Herbal Solution's Health S.A. de C.V.
FDA import alert and refusal historyIrapuato, MexicoFEI 3011478105
As of October 26, 2026, Herbal Solution's Health S.A. de C.V. (Irapuato, Mexico) is on the red list of FDA Import Alert 99-39 (Imported foods that appear to be misbranded) for insulin plant, published by FDA on August 21, 2023, is also listed on Import Alert 54-14 (red list) and Import Alert 99-22 (red list), and has 6 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Last import refusal
- Tea, n.e.c. · LIST INGRE
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Herbal Solution's Health S.A. de C.V.
9 records, newest first. Each line links to the FDA page it came from.
2023
- Import alert listingListed on Import Alert 99-39red listInsulin PlantSource
- Import refusalRefused, Tea, n.e.c.LIST INGREDIRSEXMPTUNAPPROVEDEntry 228-5172124-5Source
2019
- Import refusalRefused, Echinacea, herbal & botanicals (not teas)UNAPPROVEDEntry 228-5157161-6Source
- Import refusalRefused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.SUPPL GMPEntry 228-5157161-6Source
- Import alert listingListed on Import Alert 54-14red listActive CL Dietary Supplement; Prosmen Dietary Supplement; HP Liv Dietary SupplementSource
- Import alert listingListed on Import Alert 99-22red listActive CL Dietary SupplementSource
2018
- Import refusalRefused, Milk thistle (herbal & botanical other than teas)NUTRIT LBLEntry 228-5149591-5Source
- Import refusalSource
Refused, 2 lines in one entry: Arnica (herbal & botanicals, not teas); Oatmeal plain cookies,biscuits, and wafersUNAPPROVEDINCONSPICUEntry 228-5150442-7Show 2 linesHide lines
- Refused, Arnica (herbal & botanicals, not teas)UNAPPROVEDEntry 228-5150442-7Source
- Refused, Oatmeal plain cookies,biscuits, and wafersINCONSPICUEntry 228-5150442-7Source
Refusal charges, in plain English
- UNAPPROVED3 refused lines
Unapproved new drug
The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.
- DIRSEXMPT1 refused line
DIRSEXMPT
- INCONSPICU1 refused line
Required information not conspicuous
Information required on the label appeared not to be placed prominently or conspicuously enough to be read and understood by an ordinary consumer.
- LIST INGRE1 refused line
Ingredients not listed
The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).
- NUTRIT LBL1 refused line
Nutrition information missing from label
The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.
- SUPPL GMP1 refused line
Dietary supplement CGMP not met
The product appeared to be a dietary supplement prepared, packed, or held under conditions that do not meet current good manufacturing practice (CGMP) regulations.
Questions about Herbal Solution's Health S.A. de C.V.
- Is Herbal Solution's Health S.A. de C.V. on an FDA import alert?
- Yes. As of October 26, 2026, Herbal Solution's Health S.A. de C.V. is on the red list of FDA Import Alert 99-39, “Imported foods that appear to be misbranded”, for insulin plant; FDA published the listing on August 21, 2023.
- Has FDA refused shipments from Herbal Solution's Health S.A. de C.V.?
- Yes. FDA refused 6 shipment lines from Herbal Solution's Health S.A. de C.V. between July 25, 2018 and August 7, 2023. The most recent, on August 7, 2023, was tea, n.e.c., charged as LIST INGRE (ingredients not listed).
- Why did FDA refuse Herbal Solution's Health S.A. de C.V.'s shipments?
- The most frequent charges are UNAPPROVED (unapproved new drug, 3 lines) and DIRSEXMPT (dirsexmpt, 1 line).
- What is Herbal Solution's Health S.A. de C.V.'s FEI number?
- Herbal Solution's Health S.A. de C.V.'s FDA Establishment Identifier (FEI) is 3011478105.
- Can shipments from Herbal Solution's Health S.A. de C.V. still enter the U.S.?
- Shipments of insulin plant from Herbal Solution's Health S.A. de C.V. can be detained without physical examination under Import Alert 99-39; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).
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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.