PekCura Labs

Selected passages from the FDA letter

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

Passage 1

No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Passage 2

Despite statements on your product labeling marketing your products for “Research, [sic] Development [sic] use only” and “are Not [sic] for Human [sic] consumption of any kind,” evidence obtained from your website establishes that your products are intended to be drugs for human use.

Passage 3

Your firm offers “Bacteriostatic Water” for sale alongside peptide products, which are drugs intended for injection and require reconstitution, including the above-mentioned products. The sale of these products together demonstrates that you intend for your “Bacteriostatic Water” to be used in combination for injection. Therefore, your “Bacteriostatic Water” is a drug.