Applied Health Solutions, Inc.

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 websites establish these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Your Applied Health Solutions brand products B Complex, Daily Detox, CellRenewPRO, CellRenewSTS, and the NutriBiotic brand products Grapefruit Seed Extract CapsulesPlus and Grapefruit Seed Extract Liquid Concentrate are 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 products safely for their intended purposes. Accordingly, the B Complex, Daily Detox, CellRenewPRO, CellRenewSTS, Grapefruit Seed Extract CapsulesPlus, and Grapefruit Seed Extract Liquid Concentrate products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].

Passage 3

Examples of the website claims that establish the intended use of the products as drugs include, but may not be limited to, the following: