Ket Plug / ketaminelab.org and buyketaminepowderonline.com

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Based on a review of your website, your ketamine powder is a drug under section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.***4*** Examples from your website labeling that provide evidence of the intended use (as defined in 21 Code of Federal Regulations (CFR) 201.128) of this product as a drug include, but may not be limited to, the following:

Passage 2

Your ketamine powder is a “new drug” under section 201(p) of the FD&C Act (21 U.S.C. 321(p)), because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. No approved drug applications pursuant to section 505 of the FD&C Act (21 U.S.C. 355), are in effect for this product. Accordingly, this product is an unapproved new drug. The introduction or delivery for introduction into interstate commerce of this unapproved new drug product violates sections 301(d) and 505(a) of the FD&C Act.

Passage 3

Your ketamine powder is also misbranded under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)), in that its labeling fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. 353(b)(1)(A)), include those that, because of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. Your ketamine powder is indicated for a condition that is not amenable to self-diagnosis and treatment by a layperson, therefore adequate directions cannot be written such that a layperson can use the product safely for its intended use. In addition, your ketamine powder is also a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act, in light of its toxicity or potential for harmful effects, methods of use, or collateral measures necessary for its use. For these reasons, your ketamine powder is misbranded under section 502(f)(1) of the FD&C Act.