Chill6

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 the product is a drug 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 it is intended for use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Your Chill6 product (all flavors) is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new drug” under section 201(p) of the Act [21 U.S.C. 321(p).

Passage 3

Your Chill6 product (all flavors) is 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.

Passage 4

Even if your Chill6 product, all flavors, was not an unapproved new drug and misbranded drug, it would be adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] because it contains phenibut HCl, an unsafe food additive under section 409(a) of the Act [21 U.S.C. § 348(a)].

Passage 5

Because the definition of dietary supplement states that a dietary supplement is not a product represented as a conventional food, Chill6 is not a dietary supplement [see section 201(ff)(2)(B) of the Act]. Declaring Chill6 to be a dietary supplement is therefore false or misleading and misbrands the product under section 403(a)(1) of the Act.