LIV Health LLC dba INFINIWELL and DEAL Media L.L.C. dba HARMONIA

Warning LetterClosed

Roger Frantz and Jeremy S. Delk LIV Health LLC dba INFINIWELL and DEAL Media L.L.C. dba HARMONIA 881 Corporate Drive Lexington , KY 40503 United StatesIssued Nov 23, 2021Office of Human and Animal Foods Operations‐East V

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateNov 23, 2021

Product TypeDrugs

StatusClosed

Closeout LetterJul 5, 2022

Letter Details

Firm: LIV Health LLC dba INFINIWELL and DEAL Media L.L.C. dba HARMONIA
Location: Roger Frantz and Jeremy S. Delk LIV Health LLC dba INFINIWELL and DEAL Media L.L.C. dba HARMONIA 881 Corporate Drive Lexington , KY 40503 United States
FEI Number: N/A
Country: United States
Issue Date: November 23, 2021
Issuing Office: Office of Human and Animal Foods Operations‐East V
Product Type: Drugs
Status: Closed
Closeout Letter: July 05, 2022

Summary

LIV Health LLC (INFINIWELL) and DEAL Media L.L.C. (HARMONIA) were cited for marketing unapproved drugs through their websites, including products such as Thyroid Support, DHH-B, Balance, Clarity, Twilight, and Meditate. The companies made disease claims that established these products as drugs under federal law—specifically claiming Thyroid Support "relieves all symptoms related to an under-active thyroid" and DHH-B has "anxiolytic effects" comparable to benzodiazepines—without obtaining FDA approval as new drugs. By taking orders for these products with therapeutic claims, the companies violated the Federal Food, Drug, and Cosmetic Act by introducing misbranded and unapproved drugs into interstate commerce.

LIV Health LLC dba INFINIWELL and DEAL Media L.L.C. dba HARMONIA FDA Warning Letter, November 23, 2021