Delivery Method:Via EmailProduct:Drugs、Over-the-Counter DrugsRecipient:Kyle GuinnessCEORevitalize Energy, Inc.6401 Penn Ave. Suite 300Pittsburgh,PA15206United States(b)(6), (b)(7)(C)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERJuly 9, 2025RE: 712417Dear Mr. Guinness:This letter is to advise you that on April 14, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address https://myrevitalize.com/ where your Revitalize Energizing Eye Drops drug product is available for purchase in the United States without a prescription. We also reviewed your social media site on Facebook https://www.facebook.com/RevitalizeEnergy which direct consumers to your website to purchase your product.Based on our review, your Revitalize Energizing Eye Drops drug 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), 331(d). In addition, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under sections 301 (d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.Unapproved New Drug and Misbranded Drug ViolationsYour Revitalize Energizing Eye Drops is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.Examples of claims from the product labeling, your website, and your social media site posts that provide evidence intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:“Drug Facts . . . Uses ▪Temporarily relieves burning and irritation due to dryness of the eye. ▪ Relieves redness of the eye due to minor eye irritations.” [from the Drug Facts panel on product carton labeling]“Camphor…To Cool & Refresh” [from your product carton labeling]“Revitalize is the first eye drop designed to fight screen fatigue. Our patented formula relieves eye strain, boosts focus, and refreshes tired eyes in seconds.” [from your website, https://myrevitalize.com/pages/our-formulation-1]“Instant Energy & Screen Fatigue Relief…Refresh tired eyes with our energizing eye drops…” [from your website https://myrevitalize.com/]“Our energizing formula is built for people who live on screens. Every ingredient is selected with purpose and designed to relieve eye muscle fatigue, boost focus, and refresh tired vision…. Caffeine & Taurine: To Energize…Menthol & Camphor: To Cool and Refresh” [from your website https://myrevitalize.com/]“Revitalize also includes a proprietary blend of stimulants designed to alleviate the effects of screen fatigue.” [from your website https://myrevitalize.com/]“After applying Revitalize, users will feel a deep cooling sensation to stimulate the tear duct and help with the absorption of the remaining ingredients. From there users will feel their eyes refreshed and stimulated. That is our inactive ingredients interacting with the focus adjustment mechanism of the eye.” [from your website https://myrevitalize.com/]Article posted on your Facebook page that includes the caption “Why did we formulate Revitalize to include caffeine? Aside from its energetic benefits, its antioxidant benefits protects from cataracts caused by UV-B rays.” [from your Facebook page at https://www.facebook.com/share/p/16sSvSaQaD/ (posted to the Revitalize Energy Facebook page on May 31, 2023)]Video posted on your Facebook page with the caption “When staring at something for too long, your phone, laptop, the road, etc., reset the focus of your eyes with Revitalize!” where a user explains the benefits of caffeine for the eyes in Revitalize Energizing Eye Drops. [From your Facebook page at https://www.facebook.com/reel/1370836136981074 (posted to the Revitalize Energy Facebook page on June 2, 2023)]Unapproved New Drug ViolationsBased on the above evidence of intended use, your Revitalize Energizing Eye Drops is intended for use as an ophthalmic demulcent (lubricant) drug product. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. Your Revitalize Energizing Eye Drops is not generally are not generally recognized as safe and effective (GRASE) for its above referenced uses1and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug may not be 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 is no FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for your Revitalize Energizing Eye Drops drug product.Your drug product is marketed as an ophthalmic demulcent and vasoconstrictor drug product and is subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which generally governs nonprescription drugs marketed without an approved application. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”— may be legally marketed if they meet applicable requirements. With respect to nonprescription ophthalmic drug products, such as your Revitalize Energizing Eye Drops, in order to be GRASE and not a new drug, the product must, among other things, conform to the conditions in the applicable OTC monograph, here OTC monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use (hereinafter M018).2However, your Revitalize Energizing Eye Drops drug product does not conform to the conditions specified in M018 for the reasons described below, and thus cannot be legally marketed under section 505G.Your Revitalize Energizing Eye Drops is a demulcent product formulated with several active ingredients that are not permitted for OTC ophthalmic demulcent or vasoconstrictor drug products under M018.12 and M018.18 respectively. Specifically, according to your product’s labeling, your Revitalize Energizing Eye Drops product is formulated with active ingredients menthol, camphor, caffeine, and taurine.However, menthol, camphor, caffeine, and taurine are not active ingredients permitted for ophthalmic demulcent drug products under M018.12. We note that, although you identify these ingredients as inactive ingredients on the product label, statements on your website show that they are active ingredients because they are intended to furnish pharmacological activity for the treatment of a disease or condition.3Examples of these statements include, “Our energizing formula is built for people who live on screens. Every ingredient is selected with purpose and designed to relieve eye muscle fatigue, boost focus, and refresh tired vision…. Caffeine & Taurine: To Energize…Menthol & Camphor: To Cool and Refresh” and “Why did we formulate Revitalize to include caffeine? Aside from its energetic benefits, its antioxidant benefits protects from cataracts caused by UV-B rays.” Additionally, the following are also posted to your Facebook page: a video dated June 2, 2023 where a user explains the benefits of caffeine for the eyes; and a direct link to an article posted on June 15, 2023 with the caption “Benefits of taurine for you? Why did we add it to Revitalize? Check out research on longevity effects of taurine.” Thus, these ingredients are active ingredients and, because they are not active ingredients permitted under M018.12 or M018.18, your Revitalize Energizing Eye Drops product does not conform with the conditions for lawful marketing of an OTC ophthalmic demulcent or vasoconstrictor drug product as set forth in M018.In addition, your Revitalize Energizing Eye Drops drug product labeling includes intended uses that are not permitted in M018. Specifically, claims such as “protects from cataracts caused by UV-B rays,” “instant energy,” and “energizing eye” go beyond the allowed general intended uses for an OTC demulcent or vasoconstrictor ophthalmic drug product and do not conform to M018.60 or M018.75.Thus, your Revitalize Energizing Eye Drops drug product does not comply with the applicable conditions specified in M018 and has not otherwise been found GRASE.4 Accordingly, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which this product would be legally marketed without an approved application. Because there is no approved application in effect for this product, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).Misbranded Drug ViolationsRevitalize Energizing Eye Drops is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the “FDA” logo is displayed on your product label and website as “FDA COMPLIANT” (“Passed All Required FDA testing”), “MADE IN A FDA REGISTERED FACILITY” (“Trusted Manufacturing”), and “FDA GRAS APPROVED” (“Formulated within FDA Guidance”). Such claims create the impression that your drug is approved or legally marketable (see 21 CFR 207.77(b)). As previously noted, your Revitalize Energizing Eye Drop is not the subject of an FDA-approved application, therefore, claims that suggest your product has been FDA-reviewed or FDA-approved are false or misleading.Additionally, your Revitalize Energizing Eye Drops is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThis letter is 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.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.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/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov. Please include your firm name and the unique identifier “712417” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration__________________________1FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that your above-referenced topical ophthalmic drug products are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling.2M018 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000023, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf.3See21 CFR 201.66(b)(2), which defines an active ingredient as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.”4FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that Revitalize Energizing Eye Drops product is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined this drug product to be GRASE pursuant to an order issued under section 505G(b).

