FDA issues Q&A guidance on food fortification policy.

  • Since 1980, FDA has had a formal fortification policy for foods, codified in 21 CFR 104.20.  The policy provides a series of guiding principles regarding the conditions under which FDA views the addition of essential nutrients to foods as appropriate.
  • FDA has issued a guidance document (in Q&A format) to address questions about the existing food fortification policy.  The guidance does not change FDA’s policy, but provides clarifications and consolidates information about the fortification principles into a single document.  As before, FDA considers it inappropriate to fortify certain foods, such as fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages.
  • FDA’s fortification policy can be a source of confusion for food processors.  Although the policy is codified in FDA regulations, compliance is mandatory only where a company wishes to make a “more” claim (including “more,” “fortified,” “enriched,” “added,” “extra,” and “plus”) or a “healthy” claim (including related terms).  This is because the nutrient content claim regulations that govern “more” claims (21 CFR 101.54(e)) and “healthy” claims (21 CFR 101.65(d)(iv)) specify that where nutrients are added to the food to achieve the 10% level required to support the claim, such fortification must be done in accordance with FDA’s fortification policy.  FDA enforces the fortification policy by issuing Warning Letters where marketed foods bearing “more” or “healthy” claims contain nutrient additions that are inconsistent with the official policy.  In all other cases, FDA “strongly encourages” companies to follow the fortification guidelines.