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.
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| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Agebox Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drug/Misbranded | … iKids-Growth products contain the undeclared ingredient ibutamoren mesylate. Ibutamoren (also known as MK-677) is an active ingredient not … its safety and efficacy have not been established. Ibutamoren is a growth hormone secretagogue that stimulates … | ||||
| Prime Sports Nutrition | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | … “MK-677” (also referred to on your website as “Ibutamoren”), and “S-23” (hereinafter products marketed as … Mass Gains In As Short As Four To Six Weeks.” MK-677 Ibutamoren On the webpage … “Benefits Of Ibutamoren (MK-677) o Increases Muscle Mass and Strength o … | ||||
| Dynamic Health Group dba SARMS AMERICA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | … including, but not limited to, “Ostarine MK-2866,” “MK-677 Ibutamoren,” “Cardarine GW501516,” and “LGD-4033 Ligandrol” … in elderly males and postmenopausal females.” MK-677 Ibutamoren On the webpage https://sarmsamerica.co/products/ibutamoren-mk-677/: “MK677, also recognized as Ibutamoren, … | ||||
| Musclepower Enterprise Ltd. dba MONSTER KING and GE LABS | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
… product is marketed as a dietary supplement that contains ibutamoren as an ingredient, according to information found … labeling of the product. However, FDA has concluded that ibutamoren is excluded from the dietary supplement definition … before such authorization. Based on available evidence, ibutamoren has been authorized for investigation as a new … | ||||
| Warrior Labz SARMS | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | … modulators (SARMs) including “RAD-140 Testolone,” “MK-677 Ibutamoren,” “MK-2866 Ostarine,” and “LGD-4033 Ligandrol.” We … Weeks is best for optimal results. DOSAGE – 1ML AM” MK-677 Ibutamoren “MK- 677 – IBUTAMOREN / NUTROBOL Increased Production of GH and IGF-1 … | ||||
| Elite Supplement Center LLC and Elite Training Facility LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug | … there for “Ostarine MK-2866,” “Ligandrol LGD 4033,” “Ibutamoren MK-677,” “Testolone Rad140,” and “Cardarine … with excellent results in bulking, recomp, and cutting!” “ Ibutamoren MK-677 Known as MK-677 and Ibutamoren, is a highly potent growth hormone secretagogue as … | ||||
| Umbrella | Division of Pharmaceutical Quality Operations IV | Dietary Supplement/Misbranded | … – 20 MG/ML,” “MK-2866 Ostarine SARM – 20 MG/ML,” “MK-677 Ibutamoren Nutrobal Powder,” “RAD-140 Testolone,” “S-4 … – 20 MG/ML,” “MK-2866 Ostarine SARM – 20 MG/ML,” “MK-677 Ibutamoren Nutrobal Powder,” “RAD-140 Testolone,” “S-4 … – 20MG/ML,” “MK-2866 Ostarine SARM – 20MG/ML,” “MK-677 Ibutamoren Nutrobal Powder,” “RAD-140 Testolone,” “S-4 … |