Supplement industry glossary
Plain-English definitions of the acronyms, regulatory terms, and manufacturing jargon every health product brand 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.
Allergen Control
- The procedures a facility uses to prevent unintended allergen cross-contact, covering ingredient segregation, production scheduling, cleaning validation between runs, and testing. It determines what a label can honestly claim, since a free-from statement rests on the facility's controls rather than on the recipe alone.
B
Batch Record
- The complete manufacturing document for a single production run. It records the formula used, the lot numbers of every raw material, equipment and line settings, in-process checks, any deviations, and who signed off at each step. GMP requires one for every batch, and it is the primary evidence an auditor or a recall investigation works from. If a problem surfaces six months after shipping, the batch record is what identifies which lots were affected.
Bilingual Labeling
- Canadian natural health product labels must present every required element in both English and French. That covers the product name, medicinal and non-medicinal ingredients, recommended use, dose, risk information, and storage conditions. Health Canada enforces this, and it drives real design decisions because two languages need roughly twice the label area on the same container.
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.
Blister Pack
- Packaging that seals individual doses into formed cavities backed with foil or film. Blisters protect moisture-sensitive products better than a bottle once opened, make dose counting obvious, and support tamper evidence. They cost more per unit than bottling and are more common in practitioner, clinical, and export presentations than in retail supplements.
C
Certificate of Analysis(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 owner, 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.
Certificate of Free Sale(CFS)
- A document issued by a government authority confirming that a product is legally sold in its country of origin. Importing authorities and overseas distributors commonly require one before clearing a supplement shipment. It is one of several documents an export buyer will ask for alongside a certificate of analysis and proof of GMP compliance.
CFU(Colony Forming Units)
- 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 to 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)
- 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.
Chewable Tablet
- A tablet formulated to be chewed rather than swallowed whole, which means the formula has to carry flavour, sweetness, and an acceptable mouthfeel alongside the actives. Chewables suit children's products and anyone who struggles with capsules. Bitter or high-dose actives are the usual constraint, because there is a limit to how much taste masking a chewable base can carry.
Child-Resistant Closure
- A cap designed to be difficult for young children to open, usually a push-and-turn or squeeze-and-turn mechanism. It is required for products where accidental ingestion carries real risk, iron-containing supplements being the common example, and is worth specifying voluntarily for high-potency products aimed at households with children.
Class I, II, and III Applications
- Health Canada sorts natural health product licence applications into three classes by how much review the evidence needs. Class I applications match an existing monograph exactly and clear fastest. Class II applications use a monograph with modifications. Class III applications cover novel ingredients, novel combinations, or claims outside any monograph, and require a full evidence package assembled by the applicant. The class you fall into is usually the largest single variable in a Canadian launch schedule.
CMO and CDMO
- Contract Manufacturing Organization and Contract Development and Manufacturing Organization. A CMO manufactures to a specification you supply. A CDMO also develops the formula, which usually means in-house R&D, prototyping, and stability work. The distinction matters when you have an idea rather than a finished formula, because a pure CMO will expect you to arrive with one.
Co-Packer
- A facility that fills and finishes product manufactured somewhere else. Bulk product arrives, and the co-packer bottles or pouches it, applies labels, and cartons it for shipment. Because manufacturing and packaging sit with separate vendors, the bulk product moves between them and quality responsibility is handed over with it. Where packaging runs inside the same facility that manufactured the product, that transfer and the second quality handoff both disappear.
Compendial and Non-Compendial
- A compendial application uses ingredients, doses, and claims that already appear in a Health Canada monograph, so the supporting evidence is pre-accepted and review moves faster. A non-compendial application falls outside the monographs and requires the applicant to submit the full evidence package themselves, whether clinical, traditional-use, or pharmacopoeial. Non-compendial submissions take longer and are refused more often, usually because the evidence package is thin.
Contract Manufacturer
- A facility that manufactures finished products for other brands rather than selling under its own name. The brand owns the product and the customer relationship; the manufacturer runs production to an agreed specification. Contract manufacturers vary widely in what else they take on, from formulation and regulatory support through to packaging and testing, so scope has to be established rather than assumed.
Contract Packaging
- Filling, labeling, and cartoning a supplement into its retail presentation. Contract packaging covers the primary container that holds the product, the label applied to it, and any secondary carton or shipper. When it runs as part of the production run, what ships is retail-ready goods rather than bulk product and a separate packaging problem to solve.
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 to 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 brand owner needs to get right.
DSHEA(Dietary Supplement Health and Education Act)
- 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)
- 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.
Fulfillment
- Storing finished goods and shipping them to customers, retailers, or marketplaces. Fulfillment sits after manufacturing and packaging, and it is a separate capability from making the product. Some of our US manufacturing partners can hold and ship finished goods directly. Canadian distribution runs through a dedicated third-party logistics partner.
G
GMP(Good Manufacturing Practice)
- 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.
Gummy
- A chewable confection format carrying actives in a pectin or gelatin base. Gummies sell well because they are pleasant to take, but they are among the least forgiving formats to formulate. Active loading is limited, heat and humidity affect stability, sugar or sugar alcohol content has to be managed, and potency can drift over shelf life, which is why overages and stability testing matter more here than in most formats.
