Mr. Joseph Esposito
CEO
Aceva, LLC
624 West Glen Ave.
Peoria , IL 61614
United StatesFEI 3014511804Issued Sep 7, 2021Center for Food Safety and Applied Nutrition (CFSAN)
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 3014511804.
Violations1
Issue DateSep 7, 2021
Product TypeDrugs
StatusClosed
Closeout LetterNov 10, 2021
Letter Details
Firm
Aceva, LLC
Location
Mr. Joseph Esposito
CEO
Aceva, LLC
624 West Glen Ave.
Peoria , IL 61614
United States
FEI Number
3014511804
Country
United States
Issue Date
September 07, 2021
Issuing Office
Center for Food Safety and Applied Nutrition (CFSAN)
Product Type
Drugs
Status
Closed
Closeout Letter
November 10, 2021
Summary
Aceva, LLC was cited for marketing Sugar Balance as an unapproved drug by making disease claims on their website and social media platforms, including claims that the product improves insulin sensitivity, enhances blood sugar control, and helps decrease the body's need for insulin. The company violated the Federal Food, Drug, and Cosmetic Act by establishing through their marketing that Sugar Balance was intended for diagnosis, cure, mitigation, treatment, or prevention of disease—specifically diabetes and blood sugar disorders—without obtaining FDA approval as a new drug. The FDA and Federal Trade Commission jointly reviewed Aceva's websites and social media channels (Twitter and Facebook) in August 2021 and determined the product was being introduced into interstate commerce in violation of the Act.