[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-gsc-products-llc-729653-05182026":3,"fda-latest-sync-dates":29},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":15,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},145,"gsc-products-llc-729653-05182026","Warning Letter","GSC Products, LLC",null,"Center for Drug Evaluation and Research (CDER)","Nonprescription\u002FOTC","2026-05-26","2026-05-18","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fgsc-products-llc-729653-05182026","729653","Drugs Over-the-Counter Drugs","Via Electronic Mail - Delivery and Read Receipt Requested","Wayne Perry","\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 Electronic Mail - Delivery and Read Receipt Requested\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_2\">Reference #:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_2\">729653\u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \n            \n            \n            \n            \n                          \u003Cbr>Over-the-Counter Drugs\n                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Wayne Perry\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Founder and President \u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>GSC Products, LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1441 Van Patten Rd\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Duanesburg\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">NY\u003C\u002Fspan> \u003Cspan class=\"postal-code\">12056-2522\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:(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>May 18, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>To Wayne Perry:\u003C\u002Fp>\u003Cp>This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your websites. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.\u003C\u002Fp>\u003Cp>\u003Cstrong>FDA Review\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Violations were identified and documented during a review of your websites, https:\u002F\u002Fsinusplumber.com and https:\u002F\u002Fwww.greensations.com, in March 2026. Your https:\u002F\u002Fsinusplumber.com website also directs consumers to your Amazon storefront to purchase your product. Based on our review, your SINUS PLUMBER Headache Nasal Spray product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). In addition, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). As explained further below, introducing or delivering this product for introduction into interstate commerce is prohibited under sections 301(d) and 301(a) of the FD&C Act, 21 U.S.C. 331(d) and 331(a).\u003C\u002Fp>\u003Cp>This review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor-quality drugs.\u003C\u002Fp>\u003Cp>\u003Cstrong>Violations of the Federal Food, Drug, and Cosmetic Act\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>\u003Cstrong>Unapproved New Drug Violations\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.\u003C\u002Fp>\u003Cp>Based on a review of your websites, your SINUS PLUMBER Headache Nasal Spray is a drug under 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 any function of the body. Examples from your product labeling, including your websites, 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:\u003C\u002Fp>\u003Cp>“\u003Cstrong>Drug Facts . . . Purpose\u003C\u002Fstrong>…Relieves pain and nausea…Relieves pain & inflammation…Increases circulation . . . \u003Cstrong>Uses\u003C\u002Fstrong>: For the temporary relief of: ■ General headache and migraine symptoms.” [from the product label on the Sinus Plumber product website https:\u002F\u002Fsinusplumber.com\u002Fproducts\u002Fsinus-plumber-migraine-headache-nasal-spray-with-capsaicin]\u003C\u002Fp>\u003Cp>“Powerful & Fast Headache Relief √ Tension √ Clusters √ Migraines” [from the product label on the Sinus Plumber product website https:\u002F\u002Fsinusplumber.com\u002Fproducts\u002Fsinus-plumber-migraine-headache-nasal-spray-with-capsaicin and\u003Cbr>https:\u002F\u002Fwww.greensations.com\u002FCayenne-Pepper-Headache-Nasal-Spray-p\u002Fsp-4.htm]\u003C\u002Fp>\u003Cp>“Sinus Plumber Headache Nasal Spray targets a variety of headaches with the pain relief power of capsaicin, feverfew, peppermint and caffeine.”…“This formula is commonly used for headaches that feel sinus-related or pressure-driven, including sinus headaches, tension headaches, migraines, and cluster headaches.” [from the Sinus Plumber product website https:\u002F\u002Fsinusplumber.com\u002Fproducts\u002Fsinus-plumber-migraine-headache-nasal-spray-with-capsaicin and https:\u002F\u002Fwww.greensations.com\u002FCayenne-Pepper-Headache-Nasal-Spray-p\u002Fsp-4.htm]\u003C\u002Fp>\u003Cp>Based on the above labeling evidence, SINUS PLUMBER Headache Nasal Spray is intended for use as an internal analgesic 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).\u003C\u002Fp>\u003Cp>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 this drug product identified above.\u003C\u002Fp>\u003Cp>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 internal analgesic drug products, such as your SINUS PLUMBER Headache Nasal Spray, 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 M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (hereinafter “M013”).\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> However, SINUS PLUMBER Headache Nasal Spray does not conform to the conditions specified in M013 for the reasons described below.