Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The 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 2Accordingly, 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