Warning Letters
Learn about the types of warning letters on FDA's website.
- Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
- To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.
- Frequently requested records may be accessed on the Reading Room page.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| VasoCorp, Inc. | Human Foods Program | Unapproved New Drugs/Misbranded | … Formula. . . . You can find NeuropAWAY products in the diabetes section of major pharmacies across the country . . … | ||||
| Mineral BioSciences, LLC | Human Foods Program | Unapproved New Drugs/Misbranded | … AND Ionicell “Did you know Higher A1C levels are linked to diabetes complications? But did you also know that case … | ||||
| Blue Horizon International, LLC | Center for Biologics Evaluation and Research (CBER) | Unapproved New Drugs/Unlicensed Biological Product Violations | … Conquering Crohn’s Disease o Metabolic Transformation Diabetes Remissions Under the heading “Our Results” on your … | ||||
| OptiHealth Products, Inc. | Human Foods Program | New Drug/Misbranded | … and lowering cholesterol levels…” Under the section, “Diabetes Management” o “Bilberry extract has shown promise in … levels, making it a potential ally for individuals with diabetes or those at risk of developing the condition…” Under … | ||||
| Nupack Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | … under your Diabetech labeling: Product name: “Diabetech” [diabetes] “Diabetech powder for Diabetics” [diabetes] “Helping in daily regulation of blood glucose … “[N]atural diabetic supplement powder mix for daily diabetes support” “Diabetech (a)supports blood sugar control, … | ||||
| New Life Pharma LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Adulterated and Unapproved New Drug/Misbranded | … related to weight loss and management of type 2 diabetes; their design as lyophilized powder in sterile glass … | ||||
| Lovega LLC dba Pink Pony Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet | … with clinical precision Originally developed for type 2 diabetes, Tirzepatide has rapidly become a favorite among … | ||||
| Prime Sciences | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet | … “Application: Research peptide with potential in diabetes management and obesity treatment.” GLP1-R (10MG) … loss” “Application: Research peptide with potential in diabetes management and obesity treatment.” GLP1-T (10MG) … o Enhanced glycemic control: In patients with type 2 diabetes, mazdutide has been shown to significantly reduce … | ||||
| FormPour | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet |
… and promote a smoother, slimmer appearance.” “For: Type 2 Diabetes Treatment Weight Loss Cardiovascular Protection” “Global User Survey Results 98.6% Type 2 Diabetes Treatment Weight Loss Aid 97.5% 98.1% Cardiovascular … | ||||
| PekCura Labs | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet |
… infarction, or nonfatal stroke in subjects with type 2 diabetes treated with GLP-1-S relative to placebo (Marso et … |