FDA issues guidance on production of exempt infant formula.

• In 2014 — 17 years after the initial proposed rule was issued — FDA finalized its rulemaking related to the manufacture of infant formula.  However, the rule does not apply to facilities that manufacture “exempt infant formula,” defined by law as an infant formula which is represented and labeled for use by an infant with an inborn error of metabolism, low birth weight, or who otherwise has an unusual medical or dietary problem.  FDA indicated its intent to address requirements for exempt infant formula in a separate rulemaking.

• In April 2016, FDA issued final guidance on exempt infant formula production.  In the guidance, FDA recognizes that exempt infant formulas may need to be manufactured differently than non-exempt infant formulas due to the specific medical needs that exempt infant formulas are intended to meet.  However, FDA concludes by recommending that manufacturers of exempt infant formulas comply with the 2014 final rule to the extent practicable in the production of their products.

• According to FDA, as of March 2016, only 5 infant formula manufacturers produce exempt formulas marketed in the U.S.  Of those companies, only 1 produces solely exempt infant formula in its facilities.  Although FDA’s final guidance on exempt infant formula may not directly affect many entities, it is nevertheless likely to garner attention and interest, especially as it relates to ensuring the safety and nutritional quality of a sole-source food for a particularly vulnerable population.