Peak Performance Peptides

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.

Passage 2

GLP-3R is a synthetic peptide under investigation for its potential effects on metabolic regulation, body weight management, and glycemic control.

Passage 3

Semaglutide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist studied for its potential effects on glucose regulation, appetite control, and metabolic health.

Passage 4

SS-31 (Elamipretide) is a mitochondria-targeted peptide studied for its potential to reduce oxidative stress, improve mitochondrial function, and support cellular energy production.

Passage 5

PT-141 is a synthetic peptide studied for its potential effects on sexual arousal and neuroendocrine regulation.

Passage 6

Tesamorelin is a synthetic growth hormone–releasing hormone (GHRH) analog studied for its role in stimulating endogenous growth hormone secretion and regulating metabolic pathways.

Passage 7

The sale of these products together demonstrates that you intend for your “Bac water” to be used in combination for injection. Therefore, your “Bac water” is a drug.