Immune & Genetics Protocols, LLC

Selected passages from the FDA letter

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

Passage 1

The claims on your website establish that Immune Bio Green Cell is a drug under section 201(g)(1)(B) of the Food, Drug, Cosmetic Act (the Act), [21 U.S.C 321(g)(1)(B)] because it is intended for the use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Your Immune Bio Green Cell product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)].

Passage 3

Your Immune Bio Green Cell product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, the product fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].

Passage 4

We do not have any records that your facility is registered with FDA. Your Immune Bio Green Cell product appears to be labeled as a dietary supplement. Under section 201(ff) of the Act (21 U.S.C. § 321(ff)), a dietary supplement and a component of a dietary supplement are “foods.” Section 415 of the Act (21 U.S.C. § 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA unless the facility qualifies for an exemption from registration (21 CFR 1.226).