Regulatory Watch
June 2025: FDA raids Amino Asylum warehouse; website goes offline, operations cease Feb 2025: FDA declares semaglutide shortage resolved — compounding exception ends Sept 2025: FDA issues 50+ warning letters to GLP-1 compounders; DOJ involvement confirmed Nov 2025: Alabama obtains TRO against GLP-1 distributors — first state-level injunctive relief Sept 2023: FDA moves BPC-157, TB-500, and 15 other peptides to Category 2 — compounding prohibited Dec 2024: PCAC votes against allowing compounding of ipamorelin, MK-677, CJC-1295, AOD-9604 Jan 2025: FDA eliminates Category 2/3 system; prohibited substances remain prohibited Feb 2026: STAT News: 35 of 36 BPC-157 studies are animal-only from single lab with undisclosed conflicts 2025: Chinese peptide imports to US double to $328M; online peptide advertising up 678% since 2022 June 2025: FDA raids Amino Asylum warehouse; website goes offline, operations cease Feb 2025: FDA declares semaglutide shortage resolved — compounding exception ends Sept 2025: FDA issues 50+ warning letters to GLP-1 compounders; DOJ involvement confirmed Nov 2025: Alabama obtains TRO against GLP-1 distributors — first state-level injunctive relief Sept 2023: FDA moves BPC-157, TB-500, and 15 other peptides to Category 2 — compounding prohibited Dec 2024: PCAC votes against allowing compounding of ipamorelin, MK-677, CJC-1295, AOD-9604 Jan 2025: FDA eliminates Category 2/3 system; prohibited substances remain prohibited Feb 2026: STAT News: 35 of 36 BPC-157 studies are animal-only from single lab with undisclosed conflicts 2025: Chinese peptide imports to US double to $328M; online peptide advertising up 678% since 2022

LVLUP Health

lvluphealth.com ↗
Founded: 2020 HQ: Queensland, Australia Last reviewed: February 20, 2026
D+
Overall Grade
Transparency 40/100
Testing 45/100
Pricing 50/100
Reputation 40/100
Compliance 35/100
Publishes COA No
Third-Party Testing No
FDA Warning Letters 0
Product Types oral-capsule

Company Overview

LVLUP Health was founded in 2020 by Kyal Van Der Leest (nutritionist/naturopath) in Queensland, Australia. The company specializes exclusively in oral peptide formulations, typically combining multiple peptides with botanical ingredients in single products.

Products & Pricing

ProductFormatKey IngredientsNotable
Ultimate GI RepairCapsulesBPC-157 + KPV + GHK-CuMulti-peptide gut formula
WolverineCapsulesBPC-157 arginate + TB4-FragmentRecovery/regeneration
Neuro RegenerateCapsulesDihexa + P21Nootropic/neuroregeneration

Critical Concerns

Highly experimental compounds: Some LVLUP products contain Dihexa and P21 — compounds with extremely limited published research and essentially no human safety data. Dihexa is a synthetic angiotensin IV analogue studied in animal models for cognitive enhancement; P21 is a CNTF-derived peptide fragment. Including these in consumer products pushes beyond even the usual grey-market risk envelope.

No FDA oversight: As an Australian company, LVLUP falls under TGA jurisdiction, not the FDA. The TGA has been aggressive about peptide enforcement — Peptide Clinics Australia received a $10M penalty, and Evolution Supplements received $12M. Whether TGA has examined LVLUP specifically is not clear from available records.

Transparency Assessment

Score: 40/100 — No publicly available COAs. No named testing laboratory. No BBB listing (expected for Australian company). Limited ability for US consumers to verify quality claims.

Testing & Quality

Score: 45/100 — No evidence of third-party testing documentation accessible to consumers.

Regulatory Standing

Score: 35/100 — Scam Detector trust index of 52.5/100 (moderate-to-low). No FDA oversight. Products containing Dihexa and P21 raise additional regulatory questions. The Australian TGA’s aggressive enforcement posture against peptide companies creates ongoing compliance risk.

Customer Experience

Score: 40/100 — Trustpilot shows approximately 11 mixed reviews with shipping and customs complaints — expected for an international vendor but a practical concern for US buyers. Customs seizure is a real risk for Australian peptide imports to the US.

Red Flags

  1. Dihexa and P21: Extremely experimental compounds with negligible human safety data in consumer products
  2. Scam Detector 52.5/100: Below-average trust score
  3. International shipping risk: Customs seizure possible for peptide imports
  4. No COAs or named testing labs
  5. No US regulatory oversight: FDA cannot act against Australian vendors
  6. Very young company (2020): Limited operational track record

The Bottom Line

LVLUP Health’s product formulations are more adventurous than most — multi-peptide combinations with botanical additives — but the inclusion of highly experimental compounds like Dihexa and P21 crosses a risk threshold that should give consumers pause. The absence of any verifiable quality documentation, combined with a below-average trust score and international shipping complications, makes this a higher-risk vendor choice. The fact that the founder is a naturopath rather than a pharmacologist or chemist doesn’t necessarily reflect on product quality, but consumers should understand the formulation expertise behind what they’re taking.