Holographic Health, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your “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” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, [21 U.S.C. § 321(p)].

Passage 2

Your “Glyco-Well,” “Pan-Gest,” “Heart-Line,” “Aspara-Can,” “Cherry Gold,” “H.H.S. Formula,” “Brain Balance,” “Passionate Pursuit,” “Better Mood,” “Male Prosexual,” “Ear Well,” and “Pink Lady,” products are misbranded within the meaning of section 502(f)(1) of the FD&C Act, [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use.

Passage 3

“Pink Lady” does not meet the definition of a dietary supplement under section 201(ff)(2)(A)(i) of the FD&C Act, [21 U.S.C. 321(ff)(2)(A)(i)]. Only products that are intended solely for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body through the skin or mucosal tissues are not intended for ingestion.