Holographic Health, Inc. – FDA Warning Letter, Sep 10, 2021

The FDA issued a Warning Letter to Holographic Health, LLC, after reviewing their website, www.holographichealth.com. The FDA determined that 14 products—Glyco-Well, Pan-Gest, Heart-Line, Aspara-Can, Cherry Gold, H.H.S. Formula, Brain Balance, Passionate Pursuit, Better Mood, Male Prosexual, Ear Well, Pink Lady, Eye-C, and Hemorr-Norm—are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The products are deemed drugs because website claims indicate they are intended for disease cure, mitigation, treatment, or prevention, or to affect body structure/function. Examples of claims include "regulate blood sugar issues" for Glyco-Well, "helpful for regulating the inflammatory response" for Pan-Gest, and "help your system prevent [heart attack and stroke]" for Heart-Line.

Specifically, "Pink Lady" is misbranded as a dietary supplement because it is marketed for topical use, not ingestion. All 14 products are considered "new drugs" as they are not generally recognized as safe and effective for their claimed uses and lack FDA approval. Introducing these unapproved new drugs into interstate commerce violates the FD&C Act.

Furthermore, Glyco-Well, Pan-Gest, Heart-Line, Aspara-Can, Cherry Gold, H.H.S. Formula, Brain Balance