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Supplement supplier vs manufacturer: who does what?

A supplement supplier is the business supplying your order; it may make the product itself or arrange production elsewhere. To identify the manufacturer, ask for the legal entity and address of the site doing the production, plus the work each subcontractor performs.

Map the actual operations

FDA’s CGMP guidance distinguishes manufacturing, packaging, labeling, holding and distribution operations. Start your due diligence by asking who performs each operation. An office address or sales contact alone does not identify the production facility.

FDA: dietary supplement CGMP guidance

Read the label relationship correctly

21 CFR 101.5 requires qualifying wording when the business named on the label is not the manufacturer, such as wording indicating distribution or manufacture for another firm. The label can identify the responsible commercial relationship without naming every production site.

eCFR: 21 CFR 101.5

Write the responsibilities into the agreement

Our purchasing recommendation is to list each production, packing, testing and storage site; who approves changes; and who supplies records when a complaint arises. Check certification at the actual site and scope, then ask how any subcontracted operations are controlled.

NSF: facility certification listings

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