Supplement Industry Glossary
A plain-language reference for the terms, standards, and certifications you encounter when building a supplement brand. Written for founders and operators, not regulatory attorneys.
Regulatory Terms
cGMP (Current Good Manufacturing Practice)
FDA's mandatory quality standards for supplement manufacturing facilities.
Learn more →21 CFR Part 111
The specific FDA regulation governing dietary supplement manufacturing practices.
Learn more →DSHEA (Dietary Supplement Health and Education Act)
The 1994 law that defines dietary supplements and sets the regulatory framework for the US market.
Learn more →NDI (New Dietary Ingredient)
An ingredient not marketed in the US before October 15, 1994, requiring FDA notification before sale.
Learn more →GRAS (Generally Recognized as Safe)
A safety designation meaning an ingredient is generally recognized as safe for its intended use.
Learn more →FDA Facility Registration
Mandatory registration of food/supplement manufacturing facilities with FDA.
Learn more →Structure/Function Claims
Claims about how a supplement affects body structure or function, allowed without FDA pre-approval.
Learn more →Proposition 65 (California)
California law requiring warnings for products containing chemicals known to cause cancer or reproductive harm.
Learn more →FDA Inspection
An FDA investigator's on-site examination of a manufacturing facility.
Learn more →FDA Warning Letter
A formal FDA communication notifying a company of significant regulatory violations.
Learn more →Certification Programs
NSF International
Independent third-party organization that tests and certifies supplement manufacturing facilities and products.
Learn more →USP (United States Pharmacopeia)
Independent scientific organization that sets quality standards for medicines and supplements.
Learn more →ISO/IEC 17025
International standard for the competence of testing and calibration laboratories.
Learn more →SQF (Safe Quality Food)
GFSI-benchmarked food safety and quality management certification program.
Learn more →GFSI (Global Food Safety Initiative)
Industry body that benchmarks food safety certification schemes for equivalence and rigor.
Learn more →HACCP (Hazard Analysis Critical Control Points)
Systematic approach to identifying and controlling food safety hazards in production.
Learn more →NOP (National Organic Program)
USDA program establishing standards for organic agricultural products in the US.
Learn more →Production Terms
MOQ (Minimum Order Quantity)
The smallest production run a manufacturer will accept for an order.
Learn more →Lead Time
The time from order placement to finished product delivery.
Learn more →Batch Record
A complete documented history of the manufacturing of a specific product batch.
Learn more →Dosage Form
The physical form in which a supplement is delivered (capsule, tablet, powder, etc.).
Learn more →Pilot Run
A small-scale production run to validate a formulation before full manufacturing.
Learn more →Formulation
The specific combination of ingredients, dosages, and form that makes up a supplement product.
Learn more →Supplement Packaging
The containers, closures, and labeling that protect and identify a supplement product.
Learn more →Testing Terms
COA (Certificate of Analysis)
A document reporting test results for a specific batch of ingredients or finished product.
Learn more →Identity Testing
Testing to confirm an ingredient is what the label says it is.
Learn more →Potency Testing
Testing to verify the amount of active ingredients matches label claims.
Learn more →Stability Testing
Testing to determine how long a product maintains potency and safety under storage conditions.
Learn more →Heavy Metals Testing
Testing for toxic metals (lead, mercury, arsenic, cadmium) in supplements.
Learn more →Banned Substance Testing
Testing products for substances prohibited by athletic organizations.
Learn more →Business Terms
Private Label
Pre-made supplement formulas that a brand can sell under its own label.
Learn more →Quality Agreement
A contract defining quality responsibilities between a brand and its contract manufacturer.
Learn more →Ingredient Sourcing
The process of selecting and purchasing raw materials for supplement manufacturing.
Learn more →