[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-fancy-drops-beauty-llc-688469-10242024":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},1182,"fancy-drops-beauty-llc-688469-10242024","Warning Letter","Fancy Drops Beauty LLC",null,"Center for Drug Evaluation and Research (CDER)","Unapproved New Drugs\u002FMisbranded","2024-11-05","2024-10-24","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Ffancy-drops-beauty-llc-688469-10242024","688469","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>Fancy Drops Beauty LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1942 Broadway Suite 314C\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Boulder\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CO\u003C\u002Fspan> \u003Cspan class=\"postal-code\">80302\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:hello@fancydrops.co\"> hello@fancydrops.co\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>October 24, 2024\u003C\u002Fp>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>RE: 688469\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>Dear Fancy Drops Beauty LLC:\u003C\u002Fp>\n\n\u003Cp>This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Ffancydropsbeauty.com\u002F in July 2024 and has observed that your website offers “Fancy Drops Color Changing Solutions Eye Drops” in various colors\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> (hereinafter referred to as “Fancy Drops products”) for sale in the United States. As described below, your Fancy Drops products are unapproved new drugs 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).\u003C\u002Fp>\n\n\u003Cp>Your Fancy Drops products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.\u003C\u002Fp>\n\n\u003Cp>Based on a review of your website, your Fancy Drops 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. Examples of claims from your website https:\u002F\u002Ffancydropsbeauty.com\u002F that establish the intended use of these products as drugs include, but may not be limited to, the following:\u003C\u002Fp>\n\n\u003Cp>On the webpage https:\u002F\u002Ffancydropsbeauty.com\u002F:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>“Lighten & Brighten Dark Your Eye Color, Speed Up the Eye Color Changing Process.”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>On the webpage https:\u002F\u002Ffancydropsbeauty.com\u002Fpages\u002Freviews\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>An image of a bottle of Fancy Drops with the quote “CAN’T BELIEVE FANCY DROPS CHANGED MY EYE COLOR”\u003C\u002Fli>\n\t\u003Cli>Customer review from 02\u002F20\u002F2024: \"No blurry vision or pain. About in 3 months it will be noticeable. It works but slow. I can see the differences, now I have blue eye color, like icy blue. I like the result. Thanks!”\u003C\u002Fli>\n\t\u003Cli>Customer review from 05\u002F17\u002F2024: “I’ve had brown eyes for years, and they were blue when I was born! Now, after 5 months, I bought it hoping for green eyes and it works well. It has changed my eyes, and now having green eyes is what I’m most excited about.”\u003C\u002Fli>\n\t\u003Cli>Customer review from 02\u002F22\u002F2024: “I have been using this product for almost 6 months now and I can confidently say that it works for me. I’ve always wanted blue eyes and this Fancy Drops product really made my eye color fade from the dark brown it was in the beginning, slowly to blue”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>On the webpage https:\u002F\u002Ffancydropsbeauty.com\u002Fpages\u002Fabout-us:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>“Our Eye Color treatments harness the natural properties of plants that work in tandem with proven science to promote clean and gentle color changing process.”\u003C\u002Fli>\n\t\u003Cli>“We are committed to creating thoughtful, modern Color Changing treatments that serve to empower and embrace natural beauty.”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>On the webpage https:\u002F\u002Ffancydropsbeauty.com\u002Fpages\u002Ficy-grey-creative:\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli>“Our Fancy Drops products work by inhibiting the production of Melanin, other pigmentation, and Tyrosinase. But that's not all, our products go beyond this, working at cellular level to Inhibit the enzymes and underlying mechanisms responsible for producing and stimulating pigment-producing cells, [g]iving you a new eye color based on new lower levels of pigmentation.”\u003C\u002Fli>\n\t\u003Cli>“By inhibiting the expression of Melanin and other pigmentation, you increase the color expression of lighter tones, (such as blues, greens, hazels, and light honey shades) and the overall lightness of your eyes.”\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>Your Fancy Drops products are not generally recognized as safe and effective (GRASE) 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). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDAapproved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for Fancy Drops products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\u003C\u002Fp>\n\n\u003Cp>The violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.\u003C\u002Fp>\n\n\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>\n\n\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 products are 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. 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.