Supplement Science Corp. d/b/a Condemned Labz

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 are drugs under section 201(g)(1)(B) of 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

Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Arsyn, ConvictStim, Humaslin, Thyrogenic, and DNA Dispatch 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)].

Passage 3

To the best of FDA’s knowledge, there is no information demonstrating that higenamine was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered.

Passage 4

In fact, the available evidence underscores higenamine’s potential for serious cardiotoxic effects. In the absence of adequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury, dietary supplements containing higenamine are adulterated under section 402(f)(1)(B) of the Act [21 U.S.C. 342(f)(1)(B].

Passage 5

Your Arsyn product is adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)] because 2-aminoisoheptane HCl, hordenine HCl, and higenamine HCl are unsafe food additives under section 409(a) of the Act [21 U.S.C. 348(a)].

Passage 6

Your ConvictStim product is adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)] because 2-aminoisoheptane HCl is an unsafe food additive under section 409(a) of the Act [21 U.S.C. 348(a)].