Supplement Industry Glossary
Plain-English definitions of the acronyms, regulatory terms, and manufacturing jargon every health product brand founder needs to know.
A
Active Ingredient
- The constituent in a supplement that produces the intended biological or physiological effect. The creatine in a creatine product, the vitamin D3 in a bone-health formula, the EPA/DHA in a fish-oil softgel. Everything else on the ingredient list (fillers, binders, flow agents, coatings) is technically an excipient. Regulators judge finished product safety and efficacy primarily by the identity, dose, and quality of the active ingredient.
B
Bioavailability
- The proportion of an ingested active ingredient that actually reaches systemic circulation and is available to produce a physiological effect. Higher bioavailability means more of the labeled dose is actually usable by the body. Formulation decisions (chelated mineral forms, liposomal encapsulation, emulsified delivery, micronization) are often made specifically to improve bioavailability. Which can justify premium pricing when supported by comparative data.
C
Certificate of Analysis (COA)(COA)
- A document issued by the manufacturer or a third-party laboratory verifying that a specific batch of raw material or finished product meets its specifications. Identity, potency, purity, and safety (heavy metals, microbial, pesticide residues, etc.). A COA accompanies every legitimate ingredient shipment and every finished product batch. As a brand founder, you should review COAs before accepting a batch from your manufacturer. ISO 17025-accredited third-party COAs are the gold standard because they demonstrate impartiality.
CFU (Colony Forming Units)(CFU)
- The standard unit for quantifying the number of live, viable microorganisms in a probiotic product. Probiotic labels typically list potency in billions of CFU (e.g., 10 billion CFU per capsule). Because probiotics lose viability over shelf life, manufacturers typically add a CFU overage of 25–50% above label claim to guarantee potency through the expiration date. CFU should always be specified at time of consumption rather than time of manufacture.
cGMP (Current Good Manufacturing Practices)(cGMP)
- The US FDA's quality regulations for dietary supplement manufacturing, codified in 21 CFR Part 111. cGMP requires documented procedures for identity testing, batch records, quality control, facility sanitation, employee training, and complaint handling. The 'current' prefix signals that the standards evolve over time. In Canada, the equivalent concept is GMP under the Natural Health Products Regulations. Every reputable supplement facility in North America should be cGMP compliant. Non-compliance is the single biggest reason the FDA issues warning letters to the industry.
Custom Formulation
- A supplement formula developed from scratch for a specific brand, versus using an existing stock or private label recipe. Custom formulations give the brand full intellectual property ownership and complete control over ingredient selection, dosing, and positioning. But typically require an 8–16 week development cycle, higher MOQs, and investment in stability testing. Best suited for brands with differentiated positioning who want a genuinely unique product.
D
Delivery Form
- The physical format in which a supplement is consumed. Capsule, tablet, softgel, powder, gummy, liquid, stick pack, chewable, lozenge, or functional beverage. Delivery form affects consumer compliance, cost, stability, dose size, manufacturing complexity, and regulatory review. A single active ingredient often has multiple viable delivery forms, and the right choice depends on the target consumer, dose volume, palatability, and shelf-life requirements.
Disease Claim
- A statement that a product diagnoses, treats, cures, mitigates, or prevents a disease. Disease claims are prohibited on supplement labels and marketing in both the USA and Canada. Making one turns your supplement into an unapproved drug in the eyes of the regulator. The line between a legal structure-function claim ('supports healthy immune function') and an illegal disease claim ('prevents colds') is one of the most important distinctions every founder needs to get right.
DSHEA (Dietary Supplement Health and Education Act)(DSHEA)
- The 1994 US federal law that established dietary supplements as a distinct product category under FDA oversight, separate from food and drugs. DSHEA defined what counts as a dietary supplement, set rules for permissible structure-function claims, established the New Dietary Ingredient (NDI) notification process, and gave the FDA authority to act against unsafe products. It is the foundational statute every US supplement brand operates under.