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Tina Smith, M.S.\u003Cbr>\nCaptain, U.S. Public Health Service\u003Cbr>\nDirector\u003Cbr>\nOffice of Unapproved Drugs and Labeling Compliance\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Drug Evaluation and Research\u003Cbr>\nU.S. Food and Drug Administration\u003C\u002Fp>\n\n\u003Cp>______________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> Fancy Drops products are offered in the following colors: Light Green, Light Blue, Turquoise, Hazel, Sterling Grey, Honey, Dark Green, Dark Blue, Amber, and Purple.\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\nFancy Drops Beauty LLC\n\n1942 Broadway Suite 314C\n\nBoulder, CO 80302\n\nUnited States\n\nhello@fancydrops.co\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWARNING LETTER\n\nOctober 24, 2024\n\nRE: 688469\n\nDear Fancy Drops Beauty LLC:\n\nThis letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Ffancydropsbeauty.com\u002F in July 2024 and has observed that your website offers “Fancy Drops Color Changing Solutions Eye Drops” in various colors1 (hereinafter referred to as “Fancy Drops products”) for sale in the United States. As described below, your Fancy Drops products are unapproved new drugs 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).\n\nYour Fancy Drops products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.\n\nBased on a review of your website, your Fancy Drops 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. Examples of claims from your website https:\u002F\u002Ffancydropsbeauty.com\u002F that establish the intended use of these products as drugs include, but may not be limited to, the following:\n\nOn the webpage https:\u002F\u002Ffancydropsbeauty.com\u002F:\n\n“Lighten & Brighten Dark Your Eye Color, Speed Up the Eye Color Changing Process.”\n\nOn the webpage https:\u002F\u002Ffancydropsbeauty.com\u002Fpages\u002Freviews\n\nAn image of a bottle of Fancy Drops with the quote “CAN’T BELIEVE FANCY DROPS CHANGED MY EYE COLOR”\n\nCustomer review from 02\u002F20\u002F2024: \"No blurry vision or pain. About in 3 months it will be noticeable. It works but slow. I can see the differences, now I have blue eye color, like icy blue. I like the result. Thanks!”\n\nCustomer review from 05\u002F17\u002F2024: “I’ve had brown eyes for years, and they were blue when I was born! Now, after 5 months, I bought it hoping for green eyes and it works well. It has changed my eyes, and now having green eyes is what I’m most excited about.”\n\nCustomer review from 02\u002F22\u002F2024: “I have been using this product for almost 6 months now and I can confidently say that it works for me. I’ve always wanted blue eyes and this Fancy Drops product really made my eye color fade from the dark brown it was in the beginning, slowly to blue”\n\nOn the webpage https:\u002F\u002Ffancydropsbeauty.com\u002Fpages\u002Fabout-us:\n\n“Our Eye Color treatments harness the natural properties of plants that work in tandem with proven science to promote clean and gentle color changing process.”\n\n“We are committed to creating thoughtful, modern Color Changing treatments that serve to empower and embrace natural beauty.”\n\nOn the webpage https:\u002F\u002Ffancydropsbeauty.com\u002Fpages\u002Ficy-grey-creative:\n\n“Our Fancy Drops products work by inhibiting the production of Melanin, other pigmentation, and Tyrosinase. But that's not all, our products go beyond this, working at cellular level to Inhibit the enzymes and underlying mechanisms responsible for producing and stimulating pigment-producing cells, [g]iving you a new eye color based on new lower levels of pigmentation.”\n\n“By inhibiting the expression of Melanin and other pigmentation, you increase the color expression of lighter tones, (such as blues, greens, hazels, and light honey shades) and the overall lightness of your eyes.”\n\nYour Fancy Drops products are not generally recognized as safe and effective (GRASE) 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). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDAapproved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for Fancy Drops products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).\n\nThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.\n\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.\n\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 products are 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. 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.\n\nSincerely,\n\n\u002FS\u002F\n\nTina Smith, M.S.\n\nCaptain, U.S. Public Health Service\n\nDirector\n\nOffice of Unapproved Drugs and Labeling Compliance\n\nOffice of Compliance\n\nCenter for Drug Evaluation and Research\n\nU.S. Food and Drug Administration\n\n______________________\n\n1 Fancy Drops products are offered in the following colors: Light Green, Light Blue, Turquoise, Hazel, Sterling Grey, Honey, Dark Green, Dark Blue, Amber, and Purple.","2026-08-19T19:15:07.165+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2024-11-05T14:20:00Z\">11\u002F05\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-10-24T04:00:00Z\">10\u002F24\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Ffancy-drops-beauty-llc-688469-10242024\">Fancy Drops Beauty LLC\u003C\u002Fa>","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+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"]