[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-vasocorp-inc-732724-07092026":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":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},11,"vasocorp-inc-732724-07092026","Warning Letter","VasoCorp, Inc.",null,"Human Foods Program","Unapproved New Drugs\u002FMisbranded","2026-07-28","2026-07-09","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fvasocorp-inc-732724-07092026","732724","Dietary Supplements","Via Email","Mr. William H. Cross III","\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\">Dietary Supplements                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Mr. William H. Cross III\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\">President and CEO\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>VasoCorp, Inc.\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">808 Metromont Rd Ste 100\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Hiram\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">GA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">30141-3056\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \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>Human Foods Program\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>July 9, 2026\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp class=\"text-align-center\">CMS #732724\u003C\u002Fp>\u003Cp class=\"text-align-center\">\u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Dear Mr. Cross:\u003C\u002Fp>\u003Cp>This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.vasocorp.com in March 2026 and has determined that you take orders there for the products NeuropAWAY – Nerve Support Formula and NeuropAWAY pm – Nighttime Nerve Support Formula. The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.\u003C\u002Fp>\u003Cp>Examples of some of the claims that provide evidence that your products are intended for use as drugs include:\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cu>NeuropAWAY – Nerve Support Formula\u003C\u002Fu>\u003Cbr>“NeuropAWAY Nerve Support Formula is a patented formula that is clinically proven to reduce the overall symptoms of occasional burning, tingling, and numbness by ~76%. NeuropAWAY’s synergistic formula combines Taurine with other key ingredients to improve blood supply to damaged and needy nerves.” “NeuropAWAY Nerve Support 60 Daily Capsules Delivers Key Nutrients to Damaged & Inflamed Nerves.” (www.vasocorp.com)\u003C\u002Fli>\u003C\u002Ful>\u003Cp>“Consumption of NeuropAWAY resulted in a signification reduction [Pain] in PI-NRS after 7 days of consumption.” Note: PI-NRS is Pain Intensity Numerical Rating Scale. (https:\u002F\u002Fwww.vasocorp.com\u002Fproducts\u002Fneuropaway-capsules)\u003C\u002Fp>\u003Cp>“VasoCorp was founded by William Cross, a Type 1 diabetic driven by his personal quest for relief from nerve discomfort. After years of dedicated research, William developed the unique formula for our flagship product, NeuropAWAY Nerve Support Formula. . . . You can find NeuropAWAY products in the diabetes section of major pharmacies across the country . . ..” (https:\u002F\u002Fwww.vasocorp.com\u002Fpages\u002Fabout-us)\u003C\u002Fp>\u003Cul>\u003Cli>\u003Cu>NeuropAWAY pm – Nighttime Nerve Support Formula\u003C\u002Fu>\u003Cbr>“NeuropAWAY targets the cause of neuropathic pains in: head & neck, feet, static nerve, hands, arms, legs…” “NeuropAWAY burning, tingling, & numbness support.” “Supports damaged and needy nerves.” (https:\u002F\u002Fwww.vasocorp.com\u002Fproducts\u002Fneuropaway-pm)\u003C\u002Fli>\u003Cli>\u003Cu>NeuropAWAY – Nerve Support Formula and NeuropAWAY pm – Nighttime Nerve Support Formula\u003C\u002Fu>\u003Cbr>“R-Alpha Lipoic Acid (ALA) Protect nerves from damage…” \u003Cem>R-Alpha Lipoic Acid is an ingredient in both the NeuropAWAY – Nerve Support Formula and NeuropAWAY pm – Nighttime Nerve Support Formula products\u003C\u002Fem>. (www.vasocorp.com)\u003C\u002Fli>\u003C\u002Ful>\u003Cp>Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.\u003C\u002Fp>\u003Cp>A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.\u003C\u002Fp>\u003Cp>Your product NeuropAWAY – Nerve Support Formula is intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, NeuropAWAY – Nerve Support Formula fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].\u003C\u002Fp>\u003Cp>This 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.\u003C\u002Fp>\u003Cp>This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.\u003C\u002Fp>\u003Cp>Please notify FDA in writing, within 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 Act, include your reasoning and any supporting information for our consideration.\u003C\u002Fp>\u003Cp>Your written reply should be directed to Rebecca Allen, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #732724 and \u003Cstrong>(b)(4)\u003C\u002Fstrong> on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Maria S. Knirk, JD, MBA\u003Cbr>Director, Office of Enforcement\u003Cbr>Office of Compliance and Enforcement\u003Cbr>Human Foods Program\u003C\u002Fp>\u003Cp>Cc:\u003Cbr>\u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Email\n\nProduct:\n\nDietary Supplements\n\nRecipient:\n\nRecipient Name\n\nMr. William H. Cross III\n\nRecipient Title\n\nPresident and CEO\n\nVasoCorp, Inc.\n\n808 Metromont Rd Ste 100\n\nHiram, GA 30141-3056\n\nUnited States\n\nIssuing Office:\n\nHuman Foods Program\n\nUnited States\n\nJuly 9, 2026\nWARNING LETTER\nCMS #732724\n(b)(4)\nDear Mr. Cross:\nThis is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.vasocorp.com in March 2026 and has determined that you take orders there for the products NeuropAWAY – Nerve Support Formula and NeuropAWAY pm – Nighttime Nerve Support Formula. The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.\nExamples of some of the claims that provide evidence that your products are intended for use as drugs include:\nNeuropAWAY – Nerve Support Formula\n“NeuropAWAY Nerve Support Formula is a patented formula that is clinically proven to reduce the overall symptoms of occasional burning, tingling, and numbness by ~76%. NeuropAWAY’s synergistic formula combines Taurine with other key ingredients to improve blood supply to damaged and needy nerves.” “NeuropAWAY Nerve Support 60 Daily Capsules Delivers Key Nutrients to Damaged & Inflamed Nerves.” (www.vasocorp.com)\n“Consumption of NeuropAWAY resulted in a signification reduction [Pain] in PI-NRS after 7 days of consumption.” Note: PI-NRS is Pain Intensity Numerical Rating Scale. (https:\u002F\u002Fwww.vasocorp.com\u002Fproducts\u002Fneuropaway-capsules)\n“VasoCorp was founded by William Cross, a Type 1 diabetic driven by his personal quest for relief from nerve discomfort. After years of dedicated research, William developed the unique formula for our flagship product, NeuropAWAY Nerve Support Formula. . . . You can find NeuropAWAY products in the diabetes section of major pharmacies across the country . . ..” (https:\u002F\u002Fwww.vasocorp.com\u002Fpages\u002Fabout-us)\nNeuropAWAY pm – Nighttime Nerve Support Formula\n“NeuropAWAY targets the cause of neuropathic pains in: head & neck, feet, static nerve, hands, arms, legs…” “NeuropAWAY burning, tingling, & numbness support.” “Supports damaged and needy nerves.” (https:\u002F\u002Fwww.vasocorp.com\u002Fproducts\u002Fneuropaway-pm)\nNeuropAWAY – Nerve Support Formula and NeuropAWAY pm – Nighttime Nerve Support Formula\n“R-Alpha Lipoic Acid (ALA) Protect nerves from damage…” R-Alpha Lipoic Acid is an ingredient in both the NeuropAWAY – Nerve Support Formula and NeuropAWAY pm – Nighttime Nerve Support Formula products. (www.vasocorp.com)\nYour products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.\nA drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.\nYour product NeuropAWAY – Nerve Support Formula is intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, NeuropAWAY – Nerve Support Formula fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)].\nThis 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.\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.\nPlease notify FDA in writing, within 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 Act, include your reasoning and any supporting information for our consideration.\nYour written reply should be directed to Rebecca Allen, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #732724 and (b)(4) on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.\nSincerely,\n\u002FS\u002F\nMaria S. Knirk, JD, MBA\nDirector, Office of Enforcement\nOffice of Compliance and Enforcement\nHuman Foods Program\nCc:\n(b)(4)","2026-08-19T04:28:11.089+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-07-28T04:00:00Z\">07\u002F28\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-07-09T04:00:00Z\">07\u002F09\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fvasocorp-inc-732724-07092026\">VasoCorp, Inc.\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"]