Supplement fulfillment glossary
27 terms every supplement brand should know.
- 21 CFR Part 111
- The FDA regulation that sets current good manufacturing practice (cGMP) requirements for firms that manufacture, package, label or hold dietary supplements. It includes requirements for holding and distributing finished product and for handling returned supplements.
- Advance shipping notice (ASN)
- A document sent before an inbound shipment that lists the contents, often including SKU, lot number, expiration date and quantity per carton or pallet. It lets receiving verify rather than discover.
- Best-by date
- A date that indicates when a product is expected to be at its best quality. Some supplement brands use best-by dates instead of expiration dates.
- Certificate of analysis (COA)
- A document from a manufacturer or lab reporting test results for a specific lot, such as identity, potency and contaminant testing. Retailers and marketplaces sometimes request COAs.
- cGMP
- Current good manufacturing practice. For dietary supplements, the cGMP requirements in 21 CFR Part 111 cover manufacturing, packaging, labeling and holding operations.
- Desiccant
- A moisture-absorbing packet or canister placed in supplement containers, commonly with capsules, tablets and probiotics, to limit humidity exposure.
- Dimensional weight
- A carrier pricing method based on package volume. Carriers bill the greater of actual weight and dimensional weight, which often affects light, bulky supplement shipments.
- Disposition
- The final decision on what happens to held inventory, such as release to stock, destruction or return to the manufacturer. Decisions should be documented with lot and quantity.
- DSHEA
- The Dietary Supplement Health and Education Act of 1994, the federal law that defines dietary supplements and established much of the framework for how they are regulated in the U.S.
- Expiration date
- The date after which a brand does not guarantee the product's quality or potency. FDA does not require expiration dates on supplements, but if a brand uses one it should be supported by data.
- FDA food facility registration
- Registration with the FDA required for most facilities that manufacture, process, pack or hold food for consumption in the U.S., which includes dietary supplements. Registration must be renewed every two years.
- FEFO
- First expired, first out. An inventory rotation method that picks the units with the earliest expiration date first, regardless of when they were received.
- FIFO
- First in, first out. A rotation method that picks the oldest received inventory first. It can ship the wrong units when lots do not arrive in expiration order.
- Induction seal
- A foil liner heat-sealed to the mouth of a bottle under the cap. It provides tamper evidence and helps protect product from moisture and air.
- Kitting
- Assembling multiple items into one sellable unit or bundle, such as a starter pack, variety box or subscription kit, before or during order fulfillment.
- Lot number
- A code that identifies a specific production batch. Recording lot numbers on receiving and on each order lets a brand trace which customers received which batch.
- Market withdrawal
- A firm's removal or correction of a product involving a minor issue that would not be subject to FDA legal action, such as a quality concern without a safety risk.
- Material review
- A documented quality review of product that may not meet specifications, such as returned supplements, leading to a disposition decision like destroy, rework or release.
- Minimum remaining shelf life
- The shortest time to expiration a unit can have and still be shipped to a specific channel or customer. Retailers and marketplaces often set their own minimums.
- MoCRA
- The Modernization of Cosmetics Regulation Act of 2022, which applies to cosmetics rather than supplements. Brands selling both supplements and topical beauty products should know which rules apply to each line.
- Prop 65
- California's Proposition 65, which requires businesses to provide warnings for products that can cause exposure to listed chemicals above certain levels. It is a common compliance topic for supplements sold to California consumers.
- Quarantine
- A designated hold status or area that keeps product out of sellable inventory until a disposition decision is made. Commonly used for returns, damaged goods and lots under review.
- Recall
- A firm's removal or correction of a marketed product that FDA considers to be in violation of the laws it administers. Lot-level records make it possible to target specific batches rather than all inventory.
- Serious adverse event report
- A report of a serious adverse event associated with a dietary supplement. The manufacturer, packer or distributor named on the label must submit serious adverse event reports to FDA.
- Softgel
- A soft gelatin or plant-based capsule that holds a liquid or oil fill, such as fish oil. Softgels can stick together or deform when exposed to heat.
- Structure/function claim
- A label claim describing how a nutrient or ingredient affects the body's structure or function. Such claims require an FDA notification and a specific disclaimer on the label.
- Supplement Facts panel
- The required nutrition labeling panel on dietary supplements that lists serving size, dietary ingredients and amounts per serving. Label content is the brand's responsibility.