There is often misinformation floating around the elderberry entrepreneur community that needs some clarification. Is the FDA actually approving a fruit that’s turned into a product to eat/drink, essentially saying that it’s generally regarded as safe? Or, is the FDA providing regulatory guidelines that makers are following? For instance, has the maker…

  • Received confirmation from the FDA that their facility and/or scheduled process has been accepted into their database (happens automatically upon submission)?
  • Submitted paperwork when moving from a food to a supplement and received confirmation?
  • Received a confirmation that their labels were accepted as meeting requirements?
  • Passed an FDA-specific inspection because they are marketing as a supplement and/or are making <$500k in revenue?
For most elderberry syrup makers, when they are working with a local or state inspector, they must register their food facility with the agency in order to officially receive their license. If they are acidified food, they must also register their product on the FDA website.
This does mean that the FDA has approved them, simply they’re declaring to the agency that they exist and that they’ve filled out the proper paperwork (and it’s been received). The same goes for a select few that make over a specific revenue and thus trigger an FDA inspection.

If the elderberry syrup maker is not claiming themselves as food, but as a supplement, there is slightly more paperwork to fill out which may or may not also include an FDA inspection. In either case, it’s a registration process and not an approval process.

In no case, at the time of this blog post, has the FDA ever approved elderberry as part of the GRAS standard nor have they regulated it.

Those nuances matter!

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