IndulgeRx Brands, 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 website establish that your 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 FightBack Foods Bravezil Butter, FightBack Foods Inspiration Butter, and FightBack Foods Wellnut Butter are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].

Passage 3

Your FightBack Foods Bravezil Butter, FightBack Foods Inspiration Butter, and FightBack Foods Wellnut Butter 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 product safely for its intended purposes. Accordingly, your FightBack Foods Bravezil Butter, FightBack Foods Inspiration Butter, and FightBack Foods Wellnut Butter 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)].