2019 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.
| Letter Issue Date | Company Name | Issuing Office | Subject |
|---|---|---|---|
| Unproven Alzheimer's Disease Products - 17 letters | |||
| 12/12/2019 | Soaptronic LLC | Division of Pharmaceutical Quality Operations IV | Unapproved New Drugs/Misbranded |
| 11/22/2019 | Natural Native LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | Private I Salon, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) *Products |
| 11/22/2019 | CDRL Nutritional, Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | Red Pill Medical Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | Apex Hemp Oil LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | Daddy Burt Hemp Co | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | Sabai Ventures Ltd | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | Organix Industries, Inc. dba Plant Organix | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | Noli Oil, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | Bella Rose Labs | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | Sunflora, Inc./The CBD Store, LLC dba Your CBD Store | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | Infinite Product Company LLLP DBA Infinite CBD | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | Whole Leaf Organics, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | Mr. Pink Collections, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/22/2019 | KOI CBD LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 11/18/2019 | EPH Technologies, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 10/29/2019 | Dr Jen Hartley/Healing Artistry, LLC | Division of Pharmaceutical Quality Operations IV | New Animal Drug/Adulterated |
| 10/16/2019 | Revital U International, LLC | Office of Human and Animal Food Operations West Division 3 | CGMP/Dietary Supplement/Adulterated |
| 10/10/2019 | Rooted Apothecary LLC | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 10/04/2019 | Herbal Doctor Remedies | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated |
| 09/23/2019 | Natural Wonder Products Corp | Division of Pharmaceutical Quality Operations IV | New Animal Drug/Adulterated |
| 09/18/2019 | Alternative Laboratories | Office of Human and Animal Food Operations East Division IV | Dietary Supplement/Adulterated |
| 09/12/2019 | Herbal Healer Academy, Inc. | Division of Human and Animal Food Operations West III | Unapproved New Drugs/Misbranded |
| 08/20/2019 | Evig LLC dba Balance of Nature | Division of Human and Animal Food Operations West IV | Unapproved New Drugs/Misbranded |
| 08/20/2019 | Let's Talk Health, Inc. | Division of Human and Animal Food Operations West V | Unapproved New Drugs/Misbranded |
| 07/23/2019 | Curaleaf, Inc | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 06/25/2019 | Cali Botanicals, LLC | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| 06/11/2019 | Perfect Choice Trading, Inc. and Nutricos Ceuticals, Inc. | Division of Human and Animal Food Operations East I | CGMP/Dietary Supplement/Adulterated/Misbranded |
| 06/06/2019 | PRL Inc | Division of Human and Animal Food Operations East V | CGMP/Dietary Supplement/Adulterated/Misbranded |
| 06/04/2019 | Paisley Farms, LLC dba Paisley Farm & Crafts | 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.