E
Excipient
- An inactive ingredient used in a supplement formulation. Binders, fillers, flow agents, disintegrants, lubricants, coatings, colors, flavors, preservatives. Excipients are necessary to manufacture a stable, consistent finished product, but they are not the source of the labeled physiological benefit. Modern 'clean label' formulations attempt to minimize or eliminate excipients, which can be a marketing differentiator but also raises manufacturing complexity and cost.
F
FDA (Food and Drug Administration)(FDA)
- The US federal agency responsible for regulating dietary supplements under DSHEA. The FDA does not pre-approve supplements before market. Instead, it monitors product safety post-market through adverse event reports, facility inspections, warning letters, and enforcement actions. Brands selling in the USA must register their facilities with the FDA, follow cGMP, and stay within structure-function claim rules. Compare with Health Canada, which does pre-approve natural health products before sale.
Finished Product
- A supplement in its final, consumer-ready form. The bottled capsules, the pouch of powder, the gummy jar, the stick pack carton. Finished product specifications (identity, potency, appearance, microbial, heavy metal, shelf-life) are distinct from the specifications of any single raw ingredient. Regulators, retailers, and quality auditors all test against the finished product's spec sheet, which is the brand's source of truth.
G
GMP (Good Manufacturing Practice)(GMP)
- A quality management system for manufacturing, testing, and documenting supplement production. In the USA, the specific term is cGMP (21 CFR Part 111). In Canada, GMP for natural health products is enforced under Health Canada's NHPR. GMP certification requires documented procedures, trained personnel, controlled environments, batch-level traceability, and ongoing audits. A brand should never work with a facility that is not GMP-certified.
H
Health Canada
- The Canadian federal department responsible for regulating natural health products through the Natural and Non-prescription Health Products Directorate (NNHPD). Unlike the US FDA, Health Canada pre-approves natural health products before they can be sold, issuing each approved product a Natural Product Number (NPN). Health Canada also licenses manufacturers, importers, and packagers through a Site Licence.
I
Ingredient Overage (Potency Overage)
- The practice of formulating above label claim to compensate for expected potency loss during shelf life. Different actives degrade at different rates. Vitamin C may require a 20% overage, probiotics may need 50% or more, and stable minerals may need none. Overages should be determined by stability data, not guesswork, and documented in the master manufacturing record.
Intellectual Property (IP)(IP)
- The legal ownership of a formula, brand name, label design, or proprietary process. For supplement brands, the most important IP asset is typically the formula itself. Custom formulations developed for a brand should transfer full IP ownership to the brand; private label and white label arrangements do not convey formula IP. Clear IP ownership terms should be written into every manufacturing and formulation agreement before work begins.
ISO 17025
- The international standard for the competence of testing and calibration laboratories. A COA issued by an ISO 17025-accredited lab carries significantly more weight than one from an unaccredited or in-house facility, because the accreditation demonstrates impartiality, method validation, and technical competence. Retailers (Amazon, Whole Foods, Costco) and cautious consumers increasingly demand ISO 17025-backed test results for key product claims.
M
Monograph
- A pre-cleared Health Canada document that specifies accepted ingredients, doses, combinations, and claims for a specific natural health product category (e.g., the Multi-Vitamin/Mineral Supplement monograph, the Joint Health Products monograph). Filing an NPN application against an existing monograph is faster and cheaper than submitting a full Class III application because the safety and efficacy of the combination is already accepted by Health Canada.
MOQ (Minimum Order Quantity)(MOQ)
- The smallest production run a manufacturer will accept. Typically expressed in units (e.g., 1,000 bottles), bulk weight (e.g., 50 kg of powder), or batch value. MOQs exist because every production run has fixed setup, cleaning, and documentation costs. Lower MOQs mean easier market testing but higher per-unit cost; higher MOQs mean better economics but more upfront capital. LumaNutra's network supports MOQs starting at 1,000 units for most common dosage forms.
N
NDI (New Dietary Ingredient)(NDI)
- Under US DSHEA, a dietary ingredient that was not marketed in the USA before October 15, 1994. Brands using an NDI must submit a pre-market notification to the FDA at least 75 days before selling the product, including safety data. The NDI notification process is one of the most complex compliance areas in US supplements and is especially relevant for newer ingredients like NMN and some standardized botanicals.