\u003C\u002Fp>\u003Cp>Your SINUS PLUMBER Headache Nasal Spray is intended to be applied inside the nostrils. Under M013.1, only an OTC internal analgesic drug product in a form suitable for oral administration is generally recognized as safe and effective if it meets the conditions of M013. Thus, your internal analgesic drug product intended for administration inside the nostrils, does not conform to the conditions of M013.\u003C\u002Fp>\u003Cp>In addition, your SINUS PLUMBER Headache Nasal Spray labeling includes intended uses that are not permitted for OTC internal analgesic drug products in M013. Specifically, claims such as “This formula is commonly used for headaches that feel sinus-related or pressure-driven, including sinus headaches, tension headaches, migraines, and cluster headaches.” and “Purpose . . . Relieves . . . nausea . . . inflammation . . . increase circulation” that suggest SINUS PLUMBER Headache Nasal Spray is intended to treat sinuses, tension, clusters, and migraines, and is intended to relieve nausea, inflammation, and increase circulation go beyond the general intended uses for an OTC internal analgesic drug product and do not conform to the permitted uses set forth in M013.50(b).\u003C\u002Fp>\u003Cp>Furthermore, your SINUS PLUMBER Headache Nasal Spray is formulated with active ingredients that are not permitted for OTC internal analgesic drug products under M013.10. Specifically, feverfew, arnica montana, oleoresin capsicum, caffeine anhydrous, and peppermint oil are not permitted as single active ingredients under M013.10, nor is this combination of active ingredients permitted under M013.20. Therefore, your SINSUS PLUMBER Headache Nasal Spray product does not conform with the conditions for lawful marketing of an OTC internal analgesic drug product as set forth in M013.\u003C\u002Fp>\u003Cp>Thus, your SINUS PLUMBER Headache Nasal Spray product does not comply with the applicable conditions specified in M013 and has not otherwise been found GRASE.\u003Cem>\u003Cstrong>\u003Csup>2\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> 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.\u003C\u002Fp>\u003Cp>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).\u003C\u002Fp>\u003Cp>\u003Cstrong>Misbranded Drug Violations\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Additionally, SINUS PLUMBER Headache Nasal Spray 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.\u003C\u002Fp>\u003Cp>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).\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future compliance so that these violations and any others do not occur.\u003C\u002Fp>\u003Cp>Send your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “729653” in the subject line of the email.\u003C\u002Fp>\u003Cp>If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.\u003C\u002Fp>\u003Cp>Please note FDA posts warning letters on www.fda.gov.\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 and Labeling Compliance\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003Cbr>U.S. Food and Drug Administration\u003C\u002Fp>\u003Cp>_______________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> M013 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000027, available at FDA’s website OTC Monographs@FDA [https:\u002F\u002Fdps.fda.gov\u002Fomuf]\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>2\u003C\u002Fstrong>\u003C\u002Fem> FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that SINUS PLUMBER Headache Nasal Spray 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).\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 Electronic Mail - Delivery and Read Receipt Requested\n\nReference #:\n\n729653\n\nProduct:\n\nDrugs\n\nOver-the-Counter Drugs\n\nRecipient:\n\nRecipient Name\n\nWayne Perry\n\nRecipient Title\n\nFounder and President\n\nGSC Products, LLC\n\n1441 Van Patten Rd\n\nDuanesburg, NY 12056-2522\n\nUnited States\n\n(b)(6), (b)(7)(C)\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nMay 18, 2026\nWARNING LETTER\nTo Wayne Perry:\nThis warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your websites. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.\nFDA Review\nViolations were identified and documented during a review of your websites, https:\u002F\u002Fsinusplumber.com and https:\u002F\u002Fwww.greensations.com, in March 2026. Your https:\u002F\u002Fsinusplumber.com website also directs consumers to your Amazon storefront to purchase your product. Based on our review, your SINUS PLUMBER Headache Nasal Spray product is an unapproved new drug under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). In addition, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). As explained further below, introducing or delivering this product for introduction into interstate commerce is prohibited under sections 301(d) and 301(a) of the FD&C Act, 21 U.S.C. 331(d) and 331(a).\nThis review was conducted under FDA’s public health responsibilities to protect the public from unsafe, ineffective, and poor-quality drugs.\nViolations of the Federal Food, Drug, and Cosmetic Act\nUnapproved New Drug Violations\nThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.