Supplement, NHP or Drug: Where the Line Sits
Classification follows the claim and the market, not the molecule.
Regulatory and Program Standards
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Vegalab is a delivery technology and formulation partner. This section sets out the rules that decide what a partner can lawfully make with our platform, and the standards we apply when selecting programs.
Product classification
The supplement, natural health product and drug page sets out how the same molecule can be a lawful dietary ingredient in one market, a licensed natural health product in another, and an unapproved drug in a third. It covers the US new dietary ingredient notification route, the Canadian natural health product license, EU food supplement and novel food rules, and the point at which a claim rather than a molecule creates a drug. Classification is the first question in any feasibility scope, because it determines the evidence and the label.
Peptides and sport
The peptide regulatory status page explains why most peptides circulating in the wellness market have no approved human use, how compounding lists and research-chemical labeling work, and why an unapproved status is not a gap to be exploited. The anti-doping page covers the World Anti-Doping Code, including the non-approved substances clause that captures compounds with no regulatory approval anywhere, and the growth factor and secretagogue categories relevant to partners who serve athletes.
Program standards
Our program standards are written down so partners can see the fit before the first call. Vegalab takes on approved-molecule reformulation, licensed supplement and natural health product development, cosmetic and veterinary formats, and preclinical support for qualified sponsors, each with a defined regulatory pathway and claims the evidence supports. The page also lists the questions we ask before a feasibility agreement is signed.
Key facts
- A dietary supplement claim that a product treats, prevents or cures disease makes it an unapproved drug in the US (21 U.S.C. 321(g); 21 CFR 101.93)
- Natural health products sold in Canada require a product license and NPN before sale (Natural Health Products Regulations, SOR/2003-196)
- The WADA Code prohibits any pharmacological substance with no current approval by any governmental regulatory health authority for human therapeutic use (WADA Prohibited List, section S0)
- FDA maintains a list of bulk drug substances that may present significant safety risks in compounding, and the list is revised over time (FDA, Certain Bulk Drug Substances for Use in Compounding, current revision)
How our delivery technology applies
Delivery work is regulated by what the finished product claims, not by the carrier. Because a multi-layer particle can be filled into a supplement capsule, a cosmetic base or a licensed medicine, we scope the regulatory pathway before the formulation, so the encapsulation design matches the evidence the partner can actually generate for that market.
Tell us your target market and claim, and we will map the pathway before we formulate.
Peptide Regulatory Status
Peptides fall into four regulatory buckets: approved medicines, investigational drugs in a sponsored trial, lawful ingredients in a specific market, and compounds with no approved human use anywhere.
Sport and Anti-Doping
If a partner's product will be used by competitive athletes, anti-doping status is a formulation constraint, not a footnote.
Program Standards
Vegalab is a delivery technology and formulation partner, and our program standards are set out in advance so partners can see the fit before the first call.
More Than One Door to Approval
Many young life sciences companies plan around one regulator, usually the FDA.