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 |
|---|---|---|---|---|---|---|---|
| Meta Labs Pharmaceuticals, LLC | Human Foods Program | Dietary Supplement/New Drug/Misbranded | … as reducing the risk of colon and rectal cancer, reducing cholesterol, triglycerides, and phospholipids in the blood, … anti-parasitic effects; normalizes blood pressure; reduces cholesterol concentration . . .” “The use of the appropriate … | ||||
| OptiHealth Products, Inc. | Human Foods Program | New Drug/Misbranded | … vessel function, reducing blood pressure, and lowering cholesterol levels…” Under the section, “Diabetes Management” … E can improve heart health by reducing oxidation of cholesterol, lowering blood pressure, and improving arterial … | ||||
| Supersmart USA, LLC | Human Foods Program | New Drug/Misbranded | … berberine, with multiple benefits for blood sugar and cholesterol” “Helps regulate blood sugar …” Glucofit • “Helps … levels” Organic Moringa “Helps lower blood glucose and cholesterol levels” “Helps reduce inflammation in the body” … | ||||
| Nature’s Elements, Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | … “Shou Wu is used to reduce cholesterol in part to its lecithin content.” Advanced Shou … “Shou Wu is used to reduce cholesterol in part to its lecithin content.” Schizandra … | ||||
| Nupack Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | … state the following: “It may help…..Lowering Cholesterol, and protecting against clots which can cause … to lowering blood pressure and combat side effects of cholesterol lowering statins” Your firm’s Cleanse-CAMP label … Psyllium Husk states the following: “Support to lower LDL Cholesterol” Your firm’s website, www.unitechusk.com, states … | ||||
| Gram Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet | … – Research shows reductions in triglycerides and improved cholesterol ratios.” Bacteriostatic Water for Injection Your … | ||||
| Prime Sciences | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet | … . . . Reduced blood pressure . . . Decreased total cholesterol and LDL . . . Lowered triglycerides” BAC water … | ||||
| Dynamic Health Group dba SARMS AMERICA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | … improved body composition, bone mineral density, and cholesterol levels over several months, concurrently … fatty acid oxidation and promotes fat loss o Lower LDL cholesterol (“bad cholesterol”) o Higher HDL cholesterol (“good cholesterol”) o … | ||||
| 123Herbals | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … • “TDCARE helps to lower blood glucose and cholesterol. Prevents diabetic complications by lowering blood glucose. Lowers cholesterol to prevent cardiovascular disease.” Vall Boon … | ||||
| Time Challenger Labs International, Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated/Misbranded | … of the blood vessels farther from the heart . . . lower cholesterol by increasing the excretion of bile, reducing the formation of cholesterol, and enhancing the receptors for LDLs.” [U]sed … pressure lowering activity . . . reducing the formation of cholesterol” [U]sed for heart conditions, including heart … |