Updated: Mar 8
Food manufacturing processes and procedures can at times lead to degradation, removal or omission of nutrients typically found in the original food components. This potential for a decrease in nutritive value has been known for decades, although it is now common to add nutrients back (i.e., fortify) foods to restore nutrient levels. The practice of food fortification has been a part of the U.S. food system since at least the early 1900s, although initially food fortification was systemically implemented in the U.S. to address widespread nutrient deficiencies, discovered among draftees in World War I.1,2 As an example, iodine was initially added to salt in 1924 to address the prevalent health issue of goiter, and was followed with the fortification of milk with vitamin D to address the formation of rickets in children.
It wasn’t until 1980 that the U.S. FDA first published a policy on fortification practices, outlining FDA’s rationale on what foods can (and cannot) be fortified (21 CFR §104.20),3 with a guidance document finally released in 2015.4 However, today’s consumer is focused on “personalized nutrition” and looking to increase dietary intake of specific nutrients without having to consume a variety of dietary supplement products to meet their specific dietary needs. The ability of food manufacturers to provide specialized, nutrient dense products is coming into conflict with the food fortification policy.
One aspect stressed by the FDA policy that FDA does not consider it appropriate “to fortify fresh produce, meat, poultry or fish products.” The policy also included a prohibition against fortification of “sugars, or foods such as candies and carbonated beverages,” earning the policy the sobriquet of “the jelly bean rule.” FDA has asserted that fortification should be a “rational addition of essential nutrients to conventional foods to preserve a balance of nutrient in the diet of consumers in the United States” and ”discourages the indiscriminate addition of nutrient to foods.”4 This limitation in the food products that may be fortified limits the ability to provide nutritive value to new products such as carbonated water, tea or fruit beverages. As food manufacturers develop new food products to meet consumer desires for value-added foods and an increased number of studies are completed that underscore the benefits of various nutrients, companies may run afoul of the fortification policy. For example, the Quest Nutrition company received a warning letter from FDA concerning the formulation of a barbeque-flavored protein chip.5 FDA stated, among other issues, that the protein chip was “fortified” with a protein blend (milk protein isolate, whey protein isolate) and calcium carbonate. As such, FDA stated that “the fortification of snack foods such as potato chips is not consistent with the fortification policy in 21 CFR 104.20.” Quest Nutrition responded that their protein chip was not a “fortified” snack food, but that it is a “new food that meets the letter and spirit of applicable labeling law.”6 FDA responded in late 2017 with a letter indicating that the violations initially stated had been addressed.7 This example indicates that FDA is open to the addition of nutritive ingredients into innovative food products, while still being concerned with the potential for over-fortification of foods.
Many researchers have been studying the ability to add nutrient value to plant and animal products prior to the manufacturing process. Research into breeding crops to contain increased levels of micronutrients have been published at least since the 1990s, utilizing “biofortification,” or the improvement of the nutrient density of stable food crops through conventional plant breeding, agronomic management or genetic engineering. This effort has been recognized and applauded by the U.S. Department of Agriculture (USDA). Dr. Ross Welch, a leading figure in biofortification, was in fact inducted into USDA’s Science Hall of Fame in 2014.8 In 2016, four scientists were awarded the World Food Prize (created in 1986 by Nobel Peace Prize recipient Dr. Norman Borlaug as the Nobel Prize for Food and Agriculture)9 for the production of the orange-fleshed sweet potato, a variety biofortified to contain more than 1,000 retinol activity equivalents (RAE)/125 grams, which may provide up to 250% of the recommended daily allowance for school aged children in South Africa, an area known for vitamin A deficiency.10 Biofortification is not only focused on increased levels of nutrients in plants, but also on increasing the bioavailability of existing levels. An increase in the plant production of the enzyme phytase through genetic engineering will decrease phytic acid, a plant component that decreases the bioavailability of iron and zinc.11,12 Nutrient deficiency is not an isolated situation, as recent work by Bird et al.13concluded that 31% of the U.S. population was at risk of at least one vitamin deficiency or anemia, with a deficiency risk most common in women 19-50 years of age.
