2018 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 |
|---|---|---|---|
| 11/08/2018 | Guardian Pet Products | Center for Veterinary Medicine | Labeling/Unapproved New Animal Drug/Adulterated |
| 11/08/2018 | Avalon Packaging | Denver District Office | New Drugs/Dietary Supplements/Food Labeling/Misbranded |
| 11/07/2018 | Jack B Goods Outlet Store | Center for Food Safety and Applied Nutrition | Unapproved New Drugs/Misbranded |
| 11/07/2018 | MA Labs LLC | Center for Food Safety and Applied Nutrition | Unapproved New Drugs/Misbranded |
| 10/31/2018 | DynaPro International, Inc. | Denver District Office | Dietary Supplement/New Drug/Misbranded |
| 10/30/2018 | American Botanical Pharmacy | San Francisco District Office | Unapproved New Drugs/Misbranded |
| 10/17/2018 | No More Fleas Please, Inc. | Dallas District Office | New Animal Drug/Adulterated |
| 10/10/2018 | Original Living Coconut, LLC | Kansas City District Office | Food Labeling/Misbranded |
| 09/18/2018 | Rock Farm, LLC dba WholeFood Farmacy | Cincinnati District Office | Unapproved New Drugs/Misbranded |
| 09/07/2018 | Best Nutrition Products, Inc. | San Francisco District Office | CGMP/Dietary Supplement/Adulterated/Misbranded |
| 09/06/2018 | Adaptive Energy LLC | Center for Food Safety and Applied Nutrition | New Drug/Misbranded |
| 09/04/2018 | Chillin Mix Kratom | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 09/04/2018 | Mitra Distributing Inc. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 08/28/2018 | Celletech, Ltd | Minneapolis District Office | New Drugs/Dietary Supplements/Food Labeling/Misbranded |
| 08/15/2018 | Healthy Healing dba Crystal Star | Minneapolis District Office | New Drug/Labeling/Misbranded |
| 07/18/2018 | Hawaiian Organic Noni, LLC | Los Angeles District Office | Labeling/False & Misleading Claims/Misbranded |
| 07/13/2018 | GC Natural | Los Angeles District Office | CGMP/Dietary Supplement/Adulterated/Misbranded |
| 07/12/2018 | www.poppyseedwash.com | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 07/03/2018 | AniCell Biotech | Los Angeles District Office | Unapproved New Animal Drug/Adulterated |
| 06/26/2018 | American Chinese Medicine Association | Detroit District Office | New Drug/Misbranded |
| 06/07/2018 | Up Inya Gear | Center for Food Safety and Applied Nutrition | New Drug/Misbranded |
| 06/06/2018 | The Health Management Group Inc. | Cincinnati District Office | CGMP/Dietary Supplement/Adulterated/Misbranded |
| 05/18/2018 | Kratom Spot | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| 05/18/2018 | Revibe, Inc. | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded |
| 05/18/2018 | Pharmacy Direct, PDU | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 05/18/2018 | Front Range Kratom | Center for Food Safety and Applied Nutrition | Unapproved New Drug/Misbranded |
| 05/18/2018 | Sunergized LLC | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 05/18/2018 | Napa Valley Bioscience | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 04/25/2018 | Baker's Best Health Products, Inc. | Chicago District Office | Unapproved New Drugs/Misbranded |
| 03/30/2018 | Vital Hierbas Naturales Corporation | Chicago District Office | New Drug/Misbranded |
| 03/30/2018 | Ozark Country Herbs | Dallas District Office | Unapproved New Drugs/Misbranded |
| 03/29/2018 | South Texas Botanicals | Dallas District Office | Unapproved New Drugs/Misbranded |
| 03/21/2018 | Secret Garden of Health & Healing, LLC | Denver District Office | Unapproved New Drugs/Misbranded |
| 03/13/2018 | Biotek, Inc. | Denver District Office | Unapproved New Drugs/Misbranded |
| 02/23/2018 | PA Constans - Minnesota Emu | Minneapolis District Office | New Drug/Labeling/Misbranded |
| 02/06/2018 | Reishi D. International, Inc. | San Francisco District Office | CGMP/Dietary Supplement/Adulterated/Misbranded |
| 02/05/2018 | Infant Acid Reflux Solutions LLC | Los Angeles District Office | Unapproved New Drugs/Misbranded |
| 01/31/2018 | Long Life Unlimited | Cincinnati District Office | New Drug/Misbranded |
| 01/24/2018 | Young Health Products | Dallas District Office | New Drug/Misbranded |
| 01/11/2018 | Guna Inc. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/11/2018 | U4Life LLC dba Mitadone | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/11/2018 | Choice Detox Center, Inc. dba Nofeel | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/11/2018 | Opiate Freedom Center | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/11/2018 | Healthy Healing dba Crystal Star | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/11/2018 | Medicus Holistic Alternatives LLC | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/11/2018 | TaperAid | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/11/2018 | King Bio Inc. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/11/2018 | CalmSupport.com, LLC | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/11/2018 | NutraCore Health Products | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/11/2018 | Soothedrawal, Inc. | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/10/2018 | USA Labs AKA Power Source Distributors, Inc AKA USA Sport | Cincinnati District Office | New Drug/Misbranded |
| 01/05/2018 | Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc. | Seattle District Office | New Drug/Labeling/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.