FDA warning letter · Drugs

Phoenix Nutritionals, Inc.

Issued · Posted by FDA

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 that the products High Vitality Full Spectrum Liquid Multi-Vitamin, High Vitality Caps, Best Cholesterol Support, Blood Sugar Support, Maximum Stress Support, Complete Joint Support, Natural Anti-Inflammatory Support, and Best Immune Support 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

Accordingly, High Vitality Full Spectrum Liquid Multi-Vitamin, High Vitality Caps, Best Cholesterol Support, Blood Sugar Support, Maximum Stress Support, Complete Joint Support, Natural Anti-Inflammatory Support, and Best Immune Support 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)].

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.5