Herbal Vitality, Inc.

Warning LetterOpen

United StatesFEI 3010632980Issued Mar 7, 2023Division of Human and Animal Food Operations West IV

View Letter

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 3010632980.

Violations4

Issue DateMar 7, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Herbal Vitality, Inc.
Location: United States
FEI Number: 3010632980
Country: United States
Issue Date: March 07, 2023
Issuing Office: Division of Human and Animal Food Operations West IV
Product Type: Drugs
Status: Open

Summary

Herbal Vitality, Inc. was cited for manufacturing and distributing unapproved new drugs and misbranded drugs, including 21 herbal products such as Acute Kidney Stone Relief, Children's Antibiotic Formula, Hepatitis C Formula Glycerite, and Lung Tonic COPD that made disease claims in their labeling and product catalog. The FDA's inspection of their Sedona, Arizona facility from July 11-15, 2022 determined that these products were intended for the cure, mitigation, treatment, or prevention of disease based on their names and marketing claims, thereby violating the Federal Food, Drug, and Cosmetic Act as unapproved drugs requiring FDA approval before marketing.

Herbal Vitality, Inc. FDA Warning Letter, March 7, 2023