Delivery Method:Via EmailProduct:Drugs、Over-the-Counter DrugsRecipient:Alvaro E. Arenas, AMBREyeTech One, LLC8833 Cypress Preserve PLFort Meyers,FL33912United States(b)(6), (b)(7)(C)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERJuly 9, 2025RE: 712438Dear Mr. Arenas:This letter is to advise you that on September 26, 2024 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address, www.eyelivio.com, where your EYELIVIO lubricant eye ointment product is available for purchase in the United States without a prescription. We also reviewed your social media on Instagram at www.instagram.com/eyelivio/, which directs consumers to your website to purchase your product(s).Based on our review, your EYELIVIO lubricant eye ointment 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). In addition, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.Unapproved New Drug and Misbranded Drug ViolationsYour EYELIVIO lubricant eye ointment product is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.Examples of claims from the EYELIVIO lubricant eye ointment product labeling, your website and your Instagram site listed above, that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product include, but may not be limited to, the following:“LUBRICANT EYE OINTMENT” [from principal display panel on product carton labeling]“DRY EYE RELIEF” [from product carton labeling]“Uses… May be used as temporary relief of burning, irritation, and discomfort due to dryness of the eye(s) and relief of dry eye symptoms.” [from Drug Facts panel on product carton labeling]“lubricant ointment that helps reduce discomfort caused by dry eye symptoms.” [from product label]“This lubricating,preservative-free ointmentis formulated with soothing ingredients that directly target dry eye symptoms. EYELIVIO harnesses the power of natural ingredients to enhance eye health.” [from your home website page www.eyelivio.com (last visited August 2024)]“EYELIVIO Dry Eye Relief Ointment 5gr is a specially formulated product designed to provide long-lasting relief for individuals suffering from dry eye symptoms.” [from your website page https://eyelivio.com/product/eyelivio-ointment-5-gr/ (last visited August 2024)]“DRY EYE SYMPTOMSOcular Discomfort• Feeling sensitive to light• Gritty, sandy feeling• Painful or sore eyeseyelivio PREVALENCE: Based on data from the national Health and Wellness Survey, 6.8 percent of the United States adult population…have been diagnosed with Dry Eye Disease. Follow us for more information EYELIVIO Ointment 5gr …” [from your Instagram webpage www.instagram.com/p/CmrT2jrOV6_/ (last visited September 2024)]Unapproved New Drug ViolationsBased on the above evidence of intended use, your EYELIVIO lubricant eye ointment is intended for use as an ophthalmic emollient (lubricant) drug product. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be 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). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for your EYELIVIO lubricant eye ointment drug product.Your drug product is marketed as an ophthalmic demulcent drug product and is subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which generally governs nonprescription drugs marketed without an approved application. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to nonprescription ophthalmic drug products, such as your EYELIVIO lubricant eye ointment, in order to be GRASE and not a new drug, the product must, among other things, conform to the conditions in the applicable OTC monograph, here OTC Monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use (hereinafter M018).1However, your EYELIVIO lubricant eye ointment drug product does not conform to the conditions specified in M018 for the reasons described below.Your EYELIVIO lubricant eye ointment product is formulated with the active ingredients Mineral Oil, White Petrolatum, Aloe vera, Arnica montana, and Calendula officinalis. The botanical extracts (Aloe vera, Arnica montana, and Calendula officinalis) included in this formulation are not active ingredients permitted for ophthalmic emollient (lubricant) drug products under M018.14. Additionally, your EYEVILIO lubricant eye ointment fails to include the amounts (concentrations) for the permitted active ingredients, mineral oil and white petrolatum, on the product label/labeling. Specifically, the final rule requires that mineral oil be present at up to 50 percent, in combination with another permissible emollient agent, such as white petrolatum, up to 100 percent; see M018.14(b).We also note statements made on your website that make claims for indications that are not consistent with the permitted indications in M018. For example, your website states, “This delicate, nourishing formula, enriched with plant-based properties, offers a unique approach to soothing and protecting your eyes. It provides superior lubrication and protection for the ocular surface and delivers natural anti-inflammatory benefits.” and “The EYELIVIO Ointment combines lubrication and protection with natural anti-inflammatory benefits…” These labeled statements of protection of eyes, ocular surface, and providing anti-inflammatory benefits go beyond the general intended uses of topical OTC ophthalmic drug products set forth in M018.65(b).Thus, your EYELIVIO lubricant eye ointment drug product does not comply with the applicable conditions specified in M018 and has not otherwise been found GRASE.2Accordingly, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which this product would be legally marketed without an approved application. Because there is no approved application in effect for this product, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug ViolationsAdditionally, your EYELIVIO lubricant eye ointment drug product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list 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.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.Please notify FDA in writing, within 15 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.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “712438” in the subject line of your email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration_______________________1M018 reflects the conditions as set forth in the relevant final order(s) established and in effect under section 505G; see Order ID OTC000023, available at FDA’s website OTC Monographs@FDA.2FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that the EYELIVIO lubricant eye ointment drug product is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).

