Adverse eventAE
- Any unwanted medical occurrence in someone taking a supplement, whether or not it is causally related. Vitamet logs every AE we hear about, reports serious ones to FDA within fifteen days as required, and reviews trends quarterly.
Beyond-use dateBUD
- The date after which a compounded or individualized product should no longer be used. Set based on stability data for the formulation, the container, and the storage conditions. For most of our dry capsule formulas the BUD is 18 months from fill.
Bioavailability
- The fraction of an ingested ingredient that actually reaches systemic circulation in a usable form. Bioavailability depends on the chemical form, the dose, the meal context, and the individual. It is often quoted as a single number; it is rarely a single number.
Certificate of AnalysisCOA
- A document from a lab or supplier attesting to what is in a specific lot of material, identity, potency, contaminants. A COA is only as good as the lab that issued it and the chain of custody behind the sample. Ask for the lab name. Ask whether the sample was pulled by the supplier or by an independent party.
Chelation
- Binding a mineral ion to an organic molecule (often an amino acid like glycine) so that it survives stomach acid and is absorbed in the small intestine. Magnesium glycinate is a chelate. Magnesium oxide is not. Chelated forms are generally better absorbed and gentler on the gut.
cGMPCurrent Good Manufacturing Practice
- The set of FDA regulations under 21 CFR Part 111 that dietary supplement manufacturers must follow, covering identity testing, batch records, employee training, facility cleanliness, and complaint handling. cGMP is the floor, not the ceiling.
DSHEADietary Supplement Health and Education Act
- The 1994 U.S. law that defines dietary supplements as a category of food rather than drugs. DSHEA is why supplement labels carry the "not intended to diagnose, treat, cure, or prevent" disclaimer and why supplements are not FDA-approved.
FDA-registered
- Means the manufacturer has filed a one-page facility registration with FDA, as required for any food facility. It is not a quality mark. It is not approval. It does not mean inspected. See our journal entry on this.
Form 483
- The form an FDA inspector issues at the end of an inspection if they observed conditions that may violate the Food, Drug, and Cosmetic Act. A facility that has never received a 483 is either very clean or very new. Vitamet has not received a 483 since our 2024 inspection.
Identity testing
- Confirming, before a raw material is used, that it actually is what the supplier says it is. Required under cGMP. Done via FTIR, HPLC, or other analytical methods depending on the material. "We trust our supplier" is not identity testing.
Lot
- A specific run of a specific product made under the same conditions from the same raw material lots. Every Vitamet bottle has a lot number printed on the label. Lots of one are still lots.
Master formula
- The controlled document describing exactly how a product is to be made, ingredients, weights, equipment, in-process checks. Required for every formulation under 21 CFR Part 111. We generate one for every individualized formula at the moment of order.
Proprietary blend
- A list of ingredients on a supplement label that gives a total weight but not the individual amounts. Legal under DSHEA. Tells you almost nothing about what you are taking. Vitamet does not use proprietary blends.
Standardization
- Processing a botanical extract until a specified active compound is present at a known percentage, for example, ashwagandha standardized to 5% withanolides. Standardization makes dosing reproducible. It does not, by itself, mean the extract is high quality.
USPUnited States Pharmacopeia
- A non-governmental organization that publishes monographs, testing standards, for drug and supplement ingredients. "USP grade" means the ingredient meets the USP monograph for identity, purity, and strength. We require USP-grade actives wherever a monograph exists.
X-list
- Our internal list of ingredients we will not formulate with, regardless of demand. Some are on the list because the safety data is poor. Some are on the list because the supply chain is untrustworthy. The list is published on our Quality page and updated quarterly.