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 |
|---|---|---|---|---|---|---|---|
| Hyaluron Pen Store, LLC dba Glow Nest Beauty | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … https://www.glownestbeauty.com/product-page/pinebottle-fat-burber: “Enhance Skin Elasticity, Reduce Wrinkles. Pine … lipolysis products that can cause wrinkles” “During fat dissolution, our solution, combined with Riboflavin, … “The Ultimate Fat Burner! Ignite Your Fat Burning Potential! Are you tired of … | ||||
| Jackson Health & Wellness Clinic | Division of Human and Animal Food Operations East V | New Drug/Misbranded | … Dr Miller’s Youthin Fatburners “Regular use of Youthin Fat Burners may help control High Blood Pressure and … | ||||
| HIS Enterprise Inc dba Adam’s Secret USA, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | … “Clinically Proven Fat Binder 10 Day Plan (10 Capsules: Effective Weight Loss of … product’s label on your website states: “Clinically proven fat burner for healthy and safe weight loss.” Your Adam’s Secret … | ||||
| Advanced Nutritional Supplements LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Dietary Supplement/Adulterated | … God of Rage, God of War, New God of Fire, Legion: Extreme Fat Burner, Laxovar: Natural Recomposition, and Uprising: Natural … New God of Fire declares hordenine HCl, Legion: Extreme Fat Burner declares higenamine HCl, Laxovar: Natural … | ||||
| Genesis Nutrition Ultra Slim dba Genesis Ultra Slim | Office of Pharmaceutical Quality Operations, Division II | Unapproved New Drugs/Misbranded | … your appetite . . . [b]oosts your metabolism . . . [b]urn fat & calories . . . [i]ncrease energy levels . . ." … . . slows the rate of digestion and the absorption of both fat and carbohydrates." "[P]ineapple is anti-inflammatory . . … Ultra Slim Original Formula, Genesis Ultra Slim Fat Burner, Genesis Ultra Slim Colon Cleanse, Garcinia Max, … |