美国食品药品监督管理局（FDA）周一提议新规则，要求食品制造商在向加工食品中添加新成分或添加剂前必须通知监管机构[1][2]。这一改变针对长期存在的监管漏洞——自1958年以来实施的GRAS框架原本作为豁免制度，却逐渐成为数千种未经独立审查的成分进入美国食品供应的主要途径[2]。FDA代理主任Kyle Diamantas表示，"转向强制通知制度关闭了数十年的信息差距，给予FDA增强市场后安全所需的全面可见性"[1]。
根据提议，FDA预期在180天内审查新成分提交[1]，并将接收对该提议的评论120天[1]。美国大约有10,000种添加剂被允许用于食品[1]。自1997年起，FDA开始允许公司独立确定新添加剂是否安全，无需独立审查[1]。
与此同时，特朗普政府再次推迟了对"超加工食品"的定义[2]。虽然FDA已完成了美国首个超加工食品的联邦定义并提交白宫进一步审查[1]，但该定义尚未发布。罗伯特·肯尼迪二世曾承诺在"4月份"前定义超加工食品，但FDA代理局长Diamantas随后表示"超加工食品的定义真的很难"[2]。纽约大学营养学教授Marion Nestle对此质疑道："你必须开玩笑。就这样？"[2]
这一举措的推出恰逢美国正经历历史上最大规模的食源性疾病爆发之一，环孢子虫病确诊病例超过10,000例，另有沙门氏菌疫情影响鸡蛋和墨西哥辣椒，导致泰勒农场（Taylor Farms）产品在26个州召回[2]。
The U.S. Food and Drug Administration has proposed a new regulation requiring food manufacturers to notify regulators before adding new ingredients or additives to processed foods.[1] The rule, submitted to the Federal Register on Monday,[2] represents a shift from the voluntary system that has governed food safety approvals for decades, aiming to close a regulatory loophole that has allowed thousands of untested substances into the American food supply.[1]
The proposed change centers on the GRAS (Generally Recognized as Safe) framework, which has been in place since 1958.[2] Since 1997, the FDA has permitted companies to independently determine whether new additives are safe without requiring independent agency review.[1] Under the new mandatory notification system, the FDA expects to review new ingredient submissions within 180 days.[1] FDA Acting Director Kyle Diamantas stated: "Moving to a mandatory notification system closes a decades-long information gap, giving FDA the comprehensive visibility needed to enhance post-market safety."[1] The agency will accept public comments on the proposal for 120 days.[1]
Approximately 10,000 additives are currently permitted for use in food products in the United States.[1] The FDA has also completed the nation's first federal definition of ultra-processed foods and submitted it to the White House for further review,[1] though the Trump administration has delayed releasing this definition publicly.[2] The delay comes as the country grapples with significant foodborne illness outbreaks, including over 10,000 confirmed cases of cyclosporiasis and salmonella incidents affecting eggs and Mexican peppers that prompted product recalls across 26 states.[2]