Holographic Health, Inc.

Warning LetterOpen

Theodore Baroody President Holographic Health, Inc. 516 E. Market Street Kingsport , TN 37660 United StatesFEI 3005100089Issued Sep 10, 2021Division of Human and Animal Food Operations East V

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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 3005100089.

Violations1

Issue DateSep 10, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Holographic Health, Inc.
Location: Theodore Baroody President Holographic Health, Inc. 516 E. Market Street Kingsport , TN 37660 United States
FEI Number: 3005100089
Country: United States
Issue Date: September 10, 2021
Issuing Office: Division of Human and Animal Food Operations East V
Product Type: Drugs
Status: Open

Summary

Holographic Health, Inc. was warned for marketing 13 dietary supplement products as unapproved drugs by making disease claims on their website without proper FDA authorization. The company violated the Federal Food, Drug, and Cosmetic Act by claiming their products could regulate blood sugar, treat pancreatic issues, reduce inflammation, and treat celiac disease—statements that established the products as drugs under FDA regulations rather than dietary supplements. These marketing claims for products including Glyco-Well, Pan-Gest, Heart-Line, and others indicated intent to cure, mitigate, or treat diseases, which requires FDA approval before the products can be legally sold.

Holographic Health, Inc. FDA Warning Letter, September 10, 2021