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  1. Health Fraud Scams

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
07/15/2024 Earthly Hemps Center for Food Safety and Applied Nutrition (CFSAN) Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing
07/15/2024 Life Leaf Medical CBD Center Center for Food Safety and Applied Nutrition (CFSAN) Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing
07/15/2024 Mary Jane's Bakery Co. LLC Center for Food Safety and Applied Nutrition (CFSAN) Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing
07/15/2024 Shamrockshrooms.com Center for Food Safety and Applied Nutrition (CFSAN) Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing
07/15/2024 Grow God, LLC Center for Food Safety and Applied Nutrition (CFSAN) Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing
07/15/2024 Hippy Mood Center for Food Safety and Applied Nutrition (CFSAN) Interstate Commerce/Food/Adulterated/Unfair or Deceptive Marketing
03/25/2024 TKTX Company Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/25/2024 SeeNext Venture, Ltd. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/25/2024 Dermal Source, Inc. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/25/2024 Sky Bank Media, LLC dba Painless Tattoo Cream Co. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/25/2024 Indelicare DBA INKEEZE Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/25/2024 Tattoo Numbing Cream Co. Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/13/2024 Skull Smash LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
03/08/2024 Spirochaete Research Labs, LLC aka Scitus Laboratory Products Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
02/28/2024 Native Salts LLC Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
02/22/2024

Innovative Formulations, LLC dba Insane Labz

Center for Drug Evaluation and Research | CDER Finished Pharmaceuticals/Unapproved New Drug/Misbranded
02/13/2024 Salvacion USA Inc. Center for Drug Evaluation and Research | CDER Unapproved New Drugs/Misbranded
02/06/2024 Global Life Technologies Corp. Center for Drug Evaluation and Research | CDER 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.

 

 

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