Seller record · Telehealth service

NewSelf

By Paul Harris, Standards EditorRecorded September 2026 · Standard v1.1 · How checks are performed

Fails 2 of 8 criteria. S3, pharmacy identification: No filling pharmacy is named. The home page refers to 503A state-licensed pharmacy partners, and the terms say a preferred pharmacy may be used unless the patient names another. 1 more criterion also fails; see the table below.

At a glance

NewSelfTelehealth service

6/8criteria passed
Price
Semaglutide $99.97 a month, tirzepatide $144.49, at every dose
Sells
compounded semaglutide with B12 or glycine, and 1 more
FDA letters
1 on file
Visit NewSelfSee all eight dispositions

Telehealth service. Passes 6 of 8 criteria. Recorded against Standard v1.1.

A telehealth weight loss service selling compounded semaglutide and tirzepatide blends at one price for every dose, on a three-month commitment, with care from an affiliated network of medical corporations. Care starts with a short online questionnaire, no pharmacy is named, and an FDA warning letter names its operating company.

Operating entity NewSelf Limited LLC

Dispositions

CodeCriterionDispositionWhere it appears
S1Prescriber requirementPASSNewSelf's website; NewSelf's semaglutide page
S2Prescription gatingPASSNewSelf's website; NewSelf's semaglutide page; NewSelf's tirzepatide page
S3Pharmacy identificationFAILNewSelf's website; NewSelf's terms of use page; NewSelf's returns and refund page
S4Compounding disclosurePASSNewSelf's website
S5Analytical documentationFAILNewSelf's website; NewSelf's GLP buyer guide page
S6Business addressPASSNewSelf's website; NewSelf's terms of use page
S7Price disclosurePASSNewSelf's semaglutide page; NewSelf's tirzepatide page; NewSelf's returns and refund page
S8Enforcement statusPASSFDA's website; FDA warning letter 721472

Evidence, criterion by criterion

The evidence behind each disposition in the table above, where it appears, and its date.

S1PASSMedical treatment is provided by the NewSelf affiliated professional corporations, and the home and product pages say board-certified doctors review each questionnaire and meet the patient by telehealth before a prescription, with independent providers handling all medical services.Source: NewSelf's website; NewSelf's semaglutide page.
S2PASSThe home and product pages list a free short questionnaire to pre-qualify as the first step, then a telehealth doctor, then shipping, and every buy now and start button points to that same online visit. The product pages promise a full refund if the doctor declines.Source: NewSelf's website; NewSelf's semaglutide page; NewSelf's tirzepatide page.
S3FAILNo filling pharmacy is named. The home page refers to 503A state-licensed pharmacy partners, and the terms say a preferred pharmacy may be used unless the patient names another.Source: NewSelf's website; NewSelf's terms of use page; NewSelf's returns and refund page.
S4PASSThe home page states beside the prices that the medications are compounded drugs prepared by licensed pharmacies, that compounded drugs are not FDA-approved, and that they have not been evaluated by the FDA for safety or effectiveness.Source: NewSelf's website.
S5FAILNo certificate of analysis or lot document is published. The home page and the buyer guide say every batch is third-party tested, with no report behind the claim.Source: NewSelf's website; NewSelf's GLP buyer guide page.
S6PASSNewSelf Limited LLC at 30 N Gould St, Ste R, Sheridan, WY 82801, printed in the footer of every page. The terms name Georgia law, with arbitration in San Diego under California law.Source: NewSelf's website; NewSelf's terms of use page.
S7PASSCompounded semaglutide at $99.97 a month and compounded tirzepatide at $144.49 a month, the same price at every dose with no membership fee. The refund policy says the weight loss programs require a three-month commitment with three months of medication sent up front, and canceling before three months costs the full monthly price of the program.Source: NewSelf's semaglutide page; NewSelf's tirzepatide page; NewSelf's returns and refund page.
S8PASSFDA warning letter 721472, February 2026, names NewSelf Limited doing business as NewSelf at a New York, New York address the site itself does not publish, and it reviewed the seller's own website. It alleges that pictured labels identify NewSelf as the compounder of its semaglutide and tirzepatide products when it is not, and that claims of the same active ingredient as Ozempic, Wegovy, Mounjaro and Zepbound, with questions about their FDA-approved uses, present the compounded products as FDA-approved. No FDA action has halted the business, and the seller still trades.Source: FDA's website; FDA warning letter 721472.

Products shown on the seller's own pages at the recorded date: compounded semaglutide with B12 or glycine, compounded tirzepatide with B6 or glycine.

Other sellers of the same products

Who sells semaglutideWho sells tirzepatide

Enforcement documents on file: 1 warning letter

FDA warning letter 721472, issued February 2026, to NewSelf Limited dba NewSelfPictured labels identify NewSelf as the compounder of semaglutide and tirzepatide products when it is not, and claims of the same active ingredient as Ozempic, Wegovy, Mounjaro and Zepbound, with questions about their FDA-approved uses, present the compounded products as FDA-approved when they are not.

A warning letter alleges violations and requests a response. It does not halt a business, and it does not remove a seller from this ledger. Every letter recorded here.

Visit NewSelf

Dispositions recorded against Standard v1.1. Method and null semantics: how checks are performed. This record is not a review and contains no medical advice.