Delivery Method:Via EmailProduct:Drugs、Over-the-Counter DrugsRecipient:Clint Worley, COOCovalent Medical24600 Millstream Drive, Ste 410Aldie,VA20105United StatesCWORLEY@focusvitamins.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERJuly 9, 2025RE: 695839Dear Mr. Worley:This letter is to advise you that on September 27, 2024 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address, www.focusvitamins.com, where your FOCUS PI Post-Injection Eye Drops product is available for purchase in the United States without a prescription. We also reviewed your social media sites on Instagram (https://www.instagram.com/focus_vitamins/) and Facebook (https://www.facebook.com/focusvitamins), both of which direct consumers to your website to purchase your product(s).Based on our review, your FOCUS PI Post-Injection Eye Drops 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). In addition, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.Unapproved New Drug and Misbranded Drug ViolationsYour FOCUS PI Post-Injection Eye Drops product is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body.Examples of claims from the product labeling, your website, and your social media posts that provide evidence of the intended use (as defined in 21 CFR 201.128) of this product as a drug include, but may not be limited to, the following:“FOCUS PI … Post-Injection Eye Drops” [product name on principal display panel (PDP) of product carton labeling and product label]“Long Lasting Relief, Clinically proven to lubricate, hydrate, & relieve the eyes from irritation” [from PDP on product carton labeling]“Use▪ For use as a lubricant to prevent further irritation or to relieve dryness of the eye” [from Drug Facts panel on product carton labeling]“Designed for Post-injection Irritation Relief”[from your website https://focusvitamins.com/products/focus-pi (last visited September 2024)]“Focus PI (Post-injection) eye drops provide relief from irritation associated with eye injections.As the first product of its kind, Focus Vitamins and founding ophthalmologists formulated Focus PI to help soothe any eye discomfort patients might experience, including irritation and dry eye symptoms after eye injections.” [from your website https://focusvitamins.com/products/focus-pi (last visited September 2024)]“Focus PI is formulated and safe for use immediately after eye injections and/or during the following days when your eyes are irritated.” [from your website under FAQS: When should I use Focus PI? https://focusvitamins.com/products/focus-pi (last visited September 2024)]“If you get eye injections, Focus PI is for you! Focus PI are post-injection eye drops that are clinically proven to lubricate, hydrate, & relieve the eyes from irritation that comes after ocular injections.” [from Instagram post with 2 likes on January 23, 2023 https://www.instagram.com/p/Cn0P_CpMZJM/ (last visited September 2024)]“Searching for post-injection relief for your eyes? Focus PI eye drops are clinically proven to lubricate, hydrate, and relieve the eyes from irritation following ocular injections. Shop now…” [from Facebook post on August 15, 2023 https://www.facebook.com/focusvitamins (last visited September 2024)]Unapproved New Drug ViolationsBased on the above evidence of intended use, your FOCUS PI Post-Injection Eye Drops product is intended for use as an ophthalmic demulcent (lubricant) drug product. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be 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). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for your FOCUS PI Post-Injection Eye Drops drug product.Your drug product is marketed as an ophthalmic demulcent drug product and is subject to section 505G of the FD&C Act, 21 U.S.C. 355h, which generally governs nonprescription drugs marketed without an approved application. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements. With respect to nonprescription ophthalmic drug products, such as your FOCUS PI Post-Injection Eye Drops drug product, in order to be GRASE and not a new drug, the product must, among other things, conform to the conditions in the applicable OTC monograph, here OTC Monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use (hereinafter M018).1However, your FOCUS PI Post-Injection Eye Drops drug product does not conform to the conditions specified in M018 for the reasons described below.Specifically, the statements made in your product labeling on your website and social media sites include claims for relief of post-injection irritation, which are not permitted indications for ophthalmic demulcent drug products in monograph M018.2Thus, your FOCUS PI Post-Injection Eye Drops drug product does not comply with the applicable conditions specified in Monograph M018 and has not otherwise been found GRASE.3Accordingly, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which this product would be legally marketed without an approved application. Because there is no approved application in effect for this product, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug ViolationsAdditionally, your FOCUS PI Post-Injection Eye Drops drug product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your product(s). 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.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.Please notify FDA in writing, within 15 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(s) 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 15 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/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “695839” in the subject line of your email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration_____________________________1M018 reflects the monograph conditions as set forth in the relevant final order(s) established and in effect under section 505G; see Order ID OTC000023, available at FDA’s website OTC Monographs@FDA.2Under M018.60, “Labeling of ophthalmic demulcent drug products”, the permitted indications are listed in M018.60(b).3FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that the FOCUS PI Post-Injection Eye Drops drug product is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b) of the FD&C Act.

