Phytonutrients Beneficial Food Components, but Safety Testing Still Necessary

The term “phytonutrient” is defined in the Merriam-Webster dictionary as “a bioactive plant-derived compound (such as resveratrol) associated with positive health effects.” However, the U.S. Food and Drug Administration (FDA) has not officially recognized or defined the term, phytonutrient. In fact, while the U.S. Food, Drug and Cosmetic (FD&C) Act refers to the need and labeling of “nutrients” multiple times, the term “nutrient” was never officially defined. It is beneficial to consumers that the government define terminology so that objective evaluations can be conducted to determine if marketed substances are actually “beneficial to human health.”

FDA has defined those substances that provide “taste, aroma or nutritive value” or any other technical effect, as foods (or components thereof) and has established a Recommended Daily Allowance for those food substances that FDA recognizes are “nutritive” in value. However, within the Code of Federal Regulations (FDA’s interpretation of the U.S. law it is mandated to implement), the term “nutrient” was never defined (although “nutritive value” is narrowly defined in 21CFR§101.14 as “a value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy”). FDA recognizes and relies upon the U.S. National Academy of Science (NAS), a scientific body that provides guidance and recommendations on the nutritive value of foods and food components for truthful and informative food label statements. NAS has been working with other international experts to develop a global harmonization draft consensus report of the methodology in developing harmonized nutrient intake recommendations for young children and women of reproductive age (NAS, 2018) and, even within this international effort, has never defined the term “nutrient.” An understanding of the definition of the word “nutrient” is critical to the consumer’s perception of a substance, as “nutrient” and associated terms denote substances that are beneficial, if not critical, to the bodily health and wellness. Food companies may use labeling to promote products that contain phytonutrients and often work to increase the levels of these phytonutrients in foods.

Although certain components within a food may be considered as phytonutrients (but not recognized by FDA as nutrients) and beneficial to health, such as lutein and lycopene,1 methods used to increase phytonutrients in foods may also increase the concentration of other plant components that may be toxic when consumed in high amounts. For this reason, all food ingredients, whether containing perceived phytonutrients or other components, should be evaluated to determine their safety when used as intended. For example, toxins such as tomatine in tomatoes, glycoalkaloids in potatoes or psoralens in celery are normally present in low levels such that they are not harmful under typical conditions of use. However, alternative plant breeding methods, mishandling during harvest, storage or transportation, or novel extraction processes can increase these toxins to harmful levels.2 These or other actions that may inadvertently increase potentially toxic plant-based substances “may render” a food or food ingredient injurious to health, as defined in the FD&C Act and prohibited from interstate commerce. Due to the potential for significant, health-related effects when producing a new food ingredient, rigorous safety testing should be conducted on any new form of food ingredient. Burdock Group has the expertise to work with food companies to evaluate the safety of new food ingredients to confirm that the new ingredients are safe under the intended conditions of use.

References:

1. Toti, E., Chen, C.O., Palmery, M., Valencia, D.V. and Peluso, I. (2018). Non-Provitamin A and Provitamin A Carotenoids as Immunomodulators: Recommended Dietary Allowance, Therapeutic Index, or Personalized Nutrition? Oxidative Medicine and Cellular Longevity. Article ID 4637861

2. Dolan, L.C., Matulka, R.A. and Burdock, G.A. (2010). Naturally occurring food toxins. Toxins (Basel). 2(9): 2289-2332. Doi: 10.3390/toxins2092289 National Academies of Sciences, Engineering, and Medicine (NAS, 2018). Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age. Washington, DC: The National Academies Press

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