Department of Nutrition and Food Science, Texas A&M University, 213 Kleberg Building, College Station, TX 77843-2253, USA.
Eur J Nutr. 2009 Dec;48 Suppl 1:S27-31. doi: 10.1007/s00394-009-0073-3.
Although functional foods are currently regulated the same as conventional foods by the US Food and Drug Administration (FDA) there is some concern that they should not be. One concern is whether functional foods can/should carry the same type of health and nutrition labeling claims as conventional foods. For example, the type of nutrient content claim that describes a level of the nutrient such as "good or excellent source" presents a problem for functional foods since these claims relate back to a standard value for nutrients (the daily value or DV). At this time the bioactive or functional components in a functional food do not have daily values so they could not take advantage of this type of claim. Structure/function claims are also at issue since they are required to relate to the food's attributes of taste, aroma, and nutritive value, rather than attributes of functionality (which would pertain to functional foods). There appear to be three categories of issues concerning the regulation of functional foods: safety; efficacy; and their effect on the overall diet. Since bioactive components can be synthesized or extracted and concentrated, the concern is that the amounts of these substances in functional foods might reach levels which are actually injurious to health or they may negate beneficial effects of substances in the same food. Most people/organizations consider that functional foods need to document their functionality. This means that unlike conventional foods, all functional foods, by definition, would have to apply for a health claim. Finally, the long term overarching concern is what will be the impact of a functional food-driven market on overall health. It is of interest to see how the regulatory environment for functional foods evolves in the next few years and what impact that environment has on the future of these foods.
尽管功能性食品目前由美国食品和药物管理局 (FDA) 按照常规食品进行监管，但人们仍对其监管方式存在一些担忧。其中一个担忧是，功能性食品是否应该与常规食品一样，采用相同类型的健康和营养标签声明。例如，描述营养素含量水平的营养素内容声明，如“良好或优质来源”，这对功能性食品来说是一个问题，因为这些声明与营养素的标准值（每日推荐值或 DV）有关。此时，功能性食品中的生物活性或功能性成分没有每日推荐值，因此它们无法利用这种类型的声明。结构/功能声明也存在问题，因为它们必须与食品的味道、香气和营养价值相关，而不是与功能相关（这将涉及到功能性食品）。关于功能性食品的监管，似乎存在三个方面的问题：安全性、功效及其对整体饮食的影响。由于生物活性成分可以被合成或提取并浓缩，人们担心功能性食品中这些物质的含量可能达到对健康有害的水平，或者它们可能抵消同一种食物中物质的有益作用。大多数人/组织认为功能性食品需要证明其功能。这意味着与常规食品不同，所有功能性食品都必须申请健康声明。最后，长期关注的问题是功能性食品驱动的市场对整体健康的影响。有趣的是，观察功能性食品的监管环境在未来几年如何演变，以及这种环境对这些食品的未来会产生什么影响。
