Answers · Updated

Choosing a nutritional ingredients supplier: the compliance checks to run first

Short answer

Before approving a nutritional ingredients supplier, check four things: whether the supplier or ingredient appears in FDA recall enforcement reports, whether your Foreign Supplier Verification Program file for an imported ingredient is complete (hazard analysis, supplier evaluation and verification under 21 CFR 1.504 to 1.506), and for EU products whether the ingredient is a novel food under Regulation (EU) 2015/2283 and whether the vitamin or mineral form is permitted under Regulation (EC) No 1925/2006. Then compare quotes on landed cost, lead time and delivery reliability with a weighted scorecard.

Checks in order

  • Recall history: search FDA enforcement reports for the ingredient and the supplier name; note the recall class, reason and date.
  • FSVP file (US importers): confirm the hazard analysis, the documented supplier evaluation and approval, the verification activity and a reevaluation within the last 3 years.
  • EU novel food status: screen the ingredient list against the Union list logic of Regulation (EU) 2015/2283.
  • Vitamin and mineral forms (EU): confirm the chemical form is on the permitted list of Regulation (EC) No 1925/2006 and note any restricted substances.
  • Commercial fit: score quotes on landed cost across incoterms, lead time, delivery reliability and payment terms.

Finding candidate suppliers

The supplier search check covers an index of contract manufacturers and ingredient suppliers in DACH, Poland and the Netherlands. It is a directory being built, so a supplier missing from it has not been indexed yet; it says nothing about their quality.

Sources

Frequently Asked Questions

What should I check before approving a nutritional ingredients supplier?
Recall history in FDA enforcement reports, a complete FSVP file if you import the ingredient into the US, and for EU products the novel food status and the permitted vitamin or mineral form. Then compare commercial terms on a weighted scorecard.
Do I need an FSVP for imported nutritional ingredients?
Usually yes: 21 CFR Part 1 Subpart L applies to food imported into the United States, with exemptions listed in 21 CFR 1.501 and modified requirements for dietary supplements and their components in 21 CFR 1.511.
How do I know if an ingredient is a novel food in the EU?
An ingredient not consumed to a significant degree in the EU before 15 May 1997 is a novel food under Regulation (EU) 2015/2283 and needs authorisation on the Union list. The novel food check screens ingredient names against that logic and the EU Novel Food Catalogue.

Not legal advice. fmcg.network returns facts and the sources behind them; your team makes the call.