\nBased on a review of your websites, your SINUS PLUMBER Headache Nasal Spray is a drug under 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 any function of the body. Examples from your product labeling, including your websites, 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:\n“Drug Facts . . . Purpose…Relieves pain and nausea…Relieves pain & inflammation…Increases circulation . . . Uses: For the temporary relief of: ■ General headache and migraine symptoms.” [from the product label on the Sinus Plumber product website https:\u002F\u002Fsinusplumber.com\u002Fproducts\u002Fsinus-plumber-migraine-headache-nasal-spray-with-capsaicin]\n“Powerful & Fast Headache Relief √ Tension √ Clusters √ Migraines” [from the product label on the Sinus Plumber product website https:\u002F\u002Fsinusplumber.com\u002Fproducts\u002Fsinus-plumber-migraine-headache-nasal-spray-with-capsaicin and\nhttps:\u002F\u002Fwww.greensations.com\u002FCayenne-Pepper-Headache-Nasal-Spray-p\u002Fsp-4.htm]\n“Sinus Plumber Headache Nasal Spray targets a variety of headaches with the pain relief power of capsaicin, feverfew, peppermint and caffeine.”…“This formula is commonly used for headaches that feel sinus-related or pressure-driven, including sinus headaches, tension headaches, migraines, and cluster headaches.” [from the Sinus Plumber product website https:\u002F\u002Fsinusplumber.com\u002Fproducts\u002Fsinus-plumber-migraine-headache-nasal-spray-with-capsaicin and https:\u002F\u002Fwww.greensations.com\u002FCayenne-Pepper-Headache-Nasal-Spray-p\u002Fsp-4.htm]\nBased on the above labeling evidence, SINUS PLUMBER Headache Nasal Spray is intended for use as an internal analgesic 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).\nA 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 this drug product identified above.\nUnder 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 internal analgesic drug products, such as your SINUS PLUMBER Headache Nasal Spray, 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 M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use (hereinafter “M013”).1 However, SINUS PLUMBER Headache Nasal Spray does not conform to the conditions specified in M013 for the reasons described below.\nYour SINUS PLUMBER Headache Nasal Spray is intended to be applied inside the nostrils. Under M013.1, only an OTC internal analgesic drug product in a form suitable for oral administration is generally recognized as safe and effective if it meets the conditions of M013. Thus, your internal analgesic drug product intended for administration inside the nostrils, does not conform to the conditions of M013.\nIn addition, your SINUS PLUMBER Headache Nasal Spray labeling includes intended uses that are not permitted for OTC internal analgesic drug products in M013. Specifically, claims such as “This formula is commonly used for headaches that feel sinus-related or pressure-driven, including sinus headaches, tension headaches, migraines, and cluster headaches.” and “Purpose . . . Relieves . . . nausea . . . inflammation . . . increase circulation” that suggest SINUS PLUMBER Headache Nasal Spray is intended to treat sinuses, tension, clusters, and migraines, and is intended to relieve nausea, inflammation, and increase circulation go beyond the general intended uses for an OTC internal analgesic drug product and do not conform to the permitted uses set forth in M013.50(b).\nFurthermore, your SINUS PLUMBER Headache Nasal Spray is formulated with active ingredients that are not permitted for OTC internal analgesic drug products under M013.10. Specifically, feverfew, arnica montana, oleoresin capsicum, caffeine anhydrous, and peppermint oil are not permitted as single active ingredients under M013.10, nor is this combination of active ingredients permitted under M013.20. Therefore, your SINSUS PLUMBER Headache Nasal Spray product does not conform with the conditions for lawful marketing of an OTC internal analgesic drug product as set forth in M013.\nThus, your SINUS PLUMBER Headache Nasal Spray product does not comply with the applicable conditions specified in M013 and has not otherwise been found GRASE.2 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.\nThe 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).\nMisbranded Drug Violations\nAdditionally, SINUS PLUMBER Headache Nasal Spray 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.\nThe 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).\nConclusion\nAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future compliance so that these violations and any others do not occur.\nSend your written response to FDAAdvisory@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Include the specific steps you have taken to correct any violations, an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. Identify your response with reference number “729653” in the subject line of the email.\nIf you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.\nPlease note FDA posts warning letters on www.fda.gov.\nSincerely,\n\u002FS\u002F\nTina Smith, M.S.\nCaptain, U.S. Public Health Service\nDirector\nOffice of Unapproved Drugs and Labeling Compliance\nOffice of Compliance\nCenter for Drug Evaluation and Research\nU.S. Food and Drug Administration\n_______________________\n1 M013 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000027, available at FDA’s website OTC Monographs@FDA [https:\u002F\u002Fdps.fda.gov\u002Fomuf]\n2 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that SINUS PLUMBER Headache Nasal Spray 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).","2026-08-19T04:39:54.735+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-05-26T04:00:00Z\">05\u002F26\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-05-18T04:00:00Z\">05\u002F18\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fgsc-products-llc-729653-05182026\">GSC Products, LLC\u003C\u002Fa>","","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]