Phytonutrients are natural bioactive plant-produced compounds that are often described as being beneficial to human health. This distinction makes phytonutrients popular ingredients in food products and dietary supplements. However, in the Monday morning session, “The Safety, Regulatory, and Claims Status of Phytonutrients When Added to Food and Dietary Supplements,” speakers warned that manufacturers could find themselves embroiled in costly legal battles if phytonutrient-containing products bear claims that run aground of regulations in place to protect consumers.
According to the U.S. Food and Drug Administration (FDA), there are three categories of statute-defined claims that can appear on the labels of conventional foods and dietary supplements: 1) health claims, which describe a relationship between a food substance and reduced risk of a disease or health-related condition and must be supported by scientific evidence; 2) nutrient content claims, which characterize the level of a nutrient in a product; and 3) structure/function claims, which may describe how a role of a nutrient or dietary ingredient affects the normal structure or function of the human body. Gavin Thompson of Ramboll Environment & Health said that from a regulatory standpoint, all claims should have supporting scientific evidence and should be truthful and not misleading. However, because product marketers are sometimes more concerned with positioning a product to meet consumer demands or consumer interest in specific health benefits, claims on products can sometimes be misleading or downright false.
To illustrate his point, Thompson referred to recent incidents of misleading claims on products containing astaxanthin, a type of phytonutrient. The incidents included claims that astaxanthin protects skin and eyes from the sun, is an effective remedy for damaged cells, helps prevent or treat sun damage, and defends against damaging effects. In May 2018, the FDA issued warning letters to the manufacturers of the products bearing these claims. Thompson advises manufacturers of products containing phytonutrients to refrain from making claims for which they do not have credible scientific evidence and from asserting that the ingredient prevents or mitigates any disease condition.
Ray Matulka of Burdock Group discussed another perspective for manufacturers to consider. Matulka said that the intended use of an ingredient includes the anticipated amount to be consumed by a person. He warned that in the wrong dosage, everything—even water—can be toxic. Using vitamin A as an example, Matulka said that low doses of vitamin A are essential to human health, as it helps prevent certain skin and eye diseases. But in high doses, vitamin A becomes toxic.
“Your customer is healthy, and you want them to stay that way,” Thompson concluded.