Delivery Method:Via EmailProduct:DrugsRecipient:Jonathan DayeZachary Daye7Tabz Retail, LLC5525 Johns RoadTampa,FL33634United Statesshop@pop7tabz.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERJune 25, 2025RE: 709546Dear Jonathan and Zachary Daye:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address www.pop7tabz.com in May 2025 and has observed that your website offers various products marketed to contain 7-hydroxymitragynine (7-OH) including, 7Tabz 7-OH (15mg and 30mg) and 7Tabz 7-Hydroxy+Pseudo (20 mg) (hereinafter “your 7-OH products”).”1As described below, your 7-OH 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).FDA has observed a proliferation of products containing 7-OH and has serious concerns because 1) 7-OH products have not been evaluated by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving 7-OH containing products, including your firm’s products; 3) 7-OH is known to be a potent mu-opioid agonist and has been reported to have opioid-like effects in consumers; 4) FDA is concerned about the processes used to create the enhanced concentrations of 7-OH in the marketplace, as well as the potent effects produced by these doses of 7-OH; and 5) 7-OH products may be consumed by children, as some packaging and labeling may appeal to children.Unapproved New DrugsBased on our review of your website, www.pop7tabz.com, your 7-OH products are drugs as defined by 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/or intended to affect the structure or any function of the body. Examples of claims observed on your website that establish the intended use of your above products as drugs include, but may not be limited to, the following:On your 7Tabz 7-OH (15mg2and 30mg3) and 7Tabz 7-Hydroxy+Pseudo 20mg4product webpages:• “Pain Relief . . . Mood Boost . . . Recharge & Relax”• “7-hydroxymitragynine (7-OH) is a small-but-mighty compound found in the Kratom plant, Mitragyna speciosa. It is considered one of the most potent alkaloids in Kratom due to its powerful affinity for binding to certain brain receptors. This makes it uniquely effective at relieving pain & enhancing mood, even in low doses.”On your 7Tabz 7-OH (15mg) product webpages5• “Find your peace of mind and experience natural pain relief & relaxation. Our 7-OH tablets each contain 15mg of potent, effective 7-hydroxymitragynine extracted from organic Kratom leaf. Will leave you feeling airy, floating, and relaxed.”On your 7Tabz 7-Hydroxy+Pseudo 20mg product webpages6and your 7Tabz 7-OH (30mg) product webpage https://pop7tabz.com/products/30mg-4ct-7-oh-tablets:• “Experience targeted pain relief, intense relaxation, and a feeling of pure bliss – like never before.”On your “Kratom vs 7-Hydroxymitragynine (7-OH): What’s the Difference?” blog webpage https://pop7tabz.com/blogs/science/kratom-vs-7-oh:• “How Kratom and 7-OH Work . . . [t]hese alkaloids are believed to interact with receptors that may influence mood, energy, or relaxation.”On your “FAQs” webpage https://pop7tabz.com/pages/faqs:• “7-hydroxymitragynine (7-OH) is a small-but-mighty compound found in the Kratom plant, Mitragyna speciosa. It is considered one of the most potent alkaloids in Kratom due to its powerful affinity for binding to certain brain receptors. This makes it uniquely effective at relieving pain & enhancing mood, even in low doses.”Your 7-OH products are not generally recognized as safe and effective for the above referenced uses and, therefore, 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 approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 is in effect for your products. Accordingly, the introduction or delivery for introduction into interstate commerce of the above products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Additionally, we observed that some of your 7-OH products were previously marketed as dietary supplements on your website. Be advised, however, that dietary supplements containing 7-OH as a dietary ingredient are adulterated under section 402(f)(1)(B) of the FD&C Act, 21 U.S.C. 342(f)(1)(B), because 7-OH is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. In fact, as noted above, available information on the use of 7-OH in products raises serious safety concerns. The introduction or delivery for introduction into interstate commerce of an adulterated dietary supplement is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThis letter is 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.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.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.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov. Please include your firm name and the unique identifier “CMS 709546” in the subject line of the email.Sincerely,/S/Jill Furman, J.D.DirectorOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration____________________1You sell these products in different flavors and/or package sizes.2https://pop7tabz.com/products/15mg-1ct-7-oh-tablets, https://pop7tabz.com/products/15mg-4ct-7-oh-tablets, and https://pop7tabz.com/products/15mg-10ct-7-oh-tablets.3https://pop7tabz.com/products/30mg-4ct-7-oh-tablets4https://pop7tabz.com/products/20mg-1ct-7-oh-pseudo-tablets, https://pop7tabz.com/products/20mg-4ct-7-oh-pseudo-tablets, and https://pop7tabz.com/products/20mg-10ct-7-oh-pseudo-tablets5See webpages in footnote 2.6See webpages in footnote 4.

