FDA为乳糜泻患者制订“无麸质”标注规定

美国食品药品管理局(FDA)日前制订出了旨在界定食品包装上“无麸质”这一术语的规定条款，这样一来，乳糜泻患者和其他采取无麸质饮食者将能够更放心地购买和使用“无麸质”食品。

制订过程历时近10年的这一新规定，并未要求食品生产企业在产品标签上注明“无麸质”，但自愿在产品标签上注明“无麸质”的生产企业需遵守这一规定。

根据规定，生产企业在其食品所含麸质少于百万分之二十(20 ppm)的情况下可标注“无麸质”。麸质是一种存在于小麦、大麦和黑麦中的蛋白质。据FDA介绍，如果日常饮食中含有少量麸质，多数乳糜泻患者是可以耐受的。

这一规定禁止任何含有小麦、大麦或黑麦成分的产品标注“无麸质”，除非这些成分已经过加工而去除了麸质。本身就不含麸质的产品，如鸡蛋、水果、蔬菜和瓶装水等，也可在标签上注明“无麸质”。

负责治疗乳糜泻患者的临床医生对这一规定表示赞赏。麻省总医院乳糜泻研究中心主任Alessio Fasano医生在声明中指出：“在没有恰当的食品标注规定的情况下，乳糜泻患者就无法确定食品标签上的‘无麸质’这个词究竟是什么意思。”

目前美国大约有300万例患者，其中很多尚未获得诊断。这一监管行动使得美国与加拿大和欧盟达成了一致，后两者均将“无麸质”定义为麸质少于20 ppm。

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By: JANE ANDERSON, Internal Medicine News Digital Network

The Food and Drug Administration has finalized regulations intended to define the term "gluten free" on food packaging in an effort to give celiac disease patients and others following the gluten-free diet confidence that the food they buy is safe for them to consume.

The new regulations, which were nearly a decade in the making, do not require food manufacturers to label products as gluten free. Instead, they lay out the rules to follow if those manufacturers want to voluntarily place "gluten-free" labels on products.

The rules state that manufacturers can label foods "gluten free" if they contain less than 20 parts per million (ppm) of gluten, a protein found in wheat, barley, and rye. According to the FDA, most celiac disease patients can tolerate a small amount of gluten in their food each day.

The regulations prohibit the use of the term "gluten free" on any product that contains wheat, barley, or rye ingredients unless those ingredients have been processed to remove the gluten. Products that are naturally gluten free, such as eggs, fruits, vegetables, and bottled water, also can carry the "gluten free" label.

Physicians who treat celiac disease patients praised the ruling. "Without proper food labeling regulation, celiac patients cannot know what the words ‘gluten free’ mean when they see them on a food label," Dr. Alessio Fasano, medical director of the Center for Celiac Research at Mass General Hospital for Children, Boston, said in a statement.

About 3 million people in the United States have celiac disease; many of them are undiagnosed. The regulatory action brings the United States into line with Canada and the European Union, both of which consider "gluten free" to mean less than 20 ppm of gluten.

Manufacturers have1 year to comply with the regulations or risk facing compliance action from the FDA. The agency said that the vast majority of "gluten free"–labeled products on the shelves today – 95% – already comply with the regulations.