FDA finalizes guidance on declaration of small amounts of nutrients and dietary ingredients on nutrition labels.

  • In August 2015, FDA issued a draft guidance document stating the Agency’s policy on the declaration of small amounts of nutrients and dietary ingredients on nutrition labels.  The draft guidance provided FDA’s recommendations on how to comply with nutrition labeling requirements in cases where the presence of small amounts of nutrients or dietary ingredients creates a conflict between applicable regulatory provisions.
  • FDA recently finalized its guidance on this topic, making only “editorial changes” to the draft, which include updates to the list of nutrients in 21 CFR 101.9(g)(4) and (g)(5), consistent with the recently-issued final rule revising the Nutrition and Supplement Facts labels.
  • For a more detailed summary on the contents of the “small amounts” guidance, click here.  (The alert covers the draft guidance, but as noted above, FDA made no substantive changes).