Peaks Curative, LLC dba Peaks

Selected passages from the FDA letter

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

Passage 1

The compounded semaglutide products displayed on your website identify “Peak Now” on the pictured label, suggesting Peak Now is the compounder of those drugs when in fact it is not.

Passage 2

Compounded drug products are not FDA-approved. Your claims imply that your products have been FDA-approved or otherwise evaluated for safety and effectiveness when they have not.

Passage 3

This FDA-approved treatment promotes safe, effective weight loss, helping you reduce up to 20% of your body weight and maintain long-term results.

Passage 4

Clinically proven to aid in significant weight loss in overweight adults.

Passage 5

Safe, affordable, and effective.

Passage 6

The compounded products offered on PeaksCurative.com use FDA approved active pharmaceutical ingredients (API).

Passage 7

Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.

Passage 8

The introduction or delivery for introduction into interstate commerce of these misbranded products is a prohibited act under section 301(a) of the FDCA [21 U.S.C. § 331(a)].