Timothy A. Timmins
President
Entia Biosciences, Inc
13565 SW Tualatin Sherwood Road, Suite 800
Sherwood , OR 97140
United StatesIssued Jan 6, 2021Division of Human and Animal Food Operations West VI
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations1
Issue DateJan 6, 2021
Product TypeDrugs
StatusClosed
Closeout LetterMay 12, 2021
Letter Details
Firm
Entia Biosciences, Inc
Location
Timothy A. Timmins
President
Entia Biosciences, Inc
13565 SW Tualatin Sherwood Road, Suite 800
Sherwood , OR 97140
United States
FEI Number
N/A
Country
United States
Issue Date
January 06, 2021
Issuing Office
Division of Human and Animal Food Operations West VI
Product Type
Drugs
Status
Closed
Closeout Letter
May 12, 2021
Summary
Entia Biosciences, Inc. was cited for marketing six mushroom-based dietary supplement products (Lion's Mane, Antrodia, Maitake, Reishi, and Cordyceps) as unapproved drugs through their website www.totalnutraceutical.com. The products violated the Federal Food, Drug, and Cosmetic Act because their marketing claims—including statements that they help lower cholesterol, reduce inflammation, treat liver disease and hypertension, and promote balanced blood sugar—established them as drugs intended to cure, mitigate, treat, or prevent disease rather than as dietary supplements. The FDA identified these violations during website reviews conducted in September and December 2020.
Entia Biosciences, Inc FDA Warning Letter, January 6, 2021