The words, in the order you meet them

Supplements borrow vocabulary from pharmaceutical manufacturing and from federal regulation, and both arrive in conversations where not knowing a term is expensive.

Regulation

DSHEA. The 1994 Act creating dietary supplements as a category distinct from foods and drugs.

21 CFR 111. The cGMP rule for dietary supplement manufacturing, packaging, labeling and holding. In force for all manufacturers regardless of size since June 2010.

21 CFR 101.36. The Supplement Facts panel rule.

Structure/function claim. A permitted claim about affecting the body's structure or function, requiring substantiation and the DSHEA disclaimer.

Quality unit. The person or function that reviews and approves, required to be independent of production in intent if not always in personnel at small scale.

The powder

Hygroscopic. Absorbs moisture from the air. Describes almost everything in this category.

Bulk density. Weight per unit volume, loose or tapped. The conversion between a scoop and a serving.

Flowability. How readily a powder moves. A dosing variable, not a convenience.

Excipient. A non-active component with a job: flow agent, anticaking agent, carrier.

Blending and dosing

Geometric dilution. Doubling the diluent at each step to distribute a very small component.

Segregation. A uniform blend coming apart because components differ in size, density or shape.

Overage. Formulating above the label claim so the claim holds through shelf life.

Serving size. The declared amount, which must be expressed in a term appropriate to the form.

Testing

Identity testing. Establishing that a component is what it claims to be. The requirement the rule is most insistent about.

Assay. Measuring how much of something is present.

Certificate of analysis. A lot-specific document with methods and numbers.

Reserve sample. A retained sample of a finished batch, held so a later question can be answered by examination.

References