Inventory Ready

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.

21 CFR Part 111

The specific FDA regulation governing dietary supplement manufacturing practices.

DSHEA (Dietary Supplement Health and Education Act)

The 1994 law that defines dietary supplements and sets the regulatory framework for the US market.

NDI (New Dietary Ingredient)

An ingredient not marketed in the US before October 15, 1994, requiring FDA notification before sale.

GRAS (Generally Recognized as Safe)

A safety designation meaning an ingredient is generally recognized as safe for its intended use.

FDA Facility Registration

Mandatory registration of food/supplement manufacturing facilities with FDA.

Structure/Function Claims

Claims about how a supplement affects body structure or function, allowed without FDA pre-approval.

Proposition 65 (California)

California law requiring warnings for products containing chemicals known to cause cancer or reproductive harm.

FDA Inspection

An FDA investigator's on-site examination of a manufacturing facility.

FDA Warning Letter

A formal FDA communication notifying a company of significant regulatory violations.

Form 483 (FDA Observations)

A document listing conditions an FDA investigator observed during a facility inspection that may violate regulations.

FSMA Section 204 (Food Traceability Rule)

FDA traceability rule for foods on the Food Traceability List (FTL). Most supplements are exempt.

OAI (Official Action Indicated)

FDA's most serious inspection classification, indicating a facility is in an unacceptable state of compliance.

Food Contact Substance (FCS)

Any substance intended for use as a component of materials in contact with food, regulated by FDA through Food Contact Notifications.

Child-Resistant Packaging (PPPA)

Packaging that meets CPSC standards to prevent children under 5 from accessing hazardous contents, required for iron supplements.

Food Contact Notification (FCN)

FDA's pre-market notification process for new food contact substances, specific to the manufacturer and intended use.

21 CFR Part 111 Subpart G (Packaging/Labeling Operations)

The specific Part 111 regulations governing packaging and labeling operations for dietary supplements.

Master Manufacturing Record (MMR)

Written specification for how every batch of a finished supplement is to be made, required by 21 CFR §111.205.

Certification Programs

NSF International

Independent third-party organization that tests and certifies supplement manufacturing facilities and products.

USP (United States Pharmacopeia)

Independent scientific organization that sets quality standards for medicines and supplements.

ISO/IEC 17025

International standard for the competence of testing and calibration laboratories.

SQF (Safe Quality Food)

GFSI-benchmarked food safety and quality management certification program.

GFSI (Global Food Safety Initiative)

Industry body that benchmarks food safety certification schemes for equivalence and rigor.

HACCP (Hazard Analysis Critical Control Points)

Systematic approach to identifying and controlling food safety hazards in production.

NOP (National Organic Program)

USDA program establishing standards for organic agricultural products in the US.

SQF Storage & Distribution

GFSI-benchmarked food safety certification for storage/distribution with a public site-specific directory.

BRCGS Storage & Distribution

GFSI-benchmarked certification for storage/distribution operations with site-specific ratings (AA+ through D).

Accreditation Scope

The specific test methods, analytes, and matrices a lab is accredited to perform.

ILAC MRA (Mutual Recognition Arrangement)

International framework that makes lab accreditation recognized across borders.

Production Terms

MOQ (Minimum Order Quantity)

The smallest production run a manufacturer will accept for an order.

Lead Time

The time from order placement to finished product delivery.

Batch Record

A complete documented history of the manufacturing of a specific product batch.

Dosage Form

The physical form in which a supplement is delivered (capsule, tablet, powder, etc.).

Pilot Run

A small-scale production run to validate a formulation before full manufacturing.

Formulation

The specific combination of ingredients, dosages, and form that makes up a supplement product.

Supplement Packaging

The containers, closures, and labeling that protect and identify a supplement product.

Lot Tracking

The system for tracing every unit of product back to the specific production batch it came from.

Shelf Life

The period during which a supplement maintains its labeled potency and safety under stated storage conditions.

Bioavailability

The proportion of an ingredient that enters the bloodstream and is available for biological activity.

Excipient

A non-active ingredient added to a supplement for manufacturing, stability, or delivery purposes.

FEFO (First Expired, First Out)

An inventory rotation method where products with the earliest expiration dates ship first.

Label Reconciliation

The process of accounting for all labels issued vs used vs destroyed during a production run, required under Part 111.

Testing Terms

COA (Certificate of Analysis)

A document reporting test results for a specific batch of ingredients or finished product.

Identity Testing

Testing to confirm an ingredient is what the label says it is.

Potency Testing

Testing to verify the amount of active ingredients matches label claims.

Stability Testing

Testing to determine how long a product maintains potency and safety under storage conditions.

Heavy Metals Testing

Testing for toxic metals (lead, mercury, arsenic, cadmium) in supplements.

Banned Substance Testing

Testing products for substances prohibited by athletic organizations.

Proficiency Testing (PT)

External evaluation where labs test unknown samples to demonstrate measurement accuracy.

Chain of Custody (Laboratory)

Documented tracking of a sample from receipt through testing to disposal.

Dry Labbing

Fabricating or falsifying laboratory test results without performing the actual analysis.

Method Validation

Demonstrating that a testing method produces reliable results for its intended purpose.

Measurement Uncertainty

The range within which a test result's true value lies, reported alongside results.

HPTLC (High-Performance Thin-Layer Chromatography)

Identity-testing technique that compares a botanical sample's chromatographic fingerprint against a reference standard.

HPLC (High-Performance Liquid Chromatography)

Standard analytical method for separating, identifying, and quantifying compounds in dietary supplements.

Business Terms

Ingredient Supplier Role Classification

A supplier's role (manufacturer, processor, distributor, broker) determines what quality evidence they can provide.

Private Label

Pre-made supplement formulas that a brand can sell under its own label.

Quality Agreement

A contract defining quality responsibilities between a brand and its contract manufacturer.

Ingredient Sourcing

The process of selecting and purchasing raw materials for supplement manufacturing.

HTS Code (Harmonized Tariff Schedule)

A standardized numerical code that classifies imported goods for customs duties.