H
Halal Certification
- Verification by a certifying body that ingredients and production meet Islamic dietary requirements. As with kosher, the usual issues for supplements are animal-derived gelatin, glycerin, and processing aids, plus alcohol used in extraction. It opens specific export markets and retail channels where certification is expected rather than optional.
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.
Heavy Metals Testing
- Laboratory analysis measuring lead, arsenic, cadmium, and mercury in raw materials or finished product. Botanicals, minerals, and marine ingredients carry the highest risk because they concentrate what was in the soil or water. Testing is required for GMP compliance, and results also determine whether a product needs a Proposition 65 warning for California.
HS Code
- The Harmonized System code that classifies a product for customs. Every international shipment needs one, and it determines duty rates and which import rules apply. Supplements can fall under different codes depending on composition and presentation, and an incorrect code is a common cause of shipments being held at the border.
I
Identity Testing
- Analysis confirming a raw material is actually what the supplier says it is, using methods such as HPLC, mass spectrometry, or DNA barcoding for botanicals. It is a GMP requirement for incoming materials and the main defense against economically motivated adulteration, which is a live risk in botanical extracts where a cheaper species or a spiked filler can pass a basic potency check.
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)
- 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.
K
Kosher Certification
- Verification by a certifying agency that ingredients, equipment, and production practices meet Jewish dietary law. For supplements the usual points of attention are gelatin, glycerin, stearates, and enzymes, along with shared equipment. Certification applies to the facility as well as the formula, so it has to be planned before production rather than added afterward.
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)
- 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 2,000 units for most common dosage forms.
N
NDI(New Dietary Ingredient)
- 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)
- 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.
NNHPD(Natural and Non-prescription Health Products Directorate)
- The Natural and Non-prescription Health Products Directorate, the branch of Health Canada that reviews natural health product licence applications and issues NPNs. It also maintains the monographs that compendial applications are filed against, and sets the labeling requirements Canadian products have to meet.
Non-GMO Project Verified
- A third-party certification confirming a product has been evaluated for compliance with the Non-GMO Project standard, including ingredient testing and supply chain traceability. It is a voluntary marketing claim rather than a regulatory requirement, and it carries weight in natural retail channels where buyers screen for it.
NPN(Natural Product Number)
- 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.
O
Organic Certification
- Third-party verification that ingredients and manufacturing meet an organic standard, most commonly USDA Organic in the United States and the Canada Organic Regime under the CFIA. Certification covers the facility as well as the inputs, so a product can only be labeled organic if it was made in a certified facility. The two schemes recognize each other under an equivalency arrangement, which matters for products sold on both sides of the border.
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 brands entering a category, adding SKUs quickly, or managing capital carefully. Contrast with custom formulation, where the brand owns the IP.
Proposition 65
- A California law requiring warning labels on products that expose consumers to listed chemicals above set thresholds. It applies to any supplement sold to California consumers regardless of where it was manufactured, and heavy metals are the usual trigger for supplements. Practical compliance means testing to Proposition 65 thresholds and carrying the required warning where a listed substance sits at or above its safe harbor level.
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.
Softgel
- A one-piece sealed capsule with a flexible gelatin or plant-based shell, filled with a liquid or semi-solid. Softgels suit oils and fat-soluble actives that dissolve poorly in powder form, and they mask taste and odor well. They need specialized equipment, so minimum runs are usually higher than for two-piece capsules.
Specification
- The written definition of what a product or raw material must be: the actives and their amounts, physical characteristics, acceptable ranges, test methods, and limits for contaminants. Everything downstream references it. The manufacturer produces to it, quality control tests against it, and a certificate of analysis reports results relative to it. Disagreements late in a project usually trace back to a specification nobody pinned down at the start.
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.
Stick Pack
- A narrow single-serve sachet holding a powder or liquid, designed to be torn open and poured. Stick packs suit hydration, greens, and on-the-go formats where a scoop and tub would be impractical. They usually carry among the highest minimum runs of any format because of the filling equipment involved, though minimums vary by facility.
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
Tamper-Evident Seal
- Packaging that shows visible evidence if a container has been opened, typically an induction seal under the cap or a shrink band around the closure. Tamper evidence is expected on supplements in both the US and Canadian markets and is a standard part of the packaging specification rather than an upgrade.
Third-Party Logistics(3PL)
- An outside company that warehouses your inventory and ships orders on your behalf. A 3PL typically handles receiving, storage, pick and pack, carrier selection, and returns. Brands use one to avoid holding stock themselves and to reach customers faster from regional warehouses. LumaNutra's Canadian distribution runs through a 3PL partner.
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 owner 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 in-house teams.
U
Unit Cost
- The all-in cost of one finished, packaged unit, covering actives, excipients, the capsule or container, the label, the carton, and the labour to run it. Unit cost falls as run size rises, because setup, cleaning, and changeover are spread across more units. That relationship is why minimum order quantity and unit cost get discussed together. Comparing quotes on unit cost alone misleads unless each quote covers the same scope.
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.