Delivery Method:VIA EMAIL AND UPSProduct:Drugs、Food & BeveragesRecipient:Tim R. ShawOwnerHydroxie, LLC306 W El Norte PkwySTE N 92Escondido,CA92026United Statessupport@hydroxie.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesHuman Foods ProgramUnited StatesJune 25, 2025WARNING LETTERRE: 709661Dear Tim Shaw:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address www.hydroxie.com in May 2025 and has observed that your website offers various products that appear to contain 7-hydroxymitragynine (7-OH)1 including Hydroxie 15mg 7-OH Tablets, Hydroxie Red 15mg Tablets, Hydroxie 30mg 7-OH Tablets, Hydroxie 15mg 7-OH Sublingual Strips, Hydroxie Red 15mg Sublingual Strips, Hydroxie 7-OH Shots, Hydroxie Red Shots, Hydroxie Free Sample, and Hydroxie Red Free Sample.2 We have also reviewed your Instagram social media account at www.instagram.com/enjoyhydroxie/. Your Instagram social media account directs consumers to your https://shop.hydroxie.com website to purchase your products. As described below, your Hydroxie 15mg 7-OH Tablets, Hydroxie Red 15mg Tablets, Hydroxie 30mg 7-OH Tablets, Hydroxie 15mg 7-OH Sublingual Strips, Hydroxie Red 15mg Sublingual Strips, Hydroxie 7-OH Shots, Hydroxie Red Shots, Hydroxie Free Sample, and Hydroxie Red Free Sample 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).FDA has also determined that your Hydroxie 7-OH Drink Mix product, offered in various flavors, is marketed to contain 7-OH, and therefore is adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because it bears or contains an unsafe food additive. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.FDA has observed a proliferation of products containing 7-OH, and has serious concerns about products containing 7-OH. The concerns include the following: 1) 7-OH products have not been evaluated by FDA for safe use; 2) FDA has received adverse event reports associated with 7-OH containing products; and 3) 7-OH has been reported to have opioid-like effects.Unapproved New DrugsBased on our review of your website, www.hydroxie.com, and social media account, www.instagram.com/enjoyhydroxie/, your Hydroxie 15mg 7-OH Tablets, Hydroxie Red 15mg Tablets, Hydroxie 30mg 7-OH Tablets, Hydroxie 15mg 7-OH Sublingual Strips, Hydroxie Red 15mg Sublingual Strips, Hydroxie 7-OH Shots, Hydroxie Red Shots, Hydroxie Free Sample, and Hydroxie Red Free Sample products are drugs as defined by 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/or intended to affect the structure or any function of the body. Examples of claims observed on your website and social media account that establish the intended use of your above products as drugs include, but may not be limited to, the following:On your blog post at https://hydroxie.com/blogs/news/9-ways-to-boost-your-mental-clarity:•“7-Hydroxymitragynine acts primarily as a partial agonist of receptors in the brain. This activity leads to its unique effects. . .. Some users of products that contain 7-Hydroxymitragynine report feeling relief or a boost”•“The Path to Mental Clarity . . . Your brain's capacity for improvement is remarkable, and with dedicated practice, you can achieve significant gains in mental clarity and cognitive function. Check out Hydroxie’s full range of product offerings here and see which is best for your lifestyle.”On your blog post at https://hydroxie.com/blogs/news/how-to-have-more-energy-naturally-our-natural-energy-enhancement-guide:•“Ready to explore natural energy enhancement? Start with our premium 7-OH products”On your Instagram social media account at www.instagram.com/enjoyhydroxie/:•May 20, 2025 post: “Hydroxie strips are ultra-concentrated – powerful by design . . . they’re a simple way to empower your calm, focus, and clarity.”•May 16, 2025 post: “calm, clarity, & relief”•May 13, 2025 post: “Hydroxie offers tablets, shots, sublingual strips, and drink mixes – each designed to empower you with relief, clarity, and calmness.”Additionally, your website contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the treatment of disease and/or to affect the structure or function of the body. Examples of such testimonials include, but are not limited to, the following:•“The amount of relief that I get for my Fybromyalgia and Osteoarthritis is amazing. One dose at bedtime give me pain relief thru most if [sic] the following day.” [From the Customer Reviews section of the Hydroxie 7-OH Shots product webpage https://hydroxie.com/products/hydroxie-7-oh-shot]•“I LIV [sic] IN PAIN DAILY ALONG WITH SEVERE DEPRESSION. THIS HELPED BRING BE [sic] BACK TO LIFE.” [From the Customer Reviews section of the Hydroxie 15mg 7-OH Tablets product webpage https://hydroxie.com/products/hydroxie-15mg-7-oh-tablets]•“These have helped my anxiety so much” [From the Customer Reviews section of the Hydroxie 15mg 7-OH Tablets product webpage https://hydroxie.com/products/hydroxie-15mg-7-oh-tablets]•“Helps me out with my Achilles tendon rupture surgery . . . this has helped me actually sleep at night because it has helped so much with pain.” [From the Customer Reviews section of the Hydroxie 15mg 7-OH Tablets product webpage https://hydroxie.com/products/hydroxie-15mg-7-oh-tablets]•“I take it for chronic pain & even on the onset of severe panic attacks.” [From the Customer Reviews section of the Hydroxie Red 15mg Tablets product webpage https://hydroxie.com/products/hydroxie-red-15mg-tablets]•“I have MS and this makes the day easier because I’m able to get around more without pain.” [From the Customer Reviews section of the Hydroxie FREE SAMPLE product webpage https://hydroxie.com/products/hydroxie-free-sample]Your Hydroxie 15mg 7-OH Tablets, Hydroxie Red 15mg Tablets, Hydroxie 30mg 7-OH Tablets, Hydroxie 15mg 7-OH Sublingual Strips, Hydroxie Red 15mg Sublingual Strips, Hydroxie 7-OH Shots, Hydroxie Red Shots, Hydroxie Free Sample, and Hydroxie Red Free Sample products are not generally recognized as safe and effective for the above referenced uses and, therefore, 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 approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 is in effect for your products. Accordingly, the introduction or delivery for introduction into interstate commerce of the above products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Adulterated Human Food: Unsafe Food AdditiveAccording to your product labeling, your Hydroxie 7-OH Drink Mix product, in various flavors, is a food to which 7-OH has been added.As defined in section 201(s) of the FD&C Act, 21 U.S.C. 321(s), the term “food additive” refers to any substance the intended use of which results in it becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.3 Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). The introduction or delivery for introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).There is no food additive regulation that authorizes the use of 7-OH in food. We are not aware of any information to indicate that 7-OH is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that 7-OH is GRAS for use in conventional foods. FDA’s regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30).We know of no basis for general recognition of safety for 7-OH based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of 7-OH in food meets the criteria for GRAS status. Therefore, based on our review, the use of 7-OH in conventional food does not satisfy the criteria for GRAS status under 21 CFR 170.30. Moreover, some of the available data raise serious concerns about potential harm associated with 7-OH. Our review of published scientific literature and adverse event reports related to consumption of kratom and kratom-derived products raise a number of safety concerns, including liver toxicity, cardiovascular toxicity, seizures, gastrointestinal distress, respiratory depression, addiction, withdrawal symptoms, and death. It’s not clear from available evidence whether all of these effects were due to mitragynine or 7-OH (i.e., two of the main alkaloids found in kratom) in these products. Although 7-OH is a minor component of kratom, it is a more potent inducer of opioid-like effects than the primary kratom alkaloid, mitragynine, and mitragynine converts to 7-OH in the body. Because of this, products containing 7-OH as an added ingredient are of particular concern because we anticipate an increased risk of adverse effects as the dose of 7-OH increases.FDA is not aware of any other exception to the food additive definition that would apply to 7-OH for use as an ingredient in a conventional food. Therefore, 7-OH added to a conventional food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. 7-OH is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Therefore, your Hydroxie 7-OH Drink Mix product, in various flavors, is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act because it bears or contains an unsafe food additive. The introduction or delivery for introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act.ConclusionThis letter is 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.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.Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address 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 cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. 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.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov. Please include your firm name and the unique identifier “CMS 709661” in the subject line of the email.Sincerely,/s/Jill Furman, J.D.Director, Office of Compliance Center for Drug Evaluation and ResearchFood and Drug Administration/s/Ann M. Oxenham, J.D.Director, Office of Compliance and EnforcementHuman Foods ProgramFood and Drug Administration17-hydroxymitragynine (7-OH) is also known as 7-OHMG, 7-HMG, 7OH-mitragynine, and on the market as 7-OH, or 7OH.2You also sell some of these products in different package sizes and different strengths.3Under section 201(s) of the FD&C Act, 21 U.S.C. 321(s), the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food, (2) pesticide chemicals, (3) color additives, (4) substances used in accordance with a “prior sanction,” i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act, (5) new animal drugs, and (6) dietary ingredients in or intended for use in a dietary supplement.