Companies are looking to introduce fortified products, including biofortified products, that fall outside the “jelly bean rule.” Dairy-based beverages, cheese, yogurt and ice cream nutrients have all been the focus of biofortification efforts that are driving innovation in the dairy market. For example, the Springfield Creamery (Eugene, Oregon) has stated that the feeding of dairy cattle with grass and legumes results in milk with increased levels of omega-3 fatty acids, thereby “fortifying” their new line of whole milk probiotic yogurts with omega-3 fatty acids.14 Other companies are adding protein concentrates to milk-based beverages, as protein intake is currently sought out by consumers.
In the current food industry focus on “personalized nutrition,” it must be remembered that essential nutrients cannot be indiscriminately added to food products with claims of “added,” “extra” and “more” nutrients for specific health conditions. These terms are implied nutrient content claims and statements using these terms must comply with U.S. regulations (21 CFR §101.54(e)).15 In addition, the increased prevalence of food intolerances and sensitivities oftentimes leads to a reduced food selection, which could result in micronutrient deficiencies. For example, Vici et al.16 found that adherence to a gluten-free diet for treatment of celiac disease could lead to nutrient deficiencies of fiber, vitamins D, B12 and folate, and minerals such as zinc, magnesium, calcium and iron. Fortification of foods to target certain health conditions, including food categories previously considered under the “jelly bean rule” could be one piece of the puzzle to alleviate such deficiencies. Other options are to increase nutrient levels through biofortification processes prior to food manufacturing. For the benefit of the public, it may be time to re-evaluate the types of foods to which nutrients may be added, as “snacking” instead of classic “sit-down” meals have become much more prevalent in today’s society. In addition, modifications to common vegetables could readily increase nutrient availability and increase consumer health.
Glass, C (2013). The Deserters: A Hidden History of World War II. Penguin Group, NYC.
Institute of Medicine (IOM) (2003). Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification. Committee on the Use of Dietary Reference Intakes in Nutrition Labeling Food and Nutrition Board. Chapter 3: Overview of Food Fortification in the United States and Canada; pp. 45-55. National Academies Press.
U.S. Code of Federal Regulations (CFR), Title 21, Section 104.20. Fortification policy. Statement of purpose; site last visited November 2, 2018.
FDA (2015a). Guidance for Industry: Questions and Answers on FDA’s Fortification Policy; site last visited November 2, 2018.
FDA (2015b). FDA Warning Letter to Quest Nutrition, LLC. 7/29/15; site last visited November 2, 2018.
Quest Nutrition, LLC (2015). Company Response Letter 8/10/15; site last visited November 2, 2018.
FDA (2017). Quest Nutrition, LLC – Close Out Letter 11/13/17; site last visited November 2, 2018.
A Pioneer of Biofortification Receives Highest Honor from USDA-ARS; site last visited November 2, 2018.
Biofortification Pioneers Win 2016 World Food Prize for Fight Against Malnutrition; site last visited November 2, 2018.
International Food Policy Research Institute (IFPRI, 2006). Biofortified sweet potatoes; site last visited November 2, 2018.
Emergency Nutrition Network (ENN) (2015). Bioavailability of iron, zinc and provitamin A carotenoids in biofortified staple crops. Field Exchange 49, p21; site last visited November 2, 2018.
Gupta RK, Gangoliya SS and Singh NK (2015). Reduction of phytic acid and enhancement of bioavailable micronutrients in food grains. Journal of Food Science and Technology. 52(2): 676-684.
Bird JK, Murphy RA, Ciappio ED and McBurney MI. (2017). Risk of Deficiency in Multiple Concurrent Micronutrients in Children and Adults in the United States. Nutrients, Jun 24;9(7). pii: E655. doi: 10.3390/nu9070655.
Food Business News (2018). Fortification driving innovation in dairy; site last visited November 2, 2018.
U.S. Code of Federal Regulations (CFR), Title 21, Section 101.54. Nutrient content claims for “good source,” “high,” “more,” and “high potency.”; site last visited November 2, 2018.
Vici G, Belli L, Biondi M and Polzonetti V (2016). Gluten free diet and nutrient deficiencies: A review. Clinical Nutrition Dec; 35(6): 1236-1241. Doi: 10.1016/j.clnu.2016.05.002.