Bruce D. Curtis/Marianne L. Curtis
Co-owner(s)
Living Foods LLC
1456 Marilee Dr.
Lawrence , KS 66049
United StatesFEI 3004758431Issued Jul 5, 2022Office of Human and Animal Food- West Division II
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 3004758431.
Violations3
Issue DateJul 5, 2022
Product TypeDrugs
StatusClosed
Closeout LetterOct 3, 2024
Letter Details
Firm
Living Foods LLC
Location
Bruce D. Curtis/Marianne L. Curtis
Co-owner(s)
Living Foods LLC
1456 Marilee Dr.
Lawrence , KS 66049
United States
FEI Number
3004758431
Country
United States
Issue Date
July 05, 2022
Issuing Office
Office of Human and Animal Food- West Division II
Product Type
Drugs
Status
Closed
Closeout Letter
October 03, 2024
Summary
Living Foods LLC was cited for marketing three unapproved products: Bion+Plus Silver Ozone and ZeoHeal (both drugs) and Relax Far Infrared Ray Sauna (a medical device). The company's website contained disease claims that established these products as drugs or devices requiring FDA approval or clearance, which had not been obtained. The products were being sold without the required scientific data demonstrating safety and effectiveness, in violation of the Federal Food, Drug, and Cosmetic Act sections 301(d) and 505(a).
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