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 | Firm Name | Issuing Office | Subject |
|---|---|---|---|
| 10/28/2022 | Latin Foods Market | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 10/28/2022 | Walmart Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 05/04/2022 | BioMD Plus LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 05/04/2022 | M Six Labs, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 05/04/2022 | Kingdom Harvest | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 05/04/2022 | Delta 8 Hemp | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 05/04/2022 | ATLRx, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 04/20/2022 | C R Supplements, LLC | Office of Human and Animal Food Operations – West Division 6 | Unapproved New Drugs/Misbranded |
| 04/19/2022 | Kleenhanz, LLC | Center for Drug Evaluation and Research | CDER | Unapproved Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| 04/13/2022 | Elements Brands Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Skin Authority, L.L.C. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | AMBI Enterprises LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Genomma Lab USA, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | M & M Beauty and Wellness, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | True Earth Health Products, LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | SkinPro | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Skin PS Brands | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Clinical Formula LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Dr. Thomas Balshi/Intilight | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Ultimark Products | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/13/2022 | Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 04/06/2022 | Sensory Cloud, Inc | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 04/05/2022 | CofixRx, LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | Greenway Herbal Products LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | Cureganics | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | Functional Remedies, LLC D/B/A Synchronicity Hemp Oil | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | UPSY LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | Heaven’s Organic LLC | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | CBD Social | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/28/2022 | Nature's Highway | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/25/2022 | Iodine Products Inc | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/24/2022 | Applied Biological Laboratories Inc. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |
| 03/15/2022 | Honey Feast, Inc. | Office of Human and Animal Food Operations East Division IV | New Drug/Misbranded |
| 03/15/2022 | Iotech International, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drug and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/10/2022 | Soda Pharm | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 03/07/2022 | Viraldine, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
| 02/23/2022 | Princess Lifestyles, LLC | Office of Human and Animal Food Operations –West Division 5 | Unapproved New Drugs/Misbranded |
| 02/17/2022 | Vital Health & Wellness | Office of Human and Animal Foods Operations-East V | New Drug/Misbranded |
| 02/11/2022 | Rena's Organic | Office of Human and Animal Foods Division 4 East | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 02/09/2022 | Bea Lydecker’s Naturals, Inc. | Division of Human and Animal Food Operations West VI | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
| 02/04/2022 | Crystal Clear Supplements | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 02/03/2022 | Pharmacy2Home/LandiCom Holding LTD | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 02/01/2022 | New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
| 01/19/2022 | Glenn Burkett Naples Corporation | Office of Human and Animal Food Operations East Division IV | Unapproved New Drugs/Misbranded |
| 01/03/2022 | Amcyte Pharma, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |
*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.