Regulatory framework. Plain-English.
Lumera Labs operates under Canadian law and follows research-chemical industry standards. This page explains how that regulatory framework applies to what we sell.
1. We are not a pharmacy
Lumera Labs Inc. is a supplier of research chemicals. We do not hold a Health Canada Drug Establishment Licence, a U.S. FDA New Drug Application, or any therapeutic-product authorization. The products we sell are not approved drugs, biologics, supplements, or medical devices. They are reference standards intended for in-vitro investigation only.
2. What "Research Use Only" means
Research Use Only ("RUO") is a regulatory classification recognized by Health Canada and the FDA. RUO products:
- Have not been evaluated for safety, efficacy, identity, purity, or quality for human or animal use.
- May not be marketed with claims of therapeutic, diagnostic, or prophylactic benefit.
- May not be sold packaged as a finished drug, dietary supplement, cosmetic, or medical device.
- May not be administered to humans or animals.
3. Why labels and packaging matter
Every Lumera vial ships with a label clearly stating "For laboratory research use only. Not for human consumption." A lot-specific Certificate of Analysis (COA) accompanies each shipment. We supply bacteriostatic water as a separate sterile-filtered research reagent for in-vitro dilution use; we do not pre-bundle it with peptide vials, sell needles or syringes, or assemble dosing kits.
4. Compounding restrictions
Several peptides have been placed on the FDA's Category 2 list (substances nominated for compounding but identified as having significant safety risk). These include — among others — BPC-157, CJC-1295, and Melanotan II. Their inclusion on this list means licensed pharmacies cannot legally compound them into prescription products in the U.S. Their sale as a research chemical is permitted; their use in or sale for human compounding is not.
Health Canada maintains its own list of substances ineligible for pharmacy compounding under provincial pharmacy legislation. Lumera does not authorize, encourage, or facilitate any such use.
5. Marketing constraints
You will not see Lumera marketing copy use any of these terms in connection with our products:
- Treats, cures, prevents, diagnoses any disease or condition
- Bodybuilding, muscle growth, fat loss, weight loss, anti-aging, sexual enhancement, performance enhancement
- Safe to inject, safe to consume, dosage instructions for humans
- Supplement, nutraceutical, cosmeceutical
If you see any of the above on this site, it is an error and we want to know — email lumeralabs@proton.me.
6. Payment processing
Mainstream card processors generally classify research-chemical merchants as high-risk and frequently terminate accounts. Lumera accepts credit cards via a high-risk-friendly processor where available, plus Bitcoin/Monero/USDT through BTCPay Server (self-custodial), and Interac e-Transfer. We disclose this so buyers understand why payment options vary.
7. Quality program
Every lot is independently tested for purity (HPLC), identity (LC-MS), and endotoxin clearance (LAL). Reports are public on the Lab Results page. See the Quality page for the testing protocol.
8. Reporting concerns
Suspected adverse experience involving a Lumera product (despite RUO restriction): email immediately. We log every report.
Suspected counterfeit Lumera product: cross-check the batch number on COA verification. If unmatched, do not use it — contact us.
9. Jurisdictional note
Research-chemical legality varies by jurisdiction. The buyer is responsible for knowing whether ordering, importing, or possessing a given compound is lawful in their location. Lumera ships to Canadian addresses only.
10. Authoritative references
- Health Canada Food and Drugs Act — laws-lois.justice.gc.ca/eng/acts/F-27
- FDA Bulk Drug Substances 503A & 503B lists — fda.gov
- Office of the Privacy Commissioner of Canada — priv.gc.ca