When is it Inappropriate to Fortify a Snack Food?January 8, 2009
By Ricardo Carvajal –
On December 10, 2008, FDA issued a warning letter contending that the Coca-Cola Company’s Diet Coke Plus product violates FDC Act section 403(r)(1)(A) because it fails to comply with regulations that govern the use of the nutrient content claim “plus.” Nutrient content claims characterize the level of a nutrient in a food, and typically are authorized via FDA's issuance of a regulation. According to the agency, use of the term “plus” in conjunction with the phrase “Diet Coke with Vitamins & Minerals” constitutes a nutrient content claim that must meet the regulatory requirements in 21 CFR 101.54(e). Among other criteria, that regulation requires that the fortification be “in accordance with the policy on fortification of foods in 21 CFR 104.20.” Section 104.20 states in part that FDA “does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify. . . snack foods such as candies and carbonated beverages.” To our knowledge, this is the first time that FDA has included a citation to section 104.20 in a warning letter.
As noted in section 104.20, the rationale for the fortification policy rests on FDA’s concern that “random fortification of foods could result in over- or under-fortification in consumer diets and create nutrient imbalances in the food supply.” Such fortification “could also result in deceptive or misleading claims for certain foods.” As further explained by FDA in the preamble to the final rule on general principles for nutrient content claims, when FDA authorizes a nutrient content claim, “the agency is making a finding that the claim will assist consumers in maintaining healthy dietary practices. . . . The agency cannot make such a finding for nutrient additions that are not consistent with the fortification policy.”
The warning letter to Coca-Cola may have been presaged by agency statements in the preamble to the 1997 final rule on “high potency” nutrient content claims:
FDA has previously stated that fortifying a food of little or no nutritional value for the sole purpose of qualifying that food for a health claim is misleading for several reasons. First, there is great potential to confuse consumers if foods like sugars, soft drinks, and sweet desserts are fortified to qualify for a claim, when, at the same time, dietary guidance as contained in the U.S. Department of Agriculture's (USDA's) and U.S. Department of Health and Human Services' (DHHS') 1995 Dietary Guideline for Americans, for example, states that these foods provide calories and little else nutritionally. Indiscriminate fortification of such foods with one nutrient would not make such foods consistent with dietary guidelines and may encourage overfortification of the food supply (e.g., vitamin or mineral addition to soft drinks).
FDA’s warning letter begs the question of which types of snack foods (other than candy and soft drinks) could run afoul of its fortification policy. Presumably, if FDA intends to issue similar warning letters for fortified snack foods other than candy and soft drinks, the agency will first provide more detailed guidance on its fortification policy. Notably, the current Dietary Guidelines for Americans embrace the concept of “discretionary calories” (e.g., for a 2, 000-calorie diet, if you meet your recommended nutrient intake by consuming 1,800 calories, the remaining 200 calories would be your "discretionary calories"). The Guidelines state that “[y]ou can use your discretionary calorie allowance to. . . [e]at or drink items that are mostly fats, caloric sweeteners, and/or alcohol, such as candy, soda, wine, and beer.”