NHP (Natural Health Product)(NHP)
- The Canadian regulatory category covering vitamins, minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics, amino acids, and essential fatty acids sold as supplements. NHPs are regulated by Health Canada under the Natural Health Products Regulations (NHPR), which is stricter than the US DSHEA framework. NHPs must receive an NPN license before they can be sold in Canada.
NPN (Natural Product Number)(NPN)
- An eight-digit identifier issued by Health Canada to each approved natural health product, printed on the product label as 'NPN XXXXXXXX'. The NPN signals to retailers and consumers that Health Canada has reviewed the product's safety, efficacy, and quality. Every NHP sold in Canada must carry an NPN. Application paths include Class I (monograph-based, fastest), Class II (combination monographs), and Class III (full review, longest). Typical approval timelines range from 60 days to over a year depending on the submission class.
P
Private Label
- A business model where a brand sells an existing manufacturer-owned formula under its own brand name and label. Private label offers fast time-to-market, low upfront cost, and low MOQs. But the brand does not own the formula and cannot claim exclusivity. Ideal for founders testing a market, adding SKUs quickly, or operating with limited capital. Contrast with custom formulation, where the brand owns the IP.
S
Shelf Life
- The length of time a supplement remains within its specifications (potency, identity, appearance, microbial safety) under defined storage conditions. Shelf life claims must be supported by stability studies. You cannot simply print a date on the label. Typical supplement shelf lives range from 18 to 36 months, depending on active stability and packaging barrier properties.
Site Licence
- A Health Canada authorization issued to facilities that manufacture, package, label, or import natural health products into Canada. A Site Licence is separate from an NPN (which authorizes a specific product) and is a prerequisite for legally producing or importing NHPs. Manufacturers without a valid Site Licence cannot produce Canadian-market product, even if the formula itself has an NPN.
Stability Testing
- Scheduled analytical testing of a finished product over time to verify that potency, identity, and quality remain within specification across the claimed shelf life. Stability studies are run under controlled temperature and humidity conditions (often both real-time and accelerated). Data from stability testing supports label claims, sets ingredient overages, and establishes shelf-life dating. Required under cGMP and for NPN applications with new combinations.
Structure-Function Claim
- A statement describing how an ingredient affects normal structure or function of the human body. 'supports healthy joints', 'helps maintain normal immune function', 'supports muscle recovery'. Structure-function claims are the permitted claim category for US supplements under DSHEA (with required disclaimer) and for Canadian NHPs with monograph coverage. They are legally distinct from disease claims, which are prohibited. Crafting compliant structure-function language is one of the most important skills in supplement marketing.
T
Third-Party Testing
- Analytical testing performed by an independent laboratory (not owned by the manufacturer or brand) to verify identity, potency, purity, or contaminant levels of a supplement. Third-party testing (especially by ISO 17025-accredited labs) is increasingly demanded by premium retailers, Amazon's quality programs, and informed consumers. Certifications like NSF, USP Verified, and Informed Sport are all built on third-party testing frameworks.
Turnkey Launch
- A go-to-market approach where a single partner coordinates every step of launching a supplement (formulation, regulatory, manufacturing, packaging, design, compliance, fulfillment, and in some cases marketing) so the brand founder does not have to assemble the full vendor stack themselves. LumaNutra operates on a turnkey model specifically to eliminate the coordination burden that typically overwhelms first-time founders.
W
White Label
- Similar to private label but typically with fewer customization options. A manufacturer offers a fixed catalog of finished products that any brand can apply its own label to, with minimal changes to formula, packaging, or dosage. White label is the fastest and cheapest way to launch, but it also provides the least differentiation. Useful for testing a category before committing to custom work.
Need help navigating the jargon?
LumaNutra handles the regulatory, manufacturing, and compliance side so you can focus on building your brand. Tell us about your product and we'll walk you through what applies to you.