John T Rozkiewicz, Owner
Dustin LeBleau, Owner
Innovative Formulations, LLC dba Insane Labz
675 E Highway 43
Harrison , AR 72601
United States
Jtr120271@yahoo.com
dustin@insanelabz.comFEI 3010382813Issued Feb 22, 2024Center for Drug Evaluation and Research | CDER
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010382813.
Violations1
Issue DateFeb 22, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Innovative Formulations, LLC dba Insane Labz
Location
John T Rozkiewicz, Owner
Dustin LeBleau, Owner
Innovative Formulations, LLC dba Insane Labz
675 E Highway 43
Harrison , AR 72601
United States
Jtr120271@yahoo.com
dustin@insanelabz.com
FEI Number
3010382813
Country
United States
Issue Date
February 22, 2024
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Innovative Formulations, LLC dba Insane Labz distributed "Wake the Dead Smelling Salts," an unapproved over-the-counter stimulant drug product sold through their website and Amazon marketplace, in violation of Federal Food, Drug & Cosmetic Act sections 505(a) and 502(ee). The product was determined to be a drug based on labeling claims indicating its intended use as a stimulant and its effects on body function, yet it lacked FDA approval as a new drug and was misbranded. The company introduced and delivered the product for introduction into interstate commerce without obtaining the required new drug approval, making its distribution illegal under the FD&C Act.
Innovative Formulations, LLC dba Insane Labz FDA Warning Letter, February 22, 2024
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