根据甘肃省2025年化妆品抽样检验计划，本期检验发现不合格化妆品1批次，现予以公告。对抽检中发现的不合格化妆品，我局已要求属地监管单位对问题产品进行控制，依法依规调查处置。  特此公告。 附件：1批次检验不合格化妆品信息甘肃省药品监督管理局2025年7月11日2025年抽检不合格化妆品（第1期）序号检品名称标识生产企业包装规格批号批准文号被抽样企业检验机构不合格项目检验结果1FRANGIFANNY水光亮肤保湿面膜广州琳芝生物医药科技有限公司28ml×6片20230609粤G妆网备字2023143457兰州新区澳亚化妆品销售店甘肃省药检院检出禁用原料氯倍他索丙酸酯不合格

近期，我市2名患者使用临床研究抗癌药情况引发社会关注。重庆市卫生健康委、重庆市药监局、沙坪坝区人民政府等单位迅速组成联合调查组，采取走访调查、现场检查等方式开展调查核实。现将有关情况通报如下。   一、基本情况   经查，患者李某美于2013年6月被诊断为宫颈癌并进行手术治疗。2016年8月起，李某美在重庆大学附属肿瘤医院（以下简称肿瘤医院）进行后续治疗，主治医生为李某。此后，患者李某美多次就病情及检查治疗有关情况通过电话、短信等方式咨询医生李某，李某给予相应指导。2023年8月，患者李某美病情复发并转移，经肿瘤医院多学科专家联合会诊建议进行PD-L1（细胞程序性死亡-配体1）检测，结果为阳性。医生李某向患者李某美推荐使用卡度尼利单抗注射液（该药品已于2022年6月上市，以下简称卡度尼利单抗）。患者李某美通过其他人员获取康方药业有限公司（以下简称康方药业）销售人员冉某元联系方式，并于2024年4月17日开始自行在院外购买使用该药。   患者唐某莲于2017年6月被诊断为宫颈癌并进行手术治疗。2024年1月，唐某莲因右下腹隐痛在肿瘤医院就诊，诊断为宫颈癌术后复发并转移，经多学科专家联合会诊，建议进行放疗+化疗+免疫联合治疗，其中免疫治疗方案推荐使用帕博利珠单抗。患者唐某莲经医生李某推荐选择了价格相对便宜的卡度尼利单抗，并于2024年1月30日开始自行在院外购买使用该药。   二、核实处置情况   （一）关于医生李某医疗行为的核实处置情况   联合调查组于2025年6月9日现场询问患者李某美，其称“李主任（医生李某）推荐了卡度尼利后，我通过朋友联系上了冉某元，知道他在做这个药”。2025年6月20日，现场询问冉某元，其称“李某美通过她的朋友加了我的微信，我们约好在肿瘤医院外科门诊大楼外见面，她向我咨询卡度尼利单抗的效果、价格、援助政策、用药流程、药物副作用等”。经查询冉某元与李某美的微信聊天记录，证实2024年2月27日李某美通过朋友联系上冉某元，之后自行联系在院外购买使用该药。   联合调查组于2025年6月9日现场询问患者唐某莲，其称“2024年1月我在重庆市肿瘤医院住院期间，医生申请的专家会诊意见是帕博利珠单抗，但是李主任（医生李某）说卡度尼利是双靶点药物，比帕博利珠效果更好，且费用也更低，所以推荐我用卡度尼利。1月29日，李主任就向我推荐了医药销售冉某元，我同意和冉某元见面，李主任说冉某元一会儿会主动来病床找我”。2025年6月10日，经现场询问，医生李某承认上述情况。   经联合调查组调查，医生李某自诉在推荐治疗方案时口头告知了患者李某美用药可能引起的相关风险。卡度尼利单抗药品说明书明确有“导致免疫相关性肺炎的可能”，并载明单药治疗的患者发生免疫相关性肺炎的比例为1.7% 。销售人员冉某元于2024年9月18日通过微信向患者李某美发送了卡度尼利单抗药品使用说明书电子版。患者李某美从2024年6月1日至2025年1月21日，先后1次在肿瘤医院、2次在巫山县人民医院进行胸部CT或胸部X片检查，均未发现肺部明显异常。直至2025年2月，患者李某美在巫山县人民医院先后进行胸部X片、胸部CT检查，提示肺部感染、间质性肺炎可能。   根据《中华人民共和国医师法》，医师在注册的执业范围内，可按照有关规范选择合理的医疗、预防、保健方案。依照《中国临床肿瘤学会宫颈癌诊疗指南（2023版）》，帕博利珠单抗、卡度尼利单抗均为复发或转移性宫颈癌治疗方案的推荐药物。医生李某根据患者病情，并结合诊疗指南，向患者推荐治疗方案和已获批上市的卡度尼利单抗，属正常诊疗活动范畴。   医生李某向患者唐某莲推荐销售人员冉某元的行为，违反了《重庆市医疗机构工作人员廉洁从业九项准则实施细则（试行）》。进一步调查发现，医生李某存在应患者要求补开处方的违规行为。按照《医师法》《重庆市‌医疗机构工作人员行为规范》《重庆市医务人员不良执业行为记分管理办法（试行）》，给予医生李某警告、约谈、暂停处方权等处理。对肿瘤医院存在的行风教育不到位、处方管理有漏洞等问题，市卫生健康委对肿瘤医院进行了约谈，并责令限期整改。   关于医生李某与销售人员冉某元是否存在利益输送、商业贿赂等行为，经联合调查组对李某、冉某元初步调查，暂未发现双方存在利益往来行为。目前纪检监察机关正在进一步调查中，将根据调查结果依法依规处理。   （二）关于患者获取药品的调查情况   卡度尼利单抗于2022年6月28日作为Ⅰ类创新药获批上市，市场销售价格13220元/支。患者可通过到药店自费购买、申请康方药业“医药筹卡度尼利单抗患者救助项目”慈善赠药（买1送1，2支起赠，累计购买满12支可获赠1年的用药）、入组临床研究项目等3种途径合规获取该药品。经查，冉某元为提高销售业绩，于2024年2月向李某美承诺购买6支药品即可免费获得1年的用药，2024年4月至2025年2月，李某美共获取药品70支，其中以13220元/支的价格自行在药店购买市售药品6支（共计79320元）、获慈善赠药5支、免费领取临床研究药品59支（标注有“仅供临床研究使用”字样）。唐某莲获取药品方式与李某美类似，2024年1月至2025年1月，共获取药品90支，其中以13220元/支的价格自行在药店购买市售药品6支（共计79320元）、获慈善赠药6支、免费领取临床研究药品78支（标注有“仅供临床研究使用”字样）。   通过国家医保谈判，该药品于2025年1月1日纳入国家医保药品目录，根据地区医保报销比例不同，患者实际支付费用300-1000元/支。经核查购买记录，2名患者自费购药行为均发生在该药品纳入医保药品目录前。   （三）关于临床研究药品来源渠道的调查处置情况   针对2名患者领取的临床研究药品标注有“申办方：重庆医科大学附属第二医院”“申办方：重庆市中医院”等字样，经调取重庆医科大学附属第二医院、重庆市中医院伦理审查记录，并查询“国家医学研究登记备案信息系统”，该2家医院均未开展卡度尼利单抗的相关临床研究。经查，2024年5月8日、6月19日，康方药业重庆销售人员通过伪造上述2家医院研究立项文件、医院伦理审批文件等材料，从企业套取临床研究药品，并经冷链配送至重庆和平新健康欣特健康管理连锁有限公司沙坪坝药房、重庆关怀直达都市花园药房有限公司、国药控股关怀直达重庆健康管理有限公司新桥店等3家药店，再由李某美、唐某莲免费领取。经公安机关调查，康方药业销售人员实施了伪造印章、伪造医生处方签的行为，综合其违法事实、产生的直接危害及获利等情况，其行为尚不构成刑事犯罪。公安机关已对相关人员进行法制教育和批评。康方药业临床研究项目管理问题线索，已移送企业所在地药品监管部门调查处置。   上述3家药店为与康方药业保持合作关系，免费为其储存发放临床研究药品，未收取患者费用。但该行为不符合《药品经营质量管理规范》第一百六十条“不得放置与销售活动无关的物品”的规定。属地沙坪坝区市场监管部门依据《中华人民共和国药品管理法》第一百二十六条的规定，对3家药店给予警告处罚。   （四）关于涉事药品质量的核查情况   “临床试验药品”通常是研发过程中尚未通过注册上市的药品，需要通过试验验证药品的安全性和有效性；“临床研究药品”通常是已经批准上市的药品，主要用于探索拓展药品适应症范围等方面研究。   经相关省市协查，卡度尼利单抗于2022年6月28日经国家药监局批准上市，药品批准文号为“国药准字S20220018”，患者李某美、唐某莲使用的标注有“仅供临床研究使用”字样的药品，属于“临床研究药品”，不是尚未批准上市的“临床试验药品”，与正常上市销售的药品均按照国家批准的药品标准及处方工艺进行生产，企业的生产质量管理体系符合相关规范要求，未发现上述药品存在质量不合格的情况。   （五）关于涉事诊所的调查处置情况   经查，2名患者领取药品后到沙坪坝区刘某芬诊所输注，该个体诊所具备合法资质，可以开展输液服务。该诊所为患者输液依据的处方，系销售人员冉某元伪造。该诊所存在医务人员对输注药品未认真核查、未规范书写医疗文书等违规行为，属地沙坪坝区卫生健康行政部门已立案调查，责令立即整改，依据《医疗纠纷预防和处理条例》第四十七条第（一）款第四项，医疗机构及其医务人员未按规定填写、保管病历资料的，由县级以上人民政府卫生主管部门责令改正，给予警告，并处1万元以上5万元以下罚款的规定，对涉案诊所给予警告，并从重处罚4.1万元，对涉事医生给予警告，罚款1.5万元，纳入医疗机构和医务人员信用监管。   针对此次事件中暴露出的问题，重庆市卫生健康、药品监管等部门已开展医疗质量安全、医德医风专项整治，全面排查临床研究药品管理使用风险，依法从严查处违法违规行为；举一反三，修订完善诊所输液、零售药店药品存储、临床研究及临床试验药品质量管理等制度，坚决防止类似问题再次发生，切实维护人民群众健康权益，努力为群众提供安全有效便利的医疗卫生服务。感谢媒体和社会各界对医药卫生事业的监督和关心。                                                                       卫生健康和药品监管联合调查组                                                                        2025年7月13日

