memory”\n“Enhance Cognitive Function”\n“Prevent Alzheimer’s”\n“Indicated for\no Patients clinically diagnosed with memory decline\no Individuals diagnosed with various types of dementia\no Alzheimer’s disease patients”\nFrom your website https:\u002F\u002Fwww.alzclipp.com\u002F:\n“AlzClipp uses unique neural stimulation to activate olfactory neurons, affecting memory and cognition areas in the brain, helping slow degeneration and enhance memory and cognition, and preventing the progression of Alzheimer's and similar diseases.”\n“Improves sleep”\n“Reverses dementia, boosts brain cognition, and prevents Alzheimer's disease.”\n“AlzClipp uses continuous olfactory stimulation to keep the brain active, rejuvenate brain cells, slow neuronal degeneration, and improve memory and cognition, effectively preventing Alzheimer’s disease.”\n“AlzClipp can help reverse dementia and restore memory! If other brain cleansing treatments such as patches, drops, or sprays have failed, don't lose hope. AlzClipp addresses the core issues of Alzheimer's and memory loss . . . alleviating anxiety, and enhancing cognitive function!”\n“The safest and most effective way to bid farewell to memory decline”\nNumerous dynamic images and illustrations of the brain demonstrating the nasal use of “AlzClipp” followed by a visualization of brain activity suggesting use of the product will lead to “neural stimulation” and “activate” neurons.\nYour “AlzClipp” product is not generally recognized as safe and effective for the above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, a new drug may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). There are no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 in effect for this product. Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\nMisbranded Drug\nYour “AlzClipp” product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because your website includes statements that misleadingly suggest that the drug product is approved or endorsed by FDA in some way. For example, your website https:\u002F\u002Fwww.alzclipp.com\u002F includes an image of an FDA logo with the words “FDA approved” below it. The website also includes an image of a certificate with an FDA logo and the headline, “FDA Approves AlzClipp: A Groundbreaking Brain Health Innovation” next to the image of “AlzClipp.”\nAs previously noted, there are no FDA-approved applications in effect for your “AlzClipp” product. Therefore, this product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because its labeling is false or misleading. The introduction or delivery for introduction into interstate commerce of this misbranded drug is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\nConclusion\nThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your product. 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.\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.\nPlease notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any 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 product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.\nYour response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “CMS 711274” in the subject line of the email.\nSincerely,\n\u002FS\u002F\nTina Smith, M.S.\nCaptain, U.S. Public Health Service\nDirector\nOffice of Unapproved Drugs & Labeling Compliance\nOffice of Compliance\nCenter for Drug Evaluation and Research\nU.S. Food and Drug Administration","2026-08-19T16:28:19.394+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2025-08-26T04:00:00Z\">08\u002F26\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-07-29T04:00:00Z\">07\u002F29\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Falzclipp-uniuni-711274-07292025\">AlzClipp \u002F UniUni  \u003C\u002Fa>","","2026-08-18T06:42:28.676509+00:00","2026-08-20T02:24:55.884391+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"pma":33,"warning_letter":34},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]