Jonathan Jewett
Chief Executive Officer
American Global Health Group, LLC
11808 Northup Way, Suite W105
Bellevue , WA 98005
United StatesFEI 3006138272Issued Jan 22, 2021Division of Human and Animal Food Operations West VI
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 3006138272.
Violations1
Issue DateJan 22, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
American Global Health Group, LLC
Location
Jonathan Jewett
Chief Executive Officer
American Global Health Group, LLC
11808 Northup Way, Suite W105
Bellevue , WA 98005
United States
FEI Number
3006138272
Country
United States
Issue Date
January 22, 2021
Issuing Office
Division of Human and Animal Food Operations West VI
Product Type
Drugs
Status
Open
Summary
American Global Health Group, LLC was cited for marketing AloeCure brand products (VeraFlex, Advanced Formula Capsule, Pure Aloe Vera Extract, and Probiotic + Enzyme) as unapproved new drugs through their website and Facebook page. The company made disease claims including that products could reduce joint discomfort, improve mobility, and decrease inflammation by blocking inflammatory enzymes, which established the products as drugs under the Federal Food, Drug, and Cosmetic Act without required FDA approval or proper drug labeling. These marketing claims on www.aloecure.com and the company's social media violated federal law by introducing misbranded drug products into interstate commerce without authorization.
American Global Health Group, LLC FDA Warning Letter, January 22, 2021