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 |
|---|---|---|---|---|---|---|---|
| Peak Performance Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … in preclinical models exploring endocrine signaling, diabetes, and obesity-related research.” “Studied for effects … | ||||
| NuScience Peptides LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … in metabolic disorders, particularly obesity and type 2 diabetes. Also known as LY3437943, it functions as a triple … developed for laboratory research into obesity and type 2 diabetes metabolic pathways. Preclinical studies in rodent … for treating non-alcoholic fatty liver disease and type 2 diabetes.” PT-141 Peptide (Bremelanotide) On the webpage … | ||||
| Peptide Partners LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … of how tirzepatide works to improve metabolic health in diabetes and obesity.” “This study shows that tirzepatide . . … and blood sugar control.” “Retatrutide, a new drug for diabetes and obesity, helps lower bad fats in the blood . . . … | ||||
| TXP Innovations LLC dba Tex Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … SEM a key area of interest in the management of type 2 diabetes, obesity, and metabolic disorders.” “In addition to … and neuroprotection, expanding its relevance beyond diabetes care.” GLP-2 TRZ (Tirzepatide) On the webpage … | ||||
| R3 Medical Companies | Center for Biologics Evaluation and Research (CBER) | Unapproved New Drugs/Unlicensed Biological Product Violations | … Failure (e.g. Cardiomyopathy, COPD)…Autism…Cerebral Palsy…Diabetes…Lyme Disease...SI Joint Pain...Erectile … such as arthritis, neurological conditions, autism, diabetes, liver/kidney failure and much more. Umbilical cord … conditions, such as amyotrophic lateral sclerosis (ALS), diabetes, kidney failure, Lyme disease, Parkinson’s disease, … | ||||
| 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, … |