2025年以来，全省各级药品监管部门紧紧围绕“四个最严”要求，以守护人民群众生命健康为使命，持续强化监管执法力度，对药品安全领域违法犯罪行为予以坚决打击，相继查处一批性质恶劣、影响较大的违法违规案件，有效净化了药品市场环境，切实保障了人民群众的身体健康和公众用药安全、有效。为充分发挥典型案例的警示和教育作用，现将2025年第一批药品领域行政执法典型案例予以公布。一、遂川县郑某销售假药系列案2025年3月4日，遂川县市场监管局执法人员根据举报线索联合县公安局进行执法检查，在郑某理发店查获宣称具有治疗功效的产品19盒及标签200张，涉案产品经吉安市市场监管局认定为假药。当事人上述行为违反了《中华人民共和国药品管理法》第九十八条之规定。遂川县市场监管局依据《市场监督管理行政处罚程序规定》第十七条，《药品行政执法与刑事司法衔接工作办法》第八条的规定，将该案移送至遂川县公安局。二、婺源县某口腔诊所使用未经注册的医疗器械案2025年4月2日，婺源县市场监管局执法人员接线索移送函，反映登特司（上海）医疗器械有限公司涉嫌向县某牙科诊所销售未依法注册、无中文标签的第三类医疗器械。经查，当事人使用的牙科用种植体（Implant Fixture）从登特司（上海）医疗器械有限公司购入，共计123盒，目前已全部使用完。当事人无法提供涉案产品的医疗器械注册证等相关证明文件。当事人的上述行为违反了《医疗器械监督管理条例》第五十五条的规定。婺源县市场监管局依据《医疗器械监督管理条例》第八十六条的规定，依法对当事人作出罚款的行政处罚。三、渝水区某眼镜店未经许可从事第三类医疗器械经营案2024年11月6日，新余市市场监管局执法人员对辖区某眼镜店开展执法检查。发现当事人经营的“海俪恩（桃花秀花园／3months）软性亲水接触镜、海昌（新视界）软性亲水接触镜、博士伦（清朗一日）软性亲水接触镜”等多款产品为第三类医疗器械，当事人不能提供第三类医疗器械经营许可证。当事人的行为违反了《医疗器械监督管理条例》第四十二条的规定。新余市市场监督管理局依据《医疗器械监督管理条例》第八十一条的规定，依法对当事人作出没收违法所得、没收涉案产品并处罚款的行政处罚。四、江西某医疗器械有限公司出借医疗器械许可证件案2024年12月11日，宜丰县市场监管局收到外省线索通报，反映江西某医疗器械有限公司将《营业执照》《医疗器械经营许可证》等资质材料，出借给江西籍医疗器械经销商许某使用，并从中收取使用费。经查，当事人将《医疗器械经营许可证》出借给许某使用，并从中收取使用费。许某借用当事人的资质，中标外省政府采购合同。当事人的上述行为违反了《医疗器械经营监督管理办法》第二十八条的规定。宜丰县市场监督管理局依据《医疗器械监督管理条例》第八十三条之规定，责令当事人改正违法行为，并依法对当事人作出没收违法所得并处罚款的行政处罚。五、江西某医疗器械有限公司经营标签、说明书不符合规定的医疗器械案2024年12月，会昌县市场监管局执法人员根据市局转办线索，对辖区内某医疗器械有限公司进行检查，发现当事人存在经营标签、说明书不符合规定的医疗器械的违法行为。经查，当事人在淘宝平台销售的“爱思安®重组人干扰素a2b导光凝胶”，其产品外包装标有误导性内容，与产品备案信息中的产品名称、预期用途不符。当事人的行为违反了《医疗器械监督管理条例》第三十九条的规定。会昌县市场监管局依据《医疗器械监督管理条例》第八十八条的规定，依法对当事人作出罚款的行政处罚决定。六、渝水区某肌肤管理中心经营超过使用期限、无中文标签的化妆品案2025年2月26日，新余市市场监管局执法人员对辖区某肌肤管理中心开展执法检查。发现当事人经营的多款化妆品无中文标签，且其中一款已超过使用期限。当事人的行为违反了《化妆品监督管理条例》第三十五条、第三十九条的规定。新余市市场监管局依据《化妆品监督管理条例》第六十条、第六十一条的规定，依法对当事人作出没收违法产品并处罚款的行政处罚。

2025年4月13日我局收到天津市药品监督管理局《案件移送函》（津药监（四办）案移〔2025〕5号），载明“黑龙江省恒增盛医药连锁有限公司涉嫌销售劣药醋氯芬酸胶囊(生产企业：陕西恒诚制药有限公司，批号：230201，规格：50mg 12粒/板/盒，国药准字H20041481）”。经查，当事人于2023年3月27日从天津和治恒昌医药有限公司购进上述药品240盒，现已全部售出。当事人行为违反了《中华人民共和国药品管理法》第九十八条第一款，依据《中华人民共和国药品管理法》第一百一十七条第一款、《中华人民共和国药品管理法实施条例》第七十五条规定予以处罚。

2025年4月11日我局收到河南省药品监督管理局第六分局的《案件线索通报函》，载明齐齐哈尔市亿洋医药连锁有限公司涉嫌销售劣药四味脾胃舒颗粒。经查，当事人于2024年3月14日从南阳市恒通医药有限公司购进上述药品2盒，现已全部售出。当事人行为违反了《中华人民共和国药品管理法》第九十八条第一款，依据《中华人民共和国药品管理法》第一百一十七条第一款、《中华人民共和国药品管理法实施条例》第七十五条规定予以处罚。