In Part I, we saw that FDA treats years-old videos, posts and website claims as current evidence of intended use, so what does that mean for companies that don't make the product at all?
Private label distributors cannot contract out the claims
For companies that do not manufacture anything — who contract out production, packaging and labelling and put their own brand on the finished bottle — the enforcement record offers no shelter.
FDA’s position on own-label and private label distributors is long-settled and stated in near-identical language across many letters.
A distributor that contracts with others to manufacture, package or label dietary supplements released under its own name “has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.”
And “[a]lthough a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce ... is not adulterated.”
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