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FDA Publishes Fortification Policy Guidance

On November 6, 2015, the U.S. Food and Drug Administration (FDA) published a guidance document regarding FDA’s fortification policy.  FDA allows manufacturers to fortify (add nutrients to) certain food products in order to:

  • correct a dietary insufficiency;
  • restore nutrient levels to those prior to storage, handling, and processing (FDA says if you restore one essential nutrient, you should restore all);
  • provide a balance of vitamins, minerals, and protein in proportion to the total caloric content of the food; or
  • prevent nutrient inferiority in a food that replaces a traditional food in the diet.

FDA’s fortification policy has not changed since it was published in 1980.  This new guidance is intended to remind manufacturers of the policy and answer commonly asked questions. Below are a few key points from the guidance.

What nutrients are covered by FDA’s fortification policy?

FDA’s fortification policy covers all essential nutrients that have been assigned Reference Daily Intakes (RDIs) under 21 CFR 101.9(c)(8)(iv).  The policy also covers protein and potassium. See the chart below for a list of nutrients covered by FDA’s fortification policy.

 

What foods are covered by FDA’s fortification policy?

FDA’s fortification policy applies to certain conventional human foods.  It does not apply to dietary supplements, animal food or infant formula.

May any conventional food be fortified?

FDA does not consider it appropriate to fortify:

  • Fresh produce
  • Meat, poultry, or fish products
  • Sugars
  • Snack foods, including carbonated beverages. This includes unsweetened, low fat, and fat free snack foods.
  • Alcoholic Beverages

Fortifying inappropriate foods can lead to regulatory action.  In April 2015, the Attorney General issued a warning letter to Snap Infusion LLC for marketing its product SmartCandy as a “vitamin infused snack.”  In October 2015, two women filed a class action lawsuit against Welch Foods for allegedly fortifying its fruit snacks with vitamins.

Is fortification voluntary?

Fortification of conventional human foods is voluntary unless required by an FDA standard of identity. FDA standards of identity mandate required and optional ingredients a product may contain to be marketed in the U.S. under a certain name.  Some standards of identity require that a product be fortified with a certain ingredient. For example, the standard of identity for margarine requires that vitamin A be added.

It’s important to be aware that there are labeling requirements for certain voluntarily fortified foods. For example, salt may be fortified with iodine, but it is not required. However, salt fortified with iodine must be called “iodized salt” or “iodized table salt.” Packaging of salt that is not fortified with iodine must include the statement “This salt does not supply iodide, a necessary nutrient”.

How may I indicate that I have fortified a food?

For standardized foods, manufacturers must use the term defined in the standard of identity. “For example, you cannot substitute the term ‘fortified flour’ for ‘enriched flour’,” FDA says in its guidance.

For non-standardized foods, manufacturers can use the following terms interchangeably: “added,” “enriched,” “extra,” “fortified,” “more,” and “plus”.

Registrar Corp’s Label and Ingredient Review Specialists are familiar with FDA’s fortification policy and can help food manufacturers:

  • Determine whether it is appropriate or required to fortify their food products
  • Ensure fortified food labels are in compliance with U.S. FDA regulations

When reviewing your label, Registrar Corp will also check for proper formatting, a compliant Nutrition Facts Chart, and more. For questions or assistance with U.S. FDA fortification and labeling regulations, contact Registrar Corp at +1-757-224-0177.  Live help is available 24 hours a day at www.registrarcorp.com/livehelp.





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