Warning Letters - Health Fraud
Warning Letters - Health Fraud
Examples of FDA Warning Letters that cite unapproved or unsubstantiated claims, tainted products or other health fraud* - related violations. For all FDA Warning Letters, click here.
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| Letter Issue Date | Company Name | Issuing Office | Subject |
|---|---|---|---|
| Unproven Alzheimer's Disease Products - 17 letters | |||
| 06/25/2019 | Cali Botanicals, LLC | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| 06/06/2019 | PRL Inc | Division of Human and Animal Food Operations East V | CGMP/Dietary Supplement/Adulterated/Misbranded |
| 05/16/2019 | KratomNC | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| 05/15/2019 | ActiveHerb Technology, Inc | Division of Pharmaceutical Quality Operations IV | Unapproved New Drugs/Misbranded |
| 05/07/2019 | AMMD Labs, LLC | Division of Pharmaceutical Quality Operations II | Unapproved Drugs/Misbranded |
| 05/02/2019 | Kadesh International | Division of Pharmaceutical Quality Operations IV | Unapproved Animal Drugs/Misbranded Human Drugs |
| 04/29/2019 | Golean Detox US | Division of Pharmaceutical Quality Operations II | Unapproved New Drugs/Misbranded |
| 04/23/2019 | Newton Laboratories Inc DBA Newton Homeopathics | Division of Pharmaceutical Quality Operations II | Unapproved New Drugs/Misbranded |
| 04/11/2019 | Total Body Nutrition | Center for Food Safety and Applied Nutrition | Dietary Supplement/Adulterated |
| 04/10/2019 | Down to Earth Solutions, LLC | Center for Food Safety and Applied Nutrition | Dietary Supplement/Adulterated |
| 04/10/2019 | NeuroScience Solutions, Inc. dba NeuroScience | Center for Food Safety and Applied Nutrition | Dietary Supplement/Misbranded |
| 04/10/2019 | eflow Nutrition LLC | Center for Food Safety and Applied Nutrition | Dietary Supplement/Adulterated |
| 04/10/2019 | Hi Tech Pharmaceuticals | Center for Food Safety and Applied Nutrition | Dietary Supplement/Adulterated |
| 04/10/2019 | IQ Formulations, LLC | Center for Food Safety and Applied Nutrition | Dietary Supplement/Misbranded |
| 04/10/2019 | Line One Nutrition, Inc | Center for Food Safety and Applied Nutrition | Dietary Supplement/Adulterated |
| 04/10/2019 | Iron Brothers | Center for Food Safety and Applied Nutrition | Dietary Supplement/Adulterated |
| 04/10/2019 | Forbiddenlabz | Center for Food Safety and Applied Nutrition | Dietary Supplement/Adulterated |
| 04/10/2019 | Evol Nutrition Associates, Inc. d/b/a Red Dawn Energy | Center for Food Safety and Applied Nutrition | Dietary Supplement/Misbranded |
| 04/10/2019 | Atomixx | Center for Food Safety and Applied Nutrition | Dietary Supplement/Misbranded |
| 04/10/2019 | Empire Distributors, Inc. | Division of Pharmaceutical Quality Operations III | Inactive Ingredient, Misbranding |
| 04/03/2019 | Texas Aloe Corporation, Inc. | Division of Human and Animal Food Operations West III | Unapproved New Drugs/Misbranded |
| 03/28/2019 | Nutra Pure LLC | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded |
| 03/28/2019 | Advanced Spine and Pain, LLC (d/b/a Relievus) | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded |
| 03/28/2019 | PotNetwork Holdings, Inc. | Center for Food Safety and Applied Nutrition | New Drug/Misbranded |
| 03/27/2019 | Azmedicinalshop.com | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 03/27/2019 | Thedonrx.net | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 03/21/2019 | B. Jain Pharmaceuticals Private Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated |
| 03/20/2019 | King Bio Inc. | Dallas District Office | CGMP/Finished Pharmaceuticals/Adulterated |
| 03/20/2019 | Red Mountain Inc | Dallas District Office | CGMP/Finished Pharmaceuticals/Adulterated |
| 03/11/2019 | Nutra Pharma | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded |
| 03/08/2019 | Aidaccess.org | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded |
| 03/08/2019 | Rablon | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded |
| 03/05/2019 | Hanna's Herb Shop | Denver District Office | New Drug/Misbranded |
| 02/05/2019 | Pure Nootropics, LLC | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 02/05/2019 | TEK Naturals | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 02/05/2019 | John Gray's Mars Venus LLC | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 02/05/2019 | Nutrition Coalition Inc | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 02/05/2019 | Blue Ridge Silver | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 02/05/2019 | Sovereign Laboratories, LLC | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 02/05/2019 | DK Vitamins | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 02/05/2019 | Peak Nootropics LLC (aka Advanced Nootropics) | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 02/05/2019 | Gold Crown Natural Products | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 02/05/2019 | Emmbros Overseas Lifestyle PVT LTD. | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 02/05/2019 | Earth Turns, LLC | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 02/05/2019 | Capris Associates Inc./BR Naturals | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 01/31/2019 | Green Water, LLC | Denver District Office | Unapproved New Drugs/Misbranded |
| 01/30/2019 | Phi Sciences | Denver District Office | Unapproved New Drugs/Misbranded |
*The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or condition, or provide another beneficial effect on health, but that has not been scientifically proven safe and effective for such purposes.