For supplement businesses, begin by identifying the facilities that manufacture, process, pack or hold the goods. Food facility registration concerns those activities and locations, rather than a blanket registration of the brand's product catalogue.
Identify the responsible facilities
Map the manufacturer, packer, warehouse and other relevant sites. Ask each responsible business which activities it carries out and whether registration or an exemption applies. Dietary supplements and their components are covered by the food-facility registration framework; see FDA's registration questions and answers.
Keep the facility name, address, responsible contact and supporting confirmation with the product supply record. A reseller should understand which facility facts it holds directly and which it needs from the manufacturer.
Keep product requirements separate
FDA does not grant pre-sale product or label approval for dietary supplements. That does not remove the company's safety, labelling and claims responsibilities. FDA's supplement overview explains that boundary.
Use the FDA industry information hub to identify other relevant topics, such as ingredient and claims submissions. Do not substitute a drug-establishment listing process for a dietary supplement facility review.
Prepare a record for Amazon
Read the exact request before sending documents. Match the facility evidence to the actual manufacturer and product. Keep these separate:
- Facility-registration evidence or the documented exemption basis.
- Product labels, specifications and supplier records.
- Testing or verification evidence requested for the ASIN.
- The marketplace notice and submission response.
A document sold by a service provider should be evaluated for what it proves. Its appearance or wording does not expand the legal meaning of facility registration.
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