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Five Questions to Consider Before Fortifying Foods

In November 2015, the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) released new guidance on fortification of foods.[1] The purpose of the guidance document is to help the food industry better understand and comply with the fortification policy for various food products. In this article, we focus on five important elements of the updated guidance, providing additional information to help clarify FDA’s fortification policy.

  1. Is my fortification in the food product a rational addition?

The fundamental purpose of FDA’s regulation on food fortification is to emphasize rational addition of nutrients in foods. But what is a rational addition and what is not? As the new guidance summarizes, fortification should be performed to 1) correct a dietary insufficiency or meet a demonstrated health need; 2) restore nutrient levels to those prior to storage, handling, and processing; 3) provide a balance of vitamins, minerals, and protein in proportion to the total caloric content of the food; and 4) prevent nutrient inferiority in a food that replaces a traditional food in the diet.1 The guidance states that you cannot fortify fresh produce, meat, poultry or fish products, sugars or snack foods such as cookies, candies, cakes, chips, or carbonated or alcoholic beverages. FDA mentions a few examples of rational additions, such as adding folic acid to enriched grain products to prevent neural tube deficiency or adding calcium to soy beverages because it is a reasonable vehicle to provide calcium to people who do not drink milk. The guidance should have further explained the “reasonable vehicle” concept to preempt fortification of unreasonable vehicles. While the document clearly states that carbonated beverages or snack foods such as cookies, candies, cakes, and chips cannot be fortified, it makes no mention of FDA’s stance on fortification of tea, coffee or snack bars, leaving it up to the manufacturer to produce a convincing, science-based rationale as to why fortification of these foods should be permitted.

  1. Is it appropriate for a particular nutrient to be added to the food product?