Lipotriad 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 and your social media establish that the 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 Lipotriad Visionary, Lipotriad Adult 50, Lipotriad Dry Eye, and Lipotriad Vision Support Plus products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)].

Passage 3

Your Lipotriad Visionary, Lipotriad Adult 50, Lipotriad Dry Eye, and Lipotriad Vision Support Plus products are intended for prevention of one or more diseases that are not amenable to selfdiagnosis 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, Lipotriad Visionary, Lipotriad Adult 50, Lipotriad Dry Eye, and Lipotriad Vision Support Plus 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)].