FDA released a pre-publication version of its long-awaited New Dietary Ingredients guidance today, and early industry reactions have pinpointed four particular areas of concern: sections of the document dealing with the use of solvents in extracts (especially supercritical CO2 fluid extraction), nanotechnology, the status of synthetic botanicals and a provision that could result in multiple NDI filings were cited.

"Welcome to the brave new world of real dietary supplement ingredients," said Michael McGuffin, president of the American Herbal Products Association (AHPA). "I'm not going to pretend I've read every word, but it's an interesting combination of what we've thought all along. It provides true guidance."

The United Natural Products Alliance noted a few examples of the "big issues arising out of this watershed document":

  • Many common manufacturing changes to existing NDIs or ODIs trigger a new NDI status.
  • Changing solvents will usually trigger NDI status.
  • Synthetic dietary ingredients are not dietary supplements at all. They have been kicked out of the dietary supplement category.
  • You must describe how the combination of all the ingredients in your formula relate to the history of safe use of the dietary supplement.
  • You should address bioavailability of the ingredients as formulated.