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FDA Clarifies Fortification Policy in New Guidance

Nov 18, 2015

The Food and Drug Administration released earlier this month a guidance document that clarified the recommendations of its fortification policy for food and beverages. In a series of questions and answers, FDA provided additional information and examples of what the agency would considers foods that may be fortified, what nutrients would fall under the fortification policy and what levels may be added.

FDA’s fortification policy was originally issued in 1980 and published in the Code of Federal Regulations, setting recommendations for the appropriate fortification of conventional foods, including dairy products.

“Since so many dairy foods, including milk, yogurt, cheese and some frozen desserts, are fortified, dairy processors should be aware of this new guidance,” said Michelle Matto, IDFA’s consultant on nutrition and labeling. “The fortification policy deals with a variety of situations, so not all parts of the policy will apply to all fortified foods. That means companies should consider the food, nutrient and reason for fortifying the product to determine which portions of the fortification policy will apply.”

According to Matto, companies that produce most conventional foods should follow the fortification policy; the exceptions are fresh produce, meat, poultry, fish, sugars and snack foods, which are not considered appropriate for nutrient fortification. The guidance defines “snack foods” as “foods that are not naturally nutrient dense” and identifies cookies, candies, cakes, chips and some beverages as examples.

Essential vitamins and minerals that are either mandatory or voluntary nutrients for declaration in the Nutrition Facts panel, along with protein and potassium, may be added to conventional foods under the fortification policy. Nutrients that do not have a Daily Value defined in regulation, such as omega-3s or lycopene, would not fall under the fortification policy.

In its guidance, FDA recommends that companies should consult the upper intake levels set by the Institute of Medicine to ensure that their products are not over-fortified.

The guidance also provided additional information on “fortified” and “enriched” claims that might be appropriate for food products that fall under the fortification policy.

For more details, read “Guidance for Industry: Questions and Answers on FDA’s Fortification Policy.”

Members with questions may contact Matto at

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